On June 25, 2019, Senator Ron Wyden (D-OR) issued a letter urging Department of Health and Human Services (HHS) Secretary Alex Azar and Food and Drug Administration (FDA) Acting Commissioner Ned Sharpless to take action by addressing the confusion and
Continue Reading Senator Wyden Again Urges FDA to Clarify CBD Pathway; Agency Extends Comment Deadline and Issues New Communications
FDA
House Appropriations Committee Cautions FDA To Focus on Public Health and Preserve Clinical Study Incentives As It Examines CBD Pathways
By Kristi L. Wolff on
Earlier this week, the House Appropriations Committee approved the fiscal year 2020 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies bill by a vote of 29 to 21. The committee report accompanying the bill included notable language on…
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FDA CBD Public Meeting Features Overwhelming Calls For Robust Regulation and Enforcement; Relaxation of Obstacles to Research
By Kristi L. Wolff on
FDA’s CBD Public Meeting featured a full house of manufacturers, researchers, health professionals, trade association representatives, and other stakeholders. Each speaker was given a few minutes to offer their input in response to FDA’s call for submissions relating to health…
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TTB Updates Guidance on Hemp Ingredients, Follows FDA’s Lead
By Kristi L. Wolff on
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
…
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FDA and FTC Issue Joint Warning Letters to Three Online CBD Marketers
By Kristi L. Wolff & Kelley Drye on
The FDA and FTC jointly issued warning letters to three companies selling CBD products online. The letters allege violations of the Federal Food, Drug, and Cosmetic Act (“FDCA”) and the Federal Trade Commission Act (“FTCA”). Although this is the first…
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DEA Moves CBD Drugs to Schedule V; Follows FDA’s Lead
By Kristi L. Wolff on
The DEA announced last week that it is placing certain drug products that have been approved by the FDA and which contain cannabidiol (CBD) in schedule V of the Controlled Substances Act. The action places FDA-approved drugs that contain CBD…
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FDA Targets CBD Products, Claims Made in Social Media
By Kelley Drye on
Last February, FDA issued three warning letters to companies marketing cannabidiol (CBD) products as dietary supplements. FDA reviewed the companies’ websites and concluded that claims that CBD products could treat post-traumatic stress disorder, lupus, cancer, and other conditions rendered the…
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