Food, Drug & Medical Device Regulation
We have extensive experience advising clients within the medical device, food, drug, dietary supplement, animal feed and other regulated industries. Our relationships with clients often form during the earliest stages of their development and continue throughout each stage of growth.
What We Do
We commonly advise and assist on matters of capital formation, including acquiring or working with venture financing or grant funding from public and private sources, mergers, acquisitions, and divestitures of all types. We advise clients on general corporate matters, FDA matters, licensing, patents, trademarks and service marks, securities compliance, employment, real estate, and more. We use our technical knowledge within the competitive marketplace to help clients select how best to protect their intellectual property while avoiding infringement.
Fredrikson & Byron is also experienced in interactions with regulatory bodies, such as the FDA, FTC, and state agencies. We advise clients on FDA regulations governing the marketing, advertising, labeling, manufacturing, exporting, and development of regulated products. Our clients look to us for advice when obtaining product approvals and conducting clinical studies, as well as when the need arises to undertake corrective actions, such as product recalls or withdrawals. When appropriate, we also draw on our range of relationships with regulatory and industry consultants.
Our clients rely on us to take an integrated approach in helping them move through the product lifecycle from the initial concept to manufacturing and ongoing compliance.
We have expertise in the design, development, implementation, and management of compliance programs to address issues concerning compliance with applicable legal requirements including compliance with Anti-Kickback, Stark, HIPAA, False Claims, Foreign Corrupt Practices, and non-U.S. Anti-Bribery laws. We also conduct training programs specifically designed for our clients to assist them in complying with the requirements of these laws and their compliance programs.
When the need arises, we conduct investigations and audits, often engaging attorneys from our Health Care Fraud & Compliance Group to advise clients working with healthcare regulators on compliance matters and in responding to regulatory investigations. We also have experience in defending clients in criminal fraud trials.
Our clients span all industries regulated by the FDA and similar authorities including food, drugs and medical devices, biologics, dietary supplements, animal feed and additives, cosmetics, and combination products.
We advise food and food additive, beverage, and restaurant companies on compliance with laws governing the advertising, labeling, marketing, manufacturing, packaging, distribution, recall, and other corrective actions for products regulated by the Food and Drug Administration (FDA) and similar authorities. We also represent their interests before federal and state regulatory agencies, in government investigations, product seizures, and litigation.
Experienced in traditional food law issues, our focus is increasingly directed to today’s key industry and consumer concerns: advertising directed to children, obesity, contamination, biotechnology, bioterrorism, and restaurants. With a solid background in labeling and advertising, we regularly advise clients on how best to market products in an increasingly critical environment.
Advertising Directed to Children: Interested in a lively discussion? Then consider whether kids are led astray by advertising for high-fat, high-calorie, high-sugar foods. The discussion might focus on contemporary efforts to stimulate the FTC to impose limits on food advertisements aimed at children or the history of past FTC initiatives, including the Commission’s 1970’s offensive against cereal manufacturers. In either case, we have a sense of the issues which are important today, as well as an appreciation of the issues which were important in the past.
Obesity: The obesity epidemic is refocusing attention on issues surrounding nutrition, dietary supplements, and weight loss. In response, the FDA, FTC, and private litigants are acting. The FDA is moving to add a line to the nutrition label on every box, can, and bottle of processed food disclosing how much trans fat each contains. A recent review of weight loss ads by the FTC found that more than half contained one or more false or unsubstantiated claims, and proposals before Congress seek to slim down the number of obese and overweight. Meanwhile, private litigants are bringing lawsuits on behalf of the obese who claim that eating certain foods is addictive and that advertising for these products caused them to make inappropriate choices. At times, the role of legal counsel can change from product defender to product strategist to cultural commentator. We shift roles as necessary to provide clients with the right guidance at the right time.
Contamination: Many companies have faced challenges stemming from E-coli, listeria, salmonella, and other food-borne illnesses. This trend is having a profound effect on every facet of the industry, from producers and manufacturers, to retailers and restaurateurs. We have counseled those at each stop along the food chain with respect to the sensitive issues these challenges present.
