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Determinations/Health as made
This determination specifies both indications and requirements relating to the use of those indications, for the purposes of paragraphs 26BF(1)(a) and (b) of the Therapeutic Goods Act 1989. It sets out a list of pre-approved indications which have been assessed and determined to be low level and appropriate for listed medicines. The related requirements are designed to support the safe use of medicines for which these indications are to be used.
Administered by: Health
Registered 06 Mar 2019
Tabling HistoryDate
Tabled HR02-Apr-2019
Tabled Senate02-Apr-2019
Table of contents.

Therapeutic Goods (Permissible Indications) Determination (No.1) 2019

 

I, Cheryl McRae, as delegate of the Minister for Health, make the following determination.

Dated 28/2/2019

Cheryl McRae

Assistant Secretary

Complementary and Over the Counter Medicines Branch

Medicines Regulation Division

 


Contents

1 Name                                                                                                                                           2

2 Commencement......................................................................................................................... 2

3 Authority................................................................................................................................... 2

4 Definitions................................................................................................................................. 2

5 Permissible indications and requirements applying in relation to those indications................... 3

6 Repeals...................................................................................................................................... 4

Schedule 1 - Specified permissible indications and requirements applying to these indications when used for a medicine     5

Schedule 2 – Repeals................................................................................................................ 117

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


1 Name

                   This instrument is the Therapeutic Goods (Permissible Indications) Determination (No.1) 2019.

2 Commencement

             (1)  Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

 

Commencement information

Column 1

Column 2

Column 3

Provisions

Commencement

Date/Details

1.  The whole of this instrument

The day after registration.

 

Note:          This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

             (2)  Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

3 Authority

                   This instrument is made under subsection 26BF(1) of the Therapeutic Goods Act 1989.

4 Definitions

Note:          A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:

(a)      health practitioner;

(b)      health professional;

(b)    indications;

(c)    label;

(d)    medicine;

(e)    presentation;

(f)    Register;

(g)    Therapeutic Goods Advertising Code.

                   In this instrument:

Act means the Therapeutic Goods Act 1989

Code Tables are tables that can be accessed from the Therapeutic Goods Administration Business Service website at www.ebs.tga.gov.au under the heading “Public TGA Information”, as at the commencement of this instrument.

Dentist means a person who is registered under the Health Practitioner Regulation National Law in the dentistry profession.

Doctor means a medical practitioner.

Evidence guidelines means the TGA document titled Evidence guidelines: Guidelines on the evidence required to support indications for listed complementary medicines, published on the TGA’s website (www.tga.gov.au), as at the commencement of this instrument.

Medically diagnosed, in relation to a disease, condition, ailment or defect, is where the disease, condition, ailment or defect has been diagnosed by a suitably qualified medical practitioner.

Medical practitioner means a person who is registered under the Health Practitioner Regulation National Law in the medical profession.

Regulations mean the Therapeutic Goods Regulations 1990.

Scientific means a scientific indication.

Scientific indication means an indication that is supported by scientific evidence, such as clinical studies or systematic reviews, as described in the Evidence guidelines.

Serious, in relation to a form of a disease, condition, ailment or defect, has the same meaning as in the Therapeutic Goods Advertising Code.

TGA means the Therapeutic Goods Administration.

Traditional means a traditional indication.

Traditional Ayurvedic medicine means a traditional Ayurvedic medicine indication.

Traditional Ayurvedic medicine (TAY) indication means a traditional indication that is based on traditional use in the Ayurvedic medicine paradigm.

Traditional Chinese medicine means a traditional Chinese medicine indication.

Traditional Chinese medicine (TCM) indication means a traditional indication that is based on traditional use in the traditional Chinese medicine paradigm.

Traditional indication means an indication that is supported by evidence of traditional use, as described in the Evidence guidelines.

Traditional use has the same meaning as in the Regulations.

5 Permissible indications and requirements applying in relation to those indications

Permissible indications in Tables 1 to 15

(1) The indications in column 2 of Tables 1 to 15 in Schedule 1 to this instrument are specified for the purposes of paragraph 26BF(1)(a) of the Act.

(2) The indications in column 2 of Tables 1 to 15 in Schedule 1 to this instrument when modified using the qualifying statements in the Code Tables under the headings:

(a)    ‘Traditional context qualifier’;

(b)   ‘Population qualifiers’; 

(c)    ‘Time of use qualifiers’; or

(d)   for TCM indications, ‘TCM pattern qualifiers’;

                   are also specified for the purposes of paragraph 26BF(1)(a) of the Act.

Requirements for permissible indications

             (3)  For the purposes of paragraph 26BF(1)(b) of the Act, the indications specified under subsections 5(1) and 5(2) are subject to the following requirements:

                     (a)  they may only be used for a medicine if supported by the type of evidence specified in column 3 of Tables 1 to 15 in Schedule 1; and

                     (b)  they must comply with the requirements set out in column 4 of Tables 1 to 15 in Schedule 1; and

                     (c)  where:

(i)     the wording of an indication is varied on the label of a medicine; or

(ii)   where more than one indication is used and they are combined on the label of a medicine to form simple sentences where appropriate; or

(iii) both (i) and (ii);

then:

(iv) the meaning of the indication must not be changed; and

(v)   the varied or combined indications must not infer or imply that a medicine is for the treatment of a serious disease, ailment, defect or injury; and

(vi) the varied or combined indications must not infer or imply that a medicine is for preventing or curing a disease, ailment, defect or injury;

                     (d)  where an indication in column 2 of Tables 1 to 15 in Schedule 1 to this instrument is modified using a qualifying statement in the Code Tables as mentioned in subsection 5(2) and where that indication, including as varied or combined with another indication, is used on the medicine’s label:

(i)     the qualifying statement must also be included on the medicine’s label; and

(ii)   the modified indication, including as varied or combined with another indication, must not infer or imply that a medicine is for the treatment of a serious disease, ailment, defect or injury

                     (e)  A medicine using traditional indications must also comply with the following requirements:

(i)  the traditional indication must be qualified with an appropriate “Traditional context qualifier” from the Code Tables; and

(ii) the “Traditional context qualifier” from the Code Tables must be included on the label of the medicine.

6 Repeals

                   Each instrument that is specified in Schedule 2 to this instrument is repealed as set out in the applicable items in that Schedule.


Schedule 1 - Specified permissible indications and requirements applying to these indications when used for a medicine

(section 5)


 

 

 

 

 

 

 

Table 1 – Indications relating to general health / body parts

Column 1

Column 2

 

Indication

Column 3

 

Type of evidence

Column 4

 

Other requirements

1

Aid/assist in the healing of minor body tissue injuries

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

2

Aid/assist nail growth

Scientific or Traditional

 

3

Aid/assist/help/maintain healthy hair follicles

Scientific or Traditional

 

4

Aid/assist/helps connective tissue production/formation

Scientific

 

5

Aids/assists abdominal fat loss

Scientific

If product is indicated for weight loss, label statement: When used in conjunction with a program of reduced intake of dietary calories and increased physical activity.

6

Aids/assists body waste elimination

Scientific or Traditional

Product presentation must only refer to detoxification in relation to natural body processes.

Product presentation must not imply or refer to drugs/alcohol.

Product presentation must not imply or refer to disease in any body organ, in particular the kidney or liver.

7

Aids/assists body's natural channels of elimination

Scientific or Traditional

Product presentation must only refer to detoxification in relation to natural body processes.

Product presentation must not imply or refer to drugs/alcohol.

Product presentation must not imply or refer to disease in any body organ, in particular the kidney or liver.

8

Aids/assists excretion of metabolic waste products

Scientific or Traditional

Product presentation must only refer to detoxification in relation to natural body processes.

Product presentation must not imply or refer to drugs/alcohol.

Product presentation must not imply or refer to disease in any body organ, in particular the kidney or liver.

9

Aids/assists eye adaption to variations in light intensity/night vision

Scientific or Traditional

Product presentation must not imply or refer to vision correction, faults or serious eye disease e.g. macular degeneration.

10

Aids/assists gum development

Scientific

 

11

Aids/assists gum healing

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

12

Aids/assists head lice and egg removal

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Product presentation must not imply or refer to killing/eradicating/destroying lice, nits or eggs.

13

Aids/assists natural body cleansing/detoxification processes

Scientific or Traditional

Product presentation must only refer to detoxification in relation to natural body processes.

Product presentation must not imply or refer to drugs/alcohol.

Product presentation must not imply or refer to disease in any body organ, in particular the kidney or liver.

14

Aids/assists natural cleansing/detoxification processes of the gastrointestinal system/gut

Scientific or Traditional

Product presentation must only refer to detoxification in relation to natural body processes.

Product presentation must not imply or refer to drugs/alcohol.

Product presentation must not imply or refer to disease in any body organ, in particular the kidney or liver.

15

Aids/assists natural kidney cleansing/detoxification processes

Scientific or Traditional

Product presentation must only refer to detoxification in relation to natural body processes.

Product presentation must not imply or refer to drugs/alcohol.

Product presentation must not imply or refer to disease in any body organ, in particular the kidney or liver.

16

Aids/assists teeth development

Scientific

 

17

Aids/assists with recovery from illness/convalescence

Scientific or Traditional

Product presentation must not imply or refer to imply chronic fatigue syndrome.

18

Alterative/blood cleanser/depurative/purifier

Traditional

Product presentation must only refer to detoxification in relation to natural body processes.

Product presentation must not imply or refer to drugs/alcohol.

Product presentation must not imply or refer to disease in any body organ, in particular the kidney or liver.

19

Analgesic/Anodyne/relieve pain

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

20

Anti-inflammatory/relieve inflammation

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

21

Antioxidant/Reduce free radicals formed in the body

Scientific

 

22

Antipyretic/febrifuge/relieve mild fever/reduce body temperature/body cooling

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Label statement: Not to be used in children under 5 years.

23

Astringent/tightens tissues

Traditional

 

24

Body tonic

Traditional

 

25

Decrease/reduce bacteria in the mouth

Scientific

Product presentation must not imply or refer to serious infections.

