FDA Regulatory and Compliance

Haynes Boone attorneys serve as trusted advisors delivering timely, accurate and innovative counsel to FDA-regulated companies on a variety of transactional and regulatory matters. Our attorneys address complex regulatory and compliance challenges, risk management and multifaceted transactions for:

  • Food manufacturers and processors;
  • Restaurant chains, food retailers and other food distributors;
  • Dietary supplement manufacturers and own label distributors;
  • Medical device companies;
  • Cosmetic and personal care product manufacturers and brands;
  • Pharmaceutical and OTC drug companies;
  • Biotechnology companies; and
  • Diagnostic companies.

We assist FDA-regulated companies with all aspects of product development, labeling, advertising, pre-clearance or pre-approval issues, as well as post-market issues. Representative examples of our work include:

  • Responses to FDA inspection observations, product detentions, warning letters, and other potential enforcement actions;
  • Due diligence to support the acquisition of FDA-regulated product lines or companies and to support securities offerings;
  • Develop regulatory and distribution strategies for novel products that will or may be FDA-regulated, including the analysis of the appropriate pathway for FDA clearance or approval;
  • Provide risk management counseling, including self-evaluative audits, designing corrective action plans, and handling of possible past or existing regulatory violations;
  • Provide regulatory analysis and crisis management during threatened or actual recalls;
  • Strategic product development planning and labeling and claim review and substantiation, regulatory compliance, and risk management with respect to consumer and competitor actions;
  • Support for the development of stronger GMPs and preventive controls;
  • Review and advise on food preparation and handling and safety issues, including compliance with the Model Food Code and relevant local and state regulations and FDA regulations or guidance;
  • Counseling on compliance with the Food Safety Modernization Act (FSMA);
  • Provide effective advocacy and help to engage appropriate, specialized lobbyists and other consultants when needed.
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FDA’s First Draft Guidance Under MoCRA: Registration and Listing of Cosmetic Product Facilities and [...]
September 12, 2023

The FDA recently issued its first draft guidance addressing Registration and Listing of Cosmetic Product Facilities and Products (the “Draft Guidance”), as required under the Modernization of Cosmetics Regulation Act of 2022 (“MoCRA”). This summary provides an initial overview of the Draft Guidance and the steps that cosmetics manufacturers and processors should begin taking to ensure and/or prepa [...]