Natural Products Insider

SEP-OCT 2017

INSIDER is the leading information source for marketers, manufacturers and formulators of dietary supplements, healthy foods and cosmeceuticals. Since 1997, INSIDER has been serving the needs of the global nutrition industry.

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52 INSIDER September/October 2017 quantities of vitamins produced in Nutley, New Jersey, by arguably the patron of the modern industry, Hoffmann La Roche. In fact, Roche is no longer in the business, having sold its nutrition division several years ago to a Dutch corporation known as DSM (Dutch State Mining). DSM has remained an industry leader in research and product development and production, but has recognized that global sourcing requires global production, thus deploying innovative ways to reduce costs while protecting the environment using the most advanced technologies. Now DSM has plants all over the world and remains a key supplier to this industry. Painted on this canvas of the landscape of this ever-changing industry, we have the colorful arrival of the passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA), Nutritional Labeling Education Act (NLEA), Food Safety Modernization Act (FSMA), and a host of other associated laws and regulations. The industry had been laboring under interesting and tortured rules of engagement after the passage of the Proxmire Act, so the signing of DSHEA into law marked a key turning point for industry. This one law, and the subsequent publication of the GMPs (good manufacturing practices) called for by this legislation, forever changed the industry in meaningful ways. No longer can producers of fi nished goods rely upon the "word" or certifi cates of analysis (CoAs) of authenticity to discharge their obligations to verify identity, potency and purity of the component or fi nished product. Most of the violations of DSHEA as enforced by FDA point to this area of the law that producers have misapplied to their peril. Furthermore, with the appointment of key regulators to oversee enforcement of the provisions of DSHEA— namely Daniel Fabricant, Ph.D., former director of FDA's then-named Division of Dietary Supplement Programs (DDSP) and Corey Hilmas, M.D., Ph.D., former chief of the Dietary Supplement Regulation Implementation Branch, DDSP—industry took notice of its defi ciencies in adhering to the law, and realized the old ways of doing things were no longer applicable. Hence, the landscape we have now is clear in terms of how a company should go about sourcing raw materials from the global supply chain. It refl ects an adage by former President Ronald Reagan, "Trust, but verify." Here are just some of the questions that need to be asked of current or potential suppliers, and those areas that also require further testing either internally or by qualifi ed third-party facilities, to qualify a material for use in dietary supplements in the United States: What is the country of origin? What is the manufacturing process, with fl ow chart, list of chemicals deployed, etc.? What are the positive release parameters of the product versus the purchaser's standard? In other words, in a world where the presence of a heavy metal, such as lead, would require a warning above a certain amount, what is the concentration of heavy metals in the raw material, and how is that level ascertained? Contract Manufacturing: Ingredient Sourcing

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