26

Decrease/reduce ear irritation/inflammation

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

27

Decrease/reduce ear wax

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

28

Decrease/reduce hair loss/thinning

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Product presentation must not imply or refer to serious conditions associated with alopecia e.g. autoimmune disease, chemotherapy.

29

Decrease/reduce halitosis/bad breath

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

30

Decrease/reduce nail brittleness/splitting/chipping

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

31

Decrease/reduce/relieve cracks in the corner of the mouth

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Product presentation must not imply or refer to recurrent or persistent mouth lesions.

32

Decrease/reduce/relieve excessive perspiration/sweating

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

33

Decrease/reduce/relieve eye strain

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

34

Decrease/reduce/relieve gum soreness/pain/discomfort

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

35

Decrease/reduce/relieve itchiness associated with head lice infestation

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Product presentation must not imply or refer to killing/eradicating/destroying lice, nits or eggs.

36

Decrease/reduce/relieve mouth/oral mucosa mild inflammation

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

37

Decrease/reduce/relieve spontaneous sweating

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

38

Decrease/reduce/relieve symptoms of  mild mouth ulcers

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Product presentation must not imply or refer to recurrent or persistent mouth lesions.

Product presentation must only refer to mild mouth ulcers.

39

Decrease/reduce/relieve symptoms of dehydration

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

40

Decrease/reduce/relieve symptoms of jet lag

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

41

Decrease/reduce/relieve symptoms of mild temporomandibular joint dysfunction diagnosed by a doctor or dentist

Scientific or Traditional

Label statement: If symptoms persist or worsen talk to your medical practitioner.

Product presentation must only refer to mild temporomandibular joint dysfunction that is diagnosed by a doctor or dentist.

42

Decrease/reduce/relieve symptoms of soft tissue trauma

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

43

Decrease/reduce/relieve teething/tooth pain

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

44

Decrease/reduce/relieve tooth/teeth sensitivity

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

45

Decrease/reduce/relieve toothache

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

46

Decrease/reduce/relieve visual fatigue

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Product presentation must not imply or refer to vision correction, faults or serious eye disease e.g. macular degeneration.

47

Decrease/reduce/relieve watery eyes/excessive lacrimation

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

48

Decrease/reduce/relieves bleeding gums

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

49

Demulcent/soothe irritated tissues

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

50

Enhance/improve/promote/increase hair growth

Scientific or Traditional

 

51

Enhance/improve/promote/increase hair health

Scientific or Traditional

 

52

Enhance/improve/promote/increase hair strength/thickness

Scientific or Traditional

 

53

Enhance/improve/promote/increase nail health/strength/thickness

Scientific or Traditional

 

54

Enhance/promote energy levels

Scientific or Traditional

Product presentation must not imply or refer to imply chronic fatigue syndrome.

55

Enhance/promote weight gain

Scientific

 

56

Enhance/promote/physical endurance/capacity/stamina

Scientific or Traditional

Product presentation must not imply or refer to imply chronic fatigue syndrome.

57

Help maintain weight after weight loss

Scientific

If product is indicated for weight loss, label statement: When used in conjunction with a program of reduced intake of dietary calories and increased physical activity.

58

Helps convert (state food) into energy

Scientific

If product is indicated for weight loss, label statement: When used in conjunction with a program of reduced intake of dietary calories and increased physical activity.

59

Helps decrease/reduce body weight

Scientific

Label statement: When used in conjunction with a program of reduced intake of dietary calories and increased physical activity.

60

Helps decrease/reduce build-up of dental plaque

Scientific or Traditional

 

61

Helps decrease/reduce/relieve cartilage loss/wear/tear/damage

Scientific

Product presentation must not imply or refer to bone disease or disorders e.g. rheumatoid arthritis, juvenile arthritis, debilitating osteoarthritis, osteoporosis.

Product presentation must not imply or refer to any form of arthritis or osteoarthritis unless qualified as mild.

62

Helps decrease/reduce/relieve cold sensations in the lower back

Traditional

Label statement: If symptoms persist, talk to your health professional.

63

Helps decrease/reduce/relieve heat sensations in the extremities

Traditional

Label statement: If symptoms persist, talk to your health professional.

64

Helps decrease/reduce/relieve symptoms of nail mild fungal infection

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Product presentation must not imply or refer to serious infections.

65

Helps enhance/improve/promote/increase healthy body fat/muscle composition

Scientific

If product is indicated for weight loss, label statement: When used in conjunction with a program of reduced intake of dietary calories and increased physical activity.

66

Helps enhance/promote body energy reserves

Scientific or Traditional

Product presentation must not imply or refer to imply chronic fatigue syndrome.

67

Helps enhance/promote body tissue repair/regeneration

Scientific or Traditional

 

68

Helps enhance/promote calorie burning

Scientific

If product is indicated for weight loss, label statement: When used in conjunction with a program of reduced intake of dietary calories and increased physical activity.

69

Helps enhance/promote collagen formation

Scientific

 

70

Helps enhance/promote connective tissue health

Scientific or Traditional

 

71

Helps enhance/promote general health and wellbeing

Scientific or Traditional

 

72

Helps enhance/promote gum health

Scientific or Traditional

 

73

Helps enhance/promote healthy growth and development

Scientific or Traditional

 

74

Helps enhance/promote healthy teeth enamel

Scientific

 

75

Helps enhance/promote heat/energy production/thermogenesis

Scientific

If product is indicated for weight loss, label statement: When used in conjunction with a program of reduced intake of dietary calories and increased physical activity.

76

Helps enhance/promote teeth health

Scientific or Traditional

 

77

Helps enhance/promote teeth strength

Scientific or Traditional

 

78

Helps enhance/promote/increase body fat loss

Scientific

If product is indicated for weight loss, label statement: When used in conjunction with a program of reduced intake of dietary calories and increased physical activity.

79

Helps enhance/promote/increase lean body mass

Scientific or Traditional

If product is indicated for weight loss, label statement: When used in conjunction with a program of reduced intake of dietary calories and increased physical activity.

80

Helps enhance/promote/increase vitality

Scientific or Traditional

Product presentation must not imply or refer to imply chronic fatigue syndrome.

81

Helps enhance/promote/increase weight loss

Scientific

Label statement: When used in conjunction with a program of reduced intake of dietary calories and increased physical activity.

82

Helps improve/promote body metabolism/metabolic rate

Scientific

If product is indicated for weight loss, label statement: When used in conjunction with a program of reduced intake of dietary calories and increased physical activity.

83

Helps in the maintenance of a healthy body weight

Scientific

If product is indicated for weight loss, label statement: When used in conjunction with a program of reduced intake of dietary calories and increased physical activity.

84

Helps in the maintenance of lean body mass

Scientific

If product is indicated for weight loss, label statement: When used in conjunction with a program of reduced intake of dietary calories and increased physical activity.

85

Helps maintain/support body's natural channels of elimination

Scientific or Traditional

Product presentation must only refer to detoxification in relation to natural body processes.

Product presentation must not imply or refer to drugs/alcohol.

Product presentation must not imply or refer to disease in any body organ, in particular the kidney or liver.

86

Helps maintain/support eye macula health

Scientific

Product presentation must not imply or refer to vision correction, faults or serious eye disease e.g. macular degeneration.

87

Helps maintain/support eye retina health

Scientific

Product presentation must not imply or refer to vision correction, faults or serious eye disease e.g. macular degeneration.

88

Helps maintain/support healthy acid/alkali balance in the body.

Scientific

 

89

Helps maintain/support healthy Body Mass Index (BMI)

Scientific

If product is indicated for weight loss, label statement: When used in conjunction with a program of reduced intake of dietary calories and increased physical activity.

90

Helps maintain/support healthy eye development

Scientific

Product presentation must not imply or refer to vision correction, faults or serious eye disease e.g. macular degeneration.

91

Helps maintain/support healthy vision development

Scientific

Product presentation must not imply or refer to neurological conditions or developmental delays.

Product presentation must not imply or refer to vision correction, faults or serious eye disease e.g. macular degeneration.

92

Helps maintain/support hearing development

Scientific

Product presentation must not imply or refer to neurological conditions or developmental delays.

93

Helps prevent tooth decay/dental carries/cavities in conjunction with good oral hygiene

Scientific or Traditional

 

94

Helps reduce occurrence of mouth ulcers

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

95

Helps reduce occurrence of symptoms of jet lag

Scientific or Traditional

 

96

Helps reduce occurrence of teething/tooth pain

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

97

Helps reduce/decrease free radical damage to body cells

Scientific

 

98

Helps relieve excessive lacrimation

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

99

Helps restore body electrolyte balance

Scientific

 

100

Helps temporarily relieve light sensitivity

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

101

Longevity tonic

Traditional

 

102

Maintain/support abdominal fat loss

Scientific

If product is indicated for weight loss, label statement: When used in conjunction with a program of reduced intake of dietary calories and increased physical activity.

103

Maintain/support body electrolyte balance

Scientific

 

104

Maintain/support body metabolism/metabolic rate

Scientific

If product is indicated for weight loss, label statement: When used in conjunction with a program of reduced intake of dietary calories and increased physical activity.

105

Maintain/support body mucous membrane health

Scientific or Traditional

 

106

Maintain/support body tissue repair/regeneration

Scientific or Traditional

 

107

Maintain/support body waste elimination

Scientific or Traditional

Product presentation must only refer to detoxification in relation to natural body processes.

Product presentation must not imply or refer to drugs/alcohol.

Product presentation must not imply or refer to disease in any body organ, in particular the kidney or liver.

108

Maintain/support calorie burning

Scientific

If product is indicated for weight loss, label statement: When used in conjunction with a program of reduced intake of dietary calories and increased physical activity.

