Regulation: Joint sales not hurt by health claim hole

Strong links have been established between certain marquee nutrients like glucosamine and chondroitin and joint health/osteoarthritis benefits in the minds of millions of consumers.

It’s quite a remarkable achievement given that there are virtually no approved health claims for the ability of these kinds of dietary supplements to benefit joint health.

The US Food and Drug Administration in 2004 rejected a petition linking glucosamine and/or chondroitin sulfate and a reduced risk of osteoarthritis; osteoarthritis-related joint pain; joint tenderness; joint swelling; joint degeneration and cartilage deterioration.

Last year the European Food Safety Authority (EFSA) followed suit issuing an opinion rejecting similar benefits for glucosamine and chondroitin.

Both of these rulings have been criticized for the criteria employed in assessing the science, but as it stands, no successful challenge has been mounted.

The FDA letter of rejection can be found here.​

The EFSA glucosamine and chondroitin opinion can be found here​.

Claims conundrums​

Cal Bewicke , the president of US vegetarian-sourced supplier, Ethical Naturals, said the market was buoyant.“​​Supply of vegetable source material from both GMO and non-GMO sources continues to strengthen,”​ he said. ​

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Fellow vegetarian-sourced glucosamine supplier, Cargill, said the European situation at least was not black-and-white, given the EFSA opinion was yet to make it into the legislature across the 27 member states of the European Union.

“This is an issue that is still up in the air. Several of the member countries have elected to disagree with the recent ruling,”​ said Cargill Corn Milling brand manager of Regenasure Glucosamine, Michael R. Fleagle.

“Longer term, it may become more of an issue, particularly with the product development of any new functional food, beverage or dietary supplement.”​

In some countries, glucosamine is classified as a pharmaceutical or somewhere in between, such as in Canada where it comes under the Natural Health Products Directorate, a fact Bewicke pointed out has benefits for the whole sector.

“It is the way it is, and it works fine,”​ he said. “Where it is classified as a pharmaceutical there is more work to be done to prepare for market, and that’s fine for those suppliers who are working with enough quality assurance information.”​

On the drug/supplement divide, Fleagle added: “​We believe it would be better for the industry to have guidelines that ensure good consistent quality and reliable supplies -- whether a product be a pharmaceutical, supplement and/or functional food or beverage.”​

Health Canada produced a glucosamine monograph in August, 2008, that approved the use of certain joint-related claims. It can be found here.

The growing interest in the food area is being reflected by the likes of TSI Health recently achieving GRAS (generally recognized as safe) status in the US. That will allow their glucosamine ingredients to be used in the food supply. It is not the first and won’t be the last.

In Japan too, some glucosamine forms have FOSHU (foods for specified uses approval).

Given that most human-use glucosamine and chondroitin is derived from Chinese-sourced crustaceans, a temporary EU ban on prawn imports a few years back placed temporary strains on supply, but this has been eased.

Still in Europe, recently published health claim opinions included rejections for join health nutrients including citrus bioflavonoids; SAMe (S-adenosylmethionine); cherries; balsamodendron mukul; alchemilla vulgaris; eucalyptus globulus; meadowsweet; myristica fragrans; burdock; comarum palustre; commiphora wighti; ledebouriella seseloides; ginger extract; avocado-soy extract; bilberry; pine bark; Chinese skullcap; isoflavones; birch; echinacea; frankincense; devil's craw; turmeric

To read the first part of this series, Glucosamine market reaching maturity​, please click here​ .

To read the second part of this series, Supply: Joining the glucosamine supply gaps​, please click here​ .

To read the third part in this series, Science: The benefits of glucosamine and omega-3​, please click here​ .

To read the fourth part in this series, Science: The emerging ingredients for joint health​, please click here.​