summary...1. the testimonials (‘true stories out customers have shared with us’) 1.1. tru niagen...

Complaint to TGA - Ripple Pty Ltd, Tru Niagen, ARTG 328365

Summary From 1 July 2020, medicine advertisements in specified media do not need pre-approval from the Therapeutic Goods Administration (TGA). The appended advertisement appeared in The Age on 8 July 2020. I understand it also appeared in the Sydney Morning Herald the previous day. It is the first advertisement for a listed medicine I have seen in mainstream media since the need for pre-approval has ceased. It has serious problems despite carrying an approval number: CHPAUS 31728-0620.

The name of the active ingredient (Vitamin B3) has been deleted from the pack shot, the mandatory statement for vitamins is missing, the testimonials are problematic, the scientific citations are incomplete, and the claims misrepresent published science. The web site advertisement is even worse. 1 The product is expensive ($50-$60) for a month’s supply and is ripping off consumers with misleading and deceptive claims.2

It is a common logical fallacy for the complementary medicine industry to imply that because a product ingredient has an important role in the body (and may decline with age), taking it as a supplement to boost levels will provide additional benefit over and above consuming a healthy diet. This needs to be proven, not implied. These advertisements state that taking nicotinamide riboside chloride (Vitamin B3) long-term will boost NAD+ levels and they clearly imply this will provide people with more energy, repair tissue, regenerate cells and postpone aging.

I allege these advertisements breach the Therapeutic Goods Advertising Code (No. 2) 2018, s.9(a), (b), (d), 10(a), 15(3)(a), 16(3)(ii), 17 & 25. I insist that the TGA provides a timely public assessment (determination) about these allegations.

Because of the large number of Code breaches found, and the need to send a clear message to industry that advertisements that no longer require-pre-approval are carefully scrutinised, an example should be made of this company. Direction notices to remove unsupported representations and publish a retraction are required. Infringement notices (fines) should be instituted. Misinformation must be corrected and penalties for breaking the law seen to be applied.

Complaint details

Print advertisement in mainstream media

1. The testimonials (‘true stories out customers have shared with us’)

1.1. Tru Niagen (containing nicotinamide riboside chloride, a form of Vitamin B3) was listed on ARTG on 1 January 2020. However, two testimonials in this advertisement state that ‘Nicholas’ had been using it, ‘since March 2019’ and ‘Frank’ had been taking it for, ‘a couple of years’. It seems impossible that these testimonials can relate to the listed Australian therapeutic good.

1.2. The TGA needs to ask the sponsor if they hold statutory declarations from Ripple Pty Ltd that validates all the testimonial requirements of s.17 of the Code.

1 https://www.truniagen.com.au/ 2 https://www.truniagen.com.au/products/buy-tru-niagen

https://www.truniagen.com.au/

https://www.truniagen.com.au/products/buy-tru-niagen


2. The claims:

2.1. The advertisement claims:

'To maintain your energy and general wellness, healthy levels of NAD+ are vital'

'Boost NAD+ levels to support:

Energy Health and wellbeing Tissue repair Cellular regeneration.

I am unaware of any human scientific studies that show that boosting NAD+ levels with nicotinamide riboside chloride produces the benefits claimed above and in the testimonials. The sponsor must be asked for the evidence supporting these claims.

2.2. The claim, 'Tru Niagen provides the support your cellular metabolism needs' is not in accord with the permitted indications for ARTG no: 328365

3. Scientific references

3.1. These are not sufficiently legible to comply with s.15(3) of the Code. They also lack the name of the journal in which they are to be found.

4. Mandatory Vitamin indications requirements

4.1. The requirements listed on the ARTG public summary (328365) and required by s.25 of the Code are missing

In summary, I allege that this advertisement in mainstream media breaches the Therapeutic Goods Advertising Code (No. 2) 2018, s.9(a), (b), (d), 10(a), (c), 15(3)(a), 17 & 25. A retraction is required, published in all the media in which this advertisement appeared.

