[Webinar] EHS in the Cannabis Industry: What Happens When the E stands for Enforcement?
#WorkforceWednesday: OSHA ETS Coming Soon, OSHA Cracks Down on States, and EEOC Updates Guidance - Employment Law This Week®
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - 2020 Year in Review on FDA’s Enforcement of Rx Drug Promotions & Trends
Subro Sense Podcast - Unpacking Product Claims Against Amazon
Podcast - Developments in FDA & DOJ Regulation and Enforcement of Manufacturer Communications
Taking Notice of Notice Letters
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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