KKB provides legal and regulatory advice on the formulation, labeling, and promotion of dietary supplement products. Our focus is on strategic planning to minimize regulatory problems and maximize the ability of products to compete in the dietary supplement marketplace. We frequently work together with major US trade associations on dietary supplement policy issues to ensure that products are treated fairly by regulatory agencies.
KKB has expertise in all aspects of dietary supplement labeling, including the proper naming of supplements, the Supplement Facts panel, ingredient lists, identification of the manufacturer/distributor, and country of origin labeling. We also advise on structure-function claims, nutrient content claims and FDA-authorized health claims. We have successfully submitted petitions to FDA to seek approval for such claims.
KKB also has extensive advertising law experience relating to dietary supplement claims. We regularly interpret federal and state advertising law – as well as the decisions of advertising self-regulatory bodies – in order to support client’s claims with appropriate wording and substantiation. We frequently defend such claims in cases before the FTC, state attorneys general, federal courts and self-regulatory bodies (such as the National Advertising Division of the Council of Better Business Bureaus). In particular, we are very familiar with recent litigation against food and dietary supplement claims under state unfair trade practice laws and can assist clients in crafting claims to help reduce the risk of liability.
KKB advises on the legality of dietary supplement ingredients, including new dietary ingredients (NDIs) and the need for NDI notifications. We have worked together with scientific experts to prepare NDI notifications as well as to prepare alternative approaches to ensuring lawfully marketed dietary ingredients.
KKB frequently advises clients on issues relating to FDA-regulated good manufacturing practice for dietary supplements. We also work closely with clients to help ensure compliance when manufacturing and/or product safety issues arise.
KKB advises clients on enforcement-related issues – for example: we advise on how to respond to FDA inspectors’ requests, FDA-483 observations, and Warning Letters. We also have extensive experience responding to more significant enforcement actions, including FDA actions for seizure, injunction, criminal prosecution, and all other FDA enforcement authorities.
KKB assists clients in drafting agreements relating to regulatory issues, such as guarantees, labeling agreements (for exemption from labeling requirements for foods to be further manufactured), agreements for studies of new ingredients and claims, etc. We assist business planners in evaluating the investment needed to support new products, ingredients and claims. We also conduct due diligence reviews of dietary supplement companies and products that are being considered for acquisition.