Complaint to TGA – Blackmores Glucosamine Sulfate 1500mg

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Acknowledgements: This complaint was worked up by Monash BMS3052 students; then checked and submitted by Assoc Prof Ken Harvey.

Product and Sponsor Product name: Blackmores Glucosamine Sulfate 1500 One-A-Day Sponsor: Blackmores Ltd Address: PO Box 1725, WARRIEWOOD, NSW, 2102 Australia ARTG no: 311854 Product Ingredient: glucosamine sulfate sodium chloride 1.884 g

Permitted Indications

• Decrease/reduce/relieve symptoms of mild arthritis/mild osteoarthritis.

Linked indications:

• Helps maintain/supports healthy joint cartilage growth/development/production. • Maintain/support joint health. • Decrease/reduce/relieve mild joint aches and pains. • Decrease/reduce/relieve mild joint inflammation/swelling. • Maintain/support joint mobility/flexibility. • Decrease/reduce/relieve mild joint pain/soreness. • Decrease/reduce/relieve mild joint stiffness.

Advertisement type: Internet – Web site

Accessed on: 26 February 2020

URL(s) listed (screen shots appended) • https://www.blackmores.com.au/products/glucosamine-1500 • https://www.chemistwarehouse.com.au/buy/58934/blackmores-glucosamine-sulfate-1500mg-

one-a-day-180-tablets? • https://www.goodpricepharmacy.com.au/blackmores-glucosamine-sulfate-1500-180-tablets • https://www.woolworths.com.au/shop/productdetails/828191/blackmores-glucosamine-

sulfate-1500mg-tablets • https://www.amazon.com.au/Blackmores-Glucosamine-Sulfate-1500-Tablets/dp/B019OILI18 • https://www.ebay.com.au/p/6032581647 • https://www.pharmacyonline.com.au/blackmores-glucosamine-1500mg-tab-x-180 • https://www.australianvitamins.com/product/blackmores-vitamins-glucosamine-sulfate-1500 • https://www.chempro.com.au/BL-GLUCOSMN-1500MG-90-23178 • https://www.capitalchemist.com.au/productdetail.aspx?name=Blackmores-Glucosamine-

Sulfate-1500-180-Tablets&code=266677 • https://www.mrvitamins.com.au/blackmores-glucosamine-sulfate-1500-one-a-day-180t • https://www.naturalcity.com.au/prod-blackmores-glucosamine-sulfate-1500mg-180tabs-

save30-23871.aspx • https://shop.coles.com.au/a/national/product/blackmores-glucosamine-sulfate-tabs

Complaint to TGA – Blackmores Glucosamine Sulfate 1500mg

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• https://www.mrvitamins.com.au/blackmores-glucosamine-sulfate-1500-one-a-day-180t • https://www.davidjonespharmacy.com.au/blackmores-glucosamine-sulfate-1500mg-one-a-day-

18 • Etc.

Complaint Summary This is an illustrative complaint of a common problem with the complementary medicine industry; failure to update permitted indications and claims made about their products in the light of new scientific information.

This complaint concerns Blackmores Glucosamine Sulfate 1500 One-A-Day. But there are many other glucosamine products making similar claims. This needs a different response from the TGA than simply dealing with individual complaints.

Numerous complaints about glucosamine have been upheld by the previous CRP and more have been referred to the Office of Complementary Medicine &/or the TGA for action. However, no action appears to have resulted.

The disputed claims include, ‘contain a scientifically validated form of glucosamine’, ‘reduces the symptoms of mild arthritis’, ‘reduce mild joint aches and pains’, ‘maintain joint mobility and flexibility, ’maintain joint health, and ‘maintain healthy joint cartilage production’.

The first claim is not a permitted indication and is meaningless. The remaining claims do not reflect the consensus of current scientific and medical evidence. For example, in 2019 the American College of Rheumatology/Arthritis Foundation Guideline for the Management of Osteoarthritis of the Hand, Hip, and Knee states: 'Glucosamine is strongly recommended against in patients with knee, hip, and/or hand OA. Dr Harry Nespolon, President of the Australian Royal College of General Practitioners (RACGP) says, ‘The RACGP does not recommend the use of glucosamine as a way of preventing osteoarthritis’.

