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Podcast: Non-binding Guidance: FDA’s Regulation of Products Containing CBD
On May 12, 2025, the Department of Justice (the “DOJ”) released its criminal—and, more specifically, white collar crime enforcement—initiatives under the current administration. This is typical each time new leadership...more
Only weeks after being confirmed, the Department of Health and Human Services (HHS) secretary has advised food companies to remove artificial colors from their food products. He recently met with several major food brand...more
2025 will be a transformational year for the beverage and food industry, which has already been dramatically impacted by shifting market trends and profound policy changes. Here are the top five topics influencing the...more
U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. announced on March 10, 2025, that he directed the acting commissioner of the U.S. Food and Drug Administration (FDA) to explore potential...more
Among the wave of guidance documents issued by the U.S. Food and Drug Administration (“FDA” or the “Agency”) in the first week of 2025 were three notable draft guidance documents pertaining to medical devices (together, the...more
On January 16, 2025, the U.S. Food and Drug Administration (“FDA”) published a highly anticipated proposed rule on front-of-package (“FOP”) nutrition labeling (“proposed rule”)....more
On January 16, 2025 the federal Food and Drug Administration (FDA) issued notice requiring manufacturers to reformulate their products removing Red Dye No. 3 by January 15, 2027 for food (21 CFR §74.303) and January 18, 2028...more
On January 16, the U.S. Food and Drug Administration (FDA) announced that it is revoking the authorization for use of FD&C Red No. 3 in food (including dietary supplements) and ingested drugs. The dye is commonly used in...more
After years of talk, the U.S. Food and Drug Administration in mid-December 2024 at last finalized an updated definition of the implied nutrient content claim "healthy." The original definition of "healthy" dates back to the...more
The Food and Drug Administration (FDA) recently issued a Notice announcing the availability of an updated final guidance for the industry entitled “Registration and Listing of Cosmetic Product Facilities and Products.” The...more
On December 19, 2024, the US Food and Drug Administration (FDA) issued a new final rule titled “Food Labeling: Nutrient Content Claims; Definition of Term ‘Healthy.’” The rule revises regulations that govern when food...more
This year, we have seen several monumental events that already are, or potentially could be, pivotal to the future of the Laboratory Developed Test (“LDT”) industry – first, the issuance of the U.S. Food & Drug Administration...more
With the persisting uncertainty surrounding the next iteration of the Farm Bill and its treatment of hemp-derived consumable products, perhaps it should come as no surprise that legislators on Capitol Hill have proposed...more
In a concerted effort to combat the illegal sale of delta-8 THC edibles packaged to look like popular snacks, the US Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) have recently begun issuing...more
A group of 20 Democratic AGs, led by Massachusetts AG Andrea Campbell, has filed an amicus brief before the U.S. Supreme Court in Food and Drug Administration v. Wages and White Lion Investments, LLC., dba Triton...more
In late June, the U.S. District Court for the District of Montana held that federal law preempts the Montana Attorney General (AG) from removing the cigarette brands of Grand River Enterprises Six Nations, Ltd. (Grand River)...more
In recent years, states have been exploring innovative avenues to address rising healthcare costs and ensure access to affordable medication for their residents. One idea gaining traction involves pursuing authorization from...more
On February 2, 2024, FDA finalized its nearly two-year-long process to harmonize QS regulations with ISO standards. As we mentioned when FDA proposed the harmonization in 2022, this update represents the first update to the...more
PERKINS COIE IS PLEASED TO PUBLISH ITS Q4 FOOD AND CPG LEGAL TRENDS REPORT. This report is a bite-sized version of our annual year in review, providing timely insights on trends so far this year. In Q4 2023, the Consumer...more
The Food and Drug Administration (“FDA”) has released draft interim guidance documents that impact the use of bulk drug substances in compounding under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act...more
On December 7, U.S. Representative Greg Pence (R-IN) introduced the Innovative Feed Enhancement and Economic Development Act of 2023 (the Innovative FEED Act). Sen. Roger Marshall (R-KS) introduced the Senate version of the...more
The U.S. Food and Drug Administration (FDA) issued a long-awaited revised draft guidance on October 23, 2023, which focuses on communications to healthcare providers (HCPs) regarding scientific information on unapproved uses...more
Earlier this month, the Food and Drug Administration (“FDA” or “the Agency”) issued a highly anticipated proposed rule outlining the regulatory framework and implementation plan for Laboratory Developed Tests (“LDTs”). The...more
On September 29, 2023, the Food and Drug Administration (FDA) issued a proposed rule that would end its long-standing policy of enforcement discretion with respect to regulation of laboratory-developed tests (LDTs) (the...more
Of particular interest to clinical laboratories and medical device manufacturers, the U.S. Food and Drug Administration (FDA or the Agency) released a controversial proposed rule on September 29 that would dramatically alter...more