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Regulatory Activism in the Dietary Supplement Industry

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by Weiguo Zhang -

In almost two decades since the Dietary Supplement Health and Education Act (DSHEA, 1994) was enacted on the precepts of "preventive healthcare" and "freedom of choice," the dietary supplement market has flourished. A vibrant industry grew and a myriad of choices of supplement products are available to consumers. The industry has operated in a relatively relaxed regulatory space between food and pharmaceuticals, and the value chain of its products now stretches around the globe. As with development of any industry, prosperity of the dietary supplement sector invariably comes with its own issues, including increasing concerns with efficacy, quality, and safety, and with ingredient adulteration and supplement misbranding.

It is against this backdrop, the Food and Drug Administration (FDA) has stepped up inspections in quantity, frequency, scope, and depth. It has been reported that two thirds of the facilities visited by FDA in 2012 resulted in non-compliance: a Form 483 or a warning letter. The expectation for 2013 is that FDA will dig deeper, visiting all manufacturing facilities, and paying greater attention to spotting and stopping adulterated materials at the water's edge.

Many in the industry are responding in a positive way, beefing up cGMP compliance and instituting best practices. Addressing these regulatory concerns, however, firms often find themselves lacking in effective ways to deal with issues that arise in parts of the supply chain largely beyond their control, including raw material sourcing that involves commercial transactions of source stock input at small and rudimentary manufacturers, and between these "backyard" operations and traders and aggregators who are volume shippers of dietary ingredients. These parts of the supply chain typically fall wayside of the cGMP regime the industry and governments are putting in place on a global scale. These often become the source of problems without attentive efforts to deal with them. But some ingredient suppliers are stepping up to the challenge.

Perhaps one of the most problematic ingredients is chondroitin, a key dietary ingredient for joint health products. At Synutra, we are now the world's No. 1 producer and shipper of chondroitin sulfate materials, leading the industry in proactive responses to reign in the blighted chondroitin supply chain that has resulted from the “backyard” (sometimes literally) operations selling to traders and aggregators, who sell and ship sometimes highly questionable chondroitin to U.S. customers in volume. Our monitoring of the chondroitin supply chain shows that significant incidences of raw material adulteration are taking place, the impact of which can also be found in supplement products sold at retail.

How did we get to our current status? Synutra is currently the only ingredient supplier in the world that adopts the full range of monograph procedures required of chondroitin sulfate in determining material potency and purity. Synutra monitors the raw material market closely, and goes way beyond its own cGMP manufacturing facilities to qualify vendors and screen all of their material inputs against key quality parameters including CPC (cetylpyridinium chloride) titration content and electrophoresis purity for chondroitin sulfate. Synutra works closely with the industry's authoritative documentary standard organization to ensure the integrity of the related monograph and contribute to its improvement.

To differentiate from commodity-based ingredients that are notoriously adulterated, Synutra launched branded chondroitin sulfate ingredients that are guaranteed adulteration-free and with ultra low limits for "Big 4" heavy metals (cadmium, arsenic, lead, and mercury). With these, the company offers the industry an effective avenue to mitigate product safety and reputation risks and help customers to stay clear of pitfalls in areas where cGMP coverage is incomplete

Synutra calls on the industry participants, both the chondroitin material suppliers and the joint health supplement manufacturers, to adopt the set of CPC and electrophoresis testing procedures set forth in the USP monograph, which were provided to be easy and effective bench-top methods to detect and deter adulteration and measure quality of the products you get. The beauty of using these tests is that they add little incremental cost to your quality screening systems, if any.

Synutra regards the recent regulatory activism vis a vis dietary ingredients and supplements as a good thing for the industry in the long run. In our view, effective responses to these challenges need to address all aspects of one's value chain, with a focus on the weak spots where cGMP practices are structurally absent. This kind of approach is necessary to improve your business, the natural products industry itself, and our appearance to the skeptics and doubters. What are you doing to step up your game?

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