News & Analysis as of

Enforcement Actions Food and Drug Administration (FDA) Retail Market

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

Troutman Pepper Locke

Are State ENDS Directories Preempted? Federal Courts Are Split

Troutman Pepper Locke on

Over the past two years, at least 15 states have enacted laws requiring manufacturers of electronic nicotine delivery systems (ENDS) to certify the status of their federal premarket tobacco product applications (PMTAs) in...more

Troutman Pepper Locke

Unpacking the Illicit E-Cigarette Crackdown by State AGs

Troutman Pepper Locke on

In mid-January, a bipartisan coalition of nine state attorneys general, as well as the Washington, D.C., attorney general, announced a coordinated effort to curb illicit electronic cigarette sales. The attorneys general of...more

Troutman Pepper Locke

Retailers Tap Into Pricing & Data to Boost Cigar Sales

Troutman Pepper Locke on

Bryan Haynes, a partner in Troutman Pepper Locke’s Tobacco + Nicotine Practice Group, was quoted in the January 10, 2025 Convenience Store News article, “Retailers Tap Into Pricing & Data to Boost Cigar Sales.”...more

Troutman Pepper Locke

FDA Ramps Up Enforcement Against Flavored Disposable E-Cigarettes as External Pressures Mount

Troutman Pepper Locke on

In September, the U.S. Food and Drug Administration (FDA) issued two new rounds of warning letters to online retailers, manufacturers, and distributors for reportedly selling or distributing unauthorized e-cigarette products....more

Stinson LLP

CBD Industry Experiences Wave of New Consumer Lawsuits

Stinson LLP on

The cannabidiol (CBD) industry has been on the receiving end of over a half dozen new consumer class actions in recent weeks, which is likely only the beginning for the emerging industry....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

Seyfarth Shaw LLP

FDA Stresses CBD Safety Concerns in 15 Warning Letters and Revised Consumer Update

Seyfarth Shaw LLP on

In its largest mass enforcement action involving cannabidiol (CBD) yet, the U.S. Food & Drug Administration (FDA) announced on November 25 the issuance of 15 warning letters to various companies for illegally selling products...more

Hogan Lovells

FDA Shuts Down OTC Drug Manufacturer with Longstanding and Pervasive cGMP and Labeling Issues

Hogan Lovells on

On Tuesday, FDA announced the entry of a consent decree of permanent injunction against Keystone Laboratories, Inc. of Memphis, Tennessee for manufacturing OTC hair care and skin care products in violation of Current Good...more

Shook, Hardy & Bacon L.L.P.

Dietary Supplement & Cosmetics Legal Bulletin | February 2018

FDA Issues Draft Guidance for Homeopathic Drug Products - The U.S. Food and Drug Administration (FDA) has issued draft guidance, "Drug Products Labeled as Homeopathic," that would prioritize enforcement and regulatory...more

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