109

Maintain/support collagen formation

Scientific

 

110

Maintain/support collagen health

Scientific

 

111

Maintain/support connective tissue health

Scientific or Traditional

 

112

Maintain/support dental/periodontal health

Scientific or Traditional

 

113

Maintain/support ear health

Scientific or Traditional

 

114

Maintain/support energy levels

Scientific or Traditional

Product presentation must not imply or refer to imply chronic fatigue syndrome.

115

Maintain/support energy production

Scientific

If product is indicated for weight loss, label statement: When used in conjunction with a program of reduced intake of dietary calories and increased physical activity.

116

Maintain/support eye health

Scientific or Traditional

Product presentation must not imply or refer to vision correction, faults or serious eye disease e.g. macular degeneration.

117

Maintain/support general health and wellbeing

Scientific or Traditional

 

118

Maintain/support gum health

Scientific or Traditional

 

119

Maintain/support hair growth

Scientific or Traditional

 

120

Maintain/support hair health

Scientific or Traditional

 

121

Maintain/support hair strength/thickness

Scientific or Traditional

 

122

Maintain/support healthy body fat/muscle composition

Scientific

If product is indicated for weight loss, label statement: When used in conjunction with a program of reduced intake of dietary calories and increased physical activity.

123

Maintain/support healthy body organ functions

Traditional

Product presentation must not imply or refer to disease in any body organ.

124

Maintain/support healthy body tissues

Scientific or Traditional

 

125

Maintain/support healthy ear function

Scientific or Traditional

 

126

Maintain/support healthy eye function

Scientific or Traditional

Product presentation must not imply or refer to vision correction, faults or serious eye disease e.g. macular degeneration.

127

Maintain/support healthy eyesight/vision

Scientific or Traditional

Product presentation must not imply or refer to vision correction, faults or serious eye disease e.g. macular degeneration.

128

Maintain/support healthy growth and development

Scientific or Traditional

 

129

Maintain/support healthy hearing

Scientific or Traditional

 

130

Maintain/support healthy mouth flora

Scientific or Traditional

 

131

Maintain/support healthy teeth

Scientific or Traditional

 

132

Maintain/support heat/energy production/thermogenesis

Scientific

If product is indicated for weight loss, label statement: When used in conjunction with a program of reduced intake of dietary calories and increased physical activity.

133

Maintain/support nail health/strength/thickness

Scientific or Traditional

 

134

Maintain/support natural body cleansing/detoxification processes

Scientific or Traditional

Product presentation must only refer to detoxification in relation to natural body processes.

Product presentation must not imply or refer to drugs/alcohol.

Product presentation must not imply or refer to disease in any body organ, in particular the kidney or liver.

135

Maintain/support natural cleansing/detoxification processes of the body's five organs of elimination

Traditional

Product presentation must only refer to detoxification in relation to natural body processes.

Product presentation must not imply or refer to drugs/alcohol.

Product presentation must not imply or refer to disease in any body organ, in particular the kidney or liver.

136

Maintain/support natural cleansing/detoxification processes of the gastrointestinal system/gut

Scientific or Traditional

Product presentation must only refer to detoxification in relation to natural body processes.

Product presentation must not imply or refer to drugs/alcohol.

Product presentation must not imply or refer to disease in any body organ, in particular the kidney or liver.

137

Maintain/support natural kidney cleansing/detoxification processes

Scientific or Traditional

Product presentation must only refer to detoxification in relation to natural body processes.

Product presentation must not imply or refer to drugs/alcohol.

Product presentation must not imply or refer to disease in any body organ, in particular the kidney or liver.

138

Maintain/support natural liver cleansing/detoxification processes

Scientific or Traditional

Product presentation must only refer to detoxification in relation to natural body processes.

Product presentation must not imply or refer to drugs/alcohol.

Product presentation must not imply or refer to disease in any body organ, in particular the kidney or liver.

139

Maintain/support oral health

Scientific or Traditional

 

140

Maintain/support oral mucous membrane health

Scientific or Traditional

 

141

Maintain/support physical endurance/capacity/stamina

Scientific or Traditional

Product presentation must not imply or refer to imply chronic fatigue syndrome.

142

Maintain/support scalp health

Scientific or Traditional

 

143

Maintain/support spleen health

Scientific or Traditional

Product presentation must not imply or refer to disease in any body organ.

144

Maintain/support teeth enamel health

Scientific or Traditional

 

145

Maintain/support teeth mineralisation

Scientific

 

146

Maintain/support teeth strength

Scientific or Traditional

 

147

Maintain/support vitality

Scientific or Traditional

Product presentation must not imply or refer to imply chronic fatigue syndrome.

148

Maintain/support waste elimination via the mucous membranes

Scientific or Traditional

Product presentation must only refer to detoxification in relation to natural body processes.

Product presentation must not imply or refer to drugs/alcohol.

Product presentation must not imply or refer to disease in any body organ, in particular the kidney or liver.

149

Maintain/support waste elimination via the skin

Scientific or Traditional

Product presentation must only refer to detoxification in relation to natural body processes.

Product presentation must not imply or refer to drugs/alcohol.

Product presentation must not imply or refer to disease in any body organ, in particular the kidney or liver.

150

Nourish the body

Scientific or Traditional

 

151

Nutritive tonic

Traditional

 

152

Reduce risk of head lice attaching to hair

Scientific or Traditional

 

153

Regulate body water/fluid

Scientific or Traditional

 

154

Rejuvenating tonic

Traditional

 

155

Relieve clammy/sweaty palms and soles

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

156

Relieve dry eyes

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

157

Relieve dry mouth

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

158

Relieve eye discomfort

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

159

Relieve eye redness

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

160

Relieve eye soreness

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

161

Relieve feelings of general malaise/general debility

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Product presentation must not imply or refer to imply chronic fatigue syndrome.

Product presentation must not imply or refer to mental illnesses, disorders or conditions.

162

Relieve itchy ears

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

163

Relieve itchy eyes

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

164

Relieve mild tissue oedema

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

165

Relieve sore tongue

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

166

Relieve tongue dryness

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

167

Relieve weariness/tiredness/fatigue/feeling of weakness

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Product presentation must not imply or refer to imply chronic fatigue syndrome.

168

Restorative tonic

Traditional

 

169

Restore body fluid balance

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Product presentation must only refer to mild fluid retention.

170

Soften ear wax

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

171

Soothe/relieve mouth/oral irritation

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

172

Sudorific/diaphoretic/enhance/promote sweating/perspiration

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

173

Temporarily relieve mild fluid retention

Scientific or Traditional

Label statement: If fluid retention persists, seek medical advice (or words to that effect).

Product presentation must not imply or refer to cardiovascular or renal conditions.

Product presentation must only refer to mild fluid retention.

174

Trophorestorative/restore organ health

Traditional

Product presentation must not imply or refer to disease in any body organ.

Table 2 – Indications relating to bone

Column 1

Column 2

 

Indication

Column 3

 

Type of evidence

Column 4

 

Other requirements

1

A diet deficient in calcium can lead to osteoporosis in later life. Calcium may help prevent osteoporosis when dietary intake is inadequate

Scientific

Indication can only be used for medicines that contain calcium as an active ingredient and the recommended daily dose of the medicine must provide at least 290 milligrams of elemental calcium.

Label statement: Vitamins and minerals can only be of assistance if dietary intake is inadequate OR Vitamin and/or mineral supplements should not replace a balanced diet.

2

Aids/assists healthy bone development/growth/building

Scientific

Product presentation must not imply or refer to bone disease or disorders e.g. rheumatoid arthritis, juvenile arthritis, debilitating osteoarthritis, osteoporosis.

3

Decrease/reduce/relieve mild joint aches and pains

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Product presentation must only refer to mild joint symptoms.

Product presentation must not imply or refer to bone disease or disorders e.g. rheumatoid arthritis, juvenile arthritis, debilitating osteoarthritis, osteoporosis.

4

Decrease/reduce/relieve mild joint inflammation/swelling

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Product presentation must not imply or refer to bone disease or disorders e.g. rheumatoid arthritis, juvenile arthritis, debilitating osteoarthritis, osteoporosis.

Product presentation must only refer to mild joint symptoms.

5

Decrease/reduce/relieve mild joint pain/soreness

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Product presentation must not imply or refer to bone disease or disorders e.g. rheumatoid arthritis, juvenile arthritis, debilitating osteoarthritis, osteoporosis.

Product presentation must only refer to mild joint symptoms.

6

Decrease/reduce/relieve mild joint stiffness

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Product presentation must not imply or refer to bone disease or disorders e.g. rheumatoid arthritis, juvenile arthritis, debilitating osteoarthritis, osteoporosis.

Product presentation must only refer to mild joint symptoms.

7

Decrease/reduce/relieve mild rheumatic aches and pains

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Product presentation must only refer to mild rheumatic aches/pains.

Product presentation must not imply or refer to bone disease or disorders e.g. rheumatoid arthritis, juvenile arthritis, debilitating osteoarthritis, osteoporosis.

8

Decrease/reduce/relieve symptoms of mild arthritis/mild osteoarthritis

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Product presentation must only refer to mild joint symptoms.

Product presentation must not imply or refer to bone disease or disorders e.g. rheumatoid arthritis, juvenile arthritis, debilitating osteoarthritis, osteoporosis.

9

Decrease/reduce/relieve symptoms of occasional episodes of gout

Scientific or Traditional

Label statement: If symptoms persist, worsen or episodes become more frequent talk to your medical practitioner.

10

Help maintain/support bone mineralisation

Scientific

Product presentation must not imply or refer to bone disease or disorders e.g. rheumatoid arthritis, juvenile arthritis, debilitating osteoarthritis, osteoporosis.

11

Helps enhance/improve/promote joint mobility

Scientific or Traditional

Product presentation must not imply or refer to bone disease or disorders e.g. rheumatoid arthritis, juvenile arthritis, debilitating osteoarthritis, osteoporosis.

Product presentation must not imply or refer to any form of arthritis or osteoarthritis unless qualified as mild.

12

Helps enhance/promote bone healing/repair

Scientific or Traditional

Product presentation must not imply or refer to bone disease or disorders e.g. rheumatoid arthritis, juvenile arthritis, debilitating osteoarthritis, osteoporosis.

