Page 1 of 14 Complaint to TGA – Newly listed and past hangover product complaints Complaint Summary Alcohol use is Australia’s sixth highest risk factor contributing to disease burden. 1 Since July 2018, the following complaints about hangover products have been submitted to the TGA pointing out that there is no evidence that these products work, they are likely to encourage excessive drinking and their listing should be cancelled on public health grounds. • 30 July 2018,BioRevive® Hydrodol® Hangover Relief Products, AC-MW9QQH4F/2018 • 7 August 2018, Multiple Hangover products: Plus Daily Ltd Recoverthol, Clever Health Rejoove, Body Armour Pty Ltd Hangover Relief, D & X Pty Ltd Hey! King Premium Hangover Relief, AC-JY0FXQ3S/2018 • 10 September 2018, Phoenix Pharmaceuticals Rapid Recovery Hangover Relief, AC-EN0KHC4U/2018 • 31 October 2019, Phoenix Pharmaceuticals Rapid Recovery Hangover Relief, AC-BGKWMZBG/2019 (again). This issue has also been raised several times at the Therapeutic Goods Advertising Consultative Committee (TGACC). 2,3 Regardless, the TGA has taken no action and there is no published outcome about these complaints. 4 The TGA has now allowed two additional hangover products to be listed: • Enervite, ‘Recovery Enhance’ ARTG 309239. Product claims, ‘Recovery Enhance’. ’Wake up refreshed!’, ‘Serious help for hangover symptoms’. • Life Biotech Pty Ltd, ‘NadVita N+ Hangover Relief’ ARTG 314758. Product claims, ’Hangover relief’, Relieves symptoms of hangovers’, ‘comprehensive anti-hangover formula is designed to assist the body to effectively eradicate toxins from the system, relieving the symptoms and problems associated with overindulgence’. Not only is there no evidence supporting these claims for the ingredients listed, but the claims made are not present on the permitted indications list and are not in accord with the indication requirements: • ARTG 309239, ‘Product presentation must not imply or refer to drugs/alcohol’. • ARTG 314758, ‘Product presentation must not encourage excessive or harmful consumption of alcohol or other toxic substances’, ‘Product presentation must not imply or refer to drugs/alcohol’. These products breach the Therapeutic Goods Act 1989 s.22(5) and the Therapeutic Goods Advertising Code (No.2) 2018 s. 9(a),(b),(d), 10(a),(c) and (d)(ii). The listing of these products and all other hangover products on the ARTG should be cancelled on public health grounds using s.30 of the Act. Permitted indications 42, 63 and 92 in Table 5 of the Therapeutic Goods (Permissible Indications) Determination (No. 2) 2019 5 should be disallowed. The TGA should monitor all new entries on the ARTG to immediately deal with obvious regulatory violations. 1 https://www.aihw.gov.au/reports/burden-of-disease/impact-risk-factors-burden-disease/contents/overview 2 https://www.medreach.com.au/wp-content/uploads/2020/02/TGACC-Oct-17-2019-An-evaluation-of-the-first-12- months-of-TGA%E2%80%99s-new-advertising-system.pdf 3 https://www.medreach.com.au/wp-content/uploads/2020/03/TGACC-Meeting-Agenda-18-March-2020-Notes-from- Dr-Harvey-Choice.pdf 4 https://compliance.tga.gov.au/investigations-database/ 5 https://www.legislation.gov.au/Details/F2019L01455 6 TGACC Extraordinary Meeting, 12 June 2020
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Complaint Summary · 2020-07-08 · Page 1 of 14. Complaint to TGA – Newly listed and past hangover product complaints Complaint Summary . Alcohol use is Australia’s sixth highest
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Page 1 of 14
Complaint to TGA – Newly listed and past hangover product complaints
Complaint Summary Alcohol use is Australia’s sixth highest risk factor contributing to disease burden.1 Since July 2018, the following complaints about hangover products have been submitted to the TGA pointing out that there is no evidence that these products work, they are likely to encourage excessive drinking and their listing should be cancelled on public health grounds.
• 30 July 2018,BioRevive® Hydrodol® Hangover Relief Products, AC-MW9QQH4F/2018 • 7 August 2018, Multiple Hangover products: Plus Daily Ltd Recoverthol, Clever Health Rejoove, Body
Armour Pty Ltd Hangover Relief, D & X Pty Ltd Hey! King Premium Hangover Relief, AC-JY0FXQ3S/2018 • 10 September 2018, Phoenix Pharmaceuticals Rapid Recovery Hangover Relief, AC-EN0KHC4U/2018 • 31 October 2019, Phoenix Pharmaceuticals Rapid Recovery Hangover Relief, AC-BGKWMZBG/2019
(again).
This issue has also been raised several times at the Therapeutic Goods Advertising Consultative Committee (TGACC).2,3 Regardless, the TGA has taken no action and there is no published outcome about these complaints.4
The TGA has now allowed two additional hangover products to be listed:
• Enervite, ‘Recovery Enhance’ ARTG 309239. Product claims, ‘Recovery Enhance’. ’Wake up refreshed!’, ‘Serious help for hangover symptoms’.
• Life Biotech Pty Ltd, ‘NadVita N+ Hangover Relief’ ARTG 314758. Product claims, ’Hangover relief’, Relieves symptoms of hangovers’, ‘comprehensive anti-hangover formula is designed to assist the body to effectively eradicate toxins from the system, relieving the symptoms and problems associated with overindulgence’.
