FDA-Regulated Products
Beveridge & Diamond counsels clients on the complex requirements for chemicals and products regulated by the U.S. Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (FFDCA) and related statutes.
As an extension of our Consumer Products practice, our FDA practice combines detailed knowledge of how the FDA works with an understanding of the real-world challenges a company faces in bringing highly regulated products to market and successfully keeping them there.
Focus Areas
- FDA approvals, compliance, enforcement actions, inspections
- Bringing new products to market
- Product recalls
- Environmental claims, green marketing, labeling
- Plastics and packaging
- Advising on foreign counterparts
- Regulatory advocacy
- Electronic recordkeeping
- Nanotech issues
- Animal testing and animal-derived ingredients
Areas of Service
Cosmetics
- Advising on FDA requirements and voluntary programs for finished cosmetics and cosmetic ingredients.
- Counseling on marketing claims for cosmetics and cosmetic ingredients.
- Providing guidance on the use of antimicrobials in personal care products.
Dietary Supplements
- Assisting with the development of new dietary supplements, including counseling on requirements, data development, and regulatory review.
- Counseling on good manufacturing practice standards, reporting requirements, and marketing claims for dietary supplements.
Drugs
- Advocating with Customs and Border Protection over imports of active pharmaceutical ingredients with alleged drug labeling deficiencies.
- Counseling on good manufacturing practice standards for finished drugs and good manufacturing practice guidance for active pharmaceutical ingredients and excipients.
- Advising on clinical testing requirements and guidance and good laboratory practice standards for pre-clinical testing.
- Advising on labeling and production requirements for hand sanitizers, sunscreens, and other over-the-counter drug products.
Learn more about our Pharmaceuticals & Health Care practice.
Food, Food Additives, Food Contact Materials
- Preparing submissions to FDA, such as Food Contact Notifications and GRAS Notices, and responses to FDA inspection findings.
- Preparing letters in support of the conclusion that a substance is GRAS or present below the Threshold of Regulation.
- Advising on GRAS and food additive regulations.
- Counseling on the use of antimicrobials in food.
Learn more about our Food & Beverage practice.
Medical Devices
- Advising on the development of prospective medical devices.
- Analyzing of the Biomaterials Access Assurance Act of 1998.
- Providing guidance on company policies involving use of products as components of medical devices, including tort liability and regulatory considerations.
- Counseling on good manufacturing practice standards for medical devices and guidance for medical device components.
General
- Assisting with product recalls and market withdrawals, including advice on regulatory, contract, tort, and customer relations issues.
- Advocating to FDA on limiting the burdens associated with its electronic recordkeeping requirements and compliance advice.
- Analyzing the regulation of nanoscale components of medical devices, drugs, food, food additives, dietary supplements, color additives, and cosmetics under the FFDCA.
- Providing guidance on FDA and other requirements for Institutional Review Board review of human testing.
- Advocating for the use of cattle-derived materials in FDA-regulated products due to concerns with bovine spongiform encephalopathy.
