Hemp and CBDs: What Is Its Regulatory Status?
Updated: Feb 15, 2019
In January’s “FSMA Friday and Regulatory Update” webinar, Eric Edmunds, JD, of The Acheson Group (TAG) discussed the regulatory changes for hemp and CBD products triggered by the 2018 Farm Bill, and provided insightful predictions about future FDA rulings.
Every four years, Congress reviews and approves the “Farm Bill,” which provides funding for certain nutrition and agriculture programs. In the 2014 and 2018 bills, a new issue arose: the legalization of industrial hemp. In the 2014 Farm Bill, state pilot programs were approved, allowing individual states to run research programs through the state universities overseen by their department of agriculture. The 2018 Farm Bill (passed December 20, 2018) went much further – removing industrial hemp from the Controlled Substances Act through a new legal definition 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 [THC] concentration of not more than 0.3 percent on a dry weight basis.”
It is the last phrase of the definition that is most important – and what enabled its removal as a controlled substance: “with a delta-9 tetrahydrocannabinol [THC] concentration of not more than 0.3 percent on a dry weight basis.” That is, the hemp has such a low amount of THC that there are no psychoactive effects no matter how much is used. However, that only removed it from DEA purview; it is still subject to a number of regulations, such as those of FDA for its use in food and dietary supplements. Some uses are now legal, but there remains a lot of confusion and hurdles. In fact, the very same day that the Farm Bill was passed, FDA released a public statement, stating that it is unlawful to introduce food or dietary supplements containing CBD or THC into interstate commerce, or to market CBD or THC products regardless of whether the substances are hemp-derived.
The statement also included options for pathways to legal sales, such as the formal drug approval process. It also stated that FDA has the authority to allow the use of a pharmaceutical ingredient in food or dietary supplements. But, because this would require the passage of regulation, it intends to hold a public meeting for discussion. Additionally, there are some uses of the hemp which have been approved through a GRAS evaluation, each of which is a seed-derived ingredient: hulled hemp seed, hemp seed powder, and hemp seed oil. The GRAS determination was made when a company submitted the three for evaluation, and FDA saw no issues under their intended use. The important points of the GRAS determination are that none naturally contain THC, so those – and other ingredients which meet the same GRAS specification – are now considered legal. (For more information on this, see TAG’s post The Impact of Hemp Legalization on Food.)
Predictions About Future FDA Rulings. In discussing what we would expect for the future of industrial hemp use in foods, we need to consider FDA’s 2018 approval of Epidiolex. An issue is caused because cannabidiol (CBD) is the active ingredient in the drug, and the FD&C restricts ingredients that are approved as pharmaceutical active ingredients from being used in foods or dietary supplements.
Although there are already CBD products on the market, a look at historical precedence set by FDA’s approval of lovastatin in 1987 does not bode well for CBD in foods and dietary supplements when it is present at levels that are higher than the natural concentration of CBD in hemp. That is, red rice yeast, which contains lovastatin, has been used as a dietary supplement since the time of the Chinese Dynasty. Yet its approval as a pharmaceutical active ingredient put this in jeopardy. In the legal battle that followed, it was determined that the ingredient in the dietary supplements contained more than the natural levels of lovastatin; it was being processed to increase its levels, so it could no longer be used in OTC dietary supplements above naturally occurring levels. The similarity lies in the fact that hemp has a lot of products, of which CBD is just one. When CBD isolates are increased in a product, so that they are no longer at naturally occurring levels, the legal precedence shows companies implementing such practices would lose, and have to return to naturally occurring levels.
Thus, current status is that naturally derived hemp products without any individual compounds or component amplification will likely have a good chance of being considered GRAS. Additionally, FDA recognizes that there is substantial public interest in the topic and intends to hold public meetings and “evaluate its duty to protect public health and take enforcement actions when necessary.”
With the remaining determinations and confusion, the major issues to consider now are the sources of hemp-derived products and final product evaluation to ensure they have less than 0.3% THC; use of broad/full spectrum hemp oil which is pressed out of the hemp plant; use of items determined to be GRAS; and being very careful about claims and potentially misleading statements.
Hosted by SafetyChain Software, FSMA Fridays is a monthly live webinar with The Acheson Group (TAG), providing the industry with the latest news and insights on FSMA. Have a question about FSMA? Need assistance with FSMA compliance or gap assessments? Contact TAG today
About The Acheson Group (TAG)
Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG's team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. Learn more at: www.AchesonGroup.com