Natural Products Insider

NOV-DEC 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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Page 61 of 166 49 According to the Council for Responsible Nutrition's (CRN) Economic Impact Report, more than 750,000 Americans are employed by the dietary supplement industry in the United States. The industry is an eclectic bunch, spanning all age groups and backgrounds, specializations and skill sets, but one common trait exists: a desire to make an appreciable difference in people's lives. For those who may have just entered the space, whether new to the workforce or a seasoned executive joining from a different industry, there's a lot to learn about dietary supplements. To all the fresh faces feeling overwhelmed, a few things to know: Dietary supplements are regulated. In 1994, Congress passed the Dietary Supplement Health and Education Act (DSHEA)—a law Steve Mister, president and CEO, CRN, once called "industry's permission slip to exist." DSHEA reaffi rmed that supplements are regulated as a category of food—not drugs—and provided FDA with regulatory authority over the industry. With DSHEA serving as the law of the land, extensive regulations cover all facets of dietary supplement manufacturing, labeling and marketing. DSHEA is required reading for industry members. Full enforcement of these laws is encouraged and supported by the mainstream dietary supplement industry, as they help keep the industry free of bad actors and protect Americans' continued access to safe, benefi cial dietary supplements. For most newcomers, DSHEA is a dense read. However, those in the supplement industry need to be familiar with this law, its requirements and how it informs daily operations—both for individuals, and for companies. The industry has its naysayers. Negative commentary doesn't stem from one disgruntled group. From lawmakers on Capitol Hill to neighbors down the road, anyone can be misinformed about dietary supplements. It seems almost every day someone has something bad to say about the industry—sometimes with scientifi c evidence at the ready and sometimes not—and unfortunately, misconceptions about regulation abound. By pooh-poohing the industry, naysayers send a reminder that the system is not perfect. There is always more work to do. Industry can change the dialogue. Critics aren't mosquitos that can be easily squashed; their doubts can't just be swatted away. Regulators, retailers and consumers demand transparency from supplement companies, and since the passage of DSHEA, industry has stepped up its game to set the record straight. In addition to following the law, responsible industry proactively engages in several self-regulatory initiatives to demonstrate accountability and an openness to critique. Those getting acquainted with the industry should get to know the Supplement OWL, the CRN/NAD (National Advertising Division) pr ogram, industry's voluntary guidelines and best practices, and the services offered by third-party certifi ers. These initiatives complement the law, and, combined with a candid approach to business practices, show stakeholders industry has nothing to hide. The future is bright. Nearing the 25th anniversary of DSHEA's passage, newcomers can renew industry's vow of regulatory compliance and consumer safety. Veterans like me welcome the fresh perspectives and look forward to seeing how the supplement marketplace is shaped in the years to come. Duffy MacKay, N.D., is senior vice president, scientifi c and regulatory affairs, Council for Responsible Nutrition (CRN,, a trade association for the dietary supplement and functional food industry. Regulatory A Newcomer's Guide to the Supplement Industry by Duffy MacKay, N.D. NOW ON DEMAND Premium Series W E B I N A R SPEAKERS RICARDO CARVAJAL, Director, Hyman, Phelps & McNamara, P.C. TARA LIN COUCH, PH.D., Senior Director of Dietary Supplement and Tobacco Services, EAS Consulting Group, LLC REND AL-MONDHIRY, Senior Counsel, Amin Talati Upadhye LLP STEPHEN M. SCHMITZ, M.D., M.PH., Co-founder, Supplement Safety Solutions MODERATOR DUFFY MACKAY, N.D., Senior Vice President, Scientifi c and Regulatory Affairs, CRN Supplement Regulation 101: Cross-training in the basics for the non-regulatory industry executive CO-SPONSORED BY: To watch, visit

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