FDA Regulatory

We represent manufacturers, marketers, suppliers, wholesalers, dealers, retailers and industry participants in transactions, the provision of regulatory compliance advice and in all manner of litigation. We have worked on matters involving the FDA, CPSC, USDA, FTC, DOJ and Department of Commerce and Economic Opportunity, and various state and local regulatory agencies. Our lawyers understand the intersections of business and government and are skilled navigators of the often challenging operating environment created by all levels of government.

Our team members bring significant global experience from within the HHS, FTC and private industry.

Pharmaceuticals and Biologics

Locke Lord's regulatory and government relations practitioners represent our generic pharmaceutical and biologics clients in such matters as approvals, current Good Manufacturing Practices (cGMP) compliance, post-market requirements and regulatory exclusivities under the Food, Drug and Cosmetics Act and Biologics Competition Price and Innovation Act.

Our lawyers regularly advise clients in designing Risk Evaluation and Mitigation Strategies (REMS), responding and filing citizen petitions, preparing for agency meetings and appeals and securing agreements with third-party vendors. We have experience managing domestic and international inspections undertaken by the FDA. We have litigated industry vs. industry lawsuits as well as in cases brought under the Administrative Procedures Act (APA) and Lanham Act.

Medical Devices

Our group has experience working with a broad range of medical devices in all classes, including clearances of 510(k)s. We handle the broad spectrum of post-market compliance, including supplementation, post-market surveillance, establishment registration, product listing, inspections, medical device reporting and recalls. We have provided significant assistance and guidance on the FDA's recently issued Emergency Use Authorizations for regulated devices as a result of the pandemic.

Food and Dietary Supplements

Locke Lord's regulatory team counsels clients in the food and dietary supplement industries as well as medical food, food additives, food ingredients and pet food industries. Among the areas with which we assist in compliance are the Dietary Supplement Health Education Act (DSHEA), Food Safety Modernization Act (FSMA), Fair Packaging and Labeling Act (FPLA) and the Bioterrorism Act.

Cosmetics and Over-the-Counter Drugs

Locke Lord's regulatory team has extensive experience in counseling clients in the cosmetics industry and in the OTC drug industry for monographed OTC drugs on FDA compliance, including product packaging, labeling and advertising. We are fully versed in the impact of the new OTC Act, which was passed as part of the CARES Act. We provide counseling and representation in all areas of cosmetics and OTC drug regulations, including:

• Distinctions between FDA-considered drug claims versus cosmetic claims
• OTC drugs, cGMP and Good Laboratory Practices (GLP)
• Adoption of various required procedures and policies for marketing monographed OTC drugs and color additives approvals
• Responding to customs detentions, Warning Letters, Section 483 letters and market withdrawals
• Advising on registration and listings for OTC manufacturing facilities and OTC products advertising challenges before the FTC and NAD
• Consumer class actions and Lanham Act Section 43(a) litigation involving false and deceptive advertising and unfair competition matters
• Litigation arising under state unfair competition and false adverting laws
• Compliance with laws enforced by the CPSC and FTC
• Addressing public relations issues arising from negative social media and consumer product reviews
• Counterfeiting issues for both cosmetics and OTC drug products

Locke Lord has played a leadership role in the cosmetics and personal care industry, with one of our lawyers serving on the Board of Directors of one of the leading cosmetic and personal care trade associations, and has drafted and responded to significant legislative challenges.

USDA

Our team represents clients before the USDA and its many departments. The issues we have managed include nutrition and labeling, meat and poultry safety and labeling perishable products, animal feed, organic agriculture, transgenic crops, plant pests, animal welfare, various permitting questions, product development and recalls.

Cannabis

Our team provides guidance through the maze of the various regulatory agencies, such as the FDA, DEA and FTC and state and local authorities, for the advertising, distribution and sale of cannabis and cannabis-containing products. This includes FDA regulatory issues presented by manufacturing, using and selling of cannabis products made from industrial hemp as well as products that contain derivatives of industrial hemp, such as CBD from industrial hemp, which are now covered under the Farm Bill of 2018. Our lawyers have had extensive experience in counseling in the marketing and advertising of these products.