FDA Outlines Plan to Improve CBD Research Data

The Food and Drug Administration (FDA) is planning several research projects to improve the “gaps in current CBD data.”

In an announcement on Friday, January 8, the federal group said it intends to use poison control records and other databases to better identify CBD products associated with adverse events. A new opt-in registry for CBD consumers is also in the works.

Two years on, too few data

Since President Trump signed the Farm Bill into law in December 2018, hemp-derived CBD has effectively been legal in the US. However, two years on, many in the CBD sector feel that the regulations and guidance around the cannabis product can still be unclear.

In the recent announcement, the FDA’s Commissioner Stephen Hahn and Principal Deputy Commissioner Amy Abernethy admit that they “still don’t have clear answers to important questions such as what adverse reactions may be associated with CBD products and what risks are associated with the long-term use of CBD products.”

As such, “better data in these areas are needed for the FDA and other public health agencies to make informed, science-based decisions that impact public health,” they write.

Adverse effects, such as decreased appetite, fatigue, diarrhea, and prolonged periods of sleepiness, have all been reported in clinical trials of medical-grade CBD. But less is known about what unwanted side effects commercial CBD products – which typically contain much lower quantities of the cannabinoid – may have.

To address this deficit, the FDA has planned several research projects that should commence in the coming months. These will require the use of data systems, such as poison control databases and health records, to help identify CBD products linked with unwanted effects. Market-research data will also be sourced and evaluated to help determine how specific CBD products affect consumers in different populations.

The agency says that such “novel data sources” will complement scientific data taken from toxicology studies. Together, these points of information “will be key to providing the foundational science needed to more fully understand the safety profile of products containing CBD.”

Two years too late?

While the FDA’s announcement was optimistic, some industry reaction has been less positive.

In a written response to the notice, the president of the Council for Responsible Nutrition (CRN), a key trade association for the US dietary supplement industry, criticized the FDA’s current CBD regulations and claimed that the “public deserves better.”

“Today’s notice, late in the day, late in a week that has seen a national crisis, is nothing more than an end-of-Administration desk-clearing exercise from an FDA that has failed to lead in this crucial policy area,” Steve Mister, president of the CRN, said in a statement.

“Because of the FDA’s failure to act, the public continues to be exposed to possible harms by a wild-west market that continues to expand without meaningful regulatory bounds,” the statement continued. “And responsible manufacturers of dietary supplements containing CBD – who are dutifully abiding by those regulations, and incurring the costs of doing so – suffer as their products are sold alongside products that may or may not contain CBD, may contain THC, make illegal disease claims, or contain unsafe adulterants.”

Other FDA efforts

Prior to its new declaration, the FDA had launched several other efforts to help regulate CBD.

In May 2019, it held a public hearing on the use of CBD products that featured more than 100 speakers testifying in front of FDA officials. A subsequent public comment period drew over 4,400 submissions by the middle of July from a mixture of public organizations, industry stakeholders, and members of the general public.

Last July, the administration drafted enforcement guidance for CBD and submitted it the White House Office of Management and Budget for review. This guidance doesn’t seem to have been implemented or commented upon since.

Since the Farm Bill was enacted in December 2018, the FDA has also increased the number of warning letters it issues to companies found marketing CBD products as medical treatments.