Over the past two decades, the popularity of dietary supplements (i.e., vitamins, minerals, herbs, amino acids, and other substances) has continued to soar. During the same time, manufacturers of dietary supplements have been subject to an increasing number of laws and regulations.
This includes the Dietary Supplement Health and Education Act of 1994, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, the Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006, the Lanham Act, state laws regarding false advertising and deceptive trade practices, and the Federal Trade Commission Act, to name a few. And successfully navigating their requirements can be a huge challenge. Moreover, the Department of Justice (DOJ) has dramatically expanded the enforcement effort against dietary supplement companies.
Epstein Becker Green guides dietary supplement companies through the maze of relevant laws and requirements, as well as through U.S. Food and Drug Administration (FDA) regulatory issues and litigation with the Federal Trade Commission (FTC). In addition to litigation with these agencies, we have extensive experience defending dietary supplement companies and their executives in criminal prosecution brought by the DOJ. We are problem solvers with experience addressing all kinds of situations throughout the lifecycle of dietary supplements—from the earliest stages of a product and brand development through the approval or clearance process and into the product’s post-market life. And the depth and breadth of our experience allows us to tailor our approaches to meet our clients’ legal, regulatory, and business goals.
SCOPE OF SERVICES
Epstein Becker Green provides a full range of legal services to clients in the dietary supplements industry. Our services encompass product development, regulatory compliance, and litigation, and include:
- Advising on compliance with federal and state laws and FDA and FTC rules and regulations, including standards and procedures relating to:
- new dietary ingredients (NDIs)
- “old” dietary ingredients
- good manufacturing practices (GMPs)
- product chains
- promotional materials
- Evaluating compliance risks and helping clients take steps to reduce those risks and protect their interests
- Developing strategies for achieving Generally Recognized as Safe (GRAS) status
- Reviewing sales, distribution, supply, and licensing agreements
- Counseling on FDA post-market reporting requirements
- Providing training on FDA and FTC requirements, risk management, and enforcement trends
- Advising importers of dietary supplements regarding FDA importation requirements
- Defending DOJ investigations and prosecutions
- Providing representation in:
- FDA compliance and enforcement matters, including crafting responses to FDA inspection and warning letters, implementing corrective action programs, guiding clients through recall actions, and advising on field corrections, retrofits, supplemental labeling, and crisis management
- injunction actions and seizures
- complex adversarial proceedings with the FDA and FTC relating to the adequacy of substantiation of advertising claims
- litigation matters concerning product liability, breach of contract, breach of warranty, licensing, consumer fraud, and unfair competition disputes, class actions, and false advertising claims under the Lanham Act
- class action defense of dietary supplement companies and products