13

Helps enhance/promote bone health

Scientific

Product presentation must not imply or refer to bone disease or disorders e.g. rheumatoid arthritis, juvenile arthritis, debilitating osteoarthritis, osteoporosis.

14

Helps enhance/promote bone mass/density

Scientific

Product presentation must not imply or refer to bone disease or disorders e.g. rheumatoid arthritis, juvenile arthritis, debilitating osteoarthritis, osteoporosis.

15

Helps enhance/promote bone mineralisation

Scientific

Product presentation must not imply or refer to bone disease or disorders e.g. rheumatoid arthritis, juvenile arthritis, debilitating osteoarthritis, osteoporosis.

16

Helps enhance/promote bone strength

Scientific or Traditional

Product presentation must not imply or refer to bone disease or disorders e.g. rheumatoid arthritis, juvenile arthritis, debilitating osteoarthritis, osteoporosis.

17

Helps enhance/promote healthy joint function

Scientific or Traditional

Product presentation must not imply or refer to bone disease or disorders e.g. rheumatoid arthritis, juvenile arthritis, debilitating osteoarthritis, osteoporosis.

18

Helps enhance/promote joint health

Scientific or Traditional

Product presentation must not imply or refer to bone disease or disorders e.g. rheumatoid arthritis, juvenile arthritis, debilitating osteoarthritis, osteoporosis.

19

Helps enhance/promote/increase metabolism of (state mineral) in bones

Scientific

Product presentation must not imply or refer to bone disease or disorders e.g. rheumatoid arthritis, juvenile arthritis, debilitating osteoarthritis, osteoporosis.

20

Helps maintain/supports health joint cartilage growth/development/production

Scientific

Product presentation must not imply or refer to bone disease or disorders e.g. rheumatoid arthritis, juvenile arthritis, debilitating osteoarthritis, osteoporosis.

Product presentation must not imply or refer to any form of arthritis or osteoarthritis unless qualified as mild.

21

Helps reduce the occasional occurrence of symptoms of gout

Scientific or Traditional

Label statement: If symptoms persist, worsen or episodes become more frequent talk to your medical practitioner.

22

Maintain/support (state mineral) absorption in bones

Scientific

Product presentation must not imply or refer to bone disease or disorders e.g. rheumatoid arthritis, juvenile arthritis, debilitating osteoarthritis, osteoporosis.

23

Maintain/support bone healing/repair

Scientific or Traditional

Product presentation must not imply or refer to bone disease or disorders e.g. rheumatoid arthritis, juvenile arthritis, debilitating osteoarthritis, osteoporosis.

24

Maintain/support bone health

Scientific

Product presentation must not imply or refer to bone disease or disorders e.g. rheumatoid arthritis, juvenile arthritis, debilitating osteoarthritis, osteoporosis.

25

Maintain/support bone mass/density/integrity

Scientific

Product presentation must not imply or refer to bone disease or disorders e.g. rheumatoid arthritis, juvenile arthritis, debilitating osteoarthritis, osteoporosis.

26

Maintain/support bone strength

Scientific or Traditional

Product presentation must not imply or refer to bone disease or disorders e.g. rheumatoid arthritis, juvenile arthritis, debilitating osteoarthritis, osteoporosis.

27

Maintain/support joint cartilage health.

Scientific

Product presentation must not imply or refer to bone disease or disorders e.g. rheumatoid arthritis, juvenile arthritis, debilitating osteoarthritis, osteoporosis.

Product presentation must not imply or refer to any form of arthritis or osteoarthritis unless qualified as mild.

28

Maintain/support joint health

Scientific or Traditional

Product presentation must not imply or refer to bone disease or disorders e.g. rheumatoid arthritis, juvenile arthritis, debilitating osteoarthritis, osteoporosis.

29

Maintain/support joint mobility/flexibility

Scientific or Traditional

Product presentation must not imply or refer to bone disease or disorders e.g. rheumatoid arthritis, juvenile arthritis, debilitating osteoarthritis, osteoporosis.

30

Supports bone flexibility.

Scientific or Traditional

 

31

Vitamin D helps calcium absorption (or words of like intent) and a diet deficient in calcium can lead to osteoporosis in later life

Scientific

Indication only for use for medicines that contain vitamin D as an active ingredient. The medicines may only contain a maximum recommended daily dose of 25 micrograms or less of vitamin D and as a minimum, also contain at least 25% of the RDI in the  recommended daily dose of vitamin D.

Label statement: Vitamins and minerals can only be of assistance if dietary intake is inadequate OR Vitamin and/or mineral supplements should not replace a balanced diet.

Table 3 – Indications relating to the cardiovascular system

Column 1

Column 2

 

Indication

Column 3

 

Type of evidence

Column 4

 

Other requirements

1

Aid/assist healthy red blood cell production

Scientific

Product presentation must not imply or refer to serious cardiovascular conditions.

2

Aid/assist/helps in the maintenance of blood levels of oxygen

Scientific

Product presentation must not imply or refer to heart disease.

3

Aid/assist/helps oxygen transport to body tissues

Scientific

Product presentation must not imply or refer to heart disease.

4

Blood tonic/Enhance blood health

Traditional

Product presentation must not imply or refer to serious cardiovascular conditions.

5

Cardiotonic/strengthen heart

Traditional

Product presentation must not imply or refer to serious cardiovascular conditions.

6

Decrease/reduce appearance of mild varicose veins

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Product presentation must only refer to mild varicose veins.

7

Decrease/reduce/relieve aching/tired legs/leg heaviness associated with mild varicose veins

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Product presentation must only refer to mild varicose veins.

8

Decrease/reduce/relieve discomfort associated with haemorrhoids

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

9

Decrease/reduce/relieve itching associated with haemorrhoids

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

10

Decrease/reduce/relieve itchy legs associated with mild varicose veins

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Product presentation must only refer to mild varicose veins.

11

Decrease/reduce/relieve leg swelling associated mild varicose veins

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Product presentation must only refer to mild varicose veins.

12

Decrease/reduce/relieve minor bleeding associated with haemorrhoids

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

13

Decrease/reduce/relieve pain associated with mild varicose veins

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Product presentation must only refer to mild varicose veins.

14

Decrease/reduce/relieve swelling associated with haemorrhoids

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

15

Decrease/reduce/relieve symptoms of  haemorrhoids

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

16

Decrease/reduce/relieve symptoms of mild varicose veins

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Product presentation must only refer to mild varicose veins.

17

Helps decrease/reduce occurrence of nose bleeds

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Product presentation must not imply or refer to serious cardiovascular conditions.

18

Helps enhance/improve/promote blood circulation to the peripheral areas of the body (legs, hands and feet)

Scientific or Traditional

Product presentation must not imply or refer to serious cardiovascular conditions.

19

Helps enhance/promote artery health

Scientific

Product presentation must not imply or refer to circulatory disorders/diseases/conditions e.g. thrombosis.

20

Helps enhance/promote blood capillary health

Scientific

Product presentation must not imply or refer to serious cardiovascular conditions.

21

Helps enhance/promote blood vessel health

Scientific

Product presentation must not imply or refer to circulatory disorders/diseases/conditions e.g. thrombosis.

22

Helps enhance/promote healthy blood circulation

Scientific or Traditional

Product presentation must not imply or refer to serious cardiovascular conditions.

23

Helps enhance/promote red blood cell health

Scientific

Product presentation must not imply or refer to serious cardiovascular conditions.

24

Helps in the maintenance of healthy blood lipids/blood fats

Scientific

Product presentation must not imply or refer to lowering blood lipids, blood fats and triglycerides.

25

Helps maintain/support haemoglobin formation/synthesis

Scientific

Product presentation must not imply or refer to serious cardiovascular conditions.

26

Helps maintain/support healthy blood sugar/glucose

Scientific

Product presentation must not imply or refer to lowering or raising blood sugar/glucose levels from outside of the normal healthy range.

27

Helps maintain/support healthy cholesterol

Scientific

Product presentation must not imply or refer to lowering or raising blood cholesterol levels from outside of the normal healthy range

28

Helps maintain/support healthy heart function

Traditional

Product presentation must not imply or refer to serious cardiovascular conditions.

29

Helps maintain/support transport of oxygen in the body

Scientific

Product presentation must not imply or refer to heart disease.

30

Helps maintain/support vasodilator/ blood vessel dilation

Scientific or Traditional

Product presentation must not imply or refer to circulatory disorders/diseases/conditions e.g. thrombosis.

31

Helps reduce intestinal absorption of cholesterol from dietary sources

Scientific

Product presentation must not imply or refer to lowering or raising blood cholesterol levels from outside of the normal healthy range

32

Helps reduce occurrence of haemorrhoids

Scientific or Traditional

 

33

Helps reduce/decrease/relieve mild nose bleeds

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Product presentation must only refer to mild nose bleed.

Product presentation must not imply or refer to serious cardiovascular conditions.

34

Maintain/support artery health

Scientific

Product presentation must not imply or refer to circulatory disorders/diseases/conditions e.g. thrombosis.

35

Maintain/support blood capillary health

Scientific

Product presentation must not imply or refer to circulatory disorders/diseases/conditions e.g. thrombosis.

36

Maintain/support blood circulation/flow to the peripheral areas of the body (legs, hands and feet)

Scientific or Traditional

Product presentation must not imply or refer to serious cardiovascular conditions.

37

Maintain/support blood health

Scientific or Traditional

Product presentation must not imply or refer to serious cardiovascular conditions.

38

Maintain/support blood vessel health

Scientific

Product presentation must not imply or refer to circulatory disorders/diseases/conditions e.g. thrombosis.

39

Maintain/support cardiovascular system health

Scientific or Traditional

Product presentation must not imply or refer to serious cardiovascular conditions.

40

Maintain/support healthy blood capillary health

Scientific

Product presentation must not imply or refer to serious cardiovascular conditions.

