FDA Regulation

We counsel 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.

Our FDA practice combines detailed knowledge of how FDA operates with an understanding of the real-world challenges companies face when bringing highly regulated products to market and successfully keeping them there.

B&D helps companies in the food and chemical industries navigate one of the most significant shifts in U.S. food and chemical regulation in decades: the Trump administration’s Make America Healthy Again (MAHA) initiative. This federal commission continues to drive sweeping changes across agencies such as FDA, the U.S. Department of Health and Human Services (HHS), and the U.S. Department of Agriculture. States are pursuing their own legislative and regulatory changes in parallel, all with major implications for ingredients, labeling, and compliance strategies.

B&D also advises companies on another watershed change, this one targeting the cosmetics industry: the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). Cosmetics and their ingredient manufacturers should expect increasing scrutiny and regulatory oversight as FDA moves to implement this legislation. At the same time, States have already been enacting new restrictions on cosmetic ingredients, including banning the use of certain ingredients.

Focus Areas

• FDA approvals, compliance, enforcement actions, and inspections
• Bringing new products to market
• Product recalls
• Environmental claims, green marketing, and “healthwashing,” labeling
• Plastics and packaging
• Advising on foreign counterparts
• Regulatory advocacy
• Electronic recordkeeping
• Nanotech issues

Areas of Service

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 and food packaging.
• Assisting companies with MAHA-related challenges.

Cosmetics

• Advising on current and pending FDA requirements under MoCRA for finished cosmetics and cosmetic ingredients.
• Counseling on marketing claims for cosmetics and cosmetic ingredients.
• Guiding 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

• Counseling on good manufacturing practice standards for finished drugs and good manufacturing practice guidance for active pharmaceutical ingredients and excipients.
• Advising on labeling and production requirements for hand sanitizers and disinfectant wipes, sunscreens, and other over-the-counter drug products.
• Advising on good laboratory practice standards for pre-clinical testing.
• Advocating with Customs and Border Protection over imports of active pharmaceutical ingredients with alleged drug labeling deficiencies.

Learn more about our Pharmaceuticals & Health Care practice.

Medical Devices

• Advising on the development of prospective medical devices.
• Guiding company policies involving the 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.
• Assessing FDA and EPA jurisdiction over ultraviolet lights and other devices with intended uses in medical settings.      

General

• Assisting with product recalls and market withdrawals, including advice on regulatory, contract, tort, and customer relations issues.
• Advising on the regulation of nanoscale components of medical devices, drugs, food, food additives, dietary supplements, color additives, and cosmetics under the FFDCA.
• Counseling on FDA and other requirements for Institutional Review Board review of human testing.

We also assist with facility-related matters, including:

• Food processing plant regulatory requirements.
• Compliance and enforcement matters related to the transportation of food products and hazardous materials.
• Environmental Health and Safety audits and audit disclosures.
• Air, water, and wastewater permitting.
• Stormwater management.
• Due diligence for corporate and real estate transactions.
• Environmental indemnity and related transaction agreements.