News & Analysis as of

Warning Letters Federal Food Drug and Cosmetic Act (FFDCA)

Sheppard Mullin Richter & Hampton LLP

FDA Gets Technical on HCT/P Rules in Warning Letter to Human Tissue Company

On May 21, 2024, the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA) published a warning letter issued to Akan Biosciences, Inc. (Akan) for unresolved inspection observations...more

Gardner Law

FDA Issues Numerous Warning Letters

Gardner Law on

The U.S. Food and Drug Administration (FDA) uses warning letters to notify manufacturers that they have violated the FDA’s regulations or federal law. Manufacturers that receive warning letters must respond promptly, and they...more

Husch Blackwell LLP

A Cannabis Pivot to Smokable Herbs

Husch Blackwell LLP on

As the cannabis industry continues to navigate choppy economic and legal waters into 2024, some cannabis companies are pivoting to the smokable herbs market. And I do not mean to those hemp-derived intoxicating cannabinoids...more

King & Spalding

FDA's Latest Salvo in the LDT Wars

King & Spalding on

On September 29, 2023, the Food & Drug Administration (“FDA” or the “Agency”) published the long-awaited proposed rule on laboratory developed tests (“LDT Proposed Rule”). The proposed rule is open for public comment through...more

Mintz - Health Care Viewpoints

Those Aren’t Doritos: FTC and FDA Send Warning Letters to Companies Marketing Delta-8 Infused Munchies

The Federal Trade Commission’s (FTC) recent press release marks a continuation in government action against manufacturers of products infused with delta-8 tetrahydrocannabinol (delta-8).  In May 2022, the U.S. Food and Drug...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

Sheppard Mullin Richter & Hampton LLP

FDA Issues Warning Letter to RightEye, LLC For Misbranding and Adulteration

On January 31, 2023, the U.S. Food and Drug Administration (FDA) published a Warning Letter to RightEye, LLC (RightEye), the manufacturer of the RightEye Vision System, for misbranding and adulteration. The RightEye Vision...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

Husch Blackwell LLP

FDA Issues Warning Letters to Companies Whose Products Are Intended for Use with Food-Producing Animals

Husch Blackwell LLP on

On May 26, 2022, the U.S. Food and Drug Administration (FDA) issued Warning Letters to four companies concerning the illegal sale of unapproved animal drugs containing cannabidiol (CBD) intended for use in food-producing...more

Sheppard Mullin Richter & Hampton LLP

Warning! FDA Issues Warning Letters for Products Containing Delta-8 THC

On May 4, 2022, the Food and Drug Administration (FDA) issued warning letters to five companies it asserts are illegally marketing products labeled as containing delta-8 tetrahydrocannabinol (Delta-8 THC) in ways that violate...more

Vicente LLP

FDA Enforcement Action Targeted at Hemp-Derived Delta-8 Products

Vicente LLP on

On May 4, 2022, the FDA issued five warning letters to companies for selling products containing hemp-derived Delta-8 THC. Notably, this is the first time the FDA has issued warning letters specifically for Delta-8 products....more

Mintz - Health Care Viewpoints

Snapshot of Another Much-Too-Busy Year for FDA Before 2022 Really Gets Started

It is, somewhat amazingly, the beginning of January again. During this time of year we typically publish a series of blog posts that recap the most interesting Food and Drug Administration (FDA) activities over the prior 12...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

Troutman Pepper

FDA Remains Vigilant Against CBD-Related Health Claims

Troutman Pepper 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

Mintz - Health Care Viewpoints

CBD Regulatory Enforcement Continues with Over-the-Counter CBD Pain Relief Products

Enforcement by the Food and Drug Administration (FDA) against cannabidiol (CBD)-containing products continues through the issuance of two new warning letters. On March 22, 2021, FDA published a press release cautioning...more

Rivkin Radler LLP

FDA Warns That Topical Pain-Relief Products Containing CBD Violate FD&C Act

Rivkin Radler LLP on

This week, the U.S. Food and Drug Administration (FDA) issued Warning Letters that effectively declare that the presence of cannabidiol (CBD) as an inactive ingredient in topical over-the-counter (OTC) drug products is a ...more

Husch Blackwell LLP

FDA Issues Warning Letters On Marketing And Sale Of OTC CBD Products

Husch Blackwell LLP on

The U.S. Food and Drug Administration (FDA) issued Warning Letters this month to two companies concerning the marketing and sale of over-the-counter (OTC) drug products containing cannabidiol (CBD) as an inactive ingredient....more

Fox Rothschild LLP

Labeling Considerations For Cannabis Pet Products

Fox Rothschild LLP on

With the passing of the 2018 Farm Bill, the market for cannabis pet products has rapidly grown. As a result, broad-reaching marketing campaigns highlighting the available products and the claimed benefits have become much...more

Hogan Lovells

2020 OPDP Wrap-up: FDA monitoring drug manufacturers’ use of online communication platforms

Hogan Lovells on

In 2020, the U.S. Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) issued four warning letters and two untitled letters to pharmaceutical companies for promotional materials that allegedly...more

Hogan Lovells

FDA cracks down on pharmaceutical firm for misbranding drug as COVID-19 treatment

Hogan Lovells on

Last week, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) posted two more warning letters for 2020, bringing the tally to five warning and untitled letters for the year. These...more

Hogan Lovells

Recent FDA Warning Letters focus on inadequate allergen controls following undeclared allergen recalls

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) recently issued a fifth Warning Letter related to allergen labeling, continuing a series of Warning letters in the past six months that cite companies for failing to “identify and...more

Womble Bond Dickinson

Insight into Medical Foods and the Scope of FDA Regulation

Womble Bond Dickinson on

The FDA has issued warning letters to manufacturers of products marketed as medical foods to treat a range of medical conditions, including fibromyalgia, autoimmune disorders, irritable bowel syndrome, arthritis, asthma,...more

Epstein Becker & Green

Federal Courts Say They Will Decide Cases Against CBD Product Manufacturers When the Smoke Clears

Epstein Becker & Green on

The cannabidiol (“CBD”) consumer product marketplace is booming. And, while FDA has maintained its position that CBD, even hemp-derived CBD, may not be included as an ingredient in conventional foods or dietary supplements,...more

Morrison & Foerster LLP - Class Dismissed

FDA And FTC Send Warning Letters To Companies Marketing Products To Treat Coronavirus; State Attorneys General Follow Suit

The rapid spread of coronavirus has spawned prolific marketing claims that any number of products can treat or prevent coronavirus. It comes as no surprise then that the Food and Drug Administration (FDA) and Federal Trade...more

Rivkin Radler LLP

FTC and FDA Take Joint Action to Stop COVID-19 Fraud

Rivkin Radler LLP on

On March 6, the U.S. Food and Drug Administration (FDA) and Federal Trade Commission (FTC) issued joint Warning Letters to seven companies calling for them to cease marketing products appearing to violate federal law by...more

54 Results
 / 
View per page
Page: of 3

"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