U.S. Food and Drug Administration
Congress Punts on Regulating CBD in Year-End Spending Bill
On Dec. 16, Congress punted on legislation to regulate the growing CBD industry and set a safe level of daily consumption. The conference report directs funding for research, policy evaluation, market surveillance and enforcement discretion related to CBD and hemp. Unlike legislation, the conference report does not have the force of law. The Natural Products Association (NPA) ...
Senate Confirms Hahn as FDA Commissioner
In a 72-18 Senate vote, Stephen Hahn, MD, FASTRO was confirmed as the new head of the U.S. Food and Drug Administration (FDA), taking charge at a regulatory agency that oversees products ranging from complex cancer drugs, to food, cosmetics, tobacco and CBD. “We look forward to working with Dr. Hahn and his staff to ...
FDA Issues CBD Warning Letters
The U.S. Food and Drug Administration (FDA) recently issued warning letters to 15 companies for illegally selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act), according to the agency. The FDA also published a revised Consumer Update detailing safety concerns about CBD products more broadly. Based on the ...
NJ Senate Committee Approves Resolution Asking Congress to Set Safe Level for CBD Consumption
The New Jersey State Senate Health, Human Services, and Senior Citizens Committee unanimously passed a resolution asking the U.S. Congress to set a safe level for CBD consumption. President and CEO of the Natural Products Association (NPA), Daniel Fabricant, PhD, testified at the committee hearing. “NPA thanks the Committee for acknowledging that it is long past ...
Trump Expected to Nominate Stephen Hahn as FDA Commissioner
President Donald Trump has decided to nominate Stephen Hahn, MD, FASTRO as FDA (U.S. Food and Drug Administration) commissioner, sources familiar with the decision told BioCentury. Other news outlets have also released similar reports. Hahn, chief medical executive of the University of Texas MD Anderson Cancer Center, is HHS (United States Department of Health and ...
House of Representatives Instructs FDA to Regulate CBD
Legislation passed the House of Representatives on June 25 that would appropriate $100,000 for the U.S. Food and Drug Administration (FDA) to perform a Health Hazard Evaluation (HHE) and set a safe level of CBD for consumers to use each day. The process would follow the same precedent as red yeast rice, which allows a natural product to ...
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 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 ...
Trade Associations Warn Consumers of Dangerous Substance Illegally Marketed as a Dietary Supplement
The dietary supplement industry sounded the alarm about the dangers of “phenibut,” a substance being illegally marketed in products fraudulently labeled as dietary supplements. Developed and used as a drug in the former Soviet Union for its supposed brain-enhancing properties, phenibut is not approved as a drug in the United States, nor does it meet ...
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