Regulation of Dietary Supplements

Overview:

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.

Our Experience:

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 P. 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.

R. David Peveler, Ph.D., 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:

• Labeling and Claims Development –
  • Assess scientific substantiation and work with clients to develop appropriate labeling and claims
• Advise Clients on Filing New Dietary Ingredient Notifications Compliance –
  • Develop corporate policy and train client personnel on good manufacturing practices, advertising, promotion, direct sales, and other compliance matters
• Counseling –
  • Conduct due diligence and offer regulatory opinions in connection with financing and corporate transactions
• Marketing and Response –
  • Coordinate press and media relations
  • Advise clients on development of promotional materials, including websites and social networking
• Enforcement –
  • Manage compliance risks and promotional violations, including FDA inspections
  • Respond to deficiencies, warning letters, and other regulatory inquiries
  • Represent clients before other agencies, including CPSC and FTC, for products with multi-jurisdictional issues

Representative Engagements:

• B&C attorneys have conducted due diligence for clients seeking to purchase companies manufacturing and marketing dietary supplements.
• B&C attorneys assisted a Fortune 100 company in developing compliant labeling and marketing claims for a new line of over 25 dietary supplement products.
• B&C attorneys worked with a Fortune 100 company to develop dual dietary supplement and over-the-counter (OTC) drug labeling for two market leading products. We successfully defended the labeling and marketing claims at both FDA and FTC.
• B&C attorneys have worked with clients to analyze and assess the potential benefits of filing a New Drug Application for botanical and natural products.