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
- DuPont Challenges FDA’s Proposal to Revoke Soy-Heart Health Claim - (Posted On Tuesday, January 23, 2018)
- USDA Releases Proposed Rule to “Modernize” Pork Inspection - (Posted On Monday, January 22, 2018)
- EFSA Publishes Part 1 of Draft Guidance on Risk Assessment of Nanoscience and Nanotechnology Applications in the Food and Feed Chain - (Posted On Monday, January 22, 2018)
- Gottlieb Announces Plans to Strengthen Recall Process and FDA Publishes Draft Guidance to Clarify Its Approach to Product Recalls - (Posted On Friday, January 19, 2018)
- FDA to Begin Process of Modernizing Certain Standards of Identity - (Posted On Thursday, January 18, 2018)
- USDA’s Modernized Pork Slaughter Rule Clears OMB - (Posted On Wednesday, January 17, 2018)
- FDA Denies Qualified Health Claim Linking Vitamin D Intake and Reduced Risk of MS - (Posted On Tuesday, January 16, 2018)
- CDC expands use of Whole Genome Sequencing in Foodborne Illness - (Posted On Friday, January 12, 2018)
- Colorado Legislators Propose Stronger Version of COOL - (Posted On Thursday, January 11, 2018)
- USDA Announces Proposed Rule to Amend Egg Products Inspection Regulations - (Posted On Wednesday, January 10, 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.