41

Maintain/support healthy blood circulation

Scientific or Traditional

Product presentation must not imply or refer to serious cardiovascular conditions.

42

Maintain/support healthy cardiovascular system function

Scientific or Traditional

Product presentation must not imply or refer to serious cardiovascular conditions.

43

Maintain/support healthy lymphatic system

Scientific or Traditional

Product presentation must not imply or refer to serious cardiovascular conditions.

44

Maintain/support heart health

Scientific or Traditional

Product presentation must not imply or refer to serious cardiovascular conditions.

45

Maintain/support red blood cell health

Scientific

Product presentation must not imply or refer to serious cardiovascular conditions.

46

Nourish the heart

Traditional

Product presentation must not imply or refer to serious cardiovascular conditions.

47

Relieve cold hands and feet/limbs

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

48

Rubefaciant/stimulate blood flow to skin

Scientific or Traditional

 

Table 4 – Indications relating to the endocrine system

Column 1

Column 2

 

Indication

Column 3

 

Type of evidence

Column 4

 

Other requirements

1

Aid/assist thyroid hormone production

Scientific

Product presentation must not imply or refer to any thyroid related diseases.

2

Maintain/support adrenal gland health

Traditional

Product presentation must not imply or refer to any adrenal related diseases.

3

Maintain/support healthy adrenal gland function

Traditional

Product presentation must not imply or refer to any adrenal related diseases.

4

Maintain/support healthy pancreatic function

Traditional

Product presentation must not imply or refer to any pancreas related diseases.

5

Maintain/support healthy thyroid gland function

Scientific or Traditional

Product presentation must not imply or refer to any thyroid related diseases.

6

Maintain/support healthy thyroid hormones

Scientific

Product presentation must not imply or refer to any thyroid related diseases.

7

Maintain/support thyroid gland health

Scientific or Traditional

Product presentation must not imply or refer to any thyroid related diseases.

8

Thyroid tonic

Traditional

Product presentation must not imply or refer to any thyroid related diseases.

Table 5 – Indications relating to the gastrointestinal system

Column 1

Column 2

 

Indication

Column 3

 

Type of evidence

Column 4

 

Other requirements

1

Aid/assist digestion of glucose/sugar/carbohydrates

Scientific

Product presentation must not imply or refer to lowering or raising blood sugar/glucose levels from outside of the normal healthy range.

2

Aid/assist digestion of lactose

Scientific or Traditional

 

3

Aid/assist digestion/breakdown of dietary fat

Scientific or Traditional

If product is indicated for weight loss, label statement: When used in conjunction with a program of reduced intake of dietary calories and increased physical activity.

4

Aid/assist expulsion of intestinal gas

Traditional

Label statement: If symptoms persist, talk to your health professional.

5

Aid/assist fat distribution and assimilation in the digestive system

Scientific

Product presentation must not imply or refer to lowering blood lipids, blood fats and triglycerides.

6

Aid/assist fat emulsification in the digestive system

Scientific

Product presentation must not imply or refer to lowering blood lipids, blood fats and triglycerides.

7

Aid/assist healthy liver regeneration

Traditional

Product presentation must not imply or refer to liver disease, such as cirrhosis, hepatitis.

8

Aid/assist/helps digestion of (state nutrient)

Scientific

 

9

Aid/assist/helps digestion of fats/fatty acids/triglycerides/lipid

Scientific

Product presentation must not imply or refer to lowering blood lipids, blood fats and triglycerides.

10

Aid/assist/helps elimination of dietary fat

Scientific or Traditional

If product is indicated for weight loss, label statement: When used in conjunction with a program of reduced intake of dietary calories and increased physical activity.

11

Aid/assist/helps in the management of carbohydrate cravings

Scientific or Traditional

If product is indicated for weight loss, label statement: When used in conjunction with a program of reduced intake of dietary calories and increased physical activity.

12

Aid/assist/helps in the management of food cravings

Scientific or Traditional

If product is indicated for weight loss, label statement: When used in conjunction with a program of reduced intake of dietary calories and increased physical activity.

13

Aid/assist/helps in the management of sugar cravings

Scientific or Traditional

If product is indicated for weight loss, label statement: When used in conjunction with a program of reduced intake of dietary calories and increased physical activity.

14

Aids/assists repair of gastrointestinal/gut wall lining

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

15

Antacid/reduces stomach acid

Scientific

Label statement: If symptoms persist, talk to your health professional.

Product presentation must not imply or refer to gastro oesophageal reflux disease.

16

Antiemetic/Decrease/reduce/relieve vomiting

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

17

Aperient/laxative

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Label statement: Drink plenty of water (or words to that effect).

Label statement for stimulant laxatives: Prolonged use may cause serious bowel problems.

Label statement: Do not use when abdominal pain, nausea or vomiting are present or if you develop diarrhoea. If you are pregnant or breastfeeding - seek the advice of a healthcare professional before taking this product (or words to that effect).

Product presentation must not refer to or imply weight loss.

18

Bitter tonic/stimulate gastric secretions

Traditional

 

19

Bowel Tonic

Traditional

 

20

Cholagogue/promote bile flow from gall bladder

Traditional

Product presentation must not imply or refer to disease in any body organ.

21

Decrease/reduce carbohydrate cravings

Scientific or Traditional

Product presentation must not imply or refer to eating disorders.

If product is indicated for weight loss, label statement: When used in conjunction with a program of reduced intake of dietary calories and increased physical activity.

22

Decrease/reduce food stagnation associated with poor or sluggish digestion

Scientific or Traditional

 

23

Decrease/reduce loose stools

Scientific or Traditional

Label statement: Seek medical advice if diarrhoea persists for more than: 6 hours in infants under 6 months, 12 hours in children under 3 years, 24 hours in children aged 3 to 6 years or 48 hours in adults and children over 6 years (or words to that effect).

24

Decrease/reduce sweet taste recognition on the tongue

Scientific or Traditional

 

25

Decrease/reduce/relieve abdominal bloating/distention

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Product presentation must not imply or refer to gastro oesophageal reflux disease.

26

Decrease/reduce/relieve abdominal cramping

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

27

Decrease/reduce/relieve abdominal feeling of fullness

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

28

Decrease/reduce/relieve abdominal griping pain

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

29

Decrease/reduce/relieve abdominal pain/discomfort

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Product presentation must not imply or refer to gastro oesophageal reflux disease.

30

Decrease/reduce/relieve abdominal spasm

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Product presentation must not imply or refer to gastro oesophageal reflux disease.

31

Decrease/reduce/relieve bowel discomfort

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

32

Decrease/reduce/relieve colic (wind/gas pain)

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

33

Decrease/reduce/relieve constipation

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Label statement: Drink plenty of water (or words to that effect).

Label statement for stimulant laxatives: Prolonged use may cause serious bowel problems.

Label statement: Do not use when abdominal pain, nausea or vomiting are present or if you develop diarrhoea. If you are pregnant or breastfeeding - seek the advice of a healthcare professional before taking this product (or words to that effect).

Product presentation must not refer to or imply weight loss.

34

Decrease/reduce/relieve diarrhoea

Scientific or Traditional

Label statement: Seek medical advice if diarrhoea persists for more than: 6 hours in infants under 6 months, 12 hours in children under 3 years, 24 hours in children aged 3 to 6 years or 48 hours in adults and children over 6 years (or words to that effect).

35

Decrease/reduce/relieve digestive spasms

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Product presentation must not imply or refer to gastro oesophageal reflux disease.

36

Decrease/reduce/relieve excess intestinal gas

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

37

Decrease/reduce/relieve flatulence/carminative

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

38

Decrease/reduce/relieve gastrointestinal pain

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Product presentation must not imply or refer to gastro oesophageal reflux disease.

39

Decrease/reduce/relieve hiccups

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

40

Decrease/reduce/relieve loss of appetite

Scientific or Traditional

Product presentation must not imply or refer to eating disorders.

41

Decrease/reduce/relieve nausea

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

42

Decrease/reduce/relieve symptoms associated with occasional overindulgence

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Product presentation must not encourage excessive or harmful consumption of alcohol or other toxic substances.

43

Decrease/reduce/relieve symptoms of heartburn

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Product presentation must not imply or refer to gastro oesophageal reflux disease.

44

Decrease/reduce/relieve symptoms of indigestion/dyspepsia

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Product presentation must not imply or refer to gastro oesophageal reflux disease.

45

Decrease/reduce/relieve symptoms of lactose intolerance

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

46

Decrease/reduce/relieve symptoms of motion/travel/sea sickness

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

47

Decrease/reduce/relieve symptoms of nervous indigestion

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

48

Decrease/reduce/relieve symptoms of stomach upsets

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

49

Digestive tonic/Improve digestive weakness

Traditional

Label statement: If symptoms persist, talk to your health professional.

50

Enhance the assimilation/transportation of nutrients

Scientific or Traditional

 

51

Enhance/ promote stomach health

Scientific or Traditional

Product presentation must not imply or refer to disease in any body organ.

52

Enhance/improve/promote/increase bowel regularity

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Label statement: Drink plenty of water (or words to that effect).

Label statement for stimulant laxatives: Prolonged use may cause serious bowel problems.

Label statement: Do not use when abdominal pain, nausea or vomiting are present or if you develop diarrhoea. If you are pregnant or breastfeeding - seek the advice of a healthcare professional before taking this product (or words to that effect).

Product presentation must not refer to or imply weight loss.

53

Enhance/improve/promote/increase bowel waste elimination

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Label statement: Drink plenty of water (or words to that effect).

Label statement for stimulant laxatives: Prolonged use may cause serious bowel problems.

Label statement: Do not use when abdominal pain, nausea or vomiting are present or if you develop diarrhoea. If you are pregnant or breastfeeding - seek the advice of a healthcare professional before taking this product (or words to that effect).

Product presentation must not refer to or imply weight loss.

54

Enhance/promote healthy digestion

Scientific or Traditional

 

55

Help reduce occurrence of symptoms of medically diagnosed Irritable Bowel Syndrome

Scientific or Traditional

Label statement: If symptoms persist, worsen or episodes become more frequent talk to your medical practitioner.

