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The 2018 Farm Bill legalized hemp-derived cannabidiol (CBD) at the federal level, but in the nearly three years since then, little has changed from the perspective of the U.S. Food &amp; Drug Administration (FDA). From the start, FDA’s regulatory position has been complicated by CBD’s previous approval as the active ingredient in the prescription drug Epidiolex. Subject to limited exceptions, the active ingredient in a drug cannot be added to food or dietary supplements. This restriction makes sense in the abstract – if a doctor has to prescribe something, it shouldn’t be available over the counter as a dietary supplement – but it has created a hurdle for CBD that many in the industry view as unfair. Ingredients that are commonly added to food or dietary supplements prior to becoming a drug are exempt from this prohibition, but because cannabis has been prohibited as a controlled substance, CBD never had an opportunity to be lawfully marketed in food and dietary supplements. Now that CBD is already approved as the active ingredient in a drug, it’s proving much more difficult for FDA to work around this restriction. Consequently, FDA prohibits adding CBD to a food or dietary supplement, but for practical purposes, it has only taken enforcement action against companies making drug claims in connection to the substance.

The latest development reveals that FDA’s position is unchanged. In August 2021, <a href="https://www.regulations.gov/document/FDA-2021-S-0023-0053">the agency released a letter</a> to CBD company Charlotte’s Web stating that it will not approve the company’s application to market its Full Spectrum Hemp Extract product as a dietary supplement. This letter was in response to Charlotte’s Web’s submission under the New Dietary Ingredients (NDI) Notification process, by which a company notifies FDA that it wishes to market a dietary supplement with “new dietary ingredients.” Significantly, the process includes the agency’s review of information submitted by the manufacturer showing that the ingredient is reasonably expected to be safe. While FDA rejected the application on the grounds of CBD’s inclusion as the active ingredient in a drug, it also examined the evidence provided. FDA ultimately concluded that it still has concerns about the safety of the product, including that the studies did not address liver and reproductive toxicity. Charlotte’s Web <a href="https://s22.q4cdn.com/636117063/files/doc_downloads/2021/08/CW_Response_to_FDA.pdf">issued a letter</a> disputing FDA’s rationale and pointing to evidence on this issue, but it’s notable that the process even reached this point. Prior to this letter from FDA, and a similar one to Irwin Naturals released recently, the FDA considered NDI notifications solely on the basis of CBD’s presence in Epidiolex and did not evaluate safety information. Since CBD has been legalized, much of the conversation has centered around whether there is any testing showing its safety or benefits. The fact that manufacturers are starting to have that discussion with FDA shows how the industry is growing and developing the substantiation it will need for advertising claims. This may not alone overcome the prohibition on a drug ingredient in dietary supplements, but it is a strong sign for the industry and will be important going forward.



Charlotte’s Web likely won’t stop selling its Full Spectrum Hemp Extract product following this letter, but the unfortunate result is that CBD companies continue to operate without the full imprimatur of legal authority. A murky legal situation is detrimental to both consumers and industry, and it appears increasingly unlikely that FDA will resolve the current uncertainty. Due to the issue with CBD’s presence in Epidiolex, the best path to CBD’s approval is through Congress. Several bills have been proposed to this effect, and we’ll update you here if any go the distance.

NDI Letter Shows CBD’s Position Unchanged at FDA