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.
More Legal and Business Bylines From Food and Drug Law at Keller and Heckman
- FDA Commissioner Scott Gottlieb Comments on Intentional Adulteration - (Posted On Thursday, March 29, 2018)
- FDA Provides Remarks on their Role in Supporting Innovation in Food Technology - (Posted On Wednesday, March 28, 2018)
- Shrimp and Abalone to be Included in SIMP - (Posted On Tuesday, March 27, 2018)
- Conflict-Obstacle Preemption Bars All State-Law Claims Which Effectively Challenge a Certification Decision Pursuant to the Organic Food Production Act (OFPA) - (Posted On Monday, March 26, 2018)
- Arkansas Passes Resolution Calling for Standard for Rice - (Posted On Friday, March 23, 2018)
- California Considers Regulating Food Packaging under Green Chemistry Initiative - (Posted On Thursday, March 22, 2018)
- FDA Guidance States Live Animals Processed Under USDA Regulations Do Not Need to Comply with FSVP Regulations - (Posted On Wednesday, March 21, 2018)
- FDA Issues Draft Guidance on “Small Business” under FSMA Preventive Controls Regulations - (Posted On Tuesday, March 20, 2018)
- First Amendment constraints on FDA’s regulation of health claims - (Posted On Monday, March 19, 2018)
- Outcome of the last Codex alimentarius Committee setting standards in Nutrition and Food for Special Dietary Uses, including "baby foods" (5-9 Decembe 2017; Berlin, Germany) - (Posted On Friday, March 16, 2018)
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.