News & Analysis as of

Warning Letters Product Labels Food and Drug Administration (FDA)

Mintz - Health Care Viewpoints

FDA Warning Letter Reminds Industry that Wellness Claims Only Go So Far, Other Features Can Establish Intended Use

A July 14, 2025 U.S. Food & Drug Administration (FDA) warning letter to a prominent wellness product and services company offers a blunt reminder that medical device requirements cannot be waived or overlooked merely because...more

Perkins Coie

FDA and FTC Issue Joint Warning Letters for Copycat Delta-8 THC Food Products

Perkins Coie on

The U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued warning letters on July 16, 2024, to five companies for illegally selling and introducing into the market copycat food products...more

Sheppard Mullin Richter & Hampton LLP

Context is Key: FDA Sends a Strong Message About Efficacy Claims

On August 4, 2023, the Food and Drug Administration (“FDA”) Office of Prescription Drug Promotion (“OPDP”) issued a Warning Letter to AstraZeneca which stated that the company made misleading claims in a promotional sales aid...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - August 2023

Arnall Golden Gregory LLP's Food & Drug Newsletter is a roundup of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more

Mintz - Health Care Viewpoints

Recent Developments Signal Headwinds for Homeopathic Drug Products

Homeopathic drugs have an unusual status in the United States. On the one hand, they are incorporated into the Federal Food, Drug, and Cosmetic Act (FD&C Act) within the definition of “drug,” which specifically includes...more

BakerHostetler

AD-ttorneys@law - January 2023 #2

BakerHostetler on

Introducing Our Secret Plan to Fight Inflation - It’s simple: Don’t fall afoul of the FTC - ’Twas Ever Thus - Every year, like the swallows returning to Capistrano, the Perseid meteor shower, or a Real Housewives...more

Kaufman & Canoles

FDA Increases Warning Letter Campaign Against CBD Companies

Kaufman & Canoles on

In November the Food and Drug Administration (FDA) issued letters to various companies selling products contained cannabidiol (CBD), citing concerns that certain products may appeal to children. These CBD infused foods...more

Vicente LLP

Recent FDA Enforcement Letters Signal Increased FDA Scrutiny of Hemp Products

Vicente LLP on

On November 21, 2022, the FDA issued five warning letters to companies selling CBD, Delta-8, and other hemp products for humans and pets. These letters are notable for the following five reasons (see additional details...more

Perkins Coie

FDA Issues New Warning Letters For Delta-8 and CBD Products

Perkins Coie on

Earlier today, May 4, 2022, the FDA issued warning letters to five companies selling products that contain delta-8 tetrahydrocannabinol (Delta-8 THC). Several of the companies also manufactured products containing...more

Womble Bond Dickinson

Six Things You Need to Know About CBD and Other Hemp-containing Pet Products

Womble Bond Dickinson on

The trend toward state-level legalization of cannabis has led to a surge in cannabis-derived products and a continually evolving market with many types of cannabis products for people as well as their pets. Analysts predict...more

Arnall Golden Gregory LLP

A Series for FDA-Regulated Food Industry - Part 1: How to Adopt a Culture of Safety

An old adage is that an “ounce of prevention is worth a pound of cure.” Perhaps no setting is a more appropriate example of this than a company whose business centers on food products regulated by the Federal Food and Drug...more

Troutman Pepper Locke

FDA Remains Vigilant Against CBD-Related Health Claims

Troutman Pepper Locke on

Why It Matters - In March 2021, the FDA issued four warning letters to CBD companies around the country. The administration takes a strong stance on product labelling and marketing efforts containing health claims about...more

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update l March 2021 #3

Recent actions by the U.S. Food and Drug Administration (FDA) suggest that, in 2021, the Agency will sharpen its focus on enforcement efforts to ensure packaged foods appropriately declare the presence of major food...more

Arnall Golden Gregory LLP

A Year in Review: FDA Enforcement in the Prescription Drug Advertising and Promotion World

