Last week, the departing Food and Drug Administration (“FDA”) Commissioner, Scott Gottlieb, released a statement in which he announced that the agency, in collaboration with the Federal Trade Commission (“FTC”), had issued warning letters to three CBD manufacturers: Advanced Spine and Pain LLC (d/b/a Relievus), Nutra Pure LLC and PotNetwork Holdings Inc.. The letters were sent "in response to
On April 2, 2019, the federal Food & Drug Administration ("FDA") Commissioner Scott Gottlieb issued a press release on hemp and hemp-derived cannabidiol ("Hemp CBD"). This is Gottlieb's first major official press release since the now infamous December 20, 2018 press release which came just hours after the 2018 Farm Bill passed. In that December 20 press
During a recent interview with the Brookings Institution, Scott Gottlieb, the departing head of the Food and Drug Administration (“FDA”), explained it would take several years for the agency to come up with rules that would legalize the use of hemp-derived cannabidiol (Hemp-CBD) in food products, unless Congress steps in. Gottlieb acknowledged the strong interest
Recently the United States Post Office ("USPS") issued an advisory on "Acceptance Criteria for Cannabidiol (CBD) Oil and Products Containing CBD." Those criteria are as follows: 1. A signed self certification statement, subject to the False Statements Act (18 U.S.C. § 1001). Statements must be printed on the mailer's own letterhead, must be signed by
We advise some of the largest companies in the U.S. on hemp-derived cannabidiol (hemp-CBD) products. Those companies are filled with lawyers, and the lawyers have many specializations. Most of them, however, have little or no familiarity with hemp-CBD, and that is why they reach out and hire us. In the preliminary emails and phone calls,
Three years ago, I did a TedX Talk titled "High Dive: Are We Creating Big Marijuana?" The issues I raised in my talk are still relevant today, especially as more states legalize. Basically the new question around state cannabis legalization is who should get to profit from it--big business or those most negatively affected by
In the last few weeks, we have received a growing number of inquiries pertaining to the legality of smokable products infused with cannabidiol derived from industrial hemp (“CBD Smokables”), including vape pens and pre-rolled hemp flower joints. This post provides a brief overview of the current legal status of these products. As we have discussed
On February 27, 2019 both the Food and Drug Administration ("FDA") and the United States Department of Agriculture ("USDA") provided new insights and guidance related to their proposed regulatory processes for hemp under the 2018 Farm Bill. I will summarize these agency statements below, and give some context for what hemp and CBD businesses can
The recent wave of crackdowns on cannabidiol (“CBD”)-infused alcohol beverages has further exacerbated public confusion regarding the legal status of the cannabis plant’s non-psychoactive compound. This post provides an overview of the regulatory framework of alcoholic beverages, including pre-manufactured industrial hemp-infused drinks and "homemade" alcoholic drinks infused with CBD oil or extracts. Pre-Manufactured Alcohol Beverages
Back in September 2018, I wrote about how important it was for hemp businesses to carefully plan the routes they would use to ship hemp and hemp products, including hemp-derived CBD. This is because some states are hostile towards hemp and do not recognize a difference between hemp and marijuana. My article was written prior
