Food & Drug

A Global Practice

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.

Food Law

Our food and drug lawyers regularly assist our clients in the following areas:

  • Providing opinion letters on the compliance status of food ingredients and additives, functional foods, and substances used in food packaging and processing equipment;
  • Preparing and submitting to the relevant authorities food additive petitions, food-contact notifications, technical dossiers, and other filings, and obtaining regulatory clearance for the use of new food additives, novel foods, novel food ingredients, and substances used in packaging materials and processing equipment;
  • Assisting in establishing "Generally Recognized as Safe" status for food ingredients and food packaging materials used in the United States, and in assembling appropriate documentation to support a safety evaluation for food contact materials used in the EU;
  • Amending U.S. Food Chemicals Codex (FCC) and Association of American Feed Control Officials (AAFCO) monographs and definitions;
  • Advising clients on the status of ingredients, processing aids, and finished products (including labeling) under all of the Asian regulatory schemes;
  • Advising on food labeling, allergen labeling, and advertising issues, including criteria for making "nutrition," "health," and "structure/function" claims;
  • Assisting on compliance issues, including good manufacturing practice requirements, product recalls, U.S. FDA inspection practices and warning letters, and record keeping and traceability requirements;
  • Defending against U.S. FTC advertising complaints, enforcement actions and prosecutions, and defending against competitor challenges in court and other forums;
  • Advising on production, formulation and labeling issues for "organic" products;
  • Advising on requirements pertaining to the contained use, experimental release, marketing, and labeling of genetically modified organisms (GMOs) and products derived from GMOs; and
  • Monitoring legislation and policies affecting the regulation of food additives, ingredients, and materials used in contact with food, and providing strategic analysis of relevant laws and treaties, including proper application of the principle of mutual recognition in the EU.

In the dietary supplement, nutraceutical, and functional food area, we counsel clients on all aspects of dietary supplement requirements, including the following:

  • Advising on the U.S. Dietary Supplement Health and Education Act's (DSHEA) adulteration, current good manufacturing practices, new dietary ingredient, and misbranding provisions;
  • Reviewing labels, labeling, and advertising for compliance issues;
  • Providing advice to dietary supplement manufacturers and distributors regarding the types of claims (and the substantiation needed to support them) that may appear in advertising, labels, labeling, and promotional materials for these products, including the claims used to market dietary supplements via the Internet;
  • Advising on whether registration or prior approval is needed under Asian regulatory systems, and if so, how to obtain it;
  • Advising on the classification of a product as a dietary supplement, conventional food or a drug based on the product claims;
  • Defending against U.S. FTC advertising complaints, enforcement actions and prosecutions, and defending against competitor challenges in court and other forums;
  • Counseling on potential product liability issues and defending related court cases; and
  • Providing guidance on the safety testing of dietary ingredients, including toxicology, carcinogenicity, and sensitivity testing on volunteers.

Several of the firm's partners teach seminars on the regulation of food (including dietary supplements) and food labeling. Entitled "Practical Food Law" and "Practical Food Labeling and Advertising Law," the combined four day program is taught at various locations throughout the United States and is attended by corporate regulatory specialists and in house counsel. Keller and Heckman also sponsors an annual seminar relating to food packaging issues.

Drug Law

In the drug area, Keller and Heckman counsels clients on all aspects of human and animal drug requirements, including the following:

  • Determining the need to submit and advising on the regulatory requirements for marketing authorizations for medicinal products in the EU, investigational new drug applications (INDs) to conduct research to support applications for regulatory approval in the United States; new drug applications (NDAs) for initial approval of drug products in the U.S., and abbreviated new drug applications (ANDAs) for approval of so-called "generic" drugs in the U.S.;
  • Analyzing the complex legal and policy issues surrounding the Hatch-Waxman Act and the patent certification implications for ANDAs, and Section 505(b)(2) NDAs;
  • Developing regulatory strategies for the commercialization of new drugs and the impacts of different non-patent market exclusivity periods (5-year new chemical entity), 3-year (new product), pediatric, orphan drug, and 180-day generic drug);
  • Evaluating the potential impacts of the Prescription Drug User Fee Act and the Prescription Drug Marketing Act;
  • Helping companies comply with import/export regulatory requirements;
  • Assisting in determining the status of over-the-counter-drugs and compliance with applicable monographs;
  • Evaluating compliance with and amending USP/NF, EP, and other national pharmacopoeial monographs; preparing and filing Drug Master Files (for active ingredients, inactives, and packaging components);
  • Advising on compliance issues, including current good manufacturing practice requirements, labeling and advertising issues, conducting product recalls, U.S. FDA inspection practices, and defending against government enforcement actions; and
  • Defending against competitor challenges in court and other forums.

