Representation of clients in matters relating to the U.S. Food and Drug Administration, regulatory issues, Federal Trade Commission proceedings and litigation. Marc's practice focuses on FDA compliance, including labels, labeling, claims, and good manufacturing practices (GMPs). He has represented clients in complex adversarial proceedings with the FDA relating to the scope of the agency’s powers under the Dietary Supplement Health and Education Act of 1994 and its ability to seek remedies such as consumer restitution as well as counseling clients on general litigation related issues. Marc successfully guided the first self-GRAS (generally recognized as safe) review for stevia that allowed his client to legally import this herb as a sweetener and has assisted numerous other clients through the New Dietary Ingredient process for dietary supplements. He also counsels clients in adversarial proceedings involving the FTC, including the negotiation of consent decrees and litigation regarding the adequacy of substantiation of advertising claims. He appeared/testified on behalf of clients before the Food and Drug Administration’s Food Advisory Committee and at the FDA’s April 4, 2000 hearing concerning the impact of the First Amendment to the United States Constitution on FDA’s regulation of health claims concerning diseases and has counseled clients in connection with matters under investigation by the United States Congress.Marc worked with clients at the center of the "Pet Food Recall" connected with the adulteration of wheat gluten with melamine, the recall of StarCaps Dietary Supplements following the suspension of several NFL players whose drug screening tests indicated the presence undeclared prescription drug in the product, and one of the companies conducting a major recall of pistachios due to potential contamination with salmonella.He has assisted numerous clients responding to FDA dietary supplement GMP 483s and Warning Letters.ATTORNEY ADVERTISING
Listed skills include Supplements, Fda, Regulatory Affairs, Gmp, and 12 others.
