The Food and Drug Administration (FDA) recently issued both draft and final guidance regarding food allergen labeling requirements.  The draft guidance document, Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5), updates the previous (fourth) edition with new and revised guidance concerning food allergen labeling. FDA also issued a final guidance document with the same title in order to preserve questions and answers that were unchanged from the previous (fourth) edition, which was published in 2004 and last updated in 2006.

Continue Reading FDA Issues Final and Draft Guidance Documents Regarding Food Allergen Labeling

On November 18, 2022, the Alliance Defending Freedom (“ADF”), a conservative legal group, filed a motion with the federal district court in the Northern District of Texas against the U.S. Food and Drug Administration (“FDA”) to withdraw approval of Mifepristone, an FDA-approved drug used to end pregnancies in the first trimester.[1]  While this case addresses access to a single product and was prompted by abortion opponents’ efforts to eliminate access to medication abortion, a loss for FDA in this case could have far broader implications.

Continue Reading Anti-Abortion Advocacy Groups’ Challenge to FDA-Approved Abortion Pill May Have Far-Reaching Consequences

Much like the ambiguous landscape involving cannabidiol (CBD) products on the consumer market, an influx of delta-8 THC containing products for consumption has highlighted a recurrent regulatory issue surrounding the legality of hemp derived products at the federal level. The Agricultural Improvement Act of 2018 (the “2018 Farm Bill”), which, among other things, offered a federal definition of hemp and removed it from the list of Schedule I controlled substances, specifically carved out hemp derived products with less than 0.3% delta-9-tetrahydocannabinol (THC) on a dry weight basis, thereby allowing products that meet this definition to flood the consumer markets.

Continue Reading Recent FDA Enforcement Action Colors Regulatory Landscape for Delta-8 THC Products

On May 26, 2021, the Department of Justice (“DOJ”) announced a coordinated law enforcement action against 14 telehealth executives, physicians, marketers, and healthcare business owners for their alleged fraudulent COVID-19 related Medicare claims resulting in over $143 million in false billing.[1] This coordinated effort highlights the increased scrutiny telehealth providers are facing as rapid