In addition, there are problems with varied and insufficient warnings about this product by different advertisers. Furthermore, one glucosamine product has been categorised by the TGA as AUST R when it lacks the evidence to justify this registration.

It is alleged that these advertisements breach the Therapeutic Goods Advertising Code (No 2) 2018, s.9(a), 9(b), 9(d), 10(a)(ii), 10(c), 12(3), 13(6), 13(7) and 15(2)(a).

All glucosamine products should be delisted from the ARTG.

Introduction This is an illustrative complaint of a common problem with the complementary medicine industry; failure to update permitted indications and claims made about their products in the light of new scientific information.

This complaint concerns Blackmores Glucosamine Sulfate 1500 One-A-Day. But there are many other glucosamine products making similar claims.1,2,3 This needs a different response from the TGA than simply dealing with individual complaints.

1 https://swisse.com.au/our-products/swisse-ultiboost-glucosamine-sulfate 2 3 https://www.naturesway.com.au/product/nw-glucosamine-1500mg-200s

Complaint to TGA – Blackmores Glucosamine Sulfate 1500mg

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Numerous complaints about glucosamine have been upheld by the previous CRP4 and more have been referred to the Office of Complementary Medicine &/or the TGA for action.5 However, no action appears to have resulted.

Claims disputed • Contain a scientifically validated form of glucosamine • Reduce the symptoms of mild arthritis • Reduce mild joint aches and pains • Maintain joint mobility and flexibility • Maintain joint health • Maintain healthy joint cartilage production

The first claim is not a permitted indication and is meaningless. The remaining claims do not reflect the consensus of current scientific and medical evidence.

For example, in 2019 the American College of Rheumatology/Arthritis Foundation Guideline for the Management of Osteoarthritis of the Hand, Hip, and Knee states: 'Glucosamine is strongly recommended against in patients with knee, hip, and/or hand OA.6 It goes on to say,

'Pharmaceutical-grade preparations of glucosamine are available and have been studied in multiple trials. However, discrepancies in efficacy reported in studies that were industry sponsored as opposed to publicly funded have raised serious concerns about publication bias. In addition, there is a lack of a clear biologic understanding of how efficacy would vary with the type of salt studied. The data that were deemed to have the lowest risk of bias fail to show any important benefits over placebo. These recommendations represent a change from the prior conditional recommendation against the use of glucosamine. The weight of the evidence indicates a lack of efficacy and large placebo effects. Nonetheless, glucosamine remains among the most commonly used dietary supplements in the US, and clinicians should be aware that many patients perceive that glucosamine is efficacious. Patients also often perceive that different glucosamine formulas are associated with different degrees of efficacy and seek advice on brands and manufacturers. The potential toxicity of glucosamine is low, though some patients exposed to glucosamine may show elevations in serum glucose levels'.

Dr Harry Nespolon, President of the Australian Royal College of General Practitioners (RACGP) says,

‘The RACGP does not recommend the use of glucosamine as a way of preventing osteoarthritis’.7

The U.S. National Center for Complementary and Integrative Health (NCCIH) states, ‘Glucosamine and chondroitin sulfate—taken separately or together—are marketed for supporting joint health. They have also been widely used for treating osteoarthritis (OA). The preponderance of evidence indicates little or no meaningful effect on pain or function’.8

Safety issues are also a concern. It’s been known for some time that glucosamine can interact with blood thinners such as warfarin (see appended).9

4 https://www.tgacrp.com.au/complaint-register/?_search=glucosamine 5 https://www.tgacrp.com.au/withdrawn-complaints/?_search=glucosamine 6 https://www.rheumatology.org/Portals/0/Files/Osteoarthritis-Guideline-Early-View-2019.pdf 7 https://rheumatology.org.au/gps/documents/ARA_AAglucosaminestatement_v2_000.pdf 8 https://search.nccih.nih.gov/search?utf8=%E2%9C%93&affiliate=nccih&query=glucosamine 9 https://naturalmedicines.therapeuticresearch.com/databases/food,-herbs-supplements/professional.aspx?productid=807

