Prim, Harry "Samuel"

ANN MARIE GAITAN.  Mrs. Gaitan’s practice focuses on products regulated by the Food and Drug Administration (FDA), the Department of Agriculture (USDA), the Environmental Protection Agency (EPA) and the Federal Trade Commission (FTC).

Mrs. Gaitan regularly counsels regulated entities on the laws, regulations and policies affecting foods, dietary supplements, medical devices, drugs, cosmetics and combination products. She represents manufacturers, importers, processors, distributors and marketers on compliance and enforcement matters before a wide range of federal regulatory agencies. Mrs. Gaitan’s practice includes representation of clients in regulatory compliance issues relating to labeling, packaging, claims, ingredients, record keeping, good manufacturing practices and marketing. She also provides counsel to clients preparing for an FDA inspection as well as responding to inspectional findings (483) and warning letters. 

Mrs. Gaitan has successfully removed numerous clients from FDA Import Alert, and worked with clients to develop and implement effective Corrective Action Plans (CAP) and revised Hazard Analysis and Critical Control Points (HACCP) plans. 

In addition, Mrs. Gaitan has extensive experience in the review of websites, advertising and marketing materials, as well as the representation of companies before the FTC.  She has successfully negotiated consent decrees with the FTC, while also counseling clients on standards for truthful and non-deceptive advertising, evidentiary support for claims, use of testimonials, comparative advertising, disclosure adequacy, as well as other common advertising practices regulated by the FTC.