FDA Seeks Scientific Data on CBD

Despite the increasing popularity of CBD and CBD-infused products, FDA is questioning its safety.

That was the gist of a March 5 statement from FDA Com­missioner Stephen M. Hahn, MD. Dr. Hahn noted the agency spent a year attempting to develop a comprehensive evalu­ation of CBD products in order to develop a consistent regulatory approach and to better inform the public regarding risks in use of the product.

Educating the Public

Dr. Hahn said FDA’s initial surveillance found CBD being marketed in a variety of products, ranging from capsules to cosmetics. Specifically, the commission singled out chocolate bars and teas as some of the food products CBD was advertised in. The agency understood these products were being sought after by consumers for health-related reasons.

However, Dr. Hahn reiterated the agency had not evaluated most CBD products being sold on the market. He said that FDA had not determined CBD products to be safe or that using the chemical couldn’t hurt, aside from one prescrip­tion drug it authorized for the treatment of two rare, sever pediatric epilepsy disorders.

In a previous update, FDA noted preliminary evidence spurred concern regarding potential health implications from the use of CBD products. The agency said liver injury was a potential concern, and it remained uncertain how the chemical would interact with other drugs. Additionally, it cited male reproductive toxicity and side effects as other avenues it needed to fully research before declaring it safe.

Closing Knowledge Gaps

FDA noted the quickly evolving CBD marketplace created a data challenge for regulatory, industry, and consumer stake­holders. Dr. Hahn stated the agency was working to gather more data and extrapolate the actual benefits and risks of the products so that consumers could be better informed.

FDA indicated it would seek reliable, high-quality CBD data on, among other things: the sedative effects; the impacts of long-term sustained or cumulative exposure; transdermal penetration and pharmacokinetics; the effect of different routes of administration (e.g., oral, topical, inhaled) on its safety profile; use in pets and food-producing animals; and the processes by which “full spectrum” and “broad spectrum” hemp extracts are derived, what the content of such extracts is, and how these products may compare to CBD isolate products.

That data could be necessary, as 62% of 99 human CBD studies completed since 2014 had a conflict of interest, according to a study published in the Annals of Internal Medicine. The researchers found these studies were more likely to reach positive conclusions when compared to studies with no industry ties, reported HealthDay (March 16).

“This gives consumers an idea of where the research is coming from,” said study author Joshua Wallach, an assistant professor of epidemiology at Yale School of Public Health.

For its part, FDA on March 11 reopened the comment period for a notice intended to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or canna­bis-derived compounds.

The agency is particularly interested in data that may help to address uncertainties and data gaps related to the safety of CBD. Public comment will be collected indefinitely.

Monitoring the Market

FDA will continue to monitor the mar­ketplace to protect consumers from fraudulent or incorrect CBD health claims, with a focus on the greatest risk to public health.

The agency previously issued warning letters to 15 companies regarding illegal interstate sales of products containing CBD via the internet, including some food items in Nov. 2019. It alleged vio­lations of the FD&C Act, and requested responses from the companies within 15 working days stating how the companies will correct the violations.

“We have seen many CBD products be­ing marketed with claims of therapeutic benefit, such as treating or curing se­rious diseases such as cancer and Al­zheimer’s disease, or other drug claims, without having gone through the drug approval process. The proliferation of such products may deter consumers from seeking proven, safe medical therapies for serious illnesses—potentially endangering their health or life,” said Dr. Hahn in a statement.

FDA noted the significant public interested in CBD would propel it to better analyze its use and determine whether it was fitting for consumption.