Last Updated on February 28, 2023 by Ithos Global Regulatory Team
The FDA has issued a new ruling on CBD products in the ongoing pursuit to strike a balance between consumer demand and regulatory mechanisms that ensure public health and safety. Citing new findings from the public and a working group review of studies, the FDA has ruled that CBD products cannot be marketed as food additives or dietary supplements.
Prior to this ruling, the FDA did not allow CBD or hemp derivatives to be used in food or dietary supplements. Therefore, this new ruling from the FDA reinforces the body’s original stance on the matter.
To achieve the ruling’s objectives, the FDA will work with Congress to establish new regulatory pathways, mitigating any associated risks or adverse events linked to CBD. One such regulatory pathway includes implementing a series of risk assessment and management tools.
Some of the measures suggested, such as the printing of clear labels, are similar to the compliance processes cosmetics manufacturers take to meet new and emerging regulations. There is also the possibility of setting a minimum purchasing age of CBD products, which would implicate retailers and distributors as enforcers of the FDA’s ruling.
As of now, the FDA has yet to pass any legislation limiting the usage of CBD in cosmetics products. But with the landmark passing of MoCRA (the Modernization of Cosmetics Regulation Act) in December 2022, the FDA could be prompted to issue a new ruling on CBD in cosmetics.
In the past, the FDA has expressed concern with the fragmented nature of the growing CBD industry. Many of these concerns were expressed in warning letters sent to companies selling CBD products branded as alternative treatments to medical ailments. Because CBD products are largely sold in the digital marketplace with hundreds of small manufacturers selling their products online, the FDA has recognized a need to establish safety systems that consider the entire supply chain.
The FDA has also led research efforts to learn more about how CBD affects aspects of human health. It is probably safe to assume that the FDA’s new ruling will continue to expand on these initiatives and incorporate them into new regulatory pathways.