Is CBD Generally Recognized as Safe (GRAS) for Use in Food and Dietary Supplements?

Is CBD Generally Recognized as Safe (GRAS) for Use in Food and Dietary Supplements?

December 13, 2019 By

As the regulatory landscape continues to evolve for the nascent CBD-hemp industry in the USA, many have questioned whether cannabidiol (CBD) the non-psychoactive component naturally occurring in hemp is generally recognized as safe (GRAS) for use in food and supplements. As is often the case, the answer to this question is a complex one. In the absence of a federal regulatory pathway for the sale of hemp (CBD) extracts when sold into interstate commerce, selling your ingredient legally remains to be a hurdle.

FDA has made it clear in their recent Consumer Update on November 25, 2019, that they do not believe there is sufficient evidence to demonstrate that CBD could be GRAS for its intended use at the present time due to limited safety data. This is unsurprising given that hemp and hemp extracts have only been recently removed from the definition of marijuana in the Controlled Substances Act in the 2018 Farm Bill, thus limiting the amount of safety research to be conducted on this ingredient in the US within this timeframe. However, it is important to note that FDA has not closed the door on hemp extracts/CBD ever being GRAS, just at the present time, they conclude there is insufficient evidence.

It’s important to note that while FDA has expressed their opinion on the lack of data to support a GRAS conclusion for hemp extracts, this has not stopped major industry players from preparing and publishing press releases of their Self-Affirmed GRAS dossiers for their hemp (CBD) extracts. Such dossiers are likely to be consistent with the Cannabidiol (CBD) Critical Review Report published by the World Health Organization (WHO) in June 2018, which concludes that “CBD is generally well tolerated with a good safety profile. Reported adverse effects may be as a result of drug-drug interactions between CBD and patients’ existing medications.”

While the legal status of full-spectrum hemp extracts for use in foods and dietary ingredients remains in limbo while FDA evaluates a regulatory framework for these products, companies wading into this space should be aware that FDA is actively watching this industry and has recently issued 15 warning letters to companies selling CBD in dietary supplements, human and animal foods. Demonstrating that FDA is cautiously watching the marketplace. Which in turn has triggered a spate of Class Actions against hemp extract manufacturers. However, those willing to carefully gather the evidence to support a GRAS conclusion for this ingredient for the suspected Federal legalization of this ingredient in the future would be wise to start sooner rather than later, so you are able to launch quickly when the regulations are eventually published.

More research needs to be done on hemp (CBD) extracts to further elucidate the safety and efficacy profile of this unique ingredient. Although for those willing to invest in pre-clinical and clinical studies to determine the potential of this ingredient, the rewards are sure to pay off. dicentra can help you obtain GRAS status, ensure that your dietary supplement and food labelling is compliant with all applicable FDA rules, regulations, and guidance documents, and can assist your business through the process of clinical trial design and trial execution. Contact us today to learn how to bring your business to the next level.