Scrutiny of the cannabidiol (CBD) market appears to be growing at the US Food and Drug Administration (FDA), which has reprimanded a further 15 companies for selling CBD products as drugs and also updated its advice to consumers on potential dangers.
The FDA sent warning letters to the 15 firms for violating the Federal Food, Drug, and Cosmetic Act by marketing CBD products in such a way that they constituted unapproved new drugs or animal drugs. In practice, this usually involves making a claim that a product can be used to treat or protect against illness.
Some of the products were also considered by the FDA to be misbranded, a term which usually refers to misleading labeling. Their products included foods and dietary supplements, neither of which are currently permitted to contain CBD in the US, according to the agency.
At the same time, the FDA amended its general advice on CBD to consumers, pointing out not only that CBD-containing foods are illegal and that medical claims may be unproven, but also that it “has seen only limited data about CBD safety and these data point to real risks that need to be considered before taking CBD for any reason.”
“We remain concerned that some people wrongly think that the myriad of CBD products on the market, many of which are illegal, have been evaluated by the FDA and determined to be safe, or that trying CBD ‘can’t hurt,’” said FDA Principal Deputy Commissioner Amy Abernethy, MD, PhD.
“We want to be clear that a number of questions remain regarding CBD’s safety–including reports of products containing contaminants, such as pesticides and heavy metals–and there are real risks that need to be considered.”
Dangers of concern to the agency include interactions with other drugs, drowsiness, diarrhea, and mood changes–as well as potential liver damage