Keller and Heckman LLP

Firm Overview

Keller and Heckman, founded in 1962, has a broad practice in the areas of regulatory law, public policy, and litigation, serving both domestic and international clients. Our firm is a pioneer in the use of interdisciplinary approaches to problem-solving. Since 1971, we have had an in-house scientific staff that works closely with the firm's attorneys on matters of technical complexity. Many of Keller and Heckman's attorneys also have government experience and expertise in multiple areas of the law.

Main Areas of Practice

Advertising & Promotion

Biotechnology

California’s Proposition 65

Chemical Control

Employment & Labor

Environmental

Environmental & Toxic Tort Litigation

Food & Drug

Food & Drug Packaging

Health & Safety Compliance Audit

Insurance Coverage

Intellectual Property

International Regulatory Affairs

Litigation

Nanotechnology

Occupational Safety and Health

Pesticides

Privacy, Data Security & Digital Media

Product Safety

Sustainability and Product Stewardship

REACH

TSCA

Telecommunications

Tobacco & E-Vapor

Trade & Professional Associations

Transportation

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.

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. It counsels clients on compliance issues, including GMP requirements and product recalls; assists clients with food additive petitions; and advises clients on labeling.

Food and Drug Packaging

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.

Drugs

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.

Medical Devices

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.

Cosmetics

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.

Advertising & Promotion

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.

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.

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 multi-disciplinary teams consisting of in-house scientific staff and regulatory attorneys with specialized knowledge.

Product Liability

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.

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.