Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition, we have a very comprehensive practice in the regulation of packaging materials for food, drugs, and cosmetics and other food-contact articles. We represent clients in addressing all issues relating to these products, including the suitability of their composition, inspection of manufacturing facilities, labeling and advertising, recall procedures, quality assurance programs, and appropriate responses to consumer complaints and tampering incidents. We also vigorously defend our clients when threatened by unwarranted action by competitors or regulatory authorities. We also have substantial experience conducting "due diligence" audits of marketed products, labeling, advertising claims, and manufacturing operations, both for the clients' internal control purposes and as part of product line or corporate acquisitions.
Articles in the National Law Review database by Food and Drug Law at Keller and Heckman
- Court of Justice of the European Union Rules on GMO Crop Ban (Posted On Tuesday, August 9, 2022)
- FDA Launches LAAF Program Dashboard (Posted On Thursday, August 4, 2022)
- USDA To Declare Salmonella An Adulterant in Some Raw Poultry (Posted On Wednesday, August 3, 2022)
- FDA Finalizes NAC Enforcement Discretion Guidance (Posted On Tuesday, August 2, 2022)
- Temporary Reprieve From French Ban on “Meaty” Words in Labeling of Plant-Based Foods (Posted On Monday, August 1, 2022)
- World Health Organization Issues Draft Guideline on Non-sugar Sweeteners, Seeks Public Comment (Posted On Friday, July 29, 2022)
- New Draft Guidance on Remote Regulatory Assessments (Posted On Wednesday, July 27, 2022)
- Chocolate False Advertisement Lawsuit Dismissed (Posted On Tuesday, July 26, 2022)
- FSIS Puts Cell-Cultured Meat Labeling Regulations On Hold (Posted On Friday, July 22, 2022)
- FDA Evaluation of Agency Activities (Posted On Thursday, July 21, 2022)
- Bill Introduced to Establish Single Food Safety Agency (Posted On Wednesday, July 20, 2022)
- FDA Proposes Compliance Dates for Pre-Harvest Agricultural Water Requirements and Specifies Duration of Enforcement Discretion for Harvest and Post-Harvest Requirements (Posted On Tuesday, July 19, 2022)
- Target Argues Consumer Deception is Implausible for Bright Red, Zero-Calorie, Water Enhancer (Posted On Monday, July 18, 2022)
- Gerber Argues FDA Preemption in Baby Food Lawsuit (Posted On Friday, July 15, 2022)
- FDA Approves Six Accreditation Bodies Under LAAF (Posted On Thursday, July 14, 2022)
- FDA Warns 4 Companies for Selling Tainted Honey-Based Products (Posted On Wednesday, July 13, 2022)
- FDA to Develop Framework for Continued Expanded Access to Infant Formula (Posted On Tuesday, July 12, 2022)
- France Restricts Labeling for Plant-Based Proteins (Posted On Friday, July 8, 2022)
- Food Safety and Standards Authority of India Publishes New Regulations for Vegan Foods (Posted On Wednesday, July 6, 2022)
- PETA Petitions USDA-FSIS to Remove Animal Raising Claims from Label Approval Process (Posted On Tuesday, July 5, 2022)
Keller and Heckman’s Food and Drug Law Practice Group is a Go-To Thought Leader for 2021 for its coverage of Food Labeling Class Action Lawsuits and Regulatory news. The group regularly provides interesting, comprehensive news on topics ranging from class-action lawsuits involving Snack Foods lacking real Wasabi and Canned Green Beans inaccurately claiming to be preservative-free, to proposed federal legislation regulating CBD in food products. NLR readers appreciate the group’s efforts to break down lawsuits and pending legislation impacting the nation's food supply.
The National Law Review Recognizes Keller and Heckman’s Food and Drug Law Practice Group as Go-To Thought Leaders for the firm’s contributions on FDA Regulations and guidelines. Keller and Heckman’s expansive FDA coverage included: proposed rules expanding food traceability and record-keeping requirements, new guidance for animal food additives, a final rule concerning gluten-free food labeling, and approval of a new peanut allergy drug. Addressing the COVID-19 crisis, Keller & Heckman provided news about warnings required by the FDA for Purell and other actions about hand sanitizer and additional Coronavirus prevention and cure claims, the FDA’s and OSHA’s employee health and food safety checklist(s) and COVID-19 best practices for retail and restaurants and COVID-19 Guidance to U.S. food exporters. The firm’s most frequent FDA / Food and Drug Law attorney contributors to the NLR include Azim Chowdhury, Sheila A. Millar, Evangelia Pelonis, Natalie Rainer and LieAnn Van-Tull.