Product presentation must only refer to medically diagnosed IBS.

56

Help restore good/beneficial/friendly gut flora after antibiotic use

Scientific

 

57

Helps balance brain-gut interaction

Traditional

 

58

Helps decrease/reduce dietary fat absorption in digestive system

Scientific or Traditional

If product is indicated for weight loss, label statement: When used in conjunction with a program of reduced intake of dietary calories and increased physical activity.

59

Helps decrease/reduce/relieve brain-gut interaction

Traditional

 

60

Helps decrease/reduce/relieve mild gastrointestinal tract inflammation

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

61

Helps decrease/reduce/relieve symptoms of infant colic

Scientific or Traditional

Label statement: If symptoms persist or worsen talk to your medical practitioner.

62

Helps decrease/reduce/relieve symptoms of mild gastritis

Scientific or Traditional

Label statement: If symptoms persist or worsen talk to your medical practitioner.

Product presentation must only refer to mild gastritis.

63

Helps decrease/reduce/relieve symptoms of occasional hangovers

Scientific or Traditional

Product presentation must not encourage excessive or harmful consumption of alcohol or other toxic substances.

Label statement: If symptoms persist, talk to your health professional.

64

Helps decrease/reduce/relieve symptoms of traveller's diarrhoea

Scientific or Traditional

Label statement: Seek medical advice if diarrhoea persists for more than: 6 hours in infants under 6 months, 12 hours in children under 3 years, 24 hours in children aged 3 to 6 years or 48 hours in adults and children over 6 years (or words to that effect).

65

Helps delay stomach (gastric) emptying

Scientific or Traditional

 

66

Helps enhance/improve/promote taste sensation

Scientific or Traditional

 

67

Helps enhance/improve/promote/increase bile secretion/flow

Scientific or Traditional

 

68

Helps enhance/improve/promote/increase healthy digestive system flora/good bacteria growth

Scientific or Traditional

 

69

Helps enhance/improve/promote/increase intestinal good/beneficial/friendly bacteria growth

Scientific

 

70

Helps enhance/improve/promote/increase intestinal transit time

Scientific or Traditional

 

71

Helps enhance/promote gallbladder health

Scientific or Traditional

Product presentation must not imply or refer to disease in any body organ.

72

Helps enhance/promote gastrointestinal system health

Scientific or Traditional

 

73

Helps enhance/promote gastrointestinal system mucosa health

Scientific or Traditional

 

74

Helps enhance/promote healthy colon function

Scientific or Traditional

 

75

Helps enhance/promote healthy digestive system function

Scientific or Traditional

 

76

Helps enhance/promote healthy gallbladder function

Scientific or Traditional

Product presentation must not imply or refer to disease in any body organ.

77

Helps enhance/promote healthy liver function

Scientific or Traditional

Product presentation must not imply or refer to liver disease, such as cirrhosis, hepatitis.

78

Helps enhance/promote healthy small intestine function

Scientific or Traditional

 

79

Helps maintain/support bile secretion/flow

Scientific or Traditional

 

80

Helps reduce occurrence of abdominal bloating

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

81

Helps reduce occurrence of abdominal spasm

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

82

Helps reduce occurrence of constipation

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Label statement: Drink plenty of water (or words to that effect).

Label statement for stimulant laxatives: Prolonged use may cause serious bowel problems.

Label statement: Do not use when abdominal pain, nausea or vomiting are present or if you develop diarrhoea. If you are pregnant or breastfeeding - seek the advice of a healthcare professional before taking this product (or words to that effect).

Product presentation must not refer to or imply weight loss.

83

Helps reduce occurrence of diarrhoea

Scientific or Traditional

Label statement: Seek medical advice if diarrhoea persists for more than: 6 hours in infants under 6 months, 12 hours in children under 3 years, 24 hours in children aged 3 to 6 years or 48 hours in adults and children over 6 years (or words to that effect).

84

Helps reduce occurrence of symptoms of indigestion/dyspepsia

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Product presentation must not imply or refer to gastro oesophageal reflux disease.

85

Helps reduce occurrence of symptoms of motion/travel/sea sickness

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

86

Helps reduce occurrence of symptoms of traveller's diarrhoea

Scientific or Traditional

Label statement: Seek medical advice if diarrhoea persists for more than: 6 hours in infants under 6 months, 12 hours in children under 3 years, 24 hours in children aged 3 to 6 years or 48 hours in adults and children over 6 years (or words to that effect).

87

Helps regulate appetite

Scientific or Traditional

Product presentation must not imply or refer to eating disorders.

88

Helps restore  good/beneficial/friendly intestinal/gut/bowel flora

Scientific or Traditional

 

89

Helps stimulate/increase digestive enzymes

Scientific

 

90

Hepatoprotectant/protect the liver

Traditional

Product presentation must not imply or refer to liver disease, such as cirrhosis, hepatitis.

Product presentation must not encourage excessive or harmful consumption of alcohol or other toxic substances.

91

Increase bowel movements by increasing stool bulk

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Label statement: Drink plenty of water (or words to that effect).

Product presentation must not refer to or imply weight loss.

92

Liver tonic/Enhance liver health

Traditional

Product presentation must not imply or refer to liver disease, such as cirrhosis, hepatitis.

93

Maintain/support bile production

Scientific or Traditional

 

94

Maintain/support bowel regularity

Scientific or Traditional

Label statement: Drink plenty of water (or words to that effect).

Label statement for stimulant laxatives: Prolonged use may cause serious bowel problems.

Label statement: Do not use when abdominal pain, nausea or vomiting are present or if you develop diarrhoea. If you are pregnant or breastfeeding - seek the advice of a healthcare professional before taking this product (or words to that effect).

Product presentation must not refer to or imply weight loss.

95

Maintain/support bowel regularity by increasing stool bulk

Scientific or Traditional

Label statement: Drink plenty of water (or words to that effect).

Label statement: Do not use when abdominal pain, nausea or vomiting are present or if you develop diarrhoea. If you are pregnant or breastfeeding - seek the advice of a healthcare professional before taking this product (or words to that effect).

Product presentation must not refer to or imply weight loss.

96

Maintain/support digestion/assimilation of nutrients

Scientific or Traditional

 

97

Maintain/support digestive system health

Scientific or Traditional

 

98

Maintain/support gallbladder function

Scientific or Traditional

Product presentation must not imply or refer to disease in any body organ.

99

Maintain/support gallbladder health

Scientific or Traditional

Product presentation must not imply or refer to disease in any body organ.

100

Maintain/support gastrointestinal mucosal membrane health

Scientific or Traditional

 

101

Maintain/support gastrointestinal system health

Scientific or Traditional

 

102

Maintain/support good/beneficial/friendly bacteria adherence to intestinal mucosa.

Scientific

 

103

Maintain/support good/beneficial/friendly gut flora during antibiotic use

Scientific

 

104

Maintain/support healthy appetite

Scientific or Traditional

Product presentation must not imply or refer to eating disorders.

105

Maintain/support healthy bowel/colon function

Scientific or Traditional

 

106

Maintain/support healthy digestion

Scientific or Traditional

 

107

Maintain/support healthy digestive system function

Scientific or Traditional

 

108

Maintain/support healthy gastrointestinal function

Scientific or Traditional

 

109

Maintain/support healthy liver function

Scientific or Traditional

Product presentation must not imply or refer to liver disease, such as cirrhosis, hepatitis.

110

Maintain/support healthy liver regeneration

Traditional

Product presentation must not imply or refer to liver disease, such as cirrhosis, hepatitis.

111

Maintain/support healthy mucous linings of the digestive system

Scientific or Traditional

 

112

Maintain/support healthy small intestine function

Scientific or Traditional

 

113

Maintain/support intestinal good/beneficial/friendly flora

Scientific

 

114

Maintain/support intestinal health

Scientific or Traditional

 

115

Maintain/support intestinal transit time

Scientific or Traditional

 

116

Maintain/support liver health

Scientific or Traditional

Product presentation must not imply or refer to liver disease, such as cirrhosis, hepatitis.

117

Maintain/support small intestine  health

Scientific or Traditional

 

118

Maintain/support small intestine good/beneficial/friendly  flora

Scientific

 

119

Maintain/support smell sensation

Scientific or Traditional

 

120

Maintain/support stomach function

Scientific or Traditional

Product presentation must not imply or refer to disease in any body organ.

121

Maintain/support stomach health

Scientific or Traditional

Product presentation must not imply or refer to disease in any body organ.

122

Maintain/support taste sensation

Scientific or Traditional

 

123

Nourish  good/beneficial/friendly intestinal flora

Scientific

 

124

Orexigenic/improve/promote healthy appetite

Scientific or Traditional

Product presentation must not imply or refer to eating disorders.

125

Promote bile flow from liver/chloretic

Traditional

Product presentation must not imply or refer to liver disease, such as cirrhosis, hepatitis.

126

Promote/enhance feeling of satiety

Scientific or Traditional

 

127

Promote/increase bowel evacuation

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Label statement: Drink plenty of water (or words to that effect).

Label statement for stimulant laxatives: Prolonged use may cause serious bowel problems.

Label statement: Do not use when abdominal pain, nausea or vomiting are present or if you develop diarrhoea. If you are pregnant or breastfeeding - seek the advice of a healthcare professional before taking this product (or words to that effect).

Product presentation must not refer to or imply weight loss.

128

Reduce occurrence of excess intestinal wind/gas

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

129

Reduce occurrence of nausea/vomiting

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

130

Reduce/decrease/supress hunger/appetite

Scientific or Traditional

Product presentation must not imply or refer to eating disorders.

131

Relief of symptoms of medically diagnosed Irritable Bowel Syndrome

Scientific or Traditional

Label statement: If symptoms persist or worsen talk to your medical practitioner.

Product presentation must only refer to medically diagnosed IBS.

