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 Issues Warning Letters to Four Companies Selling Unapproved CBD Products for Food-Producing Animals - (Posted On Friday, May 27, 2022)
- FDA Webinar on Action Levels for Lead in Juice - (Posted On Thursday, May 26, 2022)
- Pop-Tarts False Ad Lawsuit Permanently Dismissed - (Posted On Wednesday, May 25, 2022)
- FDA Denies Request to Exempt D-Tagatose from Added Sugar Labeling - (Posted On Tuesday, May 24, 2022)
- New Draft Guidance on FDA Enforcement Discretion for Past-Due NDI Notifications - (Posted On Monday, May 23, 2022)
- FDA Updates Agricultural Water Protocol - (Posted On Thursday, May 19, 2022)
- House Bill To Give FDA More Funding to Address Formula Shortage - (Posted On Wednesday, May 18, 2022)
- FDA Releases Guidance on Infant Formula Enforcement Discretion Policy - (Posted On Tuesday, May 17, 2022)
- FDA Finalizes Guidance on Reducing Microbial Hazards in Seed for Sprouting - (Posted On Monday, May 16, 2022)
- FDA Works to Improve Supply of Formula Products - (Posted On Thursday, May 12, 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.