News & Analysis as of

Food and Drug Administration (FDA) Retail Market

Troutman Pepper Locke

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

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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

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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

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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

DLA Piper

Food and Beverage News and Trends - January 2025 #2

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FDA issues proposed rule on front-of-package nutrition labeling. The FDA has released its proposed rule on front-of-package nutrition labeling which, if enacted, would add a requirement to include an informational box that...more

Skadden, Arps, Slate, Meagher & Flom LLP

The Commercial Potential – and Practical Challenges – of Marketing OTC Drugs With ‘Additional Conditions for Nonprescription Use’

The Food and Drug Administration’s (FDA or Agency) final rule on Additional Conditions for Nonprescription Use (ACNU) paves the way for some drugs that are currently available only with a prescription to switch to OTC where a...more

Troutman Pepper Locke

Retailers Tap Into Pricing & Data to Boost Cigar Sales

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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

Shook, Hardy & Bacon L.L.P.

Food and Beverage Litigation and Regulatory Update - December 2024

The U.S. Food and Drug Administration (FDA) has announced a final rule updating the definition of the nutrient content claim “healthy.” To qualify as “healthy” under the updated definition, food products must contain a...more

DLA Piper

FDA Issues Updated Final Rule for "Healthy" Labeling

DLA Piper on

The US Food and Drug Administration (FDA) released the final rule providing new criteria for when foods may be labeled with the nutrient content claim “healthy.” This rule, released on December 19, 2024, has been a priority...more

Shook, Hardy & Bacon L.L.P.

FDA Announces Final Rule Updating Definition of "Healthy" Nutrient Content Claim - Food and Beverage Litigation and Regulatory...

The U.S. Food and Drug Administration (FDA) has announced a final rule updating the definition of the nutrient content claim “healthy.” To qualify as “healthy” under the updated definition, food products must contain a...more

DLA Piper

Food and Beverage News and Trends - December 2024 #2

DLA Piper on

This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal, and regulatory landscape. FSIS moving to strengthen oversight of food processing facilities with focus on...more

Troutman Pepper Locke

Federal Court Rules Montana AG Preempted from De-Listing Cigarette Manufacturer

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In late June, the U.S. District Court for the District of Montana held that federal law preempts the Montana Attorney General (AG) from removing the cigarette brands of Grand River Enterprises Six Nations, Ltd. (Grand River)...more

Troutman Pepper Locke

FDA Unauthorized ENDS Enforcement: 2024 Mid-Year Roundup

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In the first half of 2024, the U.S. Food and Drug Administration (FDA) has continued to ramp up efforts to limit sales of unauthorized electronic nicotine delivery systems (ENDS). We previously reported on FDA’s heightened...more

Epstein Becker & Green

Nuts or Not Nuts? Second Circuit Declines to Consider Whether KIND’s Use of All-Natural Is Deceptive, Misleading

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Think you’re being healthy when you reach for that KIND bar in the middle of your workday? We won’t say yes or no—since the U.S. Court of Appeals for the Second Circuit has recently declined to opine on what “all...more

Falcon Rappaport & Berkman LLP

Cannabis Rescheduling – A Look Towards the Future of the Industry

The Drug Enforcement Administration (DEA) will call for cannabis to be rescheduled according to a report by the Associated Press. The anticipated rescheduling follows the Department of Health & Human Services’ (HHS) August...more

Troutman Pepper Locke

What’s at Stake for the Premium Cigar Industry as DC Circuit Considers FDA Appeal?

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In August 2023, Judge Amit P. Mehta of the U.S. District Court for the District of Columbia partially vacated a Food and Drug Administration (FDA) rule that had “deemed” premium cigars subject to the Federal Food, Drug, and...more

Troutman Pepper Locke

FDA Launches Legally Marketed Tobacco Products Database

Troutman Pepper Locke on

FDA recently announced the launch of a new searchable database containing almost 17,000 tobacco products that may be legally marketed in the U.S. The database provides information on each tobacco product including product...more

Troutman Pepper Locke

TTB Seeking Public Input on Potential Alcoholic Beverage Labeling Changes

Troutman Pepper Locke on

As we previously reported, the Treasury Department released a 2022 report on Competition in the Markets for Beer, Wine, and Spirits (the Competition Report) recommending, in part, that the Alcohol and Tobacco Tax and Trade...more

Troutman Pepper Locke

FDA’s Center for Tobacco Products Releases Annual Regulatory Agenda

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We recently discussed the U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products’ (CTP) strategic plan intended to guide CTP’s activity for the next five years. On the same day, CTP released its annual...more

Knobbe Martens

First At-Home Artificial Insemination Kit Receives FDA Clearance

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Mosie Baby, a Texas-based fertility care company, has received clearance from the U.S. Food and Drug Administration for its over-the-counter intravaginal insemination kit.  The kit was developed for those who are unable to...more

Troutman Pepper Locke

FDA Continues ENDS Enforcement with New Injunction and Civil Money Penalty Proceedings

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The Food and Drug Administration (FDA) has recently filed new injunction and civil money penalty proceedings against unauthorized, flavored e-liquids and electronic nicotine delivery systems (ENDS) manufacturers and...more

Troutman Pepper Locke

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

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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

Foley Hoag LLP - Cannabis and the Law

FDA Shares Insights on Potential Pathway to Regulate CBD Products

The Food and Drug Administration (FDA) held a stakeholder call on May 25, 2023 to provide additional information related to the agency’s January 26 announcement that it believes a new regulatory framework for cannabidiol...more

Davis Wright Tremaine LLP

A Makeover for the Cosmetic Industry: Legal Style

On December 29, 2022, President Biden signed into law the Consolidated Appropriations Act, 2023 (H.R. 2617), which by its name does not appear to have anything to do with cosmetics. However, buried in the approximately 1,650...more

Shook, Hardy & Bacon L.L.P.

FDA Outlines Strategy for Infant Formula Market

The U.S. Food and Drug Administration has released a national strategy outlining actions it will take immediately to help increase the resiliency of the U.S. infant formula market and supply. The Food and Drug Omnibus Reform...more

Shook, Hardy & Bacon L.L.P.

Food and Beverage Litigation and Regulatory Update - April 2023

FDA Proposes Changes to Standards of Identity for Foods Including Salt- The U.S. Food and Drug Administration (FDA) has issued a proposed rule that would change the standards of identity (SOIs) for foods that include salt to...more

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