132

Relieve digestive discomfort

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

133

Relieve dry stools

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Label statement: Drink plenty of water (or words to that effect).

134

Relieve excessive belching

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

135

Sialagogue/promote saliva production

Traditional

 

136

Softens stool to ease bowel motions

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Label statement: Drink plenty of water (or words to that effect).

137

Soothe gastro-intestinal tract mucous membranes

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

138

Stimulant laxative

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Label statement: Drink plenty of water (or words to that effect).

Label statement for stimulant laxatives: Prolonged use may cause serious bowel problems.

Label statement: Do not use when abdominal pain, nausea or vomiting are present or if you develop diarrhoea. If you are pregnant or breastfeeding - seek the advice of a healthcare professional before taking this product (or words to that effect).

Product presentation must not refer to or imply weight loss.

139

Stimulates/increases digestive gastric hydrochloric acid secretion

Scientific or Traditional

 

140

Tonify/nourish/strengthen/replenish liver

Traditional

Product presentation must not imply or refer to liver disease, such as cirrhosis, hepatitis.

141

Vermifuge/helps remove intestinal threadworms/pinworms

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Product presentation must not imply or refer to other worms e.g.  roundworm, tapeworm, hookworm.

Table 6 – Indications relating to the immune system

Column 1

Column 2

 

Indication

Column 3

 

Type of evidence

Column 4

 

Other requirements

1

Decrease/reduce/relieve post nasal drip

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

2

Decrease/reduce/relieve symptoms of allergic rhinitis

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

3

Decrease/reduce/relieve symptoms of hayfever

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

4

Decrease/reduce/relieve symptoms of skin hives

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

5

Enhance/improve/promote immune defence/immunity

Scientific or Traditional

 

6

Helps decrease/reduce/relieve facial tenderness associated with allergic rhinitis

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Product presentation must not imply or refer to serious allergic conditions such as anaphylaxis.

7

Helps decrease/reduce/relieve symptoms of food intolerance

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Product presentation must not imply or refer to serious allergic conditions such as anaphylaxis.

8

Helps decrease/reduce/relieve symptoms of mild allergies

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Product presentation must not imply or refer to serious allergic conditions such as anaphylaxis.

9

Helps decrease/reduce/relieve symptoms of seasonal allergies

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Product presentation must not imply or refer to serious allergic conditions such as anaphylaxis.

10

Helps enhance/improve/promote immune system function

Scientific or Traditional

Product presentation must not imply or refer to serious immunological diseases.

11

Helps reduce occurrence of symptoms of food intolerance

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Product presentation must not imply or refer to serious allergic conditions such as anaphylaxis.

12

Helps reduce occurrence of symptoms of mild allergies

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Product presentation must not imply or refer to serious allergic conditions such as anaphylaxis.

13

Helps stimulate a healthy immune system response

Scientific or Traditional

Product presentation must not imply or refer to serious immunological diseases.

14

Maintain/support healthy gastrointestinal immune function

Scientific or Traditional

Product presentation must not imply or refer to serious immunological diseases.

15

Maintain/support healthy immune system function

Scientific or Traditional

Product presentation must not imply or refer to serious immunological diseases.

16

Maintain/support immune system health

Scientific or Traditional

Product presentation must not imply or refer to serious immunological diseases.

17

Maintain/support immune system to fight illness

Scientific or Traditional

Product presentation must not imply or refer to serious immunological diseases.

18

Soothes/relieves swelling/welts associated with hives

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Product presentation must not imply or refer to serious allergic conditions such as anaphylaxis.

Table 7 – Indications relating to muscles

Column 1

Column 2

 

Indication

Column 3

 

Type of evidence

Column 4

 

Other requirements

1

Aid/assist muscle development

Scientific or Traditional

 

2

Aid/assist muscle growth

Scientific or Traditional

 

3

Aid/assist/helps in the healing of minor muscle injuries

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

4

Aid/assist/helps in the management of muscle sprain/strain

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

5

Aid/assist/helps post exercise recovery

Scientific or Traditional

 

6

Antispasmodic/spasmolytic

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Product presentation must not imply or refer to serious musculoskeletal or neurological conditions.

7

Decrease/reduce/relieve muscle cramps

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Product presentation must not imply or refer to serious musculoskeletal or neurological conditions.

8

Decrease/reduce/relieve muscle pain/ache/soreness

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

9

Decrease/reduce/relieve muscle tension/stiffness

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

10

Decrease/reduce/relieve muscle tiredness

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

11

Decrease/reduce/relieve symptoms of mild tennis elbow

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Product presentation must only refer to mild tennis elbow.

12

Decrease/reduce/relieve symptoms of muscle injury/ailments

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

13

Decrease/reduce/relieve symptoms of whiplash

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

14

Enhance/improve/promote/increase muscle relaxation

Scientific or Traditional

 

15

Helps decrease/reduce protein breakdown in the muscles

Scientific

 

16

Helps decrease/reduce/relieve leg cramps

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

17

Helps decrease/reduce/relieve mild muscle spasms/twitches

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

18

Helps decrease/reduce/relieve symptoms of medically diagnosed fibromyalgia/fibrositis

Scientific or Traditional

Label statement: If symptoms persist or worsen talk to your medical practitioner.

Product presentation must only refer to medically diagnosed fibromyalgia/fibrositis.

19

Helps decrease/reduce/relieve symptoms of mild medically diagnosed tenosynovitis

Scientific or Traditional

Label statement: If symptoms persist or worsen talk to your medical practitioner.

Product presentation must only refer to medically diagnosed tenosynovitis.

20

Helps decrease/reduce/relieve symptoms of muscle sprain/strain

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

21

Helps enhance/improve muscle recovery time

Scientific or Traditional

 

22

Helps enhance/improve/promote/increase healthy muscle tone

Scientific or Traditional

 

23

Helps enhance/improve/promote/increase muscle fuel burning efficiency

Scientific or Traditional

 

24

Helps enhance/improve/promote/increase muscle performance/endurance/stamina

Scientific or Traditional

 

25

Helps enhance/improve/promote/increase muscle strength

Scientific or Traditional

 

26

Helps enhance/improve/promote/increase muscle strength to improve balance/stability

Scientific or Traditional

 

27

Helps enhance/improve/promote/increase physical/exercise performance

Scientific or Traditional

 

28

Helps enhance/promote healthy muscle function

Scientific or Traditional

 

29

Helps enhance/promote healthy muscle mass

Scientific or Traditional

 

30

Helps reduce occurrence of muscle cramp

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

31

Helps reduce occurrence of muscle tension/stiffness

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

32

Maintain/support healthy ligaments

Scientific or Traditional

 

33

Maintain/support healthy muscle contraction function

Scientific or Traditional

 

34

Maintain/support healthy neuromuscular system/function

Scientific or Traditional

Product presentation must not imply or refer to serious musculoskeletal or neurological conditions.

35

Maintain/support muscle fuel burning efficiency

Scientific or Traditional

 

36

Maintain/support muscle function

Scientific or Traditional

 

37

Maintain/support muscle health

Scientific or Traditional

 

38

Maintain/support muscle mass

Scientific or Traditional

 

39

Maintain/support muscle performance/endurance/stamina

Scientific or Traditional

 

40

Maintain/support muscle protein stores

Scientific

 

41

Maintain/support muscle relaxation

Scientific or Traditional

 

42

Maintain/support muscle strength

Scientific or Traditional

 

43

Maintain/support muscle strength to reduce strain on joints

Scientific or Traditional

 

44

Maintain/support muscle tone

Scientific or Traditional

 

45

Maintain/support tendon health

Scientific or Traditional

 

46

Reduce/decrease mild muscle inflammation

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Table 8 – Indications relating to the nervous system

Column 1

Column 2

 

Indication

Column 3

 

Type of evidence

Column 4

 

Other requirements

1

Adaptogen/Help body adapt to stress

Traditional

Product presentation must not imply or refer to mental illnesses, disorders or conditions.

2

Aid/assist/helps mind relaxation

Scientific or Traditional

Product presentation must not imply or refer to mental illnesses, disorders or conditions.

3

Aid/assist/helps synthesis of neurotransmitters

Scientific

 

4

Aids/assists the body to cope with environmental stress

Scientific or Traditional

 

5

Brain tonic/Enhance brain health

Scientific or Traditional

Product presentation must not imply or refer to mental illnesses, disorders or conditions.

6

Calmative/nervous system relaxant

Traditional

Product presentation must not imply or refer to mental illnesses, disorders or conditions.

7

Calms the mind

Scientific or Traditional

Product presentation must not imply or refer to mental illnesses, disorders or conditions.

8

Decrease/reduce duration of mild migraine

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Product presentation must only refer to mild migraine.

9

Decrease/reduce headache duration

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

10

Decrease/reduce mental/cognitive fatigue

Scientific or Traditional

Product presentation must not imply or refer to mental illnesses, disorders or conditions.

11

Decrease/reduce time to fall asleep

Scientific or Traditional

 

12

Decrease/reduce/relieve disturbed/restless sleep

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

13

Decrease/reduce/relieve headache symptoms

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

14

Decrease/reduce/relieve hot flushes associated with mild anxiety

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Product presentation must not imply or refer to mental illnesses, disorders or conditions.

Product presentation must only refer to mild anxiety.

15

Decrease/reduce/relieve mental overactivity

Scientific or Traditional

Product presentation must not imply or refer to mental illnesses, disorders or conditions.

16

Decrease/reduce/relieve mild dizziness/vertigo

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Product presentation must only refer to mild vertigo.

17

Decrease/reduce/relieve mild migraine symptoms

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Product presentation must only refer to mild migraine.

18

Decrease/reduce/relieve mild nerve pain/neuralgia

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Product presentation must only refer to mild nerve pain/neuralgia.

19

Decrease/reduce/relieve nervous tension/unrest

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Product presentation must not imply or refer to mental illnesses, disorders or conditions.

20

Decrease/reduce/relieve restlessness/excess nervous energy

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Product presentation must not imply or refer to mental illnesses, disorders or conditions.

