Regulation of Dietary Supplements
Ever since Congress revised the way dietary supplements are regulated, these products have shown brightly on the radar not only of the U. S. Food and Drug Administration (FDA), but also of the U.S. Federal Trade Commission (FTC). The deployment of these two agencies’ regulatory authority requires a careful and detailed approach to bringing dietary supplements to market. Companies that produce, distribute, and market supplement products must navigate FDA’s manufacturing requirements and regulations for product claims and labeling. In addition, they must be mindful not to run afoul of the FTC’s advertising and marketing controls.
Bergeson & Campbell, P.C. (B&C®) professionals think strategically, understand the pitfalls in the production and sales of dietary supplements, and can help commercialize products quickly and efficiently. We help clients maximize potential in this popular market, including through online promotional channels, while steering clear of regulatory challenges.
B&C professionals offer clients a combination of legal, strategic, and scientific expertise. That combination is key to assisting clients in bringing their products to market, staying on top of regulatory issues, and responding effectively to matters that may arise over the course of a product’s life.
Attorney Jayne Bultena has almost 20 years of experience in food and drug regulatory matters, including labeling, compliance, and promotion of dietary supplements. She has counseled Fortune 100 companies, start-ups, and venture capital investors across issues impacting the dietary supplement industry, from claims development to labeling and promotional materials. She has represented clients before FDA, the U.S. Consumer Product Safety Commission (CPSC), and FTC.
Senior Scientist Jason Johnston, M.S., holds two Master of Science degrees in Chemical Engineering Practice and in Technology and Policy from the Massachusetts Institute of Technology. He has more than 25 years of experience in the field of risk assessment and has served as the project manager/senior scientist for a diverse range of risk assessments, including dietary exposure assessments.
Dr. David Peveler, holding a Ph.D. in organic chemistry, is expert in product regulatory compliance. Dr. Peveler joins B&C from Evonik Degussa Corporation, where he managed a variety of regulatory matters under the Federal Food, Drug, and Cosmetic Act (FFDCA), with special emphasis on FDA regulations around bulk Active Pharmaceutical Ingredients.
B&C often partners with its consulting affiliate, The Acta Group (Acta®). Acta professionals bring global technical and business expertise to strategic planning, product approvals, and advocacy. Between B&C’s business and legal professionals and Acta’s scientific professionals, clients have a broad knowledge-base to draw from in navigating through the FDA approval process.
What We Do:
B&C’s professionals have extensive experience in counseling clients with dietary supplement products regulated by FDA. We also have significant experience in FTC-related matters for companies in the dietary supplement industry. Representative issues handled by B&C’s attorneys include:
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