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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.
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 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
Complaint details 1. Product and Sponsor
Product name: Enervite Recovery Enhance Sponsor: Health Spring Australia Address: 40-60 Bellona Avenue, Regents Park, NSW, 2143 ARTG no: 309239 Product Ingredients: ascorbic acid 200 mg, cyanocobalamin 20 microgram, cysteine hydrochloride 180 mg, glutamine 30 mg, glycine 40 mg, leucine 213 mg, lysine hydrochloride 50 mg, Pueraria lobata 150 mg, Equivalent: Pueraria lobata 1.05 g, pyridoxine hydrochloride 60 microgram, Equivalent: pyridoxine 49.36 microgram, taurine 5 mg, thiamine hydrochloride 60 microgram. Permitted indication:
• 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
Advertisement type: e.g. Internet – Web site
Accessed on: 9 July 2020
URL(s) listed (screen shots appended) • https://www.enervite.com.au/product/recovery-enhance/ • https://www.chemsave.com.au/enervite-recovery-enhance-12-effervescent-tablets.html
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’.
7 https://www.tga.gov.au/sites/default/files/tga-stakeholder-survey-2019.pdf
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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.
2. Product and Sponsor Product name: Life Biotech Pty Ltd, ‘NadVita N+ Hangover Relief Sponsor: Life Biotech Pty Ltd Address: Suite 601 815 Pacific Highway, Chatswood, NSW, 2067 ARTG no: 314758 Product Ingredients: alanine 10.5 mg, ascorbic acid 11.25 mg, asparagine 150 microgram, calcium pantothenate 1.37 mg, cysteine hydrochloride monohydrate 150 microgram, d-alpha-tocopheryl acid succinate 850 microgram, ferrous fumarate 296.6 microgram, Equivalent: iron 97.5 microgram, glutamine 150 microgram, glycine 3 mg, histidine 150 microgram, isoleucine 7.5 mg, leucine 7.5 mg, lysine hydrochloride 150 microgram, magnesium aspartate dihydrate 284 microgram, Equivalent: magnesium 21 microgram, methionine 150 microgram, nicotinamide 25 mg, phenylalanine 150 microgram, potassium chloride 54.89 mg, Equivalent: potassium 28.71 mg, proline 150 microgram, Pueraria lobata 150 mg, Equivalent: Pueraria lobata 1.5 g, riboflavin 325 microgram, serine 1.5 mg, Silybum marianum 85.71 mg, Equivalent: Silybum marianum 6 g, sodium chloride 611 microgram, thiamine nitrate 10.82 mg, threonine 150 microgram, tyrosine 150 microgram, valine 7.5 mg.
Permitted indication:
• 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.
Advertisement type: e.g. Internet – Web site
Accessed on: 9 July 2020
URL(s) listed (screen shots appended) • https://lifebiotech.com.au/product/hangover-relief/ • https://www.mrvitamins.com.au/nadvita-9354721000063 • https://www.amazon.com.au/Nadvita-Hangover-Support-Supplement-Capsules/dp/B081FGQV4L
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).
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Complaint to TGA – Newly listed and past hangover product complaints
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.
Additional matters The TGA should monitor all new entries on the ARTG to detect and deal with obvious regulatory violations.
The following permissible indications on Table 5 of the Therapeutic Goods (Permissible Indications) Determination (No. 2) 20198 should be disallowed:
No indication Evidence Other requirement
42 Decrease/reduce/relieve symptoms associated with occasional overindulgence
Scientific or Traditional
Product presentation must not encourage excessive or harmful consumption of alcohol or other toxic substances.
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
92 Hepatoprotectant/protect the liver, Scientific or Traditional
Product presentation must not encourage excessive or harmful consumption of alcohol or other toxic substances
Signed and dated
Dr Ken Harvey MBBS, FRCPA, AM Associate Professor
School of Public Health and Preventive Medicine
Monash University 553 St Kilda Rd
Melbourne VIC 3004 Mobile: +61 419181910
Email: [email protected] WWW: www.medreach.com.au
9 July 2020
8 https://www.legislation.gov.au/Details/F2019L01455
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Complaint to TGA – Newly listed and past hangover product complaints
Appendix (Screen shots with offending claims arrowed)
https://www.enervite.com.au/product/recovery-enhance/
https://www.enervite.com.au/product/recovery-enhance/
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Complaint to TGA – Newly listed and past hangover product complaints
https://lifebiotech.com.au/product/hangover-relief/
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Complaint to TGA – Newly listed and past hangover product complaints
https://www.mrvitamins.com.au/nadvita-9354721000063
https://www.amazon.com.au/Nadvita-Hangover-Support-Supplement-Capsules/dp/B081FGQV4L N.B. Warnings on toll-over image of bottle illegible.
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Complaint to TGA – Newly listed and past hangover product complaints
Products previously complained about, still being promoted
https://www.chemistwarehouse.com.au/search?searchtext=hangover&fh=1
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Complaint to TGA – Newly listed and past hangover product complaints
https://www.chemistwarehouse.com.au/search?searchtext=hangover&fh=1
https://www.chemistwarehouse.com.au/search?searchtext=hangover&fh=1
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Complaint to TGA – Newly listed and past hangover product complaints
https://recoverthol.com.au/
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Complaint to TGA – Newly listed and past hangover product complaints
https://rejoove.co/pages/how-rejoove-works
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Complaint to TGA – Newly listed and past hangover product complaints
https://www.bodyarmour.com.au/
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Complaint to TGA – Newly listed and past hangover product complaints
https://www.bodyarmour.com.au/
