Natural Products Insider

MAR-APR 2018

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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48 INSIDER March/April 2018 In October 2017, representatives of the Council for Responsible Nutrition (CRN), Natural Products Association (NPA) and U.S. Anti-Doping Agency (USADA) met with FDA. The topic: selective androgen receptor modulators (SARMs), a class of drugs under clinical research by the pharmaceutical industry and producing steroid-like effects that are said to pose health risks to athletes, bodybuilders and others who take them. Collaboration is key, industry leaders said, in removing from the market pharmaceutical ingredients in products falsely marketed as dietary supplements. Since the meeting with FDA, the agency has taken more action against SARMs, said Daniel Fabricant, Ph.D., president and CEO of NPA. "It speaks volumes that it's a priority at the agency," Fabricant said in a phone interview, "and I think they're [FDA offi cials] going to continue to, when they see something, act on it." Legal: Industry Collaboration The industry is working with lawmakers on potential legislation to crack do wn on SARMs. Collaboration is key in removing from the market tainted products including SARMs. Trade groups urge companies to speak up when they identify adulterants. Leaders in Dietary Supplement Industry Met in 2017 With FDA on SARMs by Josh Long INSIDER's Take Acid Resistant Vegetable Capsules ) ' u n . , u, ' . ' AN EXCELLENT CHOICE FOR DELIVERY OF ACID-SENSITIVE ACTIVE INGREDIENDTS . . . <> . BioCaps Enterprises, Inc. • US Patent 9452141 In addition to working with FDA, dietary supplement leaders have been working behind the scenes with members of Congress on potential legislation to target SARMs. The idea is to give the Drug Enforcement Administration (DEA) authority to crack down on SARMs in a similar way in which it has authority to target designer anabolic steroids under the Designer Anabolic Steroid Control Act (DASCA), said Steve Mister, president and CEO of CRN. Signed into law in 2014 by former President Barack Obama, DASCA drew the support of the dietary supplement industry, sports organizations and health groups. "Is there discussion [in Congress] of possible language on SARMs? Yes, there is, and we look forward to whatever form that takes," Fabricant said. "Those ingredients that have been approved as drugs are not part of the industry and shouldn't be." FDA and DEA declined to comment on potential SARMs legislation. The co-chairs of the congressional dietary supplement caucus—including Sen. Orrin Hatch, the senior Republican from Utah—did not respond to requests for comment. Other lawmakers who chair committees that could introduce SARMs legislation as a stand-alone bill or part of a more comprehensive package also did not respond to requests for comment. The SARMs issue refl ects unanimity among industry associations and federal regulators in targeting products marketed as dietary supplements but tainted with pharmaceutical ingredients. Such products are adulterated and mislabeled and need to come off the market, said Loren Israelsen, president of the United Natural Products Alliance (UNPA). Industry leaders advised companies should notify FDA when they detect products spiked with drugs, and encourage the agency to take prompt action. "When you see something, say something," Fabricant said. "Who are the gatekeepers? Well, everyone's the gatekeeper, and that doesn't mean everyone is guilty until proven innocent. I think everyone deserves due process." Some members of CRN have purchased competitors' supplements and identifi ed substances that didn't belong in the products, Mister noted. "In those cases, we do very strongly encourage our companies to provide that data to FDA in hopes that it gives FDA a roadmap of where they should be looking," he said.

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