The Food and Drug Law Institute is publishing Dietary Supplement Regulation: A Comprehensive Guide, which will serve as a valuable resource to dietary supplement stakeholders. The book was edited by Scott Bass, a partner at Sidley Austin in Washington, D.C., who serves as the chief counsel for the Natural Products Association (NPA), the leading representative of the dietary supplement industry.
“The book recognizes that dietary supplements are the new playing field not only for the original marketers of vitamins and minerals, but also today for big pharma and big food,” says Bass. As the dietary ingredient market continues to expand globally, and pharmaceutical manufacturers, major food processors and marketing companies offer more functional food products, herbal, and natural-source supplements, this up-to-date resource is all the more critical to the dietary supplement community, according to Bass.
“The Natural Products Association is pleased that the Food and Drug Law Institute has teamed up with Scott Bass and Sidley Austin to offer a powerful new resource for the dietary supplement industry. Scott is a pioneer in the industry whose work on protecting supplement makers from onerous regulations is second to none,” says John Gay, NPA executive director and CEO. “Scott’s deep level of knowledge and experience on dietary supplement regulations is a key asset to helping NPA meet the challenge of any regulatory overreach by the government. This important new guide offers a complete overview of federal regulations, valuable for anyone involved in making and selling dietary supplements.”
Scott Bass, partner at Sidley Austin LLP, heads the firm’s Global Life Sciences Team, coordinating pharmaceutical, medical device, food, and dietary supplement matters in the U.S., Europe and Asia. He is ranked internationally among the top authorities on FDA-related enforcement and regulatory issues, and has led audits and investigations involving off-label promotion, pharmacovigilance, the Prescription Drug Marketing Act (PDMA), GMP, and fraud and abuse issues, as well as Drug Enforcement Agency (DEA) and Federal Trade Commission (FTC) matters. He was a major contributor to the drafting of DSHEA.
FDLI’s Dietary Supplement Regulation: A Comprehensive Guide includes easy-to-understand explanations of key dietary supplement issues, including: regulatory status and formulation; product claims and intended use; dietary supplement marketing and safety; good manufacturing practices, and foreign regulation.
Appendices include: The Dietary Supplement Health and Education Act of 1994; Congressional “Statement of Agreement” on DSHEA; Summary of the Dietary Supplement Health and Education Act; Relevant Portions of the Food and Drug Administration Modernization Act of 1997; Dietary Supplement and Nonprescription Drug Consumer Protection Act; Relevant Portions of the Food and Drug Administration Amendments Act of 2007; Relevant Portions of the FDA Food Safety Modernization Act; FDA Final Rule: Dietary Supplement Statements Re: Structure/Function; FDA Final Rule: Premarket Notification for a New Dietary Ingredient; Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues; Guidance for Industry: Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act; Guidance for Industry: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements; Small Entity Compliance Guide; and Federal Trade Commission: Dietary Supplements: An Advertising Guide for Industry.
For more information about the book, call Michael Levin-Epstein, FDLI editor-in-chief, at (202) 222-0897. Order a copy at www.fdli.org
Food and Drug Law Institute
The Food and Drug Law Institute (FDLI), founded in 1949, is a nonprofit organization that provides a marketplace for discussing food and drug law issues through conferences, publications and member interaction. FDLI’s scope includes food, drugs, animal drugs, biologics, cosmetics, diagnostics, dietary supplements, medical devices and tobacco. Visit www.fdli.org
Natural Products Association
The Natural Products Association (NPA),
founded in 1936, is the largest and oldest nonprofit organization dedicated to the natural products industry. NPA represents over 1,900 members accounting for more than 10,000 locations of retailers, manufacturers, wholesalers and distributors of natural products, including foods, dietary supplements, and health/beauty aids. As the leading voice of the natural products industry, the NPA’s mission is to advocate for the rights of consumers to have access to products that will maintain and improve their health, and for the rights of retailers and suppliers to sell these products. Visit www.NPAInfo.org