21

Decrease/reduce/relieve sleeplessness

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

22

Decrease/reduce/relieve symptoms of mild anxiety

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Product presentation must not imply or refer to mental illnesses, disorders or conditions.

Product presentation must only refer to mild anxiety.

23

Decrease/reduce/relieve symptoms of mild sciatica

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Product presentation must only refer to mild sciatica.

24

Decrease/reduce/relieve symptoms of stress

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Product presentation must not imply or refer to mental illnesses, disorders or conditions.

25

Enhance/improve/promote learning ability/function

Scientific or Traditional

Product presentation must not imply or refer to mental illnesses, disorders or conditions.

26

Enhance/improve/promote/increase body relaxation

Scientific or Traditional

 

27

Enhance/improve/promote/increase cognitive performance

Scientific or Traditional

Product presentation must not imply or refer to mental illnesses, disorders or conditions.

28

Enhance/improve/promote/increase memory/recall

Scientific or Traditional

Product presentation must not imply or refer to mental illnesses, disorders or conditions.

29

Enhance/improve/promote/increase mental alertness/wakefulness

Scientific or Traditional

Product presentation must not imply or refer to mental illnesses, disorders or conditions.

30

Enhance/improve/promote/increase mental endurance/stamina

Scientific or Traditional

Product presentation must not imply or refer to mental illnesses, disorders or conditions.

31

Enhance/improve/promote/increase mind relaxation

Scientific or Traditional

Product presentation must not imply or refer to mental illnesses, disorders or conditions.

32

Enhance/improve/promote/increase short term memory

Scientific or Traditional

Product presentation must not imply or refer to mental illnesses, disorders or conditions.

33

Enhance/improve/promote/increase sleep quality/deep sleep

Scientific or Traditional

 

34

Enhance/promote body adaptation to stress

Scientific or Traditional

 

35

Enhance/promote/increase healthy sleep patterns

Scientific or Traditional

 

36

Enhance/promote/increase refreshing sleep

Scientific or Traditional

 

37

Help establish/restore/reset  sleep-wake cycle (circadian rhythm)

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

38

Help maintain/support emotional wellbeing

Scientific or Traditional

Product presentation must not imply or refer to mental illnesses, disorders or conditions.

39

Helps decrease/reduce/relieve frequent need to urinate associated with mild anxiety

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Product presentation must not imply or refer to mental illnesses, disorders or conditions.

Product presentation must only refer to mild anxiety.

40

Helps decrease/reduce/relieve symptoms of mild tension headache

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

41

Helps decrease/reduce/relieve symptoms of sensitivity to light/sound associated with mild migraine

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Product presentation must only refer to mild migraine.

42

Helps enhance/improve/promote/increase attention span

Scientific or Traditional

Product presentation must not imply or refer to mental illnesses, disorders or conditions.

43

Helps enhance/promote healthy nerve conduction/transmission/neurotransmission

Scientific

 

44

Helps maintain/support development of hand eye coordination

Scientific

Product presentation must not imply or refer to neurological conditions or developmental delays.

45

Helps reduce occurrence of irritability

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Product presentation must not imply or refer to mental illnesses, disorders or conditions.

46

Helps reduce occurrence of symptoms of headaches

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

47

Helps reduce occurrence of symptoms of mild anxiety

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Product presentation must not imply or refer to mental illnesses, disorders or conditions.

Product presentation must only refer to mild anxiety.

48

Maintain/support brain function

Scientific or Traditional

Product presentation must not imply or refer to mental illnesses, disorders or conditions.

49

Maintain/support brain health

Scientific or Traditional

Product presentation must not imply or refer to mental illnesses, disorders or conditions.

50

Maintain/support brain/central nervous system development

Scientific

Product presentation must not imply or refer to neurological conditions or developmental delays.

51

Maintain/support cognitive development

Scientific

Product presentation must not imply or refer to neurological conditions or developmental delays.

52

Maintain/support cognitive function/mental function

Scientific or Traditional

Product presentation must not imply or refer to mental illnesses, disorders or conditions.

53

Maintain/support general mental wellbeing

Scientific or Traditional

Product presentation must not imply or refer to mental illnesses, disorders or conditions.

54

Maintain/support healthy sleeping patterns

Scientific or Traditional

 

55

Maintain/support learning and information processing

Scientific or Traditional

Product presentation must not imply or refer to mental illnesses, disorders or conditions.

56

Maintain/support memory/mental recall

Scientific or Traditional

Product presentation must not imply or refer to mental illnesses, disorders or conditions.

57

Maintain/support mental concentration/focus/clarity

Scientific or Traditional

Product presentation must not imply or refer to mental illnesses, disorders or conditions.

58

Maintain/support mental endurance/stamina

Scientific or Traditional

Product presentation must not imply or refer to mental illnesses, disorders or conditions.

59

Maintain/support nerve conduction

Scientific

Product presentation must not imply or refer to mental illnesses, disorders or conditions.

60

Maintain/support nervous system function

Scientific or Traditional

Product presentation must not imply or refer to mental illnesses, disorders or conditions.

61

Maintain/support nervous system health

Scientific or Traditional

Product presentation must not imply or refer to mental illnesses, disorders or conditions.

62

Maintain/support neuroendocrine function

Scientific

Product presentation must not imply or refer to mental illnesses, disorders or conditions.

63

Maintain/support neuromuscular function

Scientific

Product presentation must not imply or refer to mental illnesses, disorders or conditions.

64

Nerve stimulant/enhance nerve function

Traditional

Product presentation must not imply or refer to mental illnesses, disorders or conditions.

65

Nerve tonic

Traditional

Product presentation must not imply or refer to mental illnesses, disorders or conditions.

66

Nervine/support nervous system.

Traditional

Product presentation must not imply or refer to mental illnesses, disorders or conditions.

67

Nourish the brain

Traditional

Product presentation must not imply or refer to mental illnesses, disorders or conditions.

68

Nourish the nervous system

Traditional

Product presentation must not imply or refer to mental illnesses, disorders or conditions.

69

Relieve facial pallor associated with mild migraines

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Product presentation must only refer to mild migraine.

70

Relieve irritability

Scientific or Traditional

Label statement: If symptoms persist, talk to your health professional.

Product presentation must not imply or refer to mental illnesses, disorders or conditions.

71

Soothe/calm nerves

Scientific or Traditional

Product presentation must not imply or refer to mental illnesses, disorders or conditions.

72

Soporific/induces sleep

Traditional

 

73

Support healthy body stress recovery.

Scientific or Traditional

Product presentation must not imply or refer to mental illnesses, disorders or conditions.

74

Support healthy emotional/mood balance

Scientific or Traditional

Product presentation must not imply or refer to mental illnesses, disorders or conditions.

75

Support healthy stress response in the body

Scientific or Traditional

Product presentation must not imply or refer to mental illnesses, disorders or conditions.

Table 9 – Indications relating to nutrition

Column 1

Column 2

 

Indication

Column 3

 

Type of evidence

Column 4

 

Other requirements

1

Aid/assist/helps glucose/sugar/carbohydrate metabolism

Scientific

Product presentation must not imply or refer to lowering or raising blood sugar/glucose levels from outside of the normal healthy range.

2

Aid/assist/helps metabolism of (state vitamin/mineral/nutrient)

Scientific

If product is indicated for supplementation, Label statement: Vitamins and minerals can only be of assistance if dietary intake is inadequate OR Vitamin and/or mineral supplements should not replace a balanced diet.

3

Aid/assist/helps protein synthesis in the body

Scientific

 

4

Aid/assist/helps synthesis of (insert vitamin) in the body

Scientific

Label statement: Vitamins can only be of assistance if the dietary vitamin intake is inadequate OR Vitamin supplements should not replace a balanced diet.

5

Enhance/improve/promote/increase (state vitamin/mineral/nutrient) levels in the body

Scientific

If product is indicated for supplementation, Label statement: Vitamins and minerals can only be of assistance if dietary intake is inadequate OR Vitamin and/or mineral supplements should not replace a balanced diet.

6

Enhance/improve/promote/increase nutrient uptake

Scientific or Traditional

 

7

Helps decrease/reduce homocysteine levels

Scientific

 

8

Helps enhance/promote/increase absorption of dietary (state vitamin/mineral/nutrient)

Scientific

Label statement: Vitamins and minerals can only be of assistance if dietary intake is inadequate OR Vitamin and/or mineral supplements should not replace a balanced diet.

9

Helps enhance/promote/increase body utilisation of (state mineral/vitamin/nutrient)

Scientific

Label statement: Vitamins and minerals can only be of assistance if dietary intake is inadequate OR Vitamin and/or mineral supplements should not replace a balanced diet.

10

Helps maintain/support cellular uptake of (state vitamin/mineral/nutrient)

Scientific

If product is indicated for supplementation, Label statement: Vitamins and minerals can only be of assistance if dietary intake is inadequate OR Vitamin and/or mineral supplements should not replace a balanced diet.

11

Helps prevent dietary (state vitamin/mineral/nutrient) deficiency

Scientific

Label statement: Vitamins and minerals can only be of assistance if dietary intake is inadequate OR Vitamin and/or mineral supplements should not replace a balanced diet.

12

Maintain/support (state vitamin/mineral) within normal range

Scientific

Label statement: Vitamins and minerals can only be of assistance if dietary intake is inadequate OR Vitamin and/or mineral supplements should not replace a balanced diet.

13

Maintain/support (state vitamin/mineral/nutrient) levels in the body

Scientific or Traditional

If product is indicated for supplementation, Label statement: Vitamins and minerals can only be of assistance if dietary intake is inadequate OR Vitamin and/or mineral supplements should not replace a balanced diet.

14

Maintain/support absorption of dietary (state vitamin/mineral/nutrient)

Scientific

Label statement: Vitamins and minerals can only be of assistance if dietary intake is inadequate OR Vitamin and/or mineral supplements should not replace a balanced diet.

Table 10 – Indications relating to the reproductive system

Column 1