KKB regularly handles a broad array of issues relating to foods, including the implementation of new requirements under the FDA Food Safety Modernization Act, marketing clearance of new ingredients, and all types of food labeling issues. We assist clients in obtaining FDA acceptance of novel ingredients and novel health-related claims. We review labels and ingredients to ensure legal compliance, and provide advice on recalls and other manufacturing and safety-related issues. We also assist clients on handling inspections and responding to enforcement actions. Our areas of expertise include products outside of FDA’s usual jurisdiction, including ingredient and labeling issues for USDA-regulated meat, poultry and egg products, and alcoholic beverages.
KKB has expertise in all aspects of food labeling for both FDA and USDA-regulated products. We advise on the proper naming of foods and standards of identity, federal and state requirements for net quantity of contents, the Nutrition Facts panel, ingredients lists, identification of the manufacturer/distributor, and country of origin labeling. We also advise on structure-function claims, nutrient content claims and health claims. We have submitted petitions to FDA to seek approval for such claims.
KKB also has extensive advertising law experience relating to food claims. We regularly interpret federal and state advertising law – as well as the decisions of advertising self-regulatory bodies – in order to support clients’ 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 and the Children’s Food and Beverage Advertising Initiative of the Council of Better Business Bureaus). In particular, we are very familiar with recent litigation against food 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 food ingredients, including food additives, GRAS substances and color additives. We have worked together with scientific experts to prepare a number of successful GRAS notifications and food additive petitions, and regularly advise on legally defensible procedures for reaching “self-GRAS” determinations.
KKB frequently advises clients on issues relating to FDA-regulated good manufacturing practice for foods. These issues include implementation of the FDA Food Safety Modernization Act and associated regulations, HACCP requirements for juices and seafood, low-acid and acidified food manufacturing requirements, and FDA’s guidance on microbiological testing. We also work closely with clients to help implement recalls and interface with FDA on recalls.
KKB has extensive experience dealing with USDA’s Food Safety Inspection Service (FSIS) on issues relating to meat, poultry and egg products. On behalf of clients, we advise on labeling issues and work with both FDA and FSIS to seek approval of new ingredients. We also work with FSIS’ Risk Innovation Management Division to seek approval of new processing aids and manufacturing technologies.
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, 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 food companies and products that are being considered for acquisition or investment.