Polsinelli’s Food and Drug practice helps clients achieve key business objectives related to the full array of products regulated by the Food and Drug Administration, as well as related health and safety regulatory agencies, in the face of state, national, and global regulatory concerns. We assist clients – large and small -- with a wide range of matters arising from the regulation of all food, dietary supplements, pharmaceuticals and biologics, medical devices, and cosmetics, including strategic advice on:
- Obtaining market approval
- Determining regulatory strategies
- Navigating regulations and business risks associated with a particular strategy
Additionally, our team represents clients facing federal, state, or local enforcement actions, and conducts due diligence in support of a range of corporate transactions.
We work closely with clients to jointly identify their needs, objectives and opportunities within the context of the regulated environment in which they operate. Our work covers products regulated by Food and Drug Administration (FDA), as well as the U.S. Department of Agriculture (USDA), Consumer Product Safety Commission (CPSC), Federal Trade Commission (FTC), Public Health Service (PHS), Environmental Protection Agency (EPA), U.S., Customs and Border Protection (CBP), National Institutes of Health (NIH) and the Drug Enforcement Administration (DEA).
Food and Agriculture
We advise a diverse mix of clients from single product early stage food companies to multinational food manufacturers, as well as trade associations, coalitions, and non-profit organizations, on issues of interest and importance to the food and agriculture industry. The core of our practice rests on decades of experience helping clients navigate the complex regulatory frameworks and policies of the FDA and the USDA, as well as those of counterpart agencies at the state and local level and, increasingly, foreign government and global regulatory bodies, including the European food and agriculture regulatory bodies and the numerous WHO entities. We help companies comply with ingredient regulation and product formulation issues, nutrient and health-related claims, required and permissible label disclosures, claim analysis and substantiation, competitor challenges, and food safety compliance, including the numerous issues arising under the Food Safety Modernization Act.
Our attorneys counsel dietary supplement companies on a range of issues arising under the Dietary Supplement Health and Education Act (DSHEA), including product formulation, current Good Manufacturing Practice (“cGMP’) compliance, labeling, advertising, and promotion. In addition, we have prepared many new dietary ingredient submissions for FDA review and prepared and submitted structure/function claim notifications to the FDA. We are actively involved in the development of regulations and guidance implementing DSHEA, as well as proposed dietary supplement legislation periodically under consideration by Congress.
Pharmaceuticals and Biologics
Representing manufacturers and marketers of both human and animal drugs and biologics on a broad spectrum of issues, including new product development and approval, monograph requirements for over-the-counter (OTC) products, abbreviated new drug applications (ANDA) for generic drugs, rules governing compounded drugs, and labeling and advertising issues for both Rx and OTC drugs. Further, our attorneys counsel manufacturers of biological products on all aspects of compliance associated with the safety, purity, and potency requirements of the Public Health Service Act and all matters pertaining to biologics licensure.
Understanding the nuances involved in medical device manufacturing and distribution allows our attorneys help clients navigate the FDA regulatory process. Polsinelli’s Food and Drug attorneys provide counseling and advocacy on FDA medical device matters, ranging from product clearance and approval to post-market requirements and enforcement/compliance issues, product promotion, and advertising issues.
Members of the Food and Drug practice provide counsel on an array of general cosmetic product issues, including determinations of whether a product is a drug or a cosmetic. We assist our clients as they seek to determine what claims can be made for a product without the product's reclassification as a drug, as well as FDA and FTC claim criteria, labeling regulations and product safety data. In addition, we work with clients facing challenges from state and local regulation that is often at odds with federal.
Advertising and Promotion
We routinely develop marketing strategies for our clients based upon FDA product classification and substantiation criteria established by the FDA and FTC, and in court under the Lanham Act, and we partner with clients and review claim substantiation materials with them in an effort to develop the most effective lawful marketing strategies.
For our prescription drug clients, we advise on FDA advertising standards and practices for advertising and promotion opportunities, and we assist clients in developing their own labeling and advertising claims, often reviewing client substantiation dossiers to develop appropriate claims, as well as defending claims before appropriate authorities.