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Practice Area

Food and Drug

Box of groceries

Keller and Heckman’s world-renowned Food and Drug practice, provides clients with comprehensive legal and regulatory advice for a vast range of food and drug products, including foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, cosmetics, and cannabis products, as well as the packaging  for these products. Our international team of attorneys, in collaboration with our in-house scientists, help clients bring their products to market and remain on the market.

We advise clients in promoting, protecting, and defending their products that are regulated by a variety of agencies and regulatory bodies, including the U.S. Food and Drug Administration (FDA), the U.S. Department of Agriculture, the Federal Trade Commission (FTC), the Codex Alimentarius Commission (including the Committee on Food Labeling, Committee on Food Additives and Contaminants, the Committee on Nutrition and Foods for Special Dietary Use, and the Committee on General Principles), the European Commission and Member States authorities in the European Union (EU), the World Trade Organization (WTO), and similar authorities and regulators throughout the world. 

Keller and Heckman counsels clients on issues relating to product composition suitability; inspection of manufacturing facilities; labeling and advertising; recall procedures, including adequate insurance coverage ; quality assurance programs; and appropriate responses to consumer complaints and tampering incidents. In collaboration with our litigation  practice, Keller and Heckman vigorously defends clients when threatened by unwarranted action by competitors or regulatory authorities. 

In the packaging arena, we counsel clients on the full range of global legal and regulatory issues, including ones in the United States, the European Union, China, Japan, and South America. We assist clients with the preparation and submission of food contact notifications, food additive petitions, technical dossiers, and other filings to obtain regulatory clearances for substances (including recycled materials) used in the production of packaging for food, drugs, and other products. Our attorneys also assist clients with drug master files (DMFs) and device master files (MAFs) submissions. 

Representative Matters

  • Obtained a favorable no objection letter from the FDA in response to a generally recognized as safe (GRAS) Notice submission to FDA. 
  • Achieved an appropriate regulatory status for food contact materials through the submission of a food contact notification to FDA.
  • Determined regulatory pathways available for a dietary ingredient used in dietary supplements and helped the client to understand the benefits and detriments of the different approaches. 
  • Assisted client in understanding labeling and claims that can be made on their label in compliance with FDA laws and regulations including a litigation risk assessment on various claims. 
  • Worked with client to understand food safety requirements such as Hazard Analysis and Risk-Based Preventive Control (HARPC) requirements.
  • Helped review foreign facility food safety plans and draft Foreign Supplier Verification Program (FSVP) records for imports to comply with FDA’s FSVP requirements. 
  • Advised client on whether a food safety incident creates a health or safety risk that requires a recall, determine recall classification, and counsel on communication with FDA and press releases. 
  • Advised client on new bioengineered labeling requirements including exemptions and labeling options.
     

Areas of Focus

Click here for more information on the Animal and Veterinary Food and Drug practice.

Click here for more information on the Cannabis, Hemp and CBD practice.

Click here for more information on the Cosmetics practice.

Click here for more information on the Dietary Supplements practice.

Click here for more information on the Food and Drug Packaging practice.

Click here for more information on the Food and Food Ingredients practice.

Click here for more information on the Food Litigation practice.

Click here for more information on the Food Recall Insurance Coverage practice.

Click here for more information on the Medical Devices practice.

Click here for more information on the Pharmaceuticals practice.

Partner

Senior Counsel

Melvin S. Drozen
Senior Counsel

Counsel

Senior Regulatory Counselor

Jenny Xin Li
Senior Regulatory Counselor

Associate

Karly C. Bader
Associate
Kristen Boyce Ballintyn
Associate
Christina M. Carone
Associate
Owen D. Chaput
Associate
Caroline Commandeur
Associate
Thayer E. Ellis
Associate
Sara M. Gaines
Associate
Connie M. Potter
Associate
Nicholas S. Prust
Associate
Arturo R. Reyes
Associate
Richard A. Starr
Associate
LieAnn T. Van-Tull
Associate
Ashley B. Yull
Associate

Scientist

Cheryl Barbati Bast, Ph.D., D.A.B.T.
Scientist
Estefania Boix, Ph.D.
Scientist
Ivan J. Boyer, PH.D, D.A.B.T.
Scientist
Peter N. Coneski, Ph.D.
Scientist
Rachel D. Deese, Ph.D.
Scientist
Holly H. Foley
Scientist
Preston Fulmer, Ph.D.
Scientist
Mark A. Hepp, Ph.D.
Scientist
Chen Hu
Scientist
Michael Hubbard, Ph.D.
Scientist
Qingdong "Karin" Ke, Ph.D., D.A.B.T., ERT
Scientist
Steven J. Manning, Ph.D.
Scientist
Michelle L. Twaroski, Ph.D.
Scientist
Kristin Price Wiglesworth, Ph.D.
Scientist

Law Graduate

Galen D. Rende
Law Graduate

Regulatory and Scientific Affairs Counselor

Nathalie Henin
Nathalie Henin
Regulatory and Scientific Affairs Counselor
Nathalie Henin
Regulatory and Scientific Affairs Counselor
Christophe Lepretre
Christophe Leprêtre
Regulatory and Scientific Affairs Counselor
Christophe Leprêtre
Regulatory and Scientific Affairs Counselor

Legal Consultant

Suyan (Sharon) Tian
Legal Consultant

Paralegal

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