The U.S. Food & Drug Administration (FDA) and the National Institute of Standards & Technology (NIST), a non-regulatory agency of under the umbrella of the U.S. Department of Commerce have published separate guidelines aimed at providing a more comprehensive and uniform regulatory environment for the cultivation, production and marketing of hemp and hemp derived consumer products.
Following review by the White House Office of Management and Budget, the FDA has published draft guidance and is now seeking comment on new standards for testing and developing cannabis derived compounds as part of an Investigational New Drug (IND) application and conducting related clinical trials. The guidance, which is non-binding and does not have the effect of actual regulations, gives direction to the burgeoning cannabis industry with respect to cultivating and producing new pharmaceuticals containing active ingredients derived from marijuana and hemp. The guidance focuses particular attention on hemp derived Cannabidiol (CBD) which manufacturers may now purchase legally as hemp was removed from schedule I of the Controlled Substances Act (CSA) under the 2018 Farm Bill. Now as part of IND, manufacturers are directed to specific FDA publications and resources which provides standardized method for chemical analysis and testing of THC content necessary to confirm that the raw material is below the .3% threshold required to meet the current USDA definition of hemp. Additional guidance is available to assist drug manufacturers in the development of consistent product of the same quality and potency. This signals a major breakthrough in the development of uniform regulations to guide the CBD market. While FDA has yet to publish regulations that permit the production, marketing and distribution of CBD as a dietary supplement, this new guidance creates a clearer path for the development of prescription pharmaceuticals containing CBD and related cannabis derived compounds. For producers of CBD products, this may also indicate the direction of the FDA with respect to permissible supplements.
At the same time, NIST published a new Cannabis Laboratory Quality Assurance Program (CannaQAP) which provides uniform guidance for testing and labeling CBD supplements. The aim of this new program is to enhance consumer confidence in the labeling of cannabis and CBD products obtained from legal dispensaries licensed under state laws. The program sets uniform standards and recommended methodology for testing and analyzing cannabis and CBD products to determine THC and CBD content and advise consumers of a product’s quality and potency. CannaQAP also provides uniform guidance for displaying these amounts and other pertinent information on a product’s label. While NIST guidelines, like FDA guidance, do not carry the weight of federal law, they are an important step in stabilizing the current regulatory environment for the cannabis and hemp industry. Now, producers of CBD products have clear direction regarding how to test their finished products for CBD content and potency and what to include on their product label to assure consumers they are receiving a consistent product.
FDA’s draft guidance is still subject to amendment pending public comment. Related information may be found through the following link:
A copy of the draft guidance is also available below along with a summary of the CannaQAP. For assistance in conforming your company’s practices and protocols to meet these new standards, please contact www.themillenniallawyer.com