Good riddance to 2020 for so many reasons. But, as the AGG Year in Review of the Food and Drug Administration’s enforcement of prescription drug advertising and promotion has become an annual ritual, let’s take a quick peek...more

Bass, Berry & Sims PLC

FDA Increases Scrutiny of CBD Companies for Marketing and Labeling Practices

Bass, Berry & Sims PLC on

As the market for hemp-based products booms, many investors are grappling with (and consumers unaware of) the grey area within which hemp products­­ are being commercialized across the country. Increasing demand for...more

Husch Blackwell LLP

FDA Reiterates Importance Of Allergen Labeling By Issuing Warning Letter Following Repeated Recalls

Husch Blackwell LLP on

On December 16, 2020, the U.S. Food and Drug Administration (“FDA”) issued a corporate Warning Letter to Whole Foods Market (“Whole Foods”) following 32 recalls Whole Foods conducted over an approximate one year period for...more

Arnall Golden Gregory LLP

FDA Issues Warning Letter for Unapproved Medical Device for Significant Product Quality and Corrective Action-Related Violations

The Food and Drug Administration issued a Warning Letter to a medical device company after conducting an inspection of the facility’s medical device operations....more

BakerHostetler

AD-ttorneys@law - March 2020 #2

BakerHostetler on

Don’t Panic, but Purell Just Got Sued Over Hand Sanitizer Packaging Claims - Class action follows FDA letter, hints at lawsuit pandemic to come - Headaches - Coronavirus news is saturating everything, and stress is...more

Dorsey & Whitney LLP

The FDA Takes Aim at CBD Labeling

Dorsey & Whitney LLP on

Despite the legalization of cannabis sales in many states and Congress’s removal of hemp and hemp-derived cannabidiol (CBD) from the list of scheduled drugs under the Controlled Substances Act, recent events serve as a...more

Dorsey & Whitney LLP

FDA a Buzzkill for 15 CBD Companies

Dorsey & Whitney LLP on

On November 25, 2019, the Food and Drug Administration sent a wave of warning letters to fifteen CBD companies claiming they are breaking federal food, drug, and cosmetic laws based on their current CBD product marketing and...more

Sheppard Mullin Richter & Hampton LLP

FDA Issues Warning Letters to 15 Companies, Consumer Update on CBD Safety

On November 25, 2019, FDA issued Warning Letters to 15 companies illegally marketing cannabidiol (CBD) products. On the same day, U.S. Food & Drug Administration (FDA) published a revised consumer update, “What You Need to...more

Holland & Hart LLP

USDA Clears Path for Hemp Production While FDA Cracks Down on CBD Products

Holland & Hart LLP on

While it appears very likely that CBD products will someday be cleared for wide-spread sale by federal regulators, that day has not yet come. Many industry participants thought that CBD products became legal when the Hemp...more

Bradley Arant Boult Cummings LLP

The FTC Issues Three New Warning Letters to CBD Companies Regarding Health Claims in Advertising - Cannabis Industry News Alert

On Tuesday, the Federal Trade Commission (FTC) sent warning letters to three companies that sell cannabidiol (CBD) products regarding the health claims found in the companies’ advertisements. The FTC did not make the letters...more

Husch Blackwell LLP

FDA Warning Letter To CBD Company Provides Many Lessons For Burgeoning Market

Husch Blackwell LLP on

The U.S. Food and Drug Administration (“FDA”) issued a Warning Letter, dated July 22, 2019, to Curaleaf, Inc. (“Curaleaf”), a multi-billion dollar market cap company that is publicly traded on the Canadian Securities...more

Harris Beach Murtha PLLC

FDA Issues Warning Letters on CBD Dietary Supplements

On March 28, 2019, the Food and Drug Administration (FDA), in collaboration with the Federal Trade Commission (FTC), issued warning letters to Advanced Spine and Pain, LLC, Nutra Pure, LLC, and PotNetwork Holdings, Inc. The...more

34 Results
 / 
View per page
Page: of 2

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide