Therapeutic Goods (Permissible Indications) Determination (No. 1) 2021 (Cth)
Therapeutic Goods (Permissible Indications) Determination (No. 1) 2021
I, Adam Cook, as delegate of the Minister for Health, make the following determination.
Dated 19 January 2021
Adam Cook
Acting Assistant Secretary
Complementary and Over the Counter Medicines Branch
Health Products Regulation Group
Department of Health
Contents
1 Name........................................................................................................................................ 1
2 Commencement........................................................................................................................ 1
3 Authority.................................................................................................................................. 1
4 Definitions................................................................................................................................ 1
5 Permissible indications............................................................................................................. 2
6 Requirements in relation to permissible indications.................................................................. 3
7 Repeals..................................................................................................................................... 3
Schedule 1—Specified permissible indications and requirements applying to these indications when contained in a medicine 4
Table 1—Indications relating to general health or body parts 4
Table 2—Indications relating to bone 19
Table 3—Indications relating to the cardiovascular system 25
Table 4—Indications relating to the endocrine system 29
Table 5—Indications relating to the gastrointestinal system 30
Table 6—Indications relating to the immune system 44
Table 7—Indications relating to muscles 46
Table 8—Indications relating to the nervous system 49
Table 9—Indications relating to nutrition 55
Table 10—Indications relating to the reproductive system 58
Table 11—Indications relating to the respiratory system 66
Table 12—Indications relating to skin 75
Table 13—Indications relating to the urinary system 82
Table 14—Traditional Chinese medicine indications 84
Table 15—Traditional Ayurvedic medicine indications 108
Schedule 2—Repeals 120
Therapeutic Goods (Permissible Indications) Determination (No.2) 2019 120
1 Name
This instrument is the Therapeutic Goods (Permissible Indications) Determination (No. 1) 2021.
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 this instrument is registered. | |
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 section 26BF 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) indications;
(c) label;
(d) medicine;
(e) presentation;
(f) Register; and
(g) Therapeutic Goods Advertising Code.
In this instrument:
Act means the Therapeutic Goods Act 1989.
code tables means the tables accessed via the Code Tables item in the Public TGA Information menu in TGA eBusiness Services, as in force or existing at the time this instrument commences.
dentist means a person registered as a dentist under a law of a State or Territory that provides for the registration of dentists.
doctor means a medical practitioner.
Evidence Guidelines means the document titled Evidence guidelines: Guidelines on the evidence required to support indications for listed complementary medicines, published by the Therapeutic Goods Administration, as in force or existing at the time this instrument commences.
Note: The Evidence Guidelines are published at professional means a person mentioned in section 42AA of the Act.
medically diagnosed, in relation to a disease, ailment, defect or injury, means a disease, ailment, defect or injury that is diagnosed by a suitably qualified medical practitioner.
medical practitioner means a person registered as a medical practitioner under a law of a State or Territory that provides for the registration of medical practitioners.
Regulations means the Therapeutic Goods Regulations 1990.
scientific, in relation to the type of evidence for an indication, means evidence that is based on scientific research and quantifiable data, as described in the Evidence Guidelines.
Note: Scientific evidence includes relevant clinical trials on humans and systematic reviews.
serious, in relation to a form of a disease, ailment, defect or injury, has the same meaning as in section 28 of the Therapeutic Goods Advertising Code, in relation to a form of a disease, condition, ailment or defect.
TGA eBusiness Services means TGA eBusiness Services on the Therapeutic Goods Administration’s website which may be accessed on the internet at Goods Administration has the same meaning as in the Regulations.
traditional, in relation to the type of evidence for an indication, means evidence of traditional use in a recognised paradigm outside modern conventional medicine, as described in the Evidence Guidelines.
Note: Traditional evidence is a term of broad application and applies to different traditional paradigms, for example, traditional Ayurvedic medicine, traditional Chinese medicine and Western herbal medicine.
traditional Ayurvedic medicine, in relation to the type of evidence for an indication, means evidence that is based on traditional use in the Ayurvedic medicine paradigm.
traditional Chinese medicine or TCM, in relation to the type of evidence for an indication, means evidence that is based on traditional use in the traditional Chinese medicine paradigm.
traditional use has the same meaning as in the Regulations.
5 Permissible indications
The following indications are covered by this instrument under paragraph 26BF(1)(a) of the Act:
(a) each indication specified in an item in column 2 of a table in Schedule 1; and
(b) each indication specified in an item in column 2 of a table in Schedule 1, as modified by the use of one or more qualifying statements set out in the code tables under one of the following headings:
(i) traditional context qualifiers;
(ii) population qualifiers;
(iii) time of use qualifiers;
(iv) in relation to an indication that is based on TCM evidence¾TCM pattern qualifiers.
6 Requirements in relation to permissible indications
(1) The requirements in this section are specified in relation to an indication covered by this instrument under paragraph 26BF(1)(b) of the Act.
(2) In relation to a medicine:
(a) the indication mentioned in an item in column 2 of a table in Schedule 1 (the relevant indication) may only be used for the medicine if that indication is supported by evidence of the type that is specified in column 3 of the item; and
(b) the requirements, if any, in relation to the relevant indication, set out in column 4 of that item must be met.
(3) If the wording of an indication is varied on the label of a medicine, then the indication, as varied, must not:
(a) change the meaning or intent of the indication as specified in an item in column 2 of a table in Schedule 1; and
(b) infer or imply that the medicine is for the treatment of a serious form of a disease, ailment, defect or injury; and
(c) infer or imply that the medicine is for preventing or curing a disease, ailment, defect or injury.
(4) If two or more indications are combined on the label of a medicine to form simple sentences where appropriate in the circumstances, then the indication, as combined, must not:
(a) change the meaning or intent of each indication as specified in an item in column 2 of a table in Schedule 1; and
(b) infer or imply that the medicine is for the treatment of a serious form of a disease, ailment, defect or injury; and
(c) infer or imply that the medicine is for preventing or curing a disease, ailment, defect or injury.
(5) If an indication in relation to a medicine is modified by one or more qualifying statements in accordance with paragraph 5(b) (whether or not the indication is varied or combined as described in subsection (3) or (4)), then:
(a) each qualifying statement must be set out on the label of the medicine; and
(b) the indication, as modified, varied or combined, must not infer or imply that a medicine is for the treatment of a serious form of a disease, ailment, defect or injury.
(6) If an indication in relation to a medicine is supported by traditional evidence, then:
(a) the indication must be qualified with an appropriate traditional context qualifier as set out in the code tables; and
(b) the traditional context qualifier mentioned in paragraph (a) must be set out on the label of the medicine.
7 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 contained in a medicine
Note: See sections 5 and 6.
Table 1—Indications relating to general health or body parts
Indications relating to general health or body parts
Column 1
Column 2
Column 3
Column 4
Item
Indication
Type of evidence
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 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 chronic fatigue syndrome.
55
Enhance/promote weight gain
Scientific
56
Enhance/promote/increase temporary weight loss
Scientific
Label statement: For healthy weight maintenance it is recommended to continue a reduced intake of dietary calories and increased physical activity
Label statement: Weight loss may not be maintained for longer than 3 months
Label statement: When used in conjunction with a program of reduced intake of dietary calories and increased physical activity.57
Enhance/promote/physical endurance/capacity/stamina
Scientific or Traditional
Product presentation must not imply or refer to chronic fatigue syndrome.
58
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.
59
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.
60
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.
61
Helps decrease/reduce build-up of dental plaque
Scientific or Traditional
62
Helps decrease/reduce/relieve cartilage loss/wear/tear/damage
Scientific
Product presentation must not imply or refer to any form of arthritis or osteoarthritis unless qualified as mild.
Product presentation must not imply or refer to bone disease or disorders e.g. rheumatoid arthritis, juvenile arthritis, debilitating osteoarthritis, osteoporosis.63
Helps decrease/reduce/relieve cold sensations in the lower back
Traditional
Label statement: If symptoms persist, talk to your health professional.
64
Helps decrease/reduce/relieve heat sensations in the extremities
Traditional
Label statement: If symptoms persist, talk to your health professional.
65
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.66
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.
67
Helps enhance/promote body energy reserves
Scientific or Traditional
Product presentation must not imply or refer to chronic fatigue syndrome.
68
Helps enhance/promote body tissue repair/regeneration
Scientific or Traditional
69
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.
70
Helps enhance/promote collagen formation
Scientific
71
Helps enhance/promote connective tissue health
Scientific or Traditional
72
Helps enhance/promote general health and wellbeing
Scientific or Traditional
73
Helps enhance/promote gum health
Scientific or Traditional
74
Helps enhance/promote healthy growth and development
Scientific or Traditional
75
Helps enhance/promote healthy teeth enamel
Scientific
76
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.
77
Helps enhance/promote teeth health
Scientific or Traditional
78
Helps enhance/promote teeth strength
Scientific or Traditional
79
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.
80
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.
81
Helps enhance/promote/increase vitality
Scientific or Traditional
Product presentation must not imply or refer to chronic fatigue syndrome.
82
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.
83
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.
84
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.
85
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.
86
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.87
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.
88
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.
89
Helps maintain/support healthy acid/alkali balance in the body
Scientific
90
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.
91
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.
92
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.93
Helps maintain/support hearing development
Scientific
Product presentation must not imply or refer to neurological conditions or developmental delays.
94
Helps prevent tooth decay/dental carries/cavities in conjunction with good oral hygiene
Scientific or Traditional
95
Helps reduce occurrence of mouth ulcers
Scientific or Traditional
Label statement: If symptoms persist, talk to your health professional.
96
Helps reduce occurrence of symptoms of jet lag
Scientific or Traditional
97
Helps reduce occurrence of teething/tooth pain
Scientific or Traditional
Label statement: If symptoms persist, talk to your health professional.
98
Helps reduce/decrease free radical damage to body cells
Scientific
99
Helps relieve excessive lacrimation
Scientific or Traditional
Label statement: If symptoms persist, talk to your health professional.