Internet advertisement The domain name: truniagen.com.au is registered to ChromaDex, Inc, registrant ID: ACN 1914984.3 That ACN number has no matching records (and should have 9 digits).4

The Sponsor of this product has the following ASIC entry:5

3 https://whois.auda.org.au/ 4 https://abr.business.gov.au/Search/ResultsActive?SearchText=1914984 5 https://connectonline.asic.gov.au/RegistrySearch/faces/landing/ panelSearch.jspx?searchText=063405265&searchType=OrgAndBusNm&_adf.ctrl-state=11whfjjcqg_15

https://whois.auda.org.au/

https://abr.business.gov.au/Search/ResultsActive?SearchText=1914984

https://connectonline.asic.gov.au/RegistrySearch/faces/landing/panelSearch.jspx?searchText=063405265&searchType=OrgAndBusNm&_adf.ctrl-state=11whfjjcqg_15

https://connectonline.asic.gov.au/RegistrySearch/faces/landing/panelSearch.jspx?searchText=063405265&searchType=OrgAndBusNm&_adf.ctrl-state=11whfjjcqg_15


Concerns

The images and text in this Internet advertisement (appended) state:

1. NAD (or nicotinamide adenine dinucleotide) is a vital resource found in all living cells. TRUE.

2. Overeating, or drinking alcohol can stress our system and cause NAD to decline. UNPROVEN.

3. Some scientists even think this NAD decline plays a major role in how we age. UNPROVEN.

4. NAD declines up to 50% between ages 40-60. The reference cited is Massudi el al, 2012. 6 This study analysed human skin removed for surgical procedures from 49 subjects of various ages. The graph portrayed in the advertisement is an extrapolation from the published data and fails to show the considerable difference between males and female subjects reported in the paper. INSUFFICENT EVIDENCE, BAD CITATION, GRAPH IN ADVERTISEMENT DOES NOT REFLECT THAT THE PAPER.

5. The images under this graph also implies that this decline is responsible for senescence. UNPROVEN.

6. Tru Niagen® increases NAD by 40–50% after 8 weeks‡ NO REFERENCE GIVEN (but there is one study that supports this statement).7

7. When NAD levels are low, our cells have a harder time producing the energy they need to maintain our health as we age. UNPROVEN.

8. Increase your NAD levels, fuel your body and support health and wellbeing. UNPROVEN.

9. Massudi el al, 2012 concluded, ‘'the therapeutic benefit of this approach (increasing NAD + stores) in humans is yet to be established'. ADVERTISEMENT DOES NOT REFLECT THE AUTHORS CONCLUSION.

10. NICOTINAMIDE RIBOSIDE (NR) STUDIES HAVE MORE THAN DOUBLED SINCE 2014. But no human studies have shown the benefits claimed.

11. We designed a supplement that would, Live it up. Do the things you love longer. Own your time. Make age only just a number. UNPROVEN AND IMPLIES THE PRODUCT DELAYS SENESCENCE.

12. Four testimonials in this advertisement are dated 2019. Tru Niagan was listed on ARTG on 1 January 2020.It seems impossible that these testimonials can relate to the listed Australian therapeutic good. The TGA needs to ask the sponsor if they hold statutory declarations from Ripple Pty Ltd that validates all the testimonial requirements of s.17 of the Code.

In addition, the paid spokesperson disclaimer on one of the testimonial images is illegible, endorsement by the chief scientific advisor is a breach of s.16(3)(ii) of the Code and the mandatory statements required by s.25 of the Code are missing.

Finally, just because an ingredient has an important role in the body (and may decline with age) does not mean that taking this ingredient as a supplement, over and above a healthy diet, will benefit normal people. The latter needs to be proven, not merely implied.

I allege that this advertisement breaches the Therapeutic Goods Advertising Code (No. 2) 2018, s.9(a), (b), (d), 10(a), (c), 15(3)(a), 16(3)(ii), 17 & 25

6 https://pubmed.ncbi.nlm.nih.gov/22848760/ 7 https://www.nature.com/articles/s41598-019-46120-z

https://pubmed.ncbi.nlm.nih.gov/22848760/

https://www.nature.com/articles/s41598-019-46120-z


Because of the large number of Code breaches found, and the need to send a clear message to industry that advertisements that no longer require-pre-approval are carefully scrutinised, an example should be made of this company. Direction notices to remove unsupported representations and publish a retraction are required. Infringement notices (fines) should be instituted. Misinformation must be corrected and penalties for breaking the law seen to be applied.

