Attachment 1: Expanded List of Permitted Indications

Therapeutic Goods Administration

Attachment 1: Expanded list of permitted indications

Ref No / Proposed permitted indication / Label disclaimers / Route of admin / Target-QT-action-QA-context / Source / Source indication /
1 / Antioxidant / Oral / 0AO-00-US-00-S00 / SAN08 / Antioxidant
2 / Traditionally used in herbal medicine as a mild antiseptic / Topical / 0AT-MI-US-00-THM / HC / Traditionally used in Herbal Medicine as a mild antiseptic
3 / Helps strengthen bone and tissue in growing and mature users. / Oral / 0BS-00-SN-00-SCO / CALC2 / Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults.
4 / Helps in the development and maintenance of bones and teeth / Oral / 0BT-00-DM-HE-S00 / HC / Helps in the development and maintenance of bones and teeth (optional: "especially in childhood, adolescence and young adulthood").
5 / Helps in the development and maintenance of bones and teeth especially in childhood, adolescence and young adulthood / Oral / 0BT-00-DM-HE-SCA / HC / Helps in the development and maintenance of bones and teeth especially in childhood, adolescence and young adulthood
6 / Helps maintain cell health / Oral / 0CE-HE-MA-HE-S00 / FNFC / Helps to maintain the cell health
7 / Helps in connective tissue formation / Oral / 0CT-00-FO-HE-S00 / HC / Helps in connective tissue formation
8 / Helps to produce and repair connective tissue / Oral / 0CT-00-PD-HE-S00 / HC / Helps to produce and repair connective tissue
9 / Helps strengthen connective tissue / Oral / 0CT-00-SN-HE-S00 / BM17 / Strengthen connective tissue
10 / Supports energy production / Oral / 0EY-00-PR-SU-S00 / SAN10 / Supports energy production
11 / Helps to support a modest reduction in fat mass when used with a program of reduced intake of dietary calories and increased physical activity / Oral / 0FM-MR-SU-HE-S00 / HC / May help to support a modest reduction in fat mass when used with a program of reduced intake of dietary calories and increased physical activity
12 / Supports foetal growth and development / Oral / 0FO-GD-SU-00-S00 / SAN12 / Required for foetal growth and development
13 / Contributes to the normal growth of the foetus / Oral / 0FO-GR-CO-00-S00 / FNFC / Contributes the normal growth of the fetus
14 / Assists in the maintenance of normal healthy blood sugar/glucose balance in healthy individuals. / Oral / 0GB-NH-MA-AS-S00 / BLDGL03 / May assist in the maintenance of normal healthy blood sugar/glucose balance in healthy individuals.
15 / Assists in the maintenance of normal healthy glycaemic controls in healthy individuals. / Oral / 0GC-NH-MA-AS-S00 / BLDGL02 / May assist in the maintenance of normal healthy glycaemic controls in healthy individuals.
16 / Helps normal growth and development / Oral / 0GD-NO-HE-00-S00 / HC / Helps normal growth and development
17 / Assists in the maintenance of normal healthy blood sugar/glucose levels in healthy individuals. / Oral / 0GL-NH-MA-AS-S00 / BLDGL01 / May assist in the maintenance of normal healthy blood sugar/glucose levels in healthy individuals.
18 / Used in herbal medicine as supportive therapy for the promotion of healthy glucose levels / Warning HS, BSL required / Oral / 0GL-HE-PR-SU-NHM / HC / (Used in Herbal Medicine as) supportive therapy for the promotion of healthy glucose levels
19 / Used in Traditional Chinese Medicine (TCM) to relieve gum, mouth and throat complaints / Warning S / Oral / 0GM-CO-RE-00-TCM / HC / Traditionally used in TCM to relieve gum, mouth and throat complaints (Bown 1995a, Bensky and Gamble 1993)
20 / Helps normal growth / Oral / 0GR-NO-HE-00-S00 / HC / Helps normal growth
21 / Helps improve general health / well being / Oral / 0HE-GE-IM-00-S00 / WELL1 / Aids, assists or helps in the maintenance of general well-being
22 / Helps maintain general health / well being / Oral / 0HE-GE-MA-00-S00 / WELL2 / Aids, assists or helps in the improvement of general well-being
23 / Promotes general health. / Oral / 0HE-GE-PR-0-S00 / PERI3 / May assist in maintaining peripheral circulation and promoting general health.
