Chondroitin needs pharma-style control: Review


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Chondroitin needs pharma-style control: Review

Related tags Chondroitin sulfate Dietary supplement European union

Joint health nutrient chondroitin varies greatly in safety and efficacy depending on its source and therefore needs greater regulation and standardisation, Canadian and Spanish researchers have said.

In a review backed by Spanish chondroitin sulfate supplier Bioiberica, Johanne Martel-Pelletier and colleagues said chondroitin intended for nutraceutical applications required pharma-style market control measures to assure quality.

“…it is very important to use a pharmaceutical-grade product to avoid any safety issues, since it is extracted from biological origin and any changes in its physico-chemical properties could modify its safety profile,”​ they wrote.

“Chondroitin sulfate products can be derived from a range of animal tissues, which could lead to products having different structures; and a variety of extraction and purification techniques can be used, resulting in different content, composition, purity, biological effects, clinical efficacy and safety.”

“Therefore, chondroitin sulfate product quality should be regulated and standardised.”

Commenting on the research, Dr Robert Verkerk, PhD, executive and scientific director of the Alliance for Natural Health-International (ANH-I), agreed quality varied but questioned whether further regulation was required.

“This is above all a quality control issue, not one requiring governmental regulation,”​ Dr Verkerk said.

“Industry self-regulation, on such quality control issues, on the other hand, would be welcomed. We would much prefer to see manufacturers declare the purity of their raw materials – and >99% purity pharmaceutical-grade chondroitin sulphate is readily available, as are inferior quality products with just 80% purity. Given the bovine or porcine origins of such products, it is only fair that consumers are informed what they are buying.”



The review published in the journal Molecules ​noted meta-analyses backed chondroitin sulfate to reduce the incidence of osteoporosis and boost cartilage volume in general, although these data have not been accepted in the European Union in the form of authorised claims under the EU nutrition and health claims regulation (NHCR).

However content and quality was variable. One US study found chondroitin content varied by between 10% and 110% from stated label content in food supplement products.

Another study analysing chondroitin sulfate content found levels were to reference for bovine, porcine and chicken but above for fish (skate and shark).

Studies showed greatly varying levels for chondroitin sulfate forms in a range of food supplement products including non-sulfated chondroitin (1%–9%); chondroitin-4-sulfate (26%–70%); chondroitin-6-sulfate (23%–63%); chondroitin-2,6-disulfate (0%–13%) and chondroitin-4,6-disulfate (0%–3%).

Regulation was required to standardise such variations, the researchers said, and to raise product purity.

“Purification protocols are important to minimise contaminants, which can include other glycosaminoglycans, proteins, small organic molecules, viruses, prions and solvents.”

Johanne Martel-Pelletier works at the Osteoarthritis Research Unit at the University of Montreal Hospital Research Centre.



March 2015 (doi:10.3390/molecules20034277)

‘Discrepancies in Composition and Biological Effects of Different Formulations of Chondroitin Sulfate’

Authors: Johanne Martel-Pelletier, Aina Farran, Eulàlia Montell, Josep Vergés and Jean-Pierre Pelletier.

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1 comment

Pharma-grade vs. food-grade

Posted by Henrik Uth,

Agree, purity and strict quality control of chondroitine is very important. However, if used in food supplements - the chondroitine sulfate has to follow EU food regulations, and all raw materials used for extraction (whether of bovine, shark or other origin) needs to be food grade material suitable for human consumption (according EU's by-product regulation). This is not a requirement for pharma-grade chondroitine, and as such a pharma-grade material could potentially be illegal to use in food (supplements). Hence, in my mind "pharma-grade" (means following Ph. Eur. or USP specs.) is a good term to use for reference to purity, but not necessarily a good term to present as an "absolute" for chondroitine sulphate in nutraceutical applications, as done in the article.

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