Medical Device Law

In the area of medical devices, we assist clients with regulatory and compliance needs, including the following:

  • Advising on the need to submit and, if necessary, helping to prepare premarket notifications (510(k)s), applications for premarket approval (PMAs) in the U.S.; and related international applications;
  • Assisting in establishing compliance with the essential requirements of the Medical Devices Directive and with similar international requirements;
  • Advising on the proper classification of devices;
  • Preparing and filing Device Master Files;
  • Counseling on product liability issues for finished device manufacturers and component suppliers and defending related court cases; and
  • Assisting with other compliance issues, including good manufacturing practice/quality system (QS) regulation matters; establishment registration and device listing; product recalls or market withdrawals; Medical Device Reports (MDRs) (Part 803) and Reports of Corrections and Removals (Part 806); U.S. FDA inspection practices; responding to Warning Letters and other actual or threatened enforcement actions; and advising on device promotion and advertising boundaries.

Cosmetic Law

With regard to cosmetics, our food and drug attorneys advise and assist clients with the full range of regulatory compliance issues, including the following:

  • Reviewing labeling and advertising for compliance with U.S., EU, and related international requirements;
  • Advising on the classification of a product as a cosmetic or a drug based on the product claims;
  • Counseling on potential product liability issues and defending related court cases;
  • Providing guidance on the safety testing of cosmetic ingredients, including toxicology, carcinogenicity, and sensitivity testing on volunteers;
  • Assisting in compliance issues, including good manufacturing practices, recordkeeping, product recalls, and governmental inspection practices; and
  • Defending against FTC advertising complaints, enforcement actions and prosecutions, and defending against competitor challenges in court and other forums.

International Law

With offices in Washington, DC, Brussels, San Francisco, and Shanghai, 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.

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Diversity

At Keller and Heckman, we recognize that our differences strengthen us as individuals and reinforce our abilities collectively. Diversity in our professional staff is an integral component of our commitment to provide the best service possible to our clients. Keller and Heckman's reputation for innovation and creativity is in great part due to the different talents and experiences we each bring to bear in advancing the interests of our clients. We pride ourselves on the fact that our professionals – partners, counsel, associates, scientists, regulatory specialists and paralegals – come from varying backgrounds and experiences, and include racial and ethnic minorities, women, and people with different sexual orientations. Diversity is a core value and we are deeply committed to recruiting, hiring, mentoring, and advancing professionals of diverse backgrounds and experiences at Keller and Heckman.

As part of our overall commitment to enhancing diversity in the legal profession, we are a sponsor of the Minority Corporate Counsel Association (MCCA). Through our involvement with the MCCA and in other fora, we have participated in recruitment and networking opportunities with minority candidates. Because our legal practice often involves a sophisticated blending of law and science, we are able to attract talented students and lawyers of diverse backgrounds who are interested in a technology-based legal practice.

In an effort to recruit and nurture legal talent at an early stage, we have established a paid Firm internship program for first-year law students with diverse backgrounds. Our first-year internship coincides with our second-year summer associate program and lasts for twelve weeks. During the twelve weeks, the students perform substantive legal work, learn more about the law and our practice areas, receive constructive performance feedback, and are mentored by members of our professional staff. We believe that this early training and guidance is invaluable to both incoming legal professionals and our Firm. We have had great success with the recruitment and hiring of diversity candidates for our first-year internship and second-year summer associate programs, and most receive offers to join the Firm.

Diversity, in all aspects, is a key goal of the Firm and we have established a Diversity Committee to actively foster and promote this goal. We welcome and encourage diversity within Keller and Heckman at all levels. By joining together people with diverse backgrounds and experiences, including people of color, women, and other groups, we enhance our creativity, our knowledge and our ability to understand and respond to the needs of our diverse clientele.

 

 

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