The FDA must move to clarify the status of CBD

Hemp-derived products are seemingly everywhere, but the Feds have yet to finalize regulations

The CBD industry has exploded with the U.S. Food and Drug Administration (FDA) making bold advances in regulating these products and a notice posted in late August by the DEA that “certain forms of cannabis no longer require DEA registration to grow or manufacture.”  However, California’s long-awaited legislation to legalize hemp-derived CBD in foods, beverages and cosmetics has been put on hold, rendering it dead on arrival for this legislative session, and the 9th Circuit Court of Appeals declined to order the state of Idaho to return the hemp biomass that police seized as suspected marijuana traveling across state lines and charged the truck driver with drug crimes. For those paying attention, this is a preview of what the post-descheduling of cannabis will look like.

It seems CBD-infused items are available almost everywhere and marketed as a variety of products including drugs, foods and beverages, dietary supplements, cosmetics and topical treatments for humans, as well as pet food and other animal health products. The FDA recognizes the significant public interest in cannabis and hemp-derived compounds, particularly CBD for therapeutic purposes and otherwise, but there are many unanswered questions about the science, safety and quality of products containing CBD.

The recent increase in the number of CBD products may be because of both recent changes in state law, and because the Agriculture Improvement Act of 2018 (commonly referred to as the 2018 Farm Bill) removed hemp from the definition of marijuana in the Controlled Substances Act (when defined as cannabis and cannabis derivatives with no more than 0.3% of THC on a dry weight basis). However, CBD products are still subject to the same laws and requirements as any FDA-regulated products that contain any other substance.

 

Levels of FDA Approval

The FDA is responsible for administering the relevant legal requirements to varying degrees, depending on which type of product is being marketed and sold. For example, if a product is being marketed as a drug intended to have a therapeutic effect such as treating a disease, then it is regulated as a drug, and it generally cannot be sold without FDA approval or, in the case of an over-the-counter drug, an FDA monograph. A company wishing to market and sell either of these types of CBD products should seek legal counsel with FDA experience to engage in an extensive review of the product and labeling claims.

CBD-infused food and beverages, including dietary supplements, are regulated differently by the FDA, but with the same overarching goal of protecting consumers. Among other things, it is currently illegal to put into interstate commerce a food or beverage to which CBD has been added, or to market CBD as a dietary supplement. Again, working with experienced attorneys can protect prudent CBD companies from costly mistakes or a break in supplying customers product by initiating FDA approvals now, in anticipation of a national enforcement action.

 

Current FDA Enforcement

Headlines about the FDA’s warning letter to the company Curaleaf for selling some unapproved CBD products with “unsubstantiated” health claims that the products treat cancer and Parkinson’s disease, among other health conditions, sent shockwaves through the industry. However, the FDA has been issuing these letters for years.

Unlike drug products approved by the FDA, unapproved CBD dietary supplement products were not subjected to FDA review as part of the drug approval process, and there was no FDA evaluation regarding whether they are safe and effective to treat a particular disease, what the proper dosage is, how they could interact with other drugs or foods, or whether they have dangerous side effects, pesticides, heavy metals, toxins or other safety concerns. FDA enforcement actions address concerns about misleading and false claims associated with CBD products that may lead consumers to put off getting important medical care, such as proper diagnosis, treatment and supportive care.

On July 12, 2019, the FDA announced that it was “expediting” its efforts to develop rules for CBD and that it planned to issue a report on the department’s progress by early fall. Amy Abernethy, the FDA’s acting chief information officer, tweeted in July that the “FDA is expediting its work to address the many questions about cannabidiol (CBD),” and describing this as “an important national issue with public health impact, & an important topic for American hemp farmers and many other stakeholders.”

 

Practical takeaways

The FDA continues to regulate cannabis products under the federal Food, Drug and Cosmetic Act and subsequent amending statutes are codified into the U.S. Code Title 21, Chapter 9. This means that any cannabis product marketed with a therapeutic claim, whether derived from hemp or otherwise, must receive FDA approval before it can be sold. The sale of unapproved products is a clear violation of the law, and the FDA may take enforcement action upon those who partake in such activity. The FDA also regulates and prohibits the introduction of CBD into the food and beverage supply and dietary supplements. However, the FDA provides numerous pathways to lawfully market CBD and other hemp-derived products.

While the FDA statements and actions address the federal law surrounding CBD, companies must also remain cognizant of CBD requirements in the states where they operate.

Until CBD products are fully regulated, there is no way of ensuring the efficacy for various purposes, ranging from anxiety, arthritis or even epilepsy. There is no guidance on dosage for CBD products, assuring there is no unanticipated THC component, nor ways to verify the purity of the product. The time may come when science has true answers, but it is not now. That said, if a CBD company owner is determined to sell infused products, it is best to provide information to answer these threshold questions: dosage standards, lack of excessive THC in the product, purity of the infused CBD and, most importantly, make no medical or misleading claims about the effects of the products.

 

Anne van Leynseele is a cannabis and hemp regulatory and deal attorney, often working across sovereign borders. She advises multi-state and multi-national cannabis clients on governance, compliance, licensing, acquisition, asset management, and import/export matters. Prior to joining Zuber Lawler, she spent four years as a federal attorney advisor in Washington, D.C. She can be reached at avanleynseele@zuberlawler.com.

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