[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 July 8, in the wake of the Federal Trade Commission’s (FTC) designation of July as “Made in the USA” (MUSA) Month, the FTC issued warning letters to four companies suspected of violating the FTC’s Made in USA Labeling Rule...more
FTC Sends Warning Letters Regarding Potential Noncompliance With “Made in USA” Requirements. On July 8, the FTC sent letters to a flagpole retailer, footwear maker, football equipment company, and personal care products...more
The U.S. Food and Drug Administration (FDA) recently issued a Warning Letter citing a failure to obtain marketing authorization via a premarket approval (PMA) or 510(k) clearance as well as Good Manufacturing Practice (GMP)...more
While the authors are not huge fans of the rock band Def Leppard, its 1983 “Photograph” hit came to mind recently, when we read a recent Warning Letter issued, in part, because of a company’s refusal to allow photographs...more
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
One of the catchiest songs written by the 1970s British glam rock band, Sweet, is “Love Is Like Oxygen,” released in 1978. The chorus includes the lyrics, “Love is like oxygen; you get too much, you get too high.” Apparently,...more
As we recently discussed, the Federal Trade Commission (“FTC”) sent warning letters to certain drug manufacturers regarding their purportedly improper listing of device patents in the Food and Drug Administration’s (“FDA”)...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
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
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
The COVID-19 pandemic highlighted both the incredible promise and challenges for life science companies developing and manufacturing drugs, biological products, and devices that enhance our lives....more
On September 1, the Food and Drug Administration issued draft guidance for post-warning letter meeting requests under the Generic Drug User Fee Amendments. Our FDA Compliance & Enforcement Team outlines factors drug...more
On June 21, 2023, the U.S. Food and Drug Administration (“FDA”) issued a warning letter to Zyto Technologies, Inc. (“Zyto”), citing Zyto’s promotion of its Hand Cradle Galvanic Skin Response (“GSR”) device and associated...more
A proposed FTC settlement that involves alleged false Made in USA representations and alleged deceptive COVID claims was recently filed by the Department of Justice on the FTC’s behalf against an individual and the two...more
Most companies want to avoid FDA warning letters. To help medical device companies identify violations that might lead to a warning letter, this post will dive deeply into which specific types of violations are often found...more
Rule Number One: If a facility is regulated by the Food and Drug Administration, the agency may inspect it (although there are some boundaries, not discussed here)....more
Earlier this year, a pet food company issued a recall of its products after reports of animals becoming sick, allegedly, from consuming the company’s pet food. Recalls and their role in ensuring food safety was addressed in a...more
On 17 May 2021, the Acting Administrator of the Health Resources and Services Administration (HRSA), Diana Espinosa, sent letters to six pharmaceutical manufacturers stating that the manufacturers’ actions to limit access to...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
In this week’s episode, Kenneth Kennedy discusses FDA’s ongoing focus on the issuance of warning letters to firms marketing fraudulent COVID-19 products, and to manufacturers who have failed to meet certain requirements under...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 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
In 2019, the U.S. Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) issued a total of ten enforcement letters targeting advertising and promotion violations for prescription drugs. Of the ten...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more