Keller and Heckman is an internationally recognized law firm with over 40 years of Food & Drug regulatory experience.  Partners and scientists in our Food & Drug regulatory practice group have extensive experience working for clients in highly regulated industries, and many have spent significant time working at government agencies prior to entering private practice.  Our Food & Drug regulatory practice encompasses a wide range of issues; we counsel our clients on all aspects of Food & Drug compliance, from product and ingredient safety and quality issues, to labeling and advertising, to dealing with regulatory enforcement actions and product recalls.   We also routinely counsel our clients on the applicability of laws, regulations, and policies enforced by non-food regulatory agencies (e.g., environmental agencies, consumer product safety agencies) and by state or Member state governments where such requirements affect the Food & Drug industry.

With offices in the United States, Europe, and China, our firm is well-positioned to prepare regulatory filings to secure appropriate marketing clearances for clients on a global scale.  Together with many well-recognized scientists on our staff – including toxicologists, chemists, and microbiologists – we are able to provide both the regulatory and technical support that many clients need.

In our day-to-day practice – and among a host of other representative matters – we regularly:

  • provide regulatory and strategic advice to assist with all phases of product commercialization from R&D to labeling to marketing
  • help to secure appropriate regulatory clearances for food/feed additives, ingredients, and finished foods/feeds and dietary supplements within the United States, European Union, and China
  • assist with the development of product marketing and advertising strategies under the applicable legal and regulatory framework
  • provide crisis counseling in the event of regulatory inspections, product recalls, competitor challenges, or consumer complaints
  • assist with internal and government investigations
  • defend clients against litigation challenges brought by competitors and consumers, including class action lawsuits

Finally, we note that Chambers & Partners – a leading legal ranking publication – has ranked Keller and Heckman’s Food and Beverages practice in the highest tier, “Band 1,” which includes the top three practices nationwide.  U.S. News & World Report ranks FDA law specialists Mel Drozen and Leslie Krasny as among the “Best Lawyers in the U.S.”  These accolades are accessible on our homepage at www.khlaw.com.