Complaint to TGA – Blackmores Glucosamine Sulfate 1500mg

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However, this warning is not mandated and is only found on some products. It's less widely known to the general public that glucosamine supplements made from shellfish and can cause serious allergic reaction.10 In 2016, the TGA required manufacturers to be clear if products contain shellfish. However, they also gave manufactures until August 2020 to do this.11,12 Many products publicly available still do not may it clear to consumers if the product contains shellfish. In addition, some advertisers who sell this product directly via the Internet lack necessary warnings.13

Finally, one glucosamine product has been categorised by the TGA as AUST R when it lacks the evidence to justify this registration (appended).14

68083 ARTHRO-AID Glucosamine hydrochloride 750mg capsule bottle

Key-Sun Laboratories Pty Ltd

08/04/1999

Alleged regulatory breaches:

Therapeutic Goods Advertising Code (No 2) 2018

s.9(a) Claims in the advertising must be valid and accurate, and all information presented must be substantiated before the advertising occurs

s.9(b) Advertisements must be truthful, balanced and not misleading or likely to mislead, including in its claims, presentations, representations and comparisons

s.9 (d) Claims must be consistent with the entry for the therapeutic goods on the ARTG.

s.10(a)(ii) Advertising for therapeutic goods must support the safe and proper use of therapeutic goods by not exaggerating product efficacy or performance

s.10(c) Advertising for therapeutic goods must not encourage inappropriate or excessive use of the goods.

s.12(3) What must advertisements contain— therapeutic goods that are not available for physical examination before purchase

13(6) Advertisement must include the words ‘FOLLOW THE DIRECTIONS FOR USE’ or ‘FOLLOW THE INSTRUCTIONS FOR USE’; and

10 https://pmj.bmj.com/content/early/2019/10/09/postgradmedj-2019-136957.long 11 https://www.tga.gov.au/allergies-and-medicines 12 https://www.ebay.com.au/p/6032581647 13 https://www.amazon.com.au/Blackmores-Glucosamine-Sulfate-1500-Tablets/dp/B019OILI18 14 https://www.tga.gov.au/list-evaluated-registered-complementary-medicines

Complaint to TGA – Blackmores Glucosamine Sulfate 1500mg

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13(7)

(if it contains a claim relating to a symptom, disease, condition, ailment or defect) the words ‘IF SYMPTOMS PERSIST, TALK TO YOUR HEALTH PROFESSIONAL’ or ‘IF SYMPTOMS WORSEN OR CHANGE UNEXPECTEDLY, TALK TO YOUR HEALTH PROFESSIONAL’

15(2)(a) Where an advertisement makes a scientific or clinical representation, any scientific or clinical terminology must be appropriate, clearly communicated and able to be readily understood by the audience to whom it is directed.

Conclusion: All glucosamine products should be delisted from the ARTG.

Signed and dated Dr Ken Harvey MB BS, FRCPA, AM

Associate Professor Public Health and Preventive Medicine

Monash University 26 February 2020

Complaint to TGA – Blackmores Glucosamine Sulfate 1500mg

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Appendix (Screen shots with offending claims arrowed

https://www.blackmores.com.au/products/glucosamine-1500

https://www.chemistwarehouse.com.au/buy/58934/blackmores-glucosamine-sulfate-1500mg-one-a-day-180-tablets

Complaint to TGA – Blackmores Glucosamine Sulfate 1500mg

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https://www.chemistwarehouse.com.au/buy/58934/blackmores-glucosamine-sulfate-1500mg-one-

a-day-180-t

Complaint to TGA – Blackmores Glucosamine Sulfate 1500mg

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https://www.goodpricepharmacy.com.au/blackmores-glucosamine-sulfate-1500-180-tablets

https://www.amazon.com.au/Blackmores-Glucosamine-Sulfate-1500-Tablets/dp/B019OILI18

Warnings illegible in rollover

Complaint to TGA – Blackmores Glucosamine Sulfate 1500mg

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https://www.ebay.com.au/p/6032581647

No warnings

Complaint to TGA – Blackmores Glucosamine Sulfate 1500mg

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https://www.amazon.com.au/Blackmores-Glucosamine-Sulfate-1500-Tablets/dp/B019OILI18

https://www.chempro.com.au/BL-GLUCOSMN-1500MG-90-23178