As the World Cup has captured the attention of viewers around the globe, so has the Food and Drug Administration (FDA) when it comes to taking enforcement action against regulated companies around the globe. We are at the midpoint of 2026, and several patterns are emerging based on FDA’s activity so far. Based on our own weekly tracking and analysis, we are sharing some of the key themes that have bubbled up as priorities for regulated industries and their stakeholders to watch as 2026 progresses.
The Dietary Supplement Listing Act of 2026 (H.R. 8370, 119th Congress) (the “Act”), introduced in the U.S. House of Representatives on April 20, 2026, has the potential to significantly impact the dietary supplement industry. The Act proposes to amend the Federal Food, Drug, and Cosmetic Act (“FDCA”), via a new Section 403D, and create the first mandatory FDA product-listing regime for dietary supplements.
In this episode of the Diagnosing Health Care Podcast: The U.S. Food and Drug Administration’s (FDA’s) broad definition of “misbranding” has created some industry confusion, while the Federal Trade Commission’s (FTC’s) updates to its Health Products Compliance Guidance have done the same.
In light of these recent actions, what challenges are dietary supplement manufacturers now facing?
On this episode, Epstein Becker Green attorneys Jack Wenik, Teddy McCormick, Zach Taylor, and Tracey Gonzalez discuss recent updates to the FDA and FTC guidelines as they apply to ...
On October 15, 2018, the Centers for Medicare and Medicaid Services (CMS) unveiled its proposed rule requiring direct-to-consumer television advertisements for prescription drug and biological products to contain the list price (defined as the Wholesale Acquisition Cost) if the product is reimbursable by Medicare or Medicaid. Medical devices are not included in the proposed rule, although CMS seeks comment on how advertised drugs should be treated if used in combination with a non-advertised device. If finalized, the requirement will be sweeping and only purports to exclude ...
Recent Updates
- Watch: Gender-Affirming Care: What Health Care Providers Need to Know About Federal Enforcement – Thought Leaders in Health Law
- Executive Order 14321 at One Year: Civil Commitment Policy Shifts and Provider Impact
- Watch: FDA’s 2026 Enforcement Priorities: What In-House Counsel Must Know – Thought Leaders in Health Law
- The Future of 340B: New Bills Offer Competing Solutions to Modernize the 340B Drug Discount Program
- "Enough Is Enough": HHS-OIG Freezes Funds for New York Medicaid Fraud Control Unit, Effective July 1