News & Analysis as of

Enforcement Actions Food and Drug Administration (FDA) Enforcement Authority

Troutman Pepper Locke

FDA Tobacco Civil Money Penalty Provisions Ruled Unconstitutional, but Not Enjoined Nationwide

Troutman Pepper Locke on

In early August, the U.S. District Court for the Northern District of Texas ruled that the civil money penalty (CMP) provision in the Food, Drug, and Cosmetic Act (FDCA) for tobacco products, 21 U.S.C. § 333(f)(9), is...more

American Conference Institute (ACI)

[Event] 42nd FDA Boot Camp - March 13th - 14th, New York, NY

ACI’s FDA Boot Camp – now in its 42nd iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under the Food and Drug Omnibus Reform Act (FDORA). This...more

American Conference Institute (ACI)

[Event] 41st FDA Boot Camp - September 20th - 21st, Boston, MA

ACI’s FDA Boot Camp is back in Boston! This essential training course – now in its 41st iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under...more

Mintz - Health Care Viewpoints

DOJ Announces Another Wide-Ranging COVID-19 Fraud Enforcement Action

For the last few years, we have been closely monitoring and reporting on COVID-19 related fraud enforcement efforts by federal agencies. We detailed those findings in our Health Care Enforcement 2020 Year in Review & 2021...more

Epstein Becker & Green

After Decades of Broad Enforcement Discretion, FDA Signals New Approach to Homeopathic Drugs

Epstein Becker & Green on

Two announcements made by FDA in late October signal a marked change to FDA’s regulatory approach to “homeopathic” drugs. On October 25, 2019, FDA withdrew the 1988 Compliance Policy Guide (“CPG”) 400.400 Conditions Under...more

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