The FDA released draft guidance July 21 for clinical research connected to developing cannabis and cannabis-derived drug products. The draft describes the agency’s “current thinking” on multiple matters pertaining to the science of developing drugs containing cannabis and hemp-derived compounds. These draft guidelines aim to help companies partake in better access to the regulated hemp supply to more easily conduct clinical research and develop new drugs from hemp. The draft also emphasizes topics such as pharmaceutical quality and chemistry, controls, testing and manufacturing. Per the FDA, said guidelines are not legally binding and for now should only be considered as recommendations. Public comment is open until Sept. 18, 2020.
Industry Guidance on CBD Regulations
The USDA submitted its Cannabidiol Enforcement Policy Draft Guidance for Industry July 22 to the White House Office of Management and Budget (OMB). Industry guidance on CBD regulations has been long-awaited. Public release of the enforcement policy is pending. According to cannabis attorney Jonathan Havens, with firm Saul Ewing Arnstein & Lehr, the enforcement policy has potential to be claims-focused, a.k.a. designed to control claims made by companies about their CBD product that are illegal and unsubstantiated. Havens noted in an email that direction and outcome are difficult to predict.
“On the standards front, it’s possible FDA could start to hold ingestible CBD marketers to the agency’s dietary-supplement regulations, for example good manufacturing practice requirements.”
Havens further noted the document would “raise the bar for the industry, push out unsavory firms who are producing unsafe products and allow marketers to say that they comply with FDA requirements, which would hopefully smooth out the true patchwork of state requirements, among other benefits.”
In the wake of these policy review requests, the FDA has posted requests for a contractor to test CBD “and related cannabinoids.” According to the documents accompanying the agency’s posting, the FDA is seeking testing for thousands of products as part of the Cannabidiol Policy Working Group. Qualifying laboratories will test “CBD-containing packaged and processed foods such as beverages, water, candy, baked goods, oils and tinctures that can be added to human or animal foods, including pills, capsules, gel caps, gummies and other forms.”
CBD Policy Oversight
Although the 2018 Farm Bill legalized industrial hemp with 0.3% THC or less in the United States, it also switched oversight of the plant and its derived products from the U.S. Drug Enforcement Administration to the USDA and the FDA. The recent forward momentum of CBD policy is occurring less than a year after the FDA issued its first consumer update regarding CBD regulations in November 2019, where it claimed cannabinoid “has the potential to harm,” listing issues such as negative effects on the metabolism of other drugs, gastrointestinal distress, increased risk of sedation and drowsiness when used with alcohol, changes in mood, changes in alertness, impairment of male reproductivity and potential liver damage.
Then in March 2020, in a mandated update to lawmakers, the FDA noted it was “evaluating issuance of a risk-based enforcement policy that would provide greater transparency and clarity regarding factors FDA intends to take into account in prioritizing enforcement decisions,” according to a report.
Of late, six states who had submitted hemp regulatory plans to the USDA were asked to make revisions and resubmit before approval will be granted. California, Colorado, Illinois, Missouri, Oklahoma and Utah were asked for revisions but the reasoning was not made public. Currently, the drug Epidiolex is the only regulated CBD product approved by the FDA. In 2018, this medicine was approved to treat seizures triggered by two severe, rare forms of childhood epilepsy: Lennox-Gastaut syndrome and Dravet syndrome. In early August 2020, the FDA approved Epidiolex for the treatment of seizures associated with tuberous sclerosis complex (TSC), which is a rare genetic disease causing the growth of non-cancerous tumors in vital organs.
Regular CBD Enforcement Changes
Suspended between legalized status and pending regulations, CBD is an industry with constant updates. In cannabis news, the House of Representatives approved a spending bill amendment in late July to protect all state, territory and tribal marijuana programs from federal interference, and aims to hold a floor vote in September on a comprehensive federal cannabis legalization bill.
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