Natural Products Insider

APR 2012

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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T What Dr. Oz Gets Wrong About Dietary Supplements he issue of "spiked supplements" has been and will continue to be an area of concern for the industry. The Natural Products Association (NPA) has been fighting this problem alongside FDA since the agency announced its initiat ive against adulterated products in December 2010. Joshua Shar fstein, M.D., then deputy commissioner, announced FDA's steps to address this serious issue, including the establishment of an RSS feed to noti fy consumers immediately of tainted products. FDA has been clear that these adulterated products are not actually supplements, and that once a product has been spiked with a legal (or illegal) pharmaceutical agent, it is no longer a supplement—it is now an illegal drug. The media, though, is not as wel l - informed on this issue as we would like. Most recently, the Dr. Oz Show, "Who's Spiking Your Supplements?" set the by Cara Welch FDA has been clear that these adulterated products are not tone from the start with an introduction claiming America has a hidden heal th scandal. It went downhill from there. Dr. Oz proceeded to describe an undercover investigation process for any new dietary ingredient (NDI) meant to be marketed in a supplement. In addition, manufacturing facilities much be registered with FDA and any claims, specifically structure/function or health claims, about supplements must be submitted to FDA with a copy of the product label. Claims that are not truthful and misleading can result in regulatory action from either FDA or FTC. Finally, getting at the basis of this entire segment, FDA has the authority to remove products from store shelves that it deems to be a health risk. The fact remains, however, that spiked products in this indust ry is a problem. How does industry fight this problem? Wel l , one step is to promote and put GMPs (good manufacturing pract ices) into pract ice. actually supplements. of weight loss supplements that he purchased in New York. Unfortunately, Dr. Oz purchased a couple of products already known to be adulterated, including Fruta Planta and Health Slimming Cof fee. FDA released warnings about them in December 2010 and October 2011, respectively. Other products Dr. Oz highlighted seemed to be labeled solely in Chinese characters. These products are troubling for reasons beyond that they are apparently contaminated. Any product labeled in a foreign language should raise an immediate red flag for any consumer buying the product as well as the store selling the product. How do consumers know what they are buying if they cannot read the label? At one point, Dr. Oz mentions the majority of supplements are safe. While we appreciate this shout-out, his segment is doing much more to hurt the industry than to help it. I will give Dr. Oz credit; he is correct that millions of Americans take supplements every day, but he doesn't include that millions take these supplements safely, without any health problems. It makes for better headlines if that part is left out. Had Dr. Oz talked to us before airing this segment, we would have been happy to offer the facts for his show. The first involves the lingering falsehood that the supplement industry is unregulated. Actually, the supplement industry is regulated and has been as a recognized product category for more than 17 years. Dietary supplements are safe and fully regulated under the Dietary Supplement Health and Education Act of 1994 (DSHEA). For example, FDA requires a pre-market safety notification We all know GMPs are impor tant to the regulat ion of dietary supplements. But more than that, GMPs are essent ial to ensure what is on the label of the product is what's actually in the product. Intentional spiking of supplements is an exciting topic to discuss, but unintentional spiking is also a problem when companies do not have GMPs in place. Retailers play a role in this, too. Retailers need to purchase products that are manufactured under GMPs. This might involve purchasing from manufacturers that have a longtime relat ionship wi th a retai ler, or retai lers purchasing from manufacturers that have been GMP certified. The industry must also take a hard look at the category of supplements covered in Dr. Oz's segment. Weight-loss supplements are notorious for intentional spiking, and products that offer an immediate solution should be avoided. And it 's not just weight-loss supplements. As Dr. Sharfstein announced in December 2010, FDA is concentrating its focus on weight loss, sexual enhancement and bodybuilding supplements. Manufacturers producing such supplements need to do their due diligence in inspecting and qualifying their ingredient suppliers. Retailers purchasing these supplements need to take extra precaution. This industry has a negative perception around spiked products. Let's work on combating this perception together. Cara Welch, Ph.D., vice president, scientific and regulatory affairs, Natural Products Association (NPA, npainfo.org), oversees NPA's quality assurance programs, including the NPA Natural Seal and GMP Certification for dietary supplements. naturalproductsinsider ¡ com 55 ASSOCIATION ADDRESS

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