Podcast: Dietary Supplements – Navigating the Regulatory Maze – Diagnosing Health Care
Eleven Republican AGs filed a petition for rulemaking to the EPA demanding that it amend its regulations under the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”) regarding additional labeling or packaging...more
Is It Necessary for Congress to Amend the FD&C Act for FDA to Have the Authority to Prohibit Tianeptine’s Sale? If the answer to this question is “no,” why are bills being introduced into Congress to give the U.S. Food and...more
Game equipment company Sport Squad Inc. deceptively marketed some of its pickleball paddles as approved by the sport’s national governing body even though the approval had been rescinded, a consumer class action alleges....more
On April 15, 2024, in a big win for the continued validity of implied preemption, the Supreme Court declined to hear an appeal of the First Circuit’s preemption-based dismissal of a proposed misbranding class action. The...more
The United States Environmental Protection Agency (“EPA”) and Logan Agride – Service, Inc (“Logan”) entered into an April 15th Consent Agreement and Final Order (“CAFO”) addressing alleged violations of the Federal...more
“Every little one, every little one,” a song lyric from Bruce Hornsby and the Range’s 1986 single, “Every Little Kiss,” comes to mind when we read a recent Food and Drug Administration Warning Letter issued to a reprocessor...more
As of May 2022, Monsanto, the company that developed the allegedly cancer-causing weed killer Roundup, has settled more than 100,000 lawsuits, and paid nearly $11 billion in settlements. Despite this massive number, 30,000...more
The U.S. Food and Drug Administration’s (FDA’s) broad definition of “misbranding” has created some industry confusion, while the Federal Trade Commission’s (FTC’s) updates to its Health Products Compliance Guidance have done...more
When is a food “healthy”? And who gets to decide? A recent decision from the Southern District of New York touched on these questions in the context of an implausible consumer class action—though the court ultimately didn’t...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
In 2022, the U.S. Food and Drug Administration (FDA or the Agency) issued a total of nine enforcement letters targeting advertising and promotion violations for prescription drugs and devices. A summary of the noteworthy...more
The Food and Drug Administration (“FDA” or the “Agency”) user fee negotiations may have hit an iceberg, but it did not sink all the legislative riders that accompanied this summer’s House and Senate bills. Buried within the...more
LEGISLATION, REGULATIONS & STANDARDS - Former FDA Commissioners, Industry Groups Show Support for Modernized FDA Regulatory Framework - In recent months, two former U.S. Food and Drug Administration (FDA) commissioners and...more
When it comes to discussing medical devices regulated by the U.S. Food and Drug Administration (FDA), words such as “approved” and “cleared” cannot be used interchangeably as these terms carry a particular meaning....more
A common maxim in the service industry is that the customer always knows best. But a recent decision from the Tenth Circuit suggests that the maxim has its limits when it comes to interpreting ambiguous marketing claims. In...more
On May 4, 2022, House Energy and Commerce (“E&C”) Committee leaders unveiled the legislative package to reauthorize the U.S. Food and Drug Administration (“FDA” or the “Agency”) user fee agreements (the “House Draft”)...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
The Food and Drug Administration (FDA) issued a consumer alert related to Delta-8 tetrahydrocannabinol (Delta-8 THC), following a recent increase in adverse event reports to FDA and poison control centers. Although Delta-8...more
Hold onto your chips. This blog has covered an array of dubious mislabeling theories, but a recent complaint filed in Illinois federal court may take the guac: a proposed class-action complaint against Frito-Lay North...more
Avanos Medical, a global medical device company, agreed to pay $22 million to resolve criminal charges relating to its fraudulent misbranding of its MicroCool surgical gowns....more
This week, we take a look at a decision addressing what a “reasonable” consumer will know in purchasing a product (and distinguishing the Seventh Circuit in the process), and at another assessing the legality of Washington’s...more
Welcome to the latest edition of the Food & Beverage Digest, our roundup of court cases and regulations affecting the food, beverage, agribusiness, and cosmetics industries. This month, plaintiffs can’t remember the taste...more
What follows is a brief account of some of the notable U.S. environmental and administrative law cases recently decided. THE U.S. SUPREME COURT - Article II, Section 2 of the Constitution vests the President, with the advice...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
Welcome to the latest edition of the Food & Beverage Digest, our roundup of court cases and settlements affecting the food, beverage, agribusiness, and cosmetics industries. This month, vanilla is the finest of the...more