Overview
Over the past few 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.
Among those laws are 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 allow 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)
- labeling
- advertising
- 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, as well as false advertising claims under the Lanham Act
- class action defense of dietary supplement companies and products
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Past Events
- November 3, 2022
- September 28, 2021
Insights
Insights
- PublicationsVague FDA Guidance Fails to Provide a Roadmap to Dietary Supplement Misbranding Minefield4 minute read
- BlogsInfluencers, Brand Ambassadors and Marketers Take Note – FTC Has Finalized Updates to Its Endorsement Guides7 minute read
- BlogsThe FTC Finalizes Changes to Endorsement Guides7 minute read
- PublicationsDietary Supplement Makers Face "Misbranding" Minefield, Need FDA Guidance7 minute read
- Firm Announcements
Jessika Tuazon Named to the 2023 Southern California Rising Stars List
6 minute read - PublicationsIs Federal Trade Commission at War with the Dietary Supplement Industry?2 minute read
- BlogsFDA Introduces Dietary Supplement Ingredient Directory3 minute read
- PublicationsRecent Federal Actions Significantly Enhance Access to Substance Use Disorder Treatment2 minute read
- PublicationsFTC’s Revisions to Dietary Supplement Advertising Guidelines: More of the Same2 minute read
- Media CoverageJack Wenik Quoted in “Consumers Vulnerable to False Supplement Claims, Plus Products for ‘Gym Rats’ Get US DoJ ...2 minute read
- PublicationsOHRP Draft Guidance on the Use of Single IRBs: Reminder to Comment by August 308 minute read
- Media CoverageDelia Deschaine Quoted in “Can States Legally Ban FDA-Approved Abortion Pills?”2 minute read
- Media CoverageDelia Deschaine Quoted in “What a Lawsuit in Mississippi Tells Us About the Future of Abortion Pills”4 minute read
- BlogsFTC’s Proposed Changes to Endorsement Guides: Social Media, “Influencers,” Consumer Reviews, and the Impact of ...5 minute read
- Media CoverageDelia Deschaine Quoted in “Science Board Meeting Could Launch US Toward Lawful Hemp Use, or Extend Market Limbo” ...2 minute read
- Firm AnnouncementsEpstein Becker Green’s Theodora McCormick Recognized as a Trailblazing Change-Maker by the Executive Women of New Jersey ...4 minute read
- PublicationsFDA's Ingredient Advisory List Raises Due Process Concerns2 minute read
- PublicationsFood and Supplement Class Action Suits That Rely on Alleged Regulatory Violations2 minute read
- BlogsThe Supreme Court Rules That Disgorgement Is Not an Available Remedy Under the FTC Act – What Comes Next?5 minute read
- BlogsClass Action False Advertising Suits Continue to Inflict Pain on the Dietary Supplement Industry4 minute read
- BlogsThird Circuit Rules That Disgorgement Is Not an Available Remedy Under the FTC Act4 minute read
- PublicationsBusinesses Beware: FTC Seeks to Codify “Made in USA” Enforcement Policy4 minute read
- PublicationsThe Dietary Supplement Industry in the Time of Trump: Potential Opportunities and Pitfalls2 minute read