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 12 July 2020

mailto:[email protected]

http://www.medreach.com.au/

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Pack shot

Bottle

Screen Shots (taken 11 July 2020)




https://www.truniagen.com.au/?

https://www.truniagen.com.au/pages/the-science-behind-the-discovery




Figure 4. Correlation between NAD+ levels and Age in (A) Males (B) Females. (A)

https://journals.plos.org/plosone/article/comments?id=10.1371/journal.pone.0042357

https://journals.plos.org/plosone/article/comments?id=10.1371/journal.pone.0042357


https://www.truniagen.com.au/pages/frequently-asked-questions


https://www.truniagen.com.au/pages/frequently-asked-questions



https://www.truniagen.com.au/products/tru-niagen



https://www.truniagen.com.au/? N.B. paid spokesperson disclaimer illegible.




Public Summary Summary for ARTG Entry: 328365 TRU NIAGEN

ARTG entry for Medicine Listed

Sponsor Ripple Pty Ltd

Postal Address Unit 32-33 110 Bourke Road, Alexandria, NSW, 2015 Australia

ARTG Start Date 8/01/2020

Product Category Medicine

Status Active

Approval Area Listed Medicines

Conditions

Colouring agents used in listed medicine for ingestion, other than those listed for export only under section 25 of the Act, shall be only those included in the listof 'Colourings permitted in medicines for oral use'.

The sponsor shall keep records relating to this listed medicine as are necessary to: (a) Expedite recall if necessary of any batch of the listed medicine, (b) Identify the manufacturer(s) of each batch of the listed medicine. Where any part of or step in manufacture in Australia of the listed medicine is sub-contractedto a third party who is not the sponsor, copies of relevant Good Manufacturing Practice agreements relation to such manufacture shall be kept.

The sponsor shall retain records of the distribution of the listed medicine for a period of five years and shall provide the records or copies of the records to the Complementary Medicines Branch, Therapeutic Goods Administration, upon request.

The sponsor of the listed medicine must not, by any means, intentionally or recklessly advertise the medicine for an indication other than those accepted in relation to the inclusion of the medicine in the Register.

All reports of adverse reactions or similar experiences associated with the use or administration of the listed medicine shall be notified to the Head, Office of Product Review, Therapeutic Goods Administration, as soon as practicable after the sponsor of the goods becomes aware of those reports. Sponsors of listedmedicines must retain records of such reports for a period of not less than 18 months from the day the Head, Office of Product Review is notified of the report or reports.

The sponsor shall not supply the listed medicine after the expiry date of the goods.

Where a listed medicine is distributed overseas as well as in Australia, product recall or any other regulatory action taken in relation to the medicine outside Australia which has or may have relevance to the quality, safety or efficacy of the goods distributed in Australia, must be notified to the National Manager Therapeutic Goods Administration, immediately the action or information is known to the sponsor.

Products

1 . TRU NIAGEN

Product Type Single Medicine Product Effective Date 8/01/2020

Permitted Indications

Maintain/support energy levels

Helps convert (state food) into energy

Maintain/support general health and wellbeing

Maintain/support body tissue repair/regeneration

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

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

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

Indication Requirements

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.

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

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.

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

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.

Standard Indications

No Standard Indications included on Record

Specific Indications

Public Summ

ary

Page 1 of 2 Produced at 09.07.2020 at 10:40:15 AESTThis is not an ARTG Certificate document.The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown. Visit www.tga.gov.au for contact information

No Specific Indications included on Record

Warnings

Not recommended for use by pregnant and lactating women (or words to that effect).

Use in children under 12 years is not recommended.

Additional Product information

Pack Size/Poison information

Pack Size Poison Schedule

Components

1 . Formulation 1

Dosage Form Capsule, hard

Route of Administration Oral Visual Identification

Active Ingredients

nicotinamide riboside chloride 300 mg

Other Ingredients (Excipients)

hypromellose

magnesium stearate

microcrystalline cellulose

© Commonwealth of Australia. This work is copyright. You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth. Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summ

ary

Page 2 of 2 Produced at 09.07.2020 at 10:40:15 AESTThis is not an ARTG Certificate document.The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown. Visit www.tga.gov.au for contact information

http://www.tga.gov.au/about/website-copyright.htm

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