100
Helps restore body electrolyte balance
Scientific
101
Helps temporarily relieve light sensitivity
Scientific or Traditional
Label statement: If symptoms persist, talk to your health professional.
102
Longevity tonic
Traditional
103
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.
104
Maintain/support body electrolyte balance
Scientific
105
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.
106
Maintain/support body mucous membrane health
Scientific or Traditional
107
Maintain/support body tissue repair/regeneration
Scientific or Traditional
108
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.109
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.
110
Maintain/support collagen formation
Scientific
111
Maintain/support collagen health
Scientific
112
Maintain/support connective tissue health
Scientific or Traditional
113
Maintain/support dental/periodontal health
Scientific or Traditional
114
Maintain/support ear health
Scientific or Traditional
115
Maintain/support energy levels
Scientific or Traditional
Product presentation must not imply or refer to chronic fatigue syndrome.
116
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.
117
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.
118
Maintain/support general health and wellbeing
Scientific or Traditional
119
Maintain/support gum health
Scientific or Traditional
120
Maintain/support hair growth
Scientific or Traditional
121
Maintain/support hair health
Scientific or Traditional
122
Maintain/support hair strength/thickness
Scientific or Traditional
123
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.
124
Maintain/support healthy body organ functions
Traditional
Product presentation must not imply or refer to disease in any body organ.
125
Maintain/support healthy body tissues
Scientific or Traditional
126
Maintain/support healthy ear function
Scientific or Traditional
127
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.
128
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.
129
Maintain/support healthy growth and development
Scientific or Traditional
130
Maintain/support healthy hearing
Scientific or Traditional
131
Maintain/support healthy mouth flora
Scientific or Traditional
132
Maintain/support healthy teeth
Scientific or Traditional
133
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.
134
Maintain/support nail health/strength/thickness
Scientific or Traditional
135
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.136
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.137
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.138
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.139
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.140
Maintain/support oral health
Scientific or Traditional
141
Maintain/support oral mucous membrane health
Scientific or Traditional
142
Maintain/support physical endurance/capacity/stamina
Scientific or Traditional
Product presentation must not imply or refer to chronic fatigue syndrome.
143
Maintain/support scalp health
Scientific or Traditional
144
Maintain/support spleen health
Scientific or Traditional
Product presentation must not imply or refer to disease in any body organ.
145
Maintain/support teeth enamel health
Scientific or Traditional
146
Maintain/support teeth mineralisation
Scientific
147
Maintain/support teeth strength
Scientific or Traditional
148
Maintain/support vitality
Scientific or Traditional
Product presentation must not imply or refer to chronic fatigue syndrome.
149
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.150
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.151
Nourish the body
Scientific or Traditional
152
Nutritive tonic
Traditional
153
Reduce risk of head lice attaching to hair
Scientific or Traditional
154
Regulate body water/fluid
Scientific or Traditional
155
Rejuvenating tonic
Traditional
156
Relieve clammy/sweaty palms and soles
Scientific or Traditional
Label statement: If symptoms persist, talk to your health professional.
157
Relieve dry eyes
Scientific or Traditional
Label statement: If symptoms persist, talk to your health professional.
158
Relieve dry mouth
Scientific or Traditional
Label statement: If symptoms persist, talk to your health professional.
159
Relieve eye discomfort
Scientific or Traditional
Label statement: If symptoms persist, talk to your health professional.
160
Relieve eye redness
Scientific or Traditional
Label statement: If symptoms persist, talk to your health professional.
161
Relieve eye soreness
Scientific or Traditional
Label statement: If symptoms persist, talk to your health professional.
162
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 chronic fatigue syndrome.
Product presentation must not imply or refer to mental illnesses, disorders or conditions.163
Relieve itchy ears
Scientific or Traditional
Label statement: If symptoms persist, talk to your health professional.
164
Relieve itchy eyes
Scientific or Traditional
Label statement: If symptoms persist, talk to your health professional.
165
Relieve mild tissue oedema
Scientific or Traditional
Label statement: If symptoms persist, talk to your health professional.
166
Relieve sore tongue
Scientific or Traditional
Label statement: If symptoms persist, talk to your health professional.
167
Relieve tongue dryness
Scientific or Traditional
Label statement: If symptoms persist, talk to your health professional.
168
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 chronic fatigue syndrome.169
Restorative tonic
Traditional
170
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.171
Soften ear wax
Scientific or Traditional
Label statement: If symptoms persist, talk to your health professional.
172
Soothe/relieve mouth/oral irritation
Scientific or Traditional
Label statement: If symptoms persist, talk to your health professional.
173
Sudorific/diaphoretic/enhance/promote sweating/perspiration
Scientific or Traditional
Label statement: If symptoms persist, talk to your health professional.
174
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.175
Trophorestorative/restore organ health
Traditional
Product presentation must not imply or refer to disease in any body organ.
Table 2—Indications relating to bone
Indications relating to bone
Column 1 Column 2 Column 3
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Schedule 2—Repeals
Note: See section 7.
Therapeutic Goods (Permissible Indications) Determination (No. 2) 2019
1. The whole of the instrument
Repeal the instrument
0
0
0