Food & Drug Keller and Heckman has a comprehensive and extensive food and drug practice. The firm promotes, protects and defends products made by the spectrum of industries regulated by the US Food and Drug Administration (FDA), and similar authorities throughout the world.
Email: [email protected]
Food & Beverages:
The firm represents companies and trade associations in all areas of the food and beverage industry, including pet foods, dietary supplements and infant formula. The firm counsels clients on compliance issues, including GMP requirements and product recalls; assists clients with food additive petitions; and advises clients on labeling.
Keller and Heckman has a comprehensive practice in the regulation of packaging materials for food, drugs, cosmetics and other FDA-regulated products. The firm counsels clients in all matters relating to these products, including the suitability of packaging components, inspection of manufacturing facilities, and quality assurance programs. The firm’s website, www.packaginglaw. com, is the premier source of information on laws and regulations that affect packages and packaging materials.
The firm counsels clients on all aspect of human and animal drug requirements, including the preparation and submission of NDAs and ANDAs, and labeling requirements. The firm also assists clients with import and export regulations for drugs.
The firm has extensive experience counseling clients on medical device regulations. The firm assists clients with the proper classification of devices, liability issues, preparation and submission of premarket notifications and Device Master Files, product recalls, preparation for FDA inspections, responding to FDA enforcement actions, and quality system requirements.
The firm advises clients on the full range of cosmetic regulatory compliance issues, including labeling and advertising requirements, the classification of a product as a cosmetic or a drug, potential product liability issues, safety testing of ingredients, GMP requirements, and responding to enforcement actions.
Tobacco & E-Vapor:
The firm provides legal and scientific support to tobacco product companies and their suppliers with respect to the statutory and regulatory requirements imposed by the Tobacco Act.
Litigation The firm’s nationally-recognized litigation attorneys aggressively represent its clients’ interests before federal and state courts, and regulatory and industry sanctioned bodies. The firm’s attorneys also participate as advocates in arbitrations, mediations and other alternative dispute regulation forums. They often work within multidisciplinary teams consisting of in-house scientific staff and regulatory attorneys with specialized knowledge.
Email: [email protected]
The firm’s litigators represent clients from a wide range of industries–including food, pharmaceutical, medical device, consumer products, chemical and pesticide, and telecommunication–before federal regulatory bodies.
Advertising & Unfair Competition:
The firm has represented clients in competitor, consumer and regulatory agency enforcement actions– at the federal, state and local levels. On the state level, the firm has successfully defended companies in the food, dietary supplement, pharmaceutical and other industries against claims brought under unfair trade practices acts.
The firm represents companies—from multi-national corporations to small businesses—in a full range of commercial litigation, including breach of contract, consumer actions, insurance claims and franchise disputes. The firm also represent clients in trade secret disputes, including ones involving computer software and confidentiality clause enforcement.
Product Liability/ Personal Injury Defense:
The firm represents manufacturers, distributors and trade associations in product liability litigation in both state and federal courts. The firm’s clients benefit from an expert technical staff, especially in complex cases, where toxicity and other scientific issues are involved.
Environmental & Toxic Tort Litigation:
The firm’s litigators represent companies and trade associations in a broad range of environmental and toxic tort litigation matters involving issues such as environmental contamination, alleged toxic exposures, enforcement actions by federal and state agencies, and insurance coverage.
The firm represents employers against charges of employment contract breaches, discrimination, improper termination and workplace injury.