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.
The state of New York has captured the dietary supplement industry’s attention. Since early 2015, several prominent manufacturers and retailers have faced “stop sale” and cease and desist letters issued by the New York Attorney General’s Office under the direction of Eric T. Schneiderman, alleging adulteration and misbranding violations against dietary supplements. While the initial investigations were based on DNA Bar Code technology that has been widely criticized as not a suitable method, the NY AG’s investigations have been costly for companies and have resulted in consent agreements and triggered class action lawsuits.
As Attorneys General continue to actively monitor and investigate dietary supplement companies under state consumer protection laws, and a steady stream of consumer class action cases continues, a robust compliance and on-going risk assessment plan are essential.
The Law Office of Bayne & Associates provides pro-active legal representation and advice to companies to address potential AG risk and consumer class action exposure. Ms. Bayne has recently appeared at an industry event moderating a distinguished panel of current and former Attorneys General addressing AG enforcement and industry’s compliance efforts.