Biotechnology: The use of organisms to make food products, such as yogurt, represents one of the oldest of food technologies. However, the major development in food science in the last decade has been the application of new biotechnologies, including recombinant DNA techniques and cell fusion, to go beyond traditional methods and make direct genetic modifications to food sources. We are active in a number of issues relating to the regulation, labeling, and marketing of biotechnology products. In addition to assisting clients with compliance issues regarding ingredients, direct, and incidental additives, we are also cognizant of the international regulatory disputes relating to biotech food ingredients and crops. Our goal is to blend the broad scientific, industry, and legal expertise necessary to move clients’ biotech initiatives forward, even in the face of EU hostility.
Bioterrorism: The events of September 11, 2001, exposed the vulnerability of food and water supplies to attacks by terrorists. The FDA’s new bioterrorism rules recently went into effect, and we have assisted clients in understanding how these new food security regulations impact their activities in a changing world.
Restaurants: Reversing earlier policy, the FDA now requires restaurants that make health or nutrient claims to substantiate them using specific criteria. This requirement applies to claims made on menus, signs, posters, and placards. But some would have the industry do more. We help restaurant clients monitor and understand measures that would require them to label food content.
Drugs and Medical Devices
Drug and medical device manufacturers look to us for our expertise on a full range of regulatory issues throughout the product life cycle. Our advice spans both FDA regulation and foreign governmental issues, such as the CE process in the European Union. We team with clients on the product approval process including interpreting statutory and regulatory requirements; setting approval strategies for NDAs, PMAs, and 510(k)s; and interacting with the FDA, including negotiating requirements, meeting with the agency, and attending advisory panel meetings. We advise on the process of obtaining clinical information, including advice on Good Laboratory Practices for pre-clinical studies; agreements for clinical trials, such as investigator and clinical research organization agreements; training of monitors and site study coordinators; and compliance advice, including handling of bioresearch monitoring inspections.
Our attorneys advise clients on the application of Good Manufacturing Practices to the entire life of drugs and devices, including Quality System Regulation advice for devices from the beginning of design controls to the delivery of product. We work with manufacturers on compliance issues such as inspections, warning letters, seizures, adverse drug reports and medical device reporting, recalls, the Application Integrity Policy, and criminal actions related to regulatory matters.
We handle all post-approval regulatory issues, including import/export, post-market studies, and patent term extensions. We advise on promotion and advertising throughout the entire product cycle, as well as on related promotional materials.
As in drug and medical device products, we advise on all regulatory issues. With biologics this also includes biologic license applications (BLAs), tissue regulation statutes, and the inspection of biologic facilities.
We represent the manufacturers of dietary supplements, including vitamins and herbal products, with regard to compliance with the Dietary Supplement Health and Education Act (DSHEA) and FTC advertising guidelines, including providing advice on labeling, advertising, and internet promotions. We also advise on the application of Current Good Manufacturing Practices (CGMP) for dietary supplements, and we work with manufacturers responding to warning letters, seizures, and investigations.
Animal Feed and Additives
Manufacturers of animal feeds and additives for animal feeds are also subject to regulation by the FDA, USDA, and state authorities. We represent the manufacturers of animal feeds on compliance issues and in response to regulatory actions including seizures, recalls, warning letters, and investigations.
We advise on the regulatory issues involved in manufacturing and promoting cosmetics. This includes Good Manufacturing Practices, labeling, and advertising. With cosmetics it is important to chart a regulatory path that does not turn the product into a drug, a dietary supplement, or other product class. We work with product claims to achieve our clients’ desired regulatory structure.
The boundaries between traditional product classifications are now blurred because new products include combinations, such as devices with drugs and devices with biologics. We guide companies’ strategies in working through the FDA process of determining in what manner the FDA or foreign countries will regulate the product. We then advise through the product life cycle, including establishing the proper manufacturing regulations for the combination.