Minor Cannabinoids: Exploring the Science, Legality, & Opportunities
The Responsible Corporate Officer Doctrine and the Food, Beverage and Agribusiness Industry — What You Need to Know
Podcast: Non-binding Guidance: FDA’s Regulation of Products Containing CBD
“Can’t be good for my health,” a song lyric from Gwen Stefani and No Doubt’s early 2000s single, “Magic’s in the Makeup,” comes to mind when we think of the Food and Drug Administration’s possible motives for recent...more
On November 6, 2023, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) issued its anticipated General Compliance Program Guidance (“GCPG”) for the health care industry. The GCPG serves as a...more
Thanks to the Food and Drug Omnibus Reform Act (FDORA), cosmetic companies will soon be subject to new requirements for registration, product listing, disclosure of ingredients, adverse event reporting, safety substantiation,...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
US President Joseph Biden signed into law the Food Allergy Safety, Treatment, Education, and Research Act (FASTER Act) in April, establishing sesame as the ninth major food allergen under the Federal Food ...more
Recently, the Federal Trade Commission (“FTC”) and the U.S. Food & Drug Administration (“FDA”) issued joint warning letters to four sellers of e-liquids, the nicotine “juice” used in vaping regarding their use of social media...more
LEGISLATION, REGULATIONS & STANDARDS - Personal Care Products Legislation Introduced in Congress - Rep. Janice Schakowsky (D-Ill.) has introduced the Safe Cosmetics and Personal Care Products Act of 2018, which would...more
On June 12, 2018, the US Food and Drug Administration (FDA) finalized its Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities – Questions and Answers guidance (Final Guidance)....more
Both the USDA and the FDA recently released updates to food labeling regulations that will significantly affect food manufacturers. On Friday, May 4, the Agricultural Marketing Service (AMS) of the USDA proposed a rule...more
On September 21, 2016, the Department of Health and Human Services (HHS) published a final rule that greatly expands the information that sponsors of “applicable drug clinical trials” and “applicable device clinical trials”...more
With Congress’s freshly enacted GMO labeling bill, the devil is in the implementing details. On July 29, US President Barack Obama signed legislation that establishes a national disclosure requirement for identifying...more
On July 29, 2016, U.S. President Barack Obama signed into law the first U.S. federal law requiring food manufacturers and distributors to label products that contain genetically modified organisms (“GMO”).[1] The law...more