On August 27, 2019, the Drug Enforcement Administration (“DEA”) issued a Federal Notice stating its intent to issue new regulations for its marijuana growers program for scientific and medical research. The adjustments to its policies and practices will include a
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FDA
Kelley Drye’s CBD Update Webinar
By Kelley Drye on
Join Kelley Drye’s Cannabis Law practice group, including partners Kristi Wolff and Laura van der Meer, and guest speaker Megan Olsen from the Council for Responsible Nutrition, for a detailed look at several relevant CBD topics; including the…
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NY and Ohio: Recent Legal Changes Diverge on Whether CBD Can Be Added to Food
By Kristi Wolff & Lee Baumgardner on
We’ve written a lot about FDA’s current position on CBD in food and the ongoing process to evaluate a potential non-drug pathway for the ingredient that emerged seemingly out of nowhere to capture the attention of consumers, legislators, and regulators…
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FDA Responds To Congressional Pressure To Speed Up CBD Review
By Kristi Wolff & Lee Baumgardner on
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.…
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Senator Wyden Again Urges FDA to Clarify CBD Pathway; Agency Extends Comment Deadline and Issues New Communications
By Kristi Wolff & Lee Baumgardner on
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…
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House Appropriations Committee Cautions FDA To Focus on Public Health and Preserve Clinical Study Incentives As It Examines CBD Pathways
By Kristi 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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Five Key Takeaways From FDA’s CBD Public Meeting
By Kristi Wolff on
With CBD projected to be a $450 Million industry in the coming year, FDA hosted a packed house of industry stakeholders last week in a day-long public meeting that was the kickoff of a discussion to determine whether there is…
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FDA CBD Public Meeting Features Overwhelming Calls For Robust Regulation and Enforcement; Relaxation of Obstacles to Research
By Kristi 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 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
FDA and FTC Issue Joint Warning Letters to Three Online CBD Marketers
By Kristi Wolff & Lee Baumgardner 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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