Not only is there no evidence supporting these claims for the ingredients listed, but the claims made are not present on the permitted indications list and are not in accord with the indication requirements:
• ARTG 309239, ‘Product presentation must not imply or refer to drugs/alcohol’.
• ARTG 314758, ‘Product presentation must not encourage excessive or harmful consumption of alcohol or other toxic substances’, ‘Product presentation must not imply or refer to drugs/alcohol’.
These products breach the Therapeutic Goods Act 1989 s.22(5) and the Therapeutic Goods Advertising Code (No.2) 2018 s. 9(a),(b),(d), 10(a),(c) and (d)(ii).
The listing of these products and all other hangover products on the ARTG should be cancelled on public health grounds using s.30 of the Act. Permitted indications 42, 63 and 92 in Table 5 of the Therapeutic Goods (Permissible Indications) Determination (No. 2) 20195 should be disallowed. The TGA should monitor all new entries on the ARTG to immediately deal with obvious regulatory violations.
The TGA has recently assisted Direct Selling Australia to petition the Health Minister (and the TGACC) to weaken Code provisions for that industry association only (to enhance their profitability).6 However, as shown above, the TGA has consistently failed to address public health and consumer protection concerns of non-industry members of the TGACC.
Complaint to TGA – Newly listed and past hangover product complaints
In short, the TGA has a track record of preferencing industry profitability over consumer protection. It is not surprising that recent surveys of consumers and health professionals show that trust in the TGA as a regulator is abysmal.7
• Maintain/support natural body cleansing/detoxification processes • Maintain/support natural liver cleansing/detoxification processes • Helps enhance/promote general health and wellbeing
Indication Requirements
• 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. • Product presentation must only refer to detoxification in relation to natural body processes.
Warnings
• Vitamins can only be of assistance if the dietary vitamin intake is inadequate. OR Vitamin supplements should not replace a balanced diet
Concerns The TGA has allowed yet another hangover product to be listed, Enervite ‘Recovery Enhance’ ARTG 30923. This product claims, ‘Recovery Enhance’. ’Wake up refreshed!’, ‘Serious help for hangover symptoms’.
Complaint to TGA – Newly listed and past hangover product complaints
Not only is there no evidence supporting these claims for the ingredients listed, but the claims made are not present on the permitted indications list and they are not in accord with the indication requirement, ‘Product presentation must not imply or refer to drugs/alcohol’.
This product is in breach of the Therapeutic Goods Act 1989 s.22(5) and the Therapeutic Goods Advertising Code (No.2) 2018 s. 9(a),(b),(d), 10(a),(c),(d)(ii).
The listing of this product and all other hangover products on the ARTG should be cancelled on public health grounds using s.30 of the Act.
• Antioxidant/Reduce free radicals formed in the body • Maintain/support collagen health • Traditionally used in Western herbal medicine to maintain/support natural body
cleansing/detoxification processes in healthy individuals • Maintain/support energy levels • Maintain/support general health and wellbeing • Hepatoprotectant/protect the liver in healthy individuals • Traditionally used in Western herbal medicine to maintain/support healthy liver function in healthy
individuals • Traditionally used in Western herbal medicine to aid/assist healthy liver regeneration in healthy
individuals • Traditionally used in Chinese medicine to helps decrease/reduce/relieve symptoms of occasional
hangovers in healthy individuals • Traditionally used in Western herbal medicine to decrease/reduce/relieve symptoms associated with
occasional overindulgence in healthy individuals • Maintain/support immune system health in healthy individuals • Helps prevent dietary (state vitamin/mineral/nutrient) deficiency • Maintain/support nervous system function
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Complaint to TGA – Newly listed and past hangover product complaints
Indication Requirements
• Product presentation must not imply or refer to chronic fatigue syndrome. • Product presentation must not imply or refer to disease in any body organ, in particular the kidney
or liver. • Product presentation must not imply or refer to serious immunological diseases. • Product presentation must not imply or refer to mental illnesses, disorders or conditions. • 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. • Product presentation must not imply or refer to liver disease, such as cirrhosis, hepatitis. • Product presentation must only refer to detoxification in relation to natural body processes. • 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. • Product presentation must not imply or refer to drugs/alcohol. Warnings
• Contains potassium. If you have kidney disease or are taking heart or blood pressure medicines, consult your doctor or pharmacist before use. Keep out of reach of children.
• Vitamins can only be of assistance if the dietary vitamin intake is inadequate. OR Vitamin supplements should not replace a balanced diet.
Concerns The TGA has allowed yet another hangover product to be listed, Life Biotech Pty Ltd, ‘NadVita N+ Hangover Relief’ ARTG 314758.
This product claims, ’Hangover relief’, Relieves symptoms of hangovers’, ‘comprehensive anti-hangover formula is designed to assist the body to effectively eradicate toxins from the system, relieving the symptoms and problems associated with overindulgence’.
Not only is there no evidence supporting these claims for the ingredients listed, but the claims made are not present on the permitted indications list and are not in accord with the indication requirements:
‘Product presentation must not encourage excessive or harmful consumption of alcohol or other toxic substances’, ‘Product presentation must not imply or refer to drugs/alcohol’.
In addition, the advertisements do not contain the mandated warnings.
The advertisements for this product breach the Therapeutic Goods Act 1989 s.22(5) and the Therapeutic Goods Advertising Code (No.2) 2018 s. 9(a),(b),(d), 10(a),(c), (d)(ii) and 12(3).