Scott Gottlieb
Gottlieb Discusses CBD at House Appropriations Committee Hearing
On April 3, former FDA (U.S. Food and Drug Administration) Commissioner Scott Gottlieb, MD, provided insights into the agency’s approach to products that contain cannabidiol (CBD) during a House Appropriations Committee hearing on FDA funding for 2020. In two exchanges with Rep. Andy Harris (R-MD), Gottlieb reiterated that the agency considers most CBD products on ...
FDA Public Meeting on Cannabis to be Held in May
On May 31, FDA (U.S. Food and Drug Administration) will hold a public meeting to “obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds,” as noted in the Federal Register. In a statement, outgoing FDA Commissioner Scott Gottlieb, MD noted that “the ...
Ned Sharpless Named Acting FDA Commissioner
Following the resignation of Scott Gottlieb, Norman E. “Ned” Sharpless, MD, has been named the acting commissioner of the FDA (U.S. Food and Drug Administration) by Alex Azar, the Health and Human Services (HHS) secretary, effective April 2019. “Dr. Sharpless’ deep scientific background and expertise will make him a strong leader for FDA,” said Azar ...
FDA Commissioner Gottlieb Resigning
U.S. Food and Drug Administration (FDA) chief Scott Gottlieb on March 5 announced his planned resignation, the Department of Health and Human Services (HHS) said, and plans to step down in one month. Gottlieb won bipartisan support for his efforts to curb the use of flavored e-cigarettes by youths, speed approval times for cheap generic ...
FDA to Convene Meeting on CBD
On Feb. 27, FDA (U.S. Food and Drug Administration) Commissioner Scott Gottlieb, MD announced the agency’s intention to convene a public meeting in April 2019 on the development of a regulatory pathway for the use of cannabidiol (CBD) in dietary supplement and food products. The announcement came during the Commissioner’s testimony at a hearing of ...
FDA Takes Action Against Products Claiming to Treat Disease, Seeks to Strengthen Oversight
On Feb. 11, the U.S. Food and Drug Administration (FDA) posted 12 warning letters and 5 online advisory letters to foreign and domestic companies that are illegally selling more than 58 products, many that are sold as dietary supplements, which are unapproved new drugs and/or misbranded drugs that claim to prevent, treat or cure Alzheimer’s disease and a ...
Senators Ask FDA to Update Rules on Certain CBD Products
Oregon’s two senators urged the head of the U.S. Food and Drug Administration to update federal regulations to permit interstate commerce of food products containing a key non-psychoactive ingredient of cannabis, via AP. The appeal by Sens. Ron Wyden and Jeff Merkley came after Congress legalized the production and sale of industrial hemp and hemp ...
Government Shutdown Impacts FDA and Industry Operations
As the government shutdown continues, FDA (Food and Drug Administration) recently announced that agency operations will continue to the extent permitted by law, maintaining core functions that address imminent threats to the safety of human life as well as activities funded by carryover user fee funds. FDA will continue to respond to emergencies—such as monitoring ...
FDA Warns Marketers of Products Labeled as Dietary Supplements That Contain Tianeptine
The U.S. Food and Drug Administration (FDA) on Nov. 20 posted warning letters issued to two companies for the illegal marketing of products labeled as dietary supplements that contain tianeptine, a chemical compound that companies are illegally claiming treats opioid use disorder (OUD), pain and anxiety, and other unlawful and unproven claims. These actions follow reports to ...
FDA Requests Consumer Feedback on Use of Plant-based Substitutes
The United States Food and Drug Administration (FDA) recently published a statement from Commissioner Scott Gottlieb, MD requesting feedback on “how consumers use plant-based alternatives and how they understand terms like ‘milk’ or ‘cheese’ when used to label products made.” A portion of Gottlieb’s statement read: “ … Many dairy products, such as milk, yogurt ...
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