The U.S. Food and Drug Administration (FDA) issued a press release on the evening of Monday, November 25 concerning its recent enforcement actions and a regulatory decision concerning products that contain cannabidiol (CBD).  The Warning Letters follow FDA’s trend of focusing its CBD product enforcement on unapproved drug claims.  The regulatory decision stated in the press release concerns FDA’s decision that CBD is not generally recognized as safe (GRAS) for use as a food additive.

Continue Reading FDA States CBD Is Not GRAS for Use in Food, Issues More Warning Letters

The Federal Trade Commission (FTC) sent Warning Letters to three companies that sell products containing cannabidiol (CBD) and advertise that the products prevent, treat, or cure disease without substantiation of the purported health benefits.  The products covered by these warnings letters were oils, tinctures, gummies, and dietary supplements.

Continue Reading FTC Issues Warning Letters to Three CBD Companies

Today, the U.S. Food and Drug Administration held a meeting to discuss its regulatory approach to products that contain cannabis and cannabis-derived compounds, including cannabidiol (CBD). The public hearing was intended to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling and sale of products containing cannabis and cannabis-derived compounds. Along with holding the public meeting, FDA is accepting written comments through a docket on those topics until July 1, 2019. 
Continue Reading At Public Meeting, FDA Requests Data on Dosage and Delivery Formats of CBD and Other Cannabis-Derived Compounds

The Alcohol and Tobacco Tax and Trade Bureau (TTB) recently issued an industry circular which makes clear that cannabidiol (CBD), a product derived from hemp, is not permitted in alcohol beverages.

TTB generally consults with the U.S. Food and Drug Administration (FDA) when establishing whether an ingredient for use in an alcoholic beverage is safe. Last December, the Agriculture Improvement Act of 2018, which is commonly referred to as the 2018 Farm Bill, was enacted. The 2018 Farm Bill amended the definition of marijuana under the Controlled Substances Act to exempt “hemp”, which is defined as:

the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9-tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis. Source: 7 U.S.C. 1639 o(1).


Continue Reading TTB Follows FDA’s Lead and Prohibits use of CBD in Alcoholic Beverages