Food & Drug Law / FDA Regulation
Food and Drug law is the law pertaining to and governing the discovery, development, production, distribution and sale of products subject to the jurisdiction of and regulated by the United States Food and Drug Administration (FDA). The FDA has been given responsibility within the Executive Branch of the United States government for administering the regulation of products that fall within the statutory definitions found within the Federal Food Drug and Cosmetic Act, 21 U.S.C. 360 et seq.
Food and Drug law is a complex area of legal practice, because the subject of the legal framework consists of products that are often highly-engineered, with performance and safety based on expansive scientific principles. Also, these products are widely used, and relied upon by the American public — and as a result, constitute some of the highest-profile products in commerce today. Recent estimates have concluded that approximately 25% of the United States’ Gross Domestic Product is subject to the jurisdiction of and regulation by the United States Food and Drug Administration.
Having spent over 30 years in FDA-regulated industry in both legal and non-legal roles, Jack Garvey is a diverse, capable expert in the practical application of Food and Drug law and regulation.
The following are just a few of the legal issues and challenges The Garvey Law Firm can assist you with:
- Regulatory submission development, reviews and submission critiques
- Product marketing and advertising reviews; Product claims reviews and support assessment
- Regulatory analysis and product risk determinations
- Food and Drug Law legal and regulatory training for executives and staff
- Executive education & responsibilities under the FFDCA and corresponding case law and Policy (e.g., Park, Dotterweich & the Yates Memorandum)
- Section 513G Requests for Information (FDA product classification feedback)