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.
In the U.S., Keller and Heckman has represented companies and trade associations before the FDA and Federal Trade Commission (FTC) for over 40 years in all areas of the food (including animal and pet food) industry and allied industries. Keller and Heckman also has represented clients in the EU for several decades. Since 1992, with the opening of its Brussels office, the firm takes an even more active role in providing input and advising clients regarding changes that will affect the marketing of food, dietary supplement, cosmetic, drug, and device products in Europe as the EU moves towards harmonization. With the opening of our Shanghai office in 2004, we are further enhancing our capacity to provide global food and drug services.
Our food and drug lawyers regularly assist our clients in the following areas:
In the dietary supplement, nutraceutical, and functional food area, we counsel clients on all aspects of dietary supplement requirements, including the following:
Several of the firm's partners teach seminars on the regulation of food (including dietary supplements) and food labeling. The programs are taught at various locations throughout the United States and are attended by corporate regulatory specialists and in house counsel. Keller and Heckman also sponsors an annual seminar relating to food packaging issues. See Events for more information.
In the drug area, Keller and Heckman counsels clients on all aspects of human and animal drug requirements, including the following:
Medical Device Law
In the area of medical devices, we assist clients with regulatory and compliance needs, including the following:
With regard to cosmetics, our food and drug attorneys advise and assist clients with the full range of regulatory compliance issues, including the following:
With offices in Washington, DC, Brussels, San Francisco, Shanghai and Paris, Keller and Heckman advises its multinational and smaller clients on compliance with a variety of laws and regulations, globally. Keller and Heckman attorneys regularly counsel clients on the status of food and cosmetic products including novel foods and "functional foods," along with labeling requirements, for products to be marketed in the U.S., South America, Europe, and Asia. In addition, we provide information on the specific procedures necessary to obtain approvals for novel foods, drugs, medical devices, food additives and food contact substances (including packaging materials) in these regions of the world.
Our attorneys are also very active in the workings of the committees of the Codex Alimentarius Commission, including the Committee on Food Labeling, Committee on Food Additives and Contaminants, Committee on Nutrition and Foods for Special Dietary Use, and the Committee on General Principles. The work of Codex has become increasingly important in recent years with the advent of the World Trade Organization (WTO), as a country's failure to recognize or permit a product meeting a Codex standard may subject that country to a WTO complaint. We work closely with our clients and Government representatives involved with Codex, including U.S. FDA, the U.S. Department of Agriculture, the U.S. Department of State, the U.S. Trade Representative, and the European Commission in devising strategies for obtaining Codex results that are in our clients' best interests.
For more information on Keller and Heckman's Food and Drug capabilities, please visit our website at saalts.com or www.packaginglaw.com.