Our regulatory compliance practice for the marketing and advertising of drugs, devices, foods, dietary supplements, cosmetics, and other consumer products is deep and long-standing. Our extensive experience with both FDA and FTC regulatory and enforcement policies allows us to effectively anticipate and mitigate legal risks across the multi-faceted aspects of a marketing campaign. We regularly counsel drug and device clients on the permissible boundaries of promotional claims and marketing activities for specific products, represent companies who have received FDA warning or untitled letters, and FTC CIDs and negotiate for the termination of investigations or limitations to proposed consent decrees, involving criminal enforcement actions arising from the promotion of prescription and OTC drugs, dietary supplements, and medical devices.
We also counsel clients on labeling and advertising claims compliance for food, dietary supplements, cosmetics, and other consumer products, provide risk assessments for proposed promotional strategies, and represent clients responding to FTC CIDs, National Advertising Division inquiries, Lanham Act, and other disputes involving allegations of false or misleading advertising.
Key aspects of our work include the following:
- Providing legal counsel on the substantiation standards for health-related, efficacy, and safety claims;
- Reviewing advertising claim substantiation to help ensure that the type, quantity, and quality of evidence meets the standard expected by regulators and courts;
- Developing legal strategies to defend clients in government investigations and competitor challenges, as well as initiate legal challenges against our client’s competitors for false and misleading advertising;
- Advising on appropriate label and marketing claims that meet FDA regulatory requirements for a product category; and
- Counseling clients on a broad range of marketing dissemination strategies, including through endorsements and testimonials, and social media.
- Administrative Advocacy and Litigation
- Advertising and Promotion
- Drug Product Development and Approval Strategies
- Due Diligence and Transactional Support
- Enforcement & Recalls
- Hatch-Waxman Act Litigation
- Human and Animal Food Ingredient Review and Approval Strategies
- Regulatory Compliance
- White Collar Defense & Government Investigations