24 / For the maintenance of good health / Oral / 0HE-GO-MA-00-S00 / HC / Source of vitamin A/essential amino acid/essential fatty acids/linoleic acid (LA)/omega-3 fatty acids/omega-6 fatty acids/eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)/Provitamin A for the maintenance of good health
25 / Provides antioxidants for the maintenance of good health / Oral / 0HE-GO-MA-AO-S00 / HC / Provides antioxidants for the maintenance of good health
26 / Helps in the maintenance of good health / Oral / 0HE-GO-MA-HE-S00 / HC / A factor in the maintenance of good health
27 / Used in Traditional Chinese Medicine (TCM) to support the healing of minor injuries / Warning S required / Topical / 0IN-00-HE-PR-TCM / HC / Traditionally used in TCM to promote healing of injuries (Bown 1995a, Bensky and Gamble 1993)
28 / Helps reduce minor inflammation / Warning S required / Oral / 0IN-00-RD-HE-S00 / SAN07 / Antiinflammatory
29 / Traditionally used in herbal medicine to help soothe minor inflammation / Warning S required / Topical / 0IN-MI-SO-HE-THM / HC / Traditionally used in Herbal Medicine to help heal minor cuts and wounds (vulnerary) and to help soothe minor inflammation by topical application
30 / Helps to maintain healthy mucosa / Oral / 0MC-HE-MA-HE-S00 / SAN15/FNFC / Beneficial for healthy skin/helps to maintain skin and mucosa healthy
31 / Traditionally used in herbal medicine as a tonic to strengthen and soothe the mucous tissue of both respiratory and gastro-intestinal tract / Oral / 0MC-RG-SS-TO-T00 / HC / Traditionally used as a tonic to strengthen and soothe the mucous tissue of both respiratory and gastro-intestinal tract (Blumenthal 1998; Hoffman 1996; Felter and Lloyd 1983).
32 / Beneficial to men in satisfying physiological requirements of the male body. / Oral / 0ME-00-BE-00-S00 / MALE2 / Male support. May be beneficial to men in satisfying physiological requirements of the male body.
33 / Balances and supports normal male reproductive function. / Oral / 0ME-00-BS-00-S00 / MALE1 / Male support. Balances and supports normal male physiology and function.
34 / Traditionally used in Ayurveda for memory enhancement / HS / Oral / 0ME-00-EN-00-TAY / HC / Traditionally used in Ayurveda for memory enhancement (Upton 2000, Nadkarni and Nadkarni 1954)
35 / Helps to enhance memory in adults / HS / Oral / 0ME-00-EN-HE-SAD / HC / Helps to enhance memory in adults
36 / Nutritional and herbal support designed to supply masculine needs. / Oral / 0ME-00-SE-00-S00 / MALE3 / Male support. Nutritional and herbal support designed to support and enhance masculine needs.
37 / Increases [fat-free/body/muscle/lean] [mass/size] when used in conjunction with a resistance training regimen and a healthy energy-controlled diet / Oral / 0MM-00-IN-00-S00 / HC / Increases [fat-free/body/muscle/lean] [mass/size] when used in conjunction with a resistance training regimen
38 / Helps to assist in muscle cell repair after exercise / Oral / 0MU-CR-AS-HE-S00 / HC / Helps to assist in muscle cell repair after exercise
39 / Helps to maintain proper muscle function / Oral / 0MU-FU-MA-HE-S00 / HC / Helps to maintain proper muscle function
40 / Assists in the management of the symptoms of over-indulgence such as indigestion, constipation, bloating and fatigue. / Oral / 0OI-00-MG-AS-S00 / GAST11 / May assist in the management of over-indulgence.
41 / Relieves the symptoms of overindulgence such as indigestion, constipation, bloating and fatigue / Oral / 0OI-SY-RE-00-S00 / GAST6 / For the symptomatic relief of overindulgence.
42 / Used in herbal medicine to help enhance physical capacity/performance in cases of physical stress / Oral / 0PC-00-EN-HE-NHM / HC / Used in Herbal Medicine to help enhance physical capacity/performance (in cases of physical stress) (ESCOP 2003 , WHO 1999 , Gross et al. 1995 , Kim et al. 2005 , Schepdael 1993 , Sotaniemi et al. 1995 , Gross et al. 2002 )
43 / Traditionally used in Ayurveda to relieve pain and minor inflammation / Warning S required / Topical / 0PI-00-RE-HE-TAY / HC / Traditionally used in Ayurveda to relieve pain and inflammation, and assist in the healing of minor wounds such as cuts and burns, and minor skin irritations
44 / Traditionally used in herbal medicine as a galactogogue/lactogogue to help promote milk production/secretion / Oral / 0PS-MI-PR-HE-THM / HC / Traditionally used in Herbal Medicine as a galactogogue/lactogogue to help promote milk production/secretion
45 / Used in Traditional Chinese Medicine (TCM) to reinforce qi (vital energy) / Oral / 0QI-00-RI-00-TCM / HC / Used in TCM to reinforce qi, benefit the spleen and lung, relieve symptoms of thirst due to impairment of body fluids and internal heat
46 / Used inTraditional Chinese Medicine (TCM) to promote circulation of qi (vital energy) / Oral / 0QI-CI-PR-00-TCM / HC / Traditionally used in TCM to promote circulation of qi (Long 1998, Bensky and Gamble 1993)
47 / Used in Traditional Chinese Medicine (TCM) for deficiency of qi (vital energy) and yin, internal heat, cough, cools heat from yin deficiency, tiredness, dry and thirsty mouth and throat / Warning S, COU1 & COU2 required / Oral / 0QI-DE-US-00-TCM / HC / Used in Traditional Chinese Medicine (TCM) for deficiency of qi and yin, internal heat, cough and asthma, bloody phlegm, fire in the deficiency syndrome, dysphoria and tiredness, dry and thirsty mouth and throat (PRC 2005)
48 / Used in Traditional Chinese Medicine (TCM) to promote the flow of qi (vital energy) / Oral / 0QI-FL-PR-00-TCM / HC / Used in TCM to eliminate blood stasis, promote the flow of qi and relieve pain of menstruation due to blood stasis
49 / Used in Traditional Chinese Medicine (TCM) to augment the protective Qi (vital energy) and stabilize the exterior: for deficiency with spontaneous sweating / Warning S required / Oral / 0QI-PR-AG-00-TCM / HC / Used in TCM to augment the protective Qi and stabilize the exterior: for deficiency with spontaneous sweating (PPRC 2000, Bensky and Gamble 1993)
50 / Traditionally used in Ayurveda as Rasayana (rejuvenative tonic) / Oral / 0RA-00-US-00-TAY / HC / Traditionally used in Ayurveda as Rasayana (rejuvenative tonic) (Sukh 2005, API 2001, Upton 2000)
51 / Used as a sleep aid / Oral / 0SL-00-AI-00-N00 / HC / Used as a sleep aid (Soulairac and Lambinet 1977; Wyatt et al. 1971).
52 / Traditionally used in Ayurveda as a sleep aid / Oral / 0SL-00-AI-00-TAY / HC / Traditionally used in Ayurveda as a sleep aid (Khare 2004, Upton 2000)
53 / Traditionally used in herbal medicine as a mild sedative and/or sleep aid / Oral / 0SL-00-AI-00-THM / HC / Traditionally used in Herbal Medicine as a mild sedative and/or sleep aid (hypnotic)
54 / Traditionally used in herbal medicine as a sleep aid / Oral / 0SL-00-AI-00-TWH / HC / Traditionally used (in Western herbalism) as a sleep aid (Ellingwood 1983; Felter and Lloyd 1983; BHP 1983).
55 / Helps to promote sleep / Oral / 0SL-00-PR-HE-S00 / HC / Helps to promote sleep / used as a sleep aid
56 / Traditionally used in herbal medicine as a sleep aid to help promote sleep / Oral / 0SL-00-PR-HE-THM / HC / Traditionally used in Herbal Medicine as a sleep aid to help promote sleep
57 / Traditionally used in herbal medicine as a calmative and/or sleep aid / Oral / 0SL-CA-AI-00-THM / HC / Traditionally used in Herbal Medicine as a calmative and/or sleep aid
58 / Traditionally used in herbal medicine as a sleep aid (in cases of restlessness or insomnia due to mental stress) / Oral / 0SL-RI-AI-00-S00 / HC / Traditionally used in Herbal Medicine as a sleep aid (in cases of restlessness or insomnia due to mental stress)
59 / Traditionally used in herbal medicine as a sleep aid (in cases of restlessness or insomnia due to stress) / Oral / 0SL-RI-AI-00-THM / HC / Traditionally used in Herbal Medicine as a sleep aid (in cases of restlessness or insomnia due to stress)
60 / Traditionally used in Traditional Chinese Medicine (TCM) to support the healing of minor sores / Topical / 0SO-00-HE-PR-TCM / HC / Traditionally used in TCM to promote healing of sores
61 / Herbal medicinal product in conditions in which easy defaecation with soft stool is desirable / Oral / 0SS-00-US-00-NHM / EMA / Herbal medicinal product in conditions in which easy defaecation with soft stool is desirable, e.g. In cases of painful defaecation after rectal or anal surgery, anal fissures or haemorrhoids
62 / Improves stamina and endurance / Oral / 0ST-00-IM-00-S00 / SAN13 / Improves stamina and endurance
63 / Traditionally used in herbal medicine to induce sweating / Oral / 0SW-00-IN-00-T00 / HC / Traditionally used to induce sweating (a diaphoretic) (Hoffman 1996; Grieve 1971).
64 / Traditionally used in herbal medicine to induce sweating (diaphoretic) / Oral / 0SW-00-IN-00-THM / HC / Traditionally used in Herbal Medicine to induce sweating (diaphoretic)
65 / Traditional herbal medicinal product for relief of excessive sweating / Warning S required / Topical / 0SW-EX-RE-00-THM / EMA / Traditional herbal medicinal product for relief of excessive sweating
66 / Traditional herbal medicinal product for management of small superficial wounds / Warning S required / Topical / 0SW-SM-MG-00-THM / EMA / Traditional herbal medicinal product for treatment of small superficial wounds
67 / Helps in tissue formation / Oral / 0TI-00-FO-HE-S00 / HC / Helps in tissue formation
68 / Used in Traditional Chinese Medicine (TCM) to support tissue regeneration / Topical / 0TI-00-RE-PR-TCM / HC / Traditionally used in TCM to promote tissue regeneration