Leading chondroitin supplier identifies new adulterant. FDA: 'We look at this with great interest'
Synutra Ingredients: ‘The market is responding well to our call to action addressing chondroitin adulteration’
Chondroitin-containing supplement products are in the top five best-selling dietary supplements, with annual sales of about $1 billion, and all chondroitin sold in the US is from overseas. The US is estimated to have imported about 3,500 metric tons of chondroitin in 2012, and about 3,000 in 2011.
“Those factors create the kind of environment for ingredients to be subjected to adulteration,” said Weiguo Zhang, President and COO of Synutra Ingredients.
“In such circumstances, effective testing is essential, and yet if the method used isn’t suited for identifying the common adulterants, the end result is that consumers are not getting the benefits they expect, so confidence, and sales, in the category are being eroded.”
Responding to the call
Chondroitin sulfate is extracted from animal cartilage. In dietary supplements the compound is often formulated in combination with glucosamine. (Attempts by DSM to produce a vegetarian source of chondroitin were put on ice in 2012 after the company determined that the final product would probably be prohibitively expensive.)
Speaking with NutraIngredients-USA in May at the SupplySide Marketplace show in New York, Zhang promised to clean up chondroitin supply. The company launched its branded materials, Chondro Gold and Chondro Cal, which are described as ‘adulterant-free branded chondroitin products with guaranteed source traceability’.
Zhang said that many chondroitin suppliers cannot tell you the source of their product, while Synutra has full traceability of sources, which include bovine, porcine, and avian.
“The market is responding well to our call to action addressing chondroitin adulteration,” Zhang told NutraIngredients-USA this week. “We are now the largest supplier of chondroitin to the US. Specifically we became the largest volume as well as dollar value supplier of chondroitin in the world in June of this fiscal year. Last year we ranked number 5 in US imports.”
“Zero One”
Zhang told attendees at the Food and Drug Law Institute (FDLI)-hosted conference on Safeguarding the Functional Food and Dietary Ingredient Supply Chain that common adulterants found in chondroitin include sodium alginate, and alginate suflate di-ester. Zhang also revealed that the company has recently identified another adulterant that it is calling "Zero One" (Z1).
The commonly used chondroitin assay procedure is called cetylpyridinium chloride (CPC) titrimetry, and all of the adulterants used, like chondroitin, titrate with CPC to produce assay readings as chondroitin at levels equal to or much higher than chondroitin itself.
“Research is ongoing with Z1,” Zhang told us. “For example we originally suspected this to be a more purified alginate sulfate di-ester, but NMR shows it's not a carbohydrate. The high fusion point indicates it is not an organic substance.
“Given the presence of sulfur, there is a possibility that it might be a processed material from easily available fertilizers. These, however, are only inductions and we cannot be certain until we can structurally identify it. We continue to pursue this.”
Z1 has a fusion point of more than 278 degrees Centigrade, he added, and is such a potent adulterant that it appears in CPC as chondroitin at 235% assay value.
“At a price comparable to chondroitin, there is ample incentive for adulterators to use this substance, since they can use less. This stuff has no place in a dietary supplement.”
FDA – “We look at this with great interest”
The FDLI conference was hosted by Daniel Fabricant, PhD, Director of the Division of Dietary Supplement Programs for the FDA. Dr Fabricant told us that the identification of the new adulterant was news to FDA.
“What stood out for me was the assay value – for every 100 grams it looks like 235 grams of chondroitin.”
“We look at this with great interest,” said Dr Fabricant. “We expect the companies to be up on the science and the identity of the adulterants.”
Testing
“We are reassured by the fact that our test procedure is able to detect the presence of Z1 in chondroitin materials,” said Zhang. “But the industry being still largely at a loss as to the purity of what they are buying and selling as chondroitin (only a few players proactively require the use of the effective test method) demands an urgent push for widespread adoption of electrophoresis as the chondroitin screening standard and tool.”
“By widespread adoption of effective methods the industry will be able to deter the practice of chondroitin adulteration,” he said.
Branded ingredients on labels?
Zhang said that the company has been receiving interest inquiries in its branded offerings of both sodium and calcium chondroitin sulfate materials.
“Since we just branded our chondroitin products in May, it's too soon to tell how many brands will put our branded ingredient names on the labels, but that really isn't the point,” he added. “Assuming manufacturers use a therapeutic dose in the formulas, their consumers will experience benefits that they wouldn't with adulterated chondroitin.
Synutra intends to broaden its education efforts, he said, with new research on chondroitin testing set to be published soon. “At that time we expect to see this issue start to get on consumers' radar. At that time we will also be working to involve trade associations and launch our consumer education plans.”
