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The FDA’s Position on Regulating Cannabis Products Post-Farm Bill

As mentioned in our prior blog post here, on December 20, 2018, President Trump signed into law the Agricultural Improvement Act of 2018 (the “Farm Bill”).  The bill de-scheduled hemp from being a federally controlled substance, and legalized hemp-derived cannabidiol (“CBD”) provided it meets the legal definition of industrial hemp.  The Farm Bill provided that the growth, production, research, and cultivation of hemp and its derivatives will be overseen by the individual states and the U.S. Department of Agriculture (“USDA”), while the Food and Drug Administration (“FDA”) will regulate relevant consumer products.  If you would like to learn more about the Farm Bill and its effect on the future of CBD, read our prior posts here and here; this post will focus specifically on the FDA’s recent response to the Farm Bill.

Immediately following the signing of the Farm Bill, FDA Commissioner Scott Gottlieb, M.D., issued a statement addressing the new bill. Commissioner Gottlieb reminded the public that the Farm Bill did not change the FDA’s authority to regulate products with cannabis and cannabis derivatives but pointed out that with the increased public interest in cannabis and cannabis derivatives, it is important for the FDA to clarify its regulations.  So, it is anticipated that changes to FDA regulations are forthcoming, in hopes of providing more legal pathways to introduce hemp and CBD in the sale of food, beverages, dietary supplements and other products across state lines.

Even though the Farm Bill de-scheduled CBD as a controlled substance, it did not give companies the green light to add CBD to food and beverages, as one might think.  Although CBD is no longer an illegal substance, the FDA’s position has not changed significantly. The FDA intends to continue to closely monitor products that claim therapeutic benefits.  Regardless of whether the product contains CBD or not, if a product is marketed with therapeutic benefits claims, the FDA requires that it be approved by the FDA before introduction into the market, otherwise it is in violation of FDA regulations.

The Commissioner further points out that even if a product makes no therapeutic claims, under the Federal Food, Drug and Cosmetic Act (“FD&C”) it is illegal to sell food, beverages, or supplements containing CBD in interstate commerce.  The FDA imposes this prohibition because it deems CBD to be an active ingredient of a FDA-approved drug.  This is not a unique prohibition for cannabis or cannabis derivatives.  Under the law, no active ingredient of any FDA-approved drug can be added into food, beverages, or dietary supplements.  In his press release, the Commissioner noted in some circumstances the FDA may permit certain cannabis-derived compounds to be used in food or dietary supplements.  Additionally, in response to the Farm Bill, the FDA is taking steps to “evaluate whether [they] should pursue such a process.”

The press release notes that the prohibition is not on all hemp plant derivatives, and that hemp seed derivatives such as hulled hemp seeds, hemp seed protein, and hemp seed oil can be added to food.  Products containing hemp seed derivatives cannot claim therapeutic benefits and must identify the ingredient on the ingredient list. Irrespective of FDA’s prohibitions, CBD in the food and beverage industry has been growing at an impressive rate.  While the recent progress that has been made in the cannabis world is encouraging, anyone looking to incorporate CBD into their product should proceed with caution and continue to monitor the development of the law.   Further guidance is anticipated from FDA, which will hopefully bring with it more clarity on the process to lawfully introduce CBD into products being marketed for consumption.

The FDA intends to hold a public hearing to address cannabis and cannabis derived products to help them determine how to amend their regulations.  So far, FDA has not scheduled the anticipated public hearing.  We will continue to closely monitor any development in this area.

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