In August, the U.S. Food and Drug Administration (FDA) maintained its position that CBD in any ingestible form is subject to the drug preclusion language in the federal Food Drug and Cosmetic Act via refusal letters posted regarding New Dietary Ingredient Notifications (NDIN) filed by Charlotte’s Web and Irwin Naturals, respectively. In addition to the drug preclusion position, which refers to the prohibition on an ingredient that was first studied as a drug from being a food or a dietary supplement, the FDA also expressed concern that the NDIN submissions did not adequately establish that the extracts can be safely consumed by the intended users, nor did they respond to concerns that the FDA has previously identified relative to CBD safety, including liver toxicity.
NDIN notifications are submissions intended to satisfy the FDA that the dietary ingredient—full spectrum hemp extract, in this instance—is safe for the intended use, typically based on a demonstrated history of safe use or clinical studies relevant to the ingredient. An NDIN notification must be submitted to the FDA for a dietary ingredient that was not marketed in the U.S. as a dietary supplement, prior to October 15, 1994, the date that the Dietary Supplement Health and Education Act became law.
Charlotte’s Web took the unusual step of issuing a public response to the refusals, available here, with a link to the company’s also public letter to the FDA here, which responds directly to the agency’s criticisms of the data provided and alleging factual inaccuracies in its response.
For anyone wondering what the practical implications of these refusals are, consider these highlights.
Still About Safety
The FDA has relied on the drug preclusion rationale consistently since the very early CBD warning letters but has also expressed an interest in working with the industry to explore a non-drug pathway. Two and a half years since the passage of the 2018 Farm Bill, the FDA’s recent refusals make clear that the agency has unresolved safety concerns.
This is not the first time that the FDA has responded to an NDIN regarding CBD. In prior instances, though, the FDA’s refusal rationale was limited to the drug preclusion language, likely because prior petitions failed to include safety data. In these most recent refusals, however, the agency had safety data to review. The Charlotte’s Web letter cites to preclinical and clinical data, including published data. The agency’s response indicates that, even with what seems to be an unprecedented volume of data, the agency remains concerned that it fails to adequately demonstrate safe use. It is unclear from the publicly available materials the degree to which the data addressed CBD use from multiple products, however, an issue that has concerned the FDA in the past.
A Legislative Fix?
Many in the industry now are looking to Congress to pass one of the pending bills that would regulate CBD as a dietary supplement. These FDA refusals will be a factor in any future legislative efforts to formalize a dietary supplement pathway for CBD. As proposed, Sen. [Chuck] Schumer’s bill, the Cannabis Administration and Opportunity Act (CAOA) would not exempt all CBD supplements from the NDIN process, based on a discussion summary (see p. 27 of the bill). H.R. 841, the Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2021, which has the support of many in the dietary supplement industry, would regulate hemp, cannabidiol (CBD) derived from hemp, and any other ingredient derived from hemp (delta-8 THC possibly?) as a dietary supplement provided that such dietary supplement complies with the requirements for a dietary supplement which contains a new dietary ingredient under Section 413 of the Food Drug and Cosmetic Act (FDCA) and all other applicable requirements for a dietary supplement under the FDCA and the Fair Packaging and Labeling Act.
Now that we’ve seen the FDA’s refusals on two such notifications, we should expect both calls to exempt CBD from the NDIN process and concerns about the implications of that. Given the varying degrees of sophistication regarding manufacturing, product safety, testing, etc., some controls will be necessary in any legislation to protect both the industry and consumers.
Not About Enforcement
Some companies may be wondering whether these refusals signal that the FDA is changing its enforcement approach. These issues likely are separate. In fact, in October 2017, the FDA sent Stanley Brothers Social Enterprises, LLC, the company that markets Charlotte’s Web, a warning letter that stated that the dietary supplements discussed therein were being marketed in violation of the FDCA based on the drug preclusion clause, and as new drugs based on several disease treatment claims identified in the letter. It is unclear how Stanley Brothers responded to the warning letter as neither a response nor a closeout letter are posted on the FDA’s website. However, it is clear that had the FDA had more serious concerns about the safety of the products, the agency could have pursued more aggressive enforcement measures at that time but did not do so. That the FDA has now refused Stanley Brothers’ NDIN is not an indication that the agency is changing its enforcement posture as to that company or others.
The FDA’s refusals here may serve as a disincentive for other companies to utilize the NDIN process, whether for CBD or other ingredients. The CBD industry has proliferated in the face of regulatory uncertainty. While we do not know the details of the companies’ submissions, the FDA’s rejections in this instance raise fair questions as to why any other company would now pursue the same pathway if the risk of enforcement is limited.
Where Do We Go From Here?
The FDA’s refusals are likely to continue to cloud CBD’s pathway at the federal level for the foreseeable future. While hemp has bipartisan support in Congress, given the other issues with which the Senate and House are grappling, industry supporters may face challenges in getting adequate attention for their cause. But, all is not lost for 2021: California’s passage of Assembly Bill 45 clarifies the pathway to market and expressly states that a dietary supplement, food, beverage, cosmetic, or pet food is not adulterated by the inclusion of industrial hemp or cannabinoids, extracts, or derivatives from industrial hemp if those substances meet specified requirements, and would prohibit restrictions on the sale of dietary supplements, food, beverages, cosmetics, or pet food that include industrial hemp or cannabinoids, extracts, or derivatives from industrial hemp based solely on the inclusion of those substances. While not yet signed by the governor as of the time of this writing, and not everyone is happy with the final language, this development could be the good news that industry needed in an otherwise challenging year.