Last week, FDA Principal Deputy Commissioner and Acting Chief Information Officer Dr. Amy Abernethy released a series of tweets indicating that the agency is “expediting” its work towards addressing the confusion and uncertainty surrounding the regulation of hemp-derived CBD. Dr. Abernethy also stated that FDA plans to report on the agency’s progress around the end

The Alcohol and Tobacco Tax and Trade Bureau (“TTB”) recently updated its guidance on inclusion of hemp ingredients in beverages containing alcohol. Here’s a summary:

• It remains TTB’s policy that it will not approve any formulas for alcohol beverages that contain ingredients that are controlled substances under the federal Controlled Substances Act.
• TTB

On March 5, 2019, FDA Commissioner Scott Gottlieb, M.D. and FDA/CFSAN Director, Susan Mayne, Ph.D., released new independent test results confirming asbestos contamination in certain cosmetic products sold by Claire’s and Justice retailers.  The agency also issued a safety alert warning consumers not to use the cosmetic products sold by Claire’s that had tested positive

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 regarding the National Bioengineered Food Disclosure Standard providing labeling requirements for disclosing whether a food product has been bioengineered.

The proposed

FDA Commissioner Scott Gottlieb trumpeted the agency’s “modern and flexible” approach to digital health regulation when speaking at Health Datapalooza last week.  As we have written about here, FDA has announced multiple initiatives over the last several months designed to clarify the regulatory considerations around new and emerging digital health technologies.  Last week’s speech

FDA announced last week that it is permitting marketing of an mHealth app that uses artificial intelligence (AI) to analyze CT images for signs of stroke. The app, called Contact, is a clinical decision support tool marketed by Viz.AI.  It relies on triage software to scan for potential blockages and then notifies a medical specialist

Yesterday, U.S. Senate Agriculture Committee Chairman Pat Roberts, R-Kan., and Ranking Member Debbie Stabenow, D-Mich., announced a bipartisan compromise bill regarding labeling of bioengineered foods, sometimes referred to as “genetically modified organisms” or “GMOs.”  They stated, “This bipartisan agreement is an important path forward that represents a true compromise. Since time is of the essence,

FDA has finalized its guidance document relating to medical foods, a special class of products defined under the Orphan Drug Act.

Although most of the content of the final guidance mirrors the draft guidance released in August 2013, the final guidance clarifies the following points:

  • Medical foods are exempt from the labeling requirements for nutrient

appleAlthough “healthy” might sound like a subjective term, FDA has long-defined “healthy” under nutrient content claim regulations. For example, to be “healthy” an item must be low in fat and saturated fat.  Many stakeholders and health advocates have argued that this conception of “healthy” may be outdated, and the agency hinted this week that it