Understanding the shared jurisdiction between FDA and other federal and state regulatory agencies is essential to avoiding costly disruptions to your business.
United States Department of Agricuture (USDA)
The National Organic Program (NOP) is a regulatory program of the USDA 's Agricultural Marketing Service (AMS). Bayne & Associates advises companies on NOP regulatory requirements with respect to organic certification; the National List of Allowed and Prohibited Substances; organic food, dietary supplement, and cosmetic formulation issues; and the use of "organic" claims in product labeling.
We also advise companies on compliance with USDA’s final rule that sets forth the national mandatory standard for disclosing foods that are bioengineered, including which foods are subject to the standard, the location and size of the disclosure, and the different options for disclosure.
USDA's Animal and Plant Health Inspection Service (APHIS) regulates the importation of animals and animal-derived materials to ensure that animal-borne diseases are not introduced into the United States.. We advise dietary supplement companies engaged in the import of gelatin-containing products with respect to USDA Import Permit requirements for the import or transport of controlled material or organisms or vectors (VS Form 16-3).
U.S. Customs & Border Protection (CBP)
For companies importing FDA-regulated products into the United States.S., it is essential to avoid disruptions stemming from import holds, detentions, or refusals. We have in-depth knowledge in the intersection of FDA law with the laws and regulations enforced by CBP, to assist clients in anticipating potential legal and regulatory issues before problems arise at the border.
We also routinely advise companies on country-of-origin marking requirements for imported merchandise.
California Law & Prop. 65
Companies engaged in the business of selling FDA-regulated products must also be concerned about compliance with state laws and regulations, including consumer protection and envirornmentalenvironmental laws.
Favorable plaintiffs' laws in California make food, dietary supplement, and cosemticcosmetic companies a target for consumer class action litigation. We routinely review companies' labeling and advertising claims in consideration of managing consumer class action risk, and provide litigation support with respect to FDA, FTC, and claims substantiation issues in connection with the defense of consumer class action cases.
California has the most stringent law and regulations with respect to a product causing exposure to potentially toxic substances. "Proposition 65,”, passed by voter referendum as the Safe Drinking Water and Toxic Enforcement Act of 1986, requires, in relevant part, that a “clear and reasonable” warning must appear on the label of a product that will “expose” a person to any chemical known to the State to cause cancer or reproductive harm, UNLESS unless the level is within an established “safe harbor” limit.
We provide legal advice to companies in addressing Proposition 65 compliance and, working with dedicated Proposition 65 counsel based in Sacramento, assist with the defense of such actions.