FDA’s Latest News On CBD Products – More Strict Controls In 2023

After years of keeping the industry guessing, the FDA announced on January 26th that CBD could not be regulated under current dietary supplements and food standards.

The FDA plans to collaborate with Congress to develop a cross-agency regulation policy for these products that balance consumer access with the need to monitor the risks associated with CBD products.

The FDA also denied citizen petitions filed by the Council for Responsible Nutrition (CRN), Consumer Healthcare Products Association (CHPA), and the Natural Products Association (NPA) where they asked the agency to conduct amendments to allow the marketing of CBD products as dietary supplements as part of this announcement.

How CBD got here

The FDA reaffirmed its stance in December 2018, soon after the 2018 Farm Bill was passed into law, that CBD (and THC) cannot be marketed as a dietary supplement or food since major scientific trials on CBD were permitted before its marketing as a supplement or food. At the same time, the FDA expressed its commitment to developing a framework for the legal marketing of CBD products.

In the years afterward, the FDA has issued several warning letters and similar public pronouncements. It also launched a docket to gather data on the safety of CBD and conduct its evaluation of the literature and research on CBD.

Fast forward to January 2023, and the FDA’s decision that “it is not clear how CBD products might fulfill safety criteria for dietary supplements or food additives” based on its examination. The FDA also expressed concerns about long-term CBD usage, interactions with certain drugs, potential damage to the male genitalia, and CBD exposure in vulnerable groups such as children and the elderly.

The FDA claims its current authority gives “limited instruments” to mitigate these risks. However, dietary supplements, in particular, are subject to a slew of rules to ensure safety across the supply chain. In terms of enforcement, the FDA emphasized that it would continue to monitor the market and take necessary action, implying that a significant adjustment in approach is unlikely.

The news comes after many years of remarks on CBD, and although disheartening, it comes as no surprise to those who have been observing this matter.

So, why did the FDA adopt this stance, what will happen next, and when will it happen? There are now more questions than answers, but current and past FDA statements provide insight into what prompted this new declaration and what may be in store in the coming months.

Why are we here with CBD?

 First, this recent revelation isn’t only about CBD but the FDA’s dissatisfaction with the 2018 Farm Bill. Even though the Farm Bill excluded hemp from (CSA) the Controlled Substances Act, it did not establish a regulatory framework for the FDA to oversee hemp products.

In other words, Congress kept the agency’s jurisdiction to regulate such goods but did not require FDA to adopt rules in accordance with any of the current frameworks that govern foods, dietary supplements, cosmetics, or pharmaceuticals. The result was a market swamped with hemp products and a regulator unable to manage the commodities surge.

Second, as stated in the Reagan-Udall Foundation research, the FDA—particularly the CFSAN (Center for Food Safety and Applied Nutrition), which regulates foods, supplements, and cosmetics—has a “culture of indecision and delay, creating disincentives for cooperation.”

In the case of CBD, the FDA saw little benefit in taking a definitive move, either via enforcement or by authorizing its usage in dietary supplements or food. Even frequent legislative nudges or threats resulted in little action, except the often repeated phrase about a lack of safety data, followed by public declarations claiming the same.

Third, the FDA had the drug exclusion argument on its side, which the industry could not argue in court. The FDA has issued several warning letters, but they are not considered final agency actions, which are necessary before a court may review an FDA decision.

It is crucial to emphasize that, even if FDA’s view on medicine exclusion is valid (we disagree), Congress gave FDA the authority to establish rules allowing the prohibited component to be used in a dietary supplement. Unfortunately, the FDA is unwilling to use such discretion, stating that “it is not clear how CBD products may fulfill safety guidelines for dietary supplements or food additives.”

The FDA is unwilling to exercise its current jurisdiction because it feels doing so would set a precedent that will make it more difficult to oversee the dietary supplement sector. For example, the FDA has constantly emphasized its “limited options” in this area (as mentioned in the most recent notice) and in its responses to public requests.

We will continue to see a push for more FDA funding, as well as greater jurisdiction via mandatory product listing (MPL) and the development of a new “prohibited act” for items that do not match the description of “dietary supplement” under the legislation. However, the FDA will continue to claim that if CBD is approved in dietary supplements, its resources will be overburdened.

The FDA even explains in length in the petitions why the new dietary ingredient notification (NDIN) procedure is insufficient to safeguard the public from potentially dangerous supplements and how CBD will burden its resources to the disadvantage of public health. This raises the question: Is FDA’s recent CBD ruling a negotiation tool for more jurisdiction beyond MPL?

Takeaway

Although the FDA’s declaration is noteworthy, a significant change in enforcement is unlikely. Now is the moment to thoroughly examine the safety of hemp-derived products, not only CBD. Ensure you are buying products like Galaxy Treats with proper labeling and that goods are made in line with cGMPs (current good manufacturing practices)

Keep an eye on Congress’ next move, look for legislation that affects dietary supplements—not just CBD—and be ready to collaborate with US politicians.

Finally, keep an eye out for developments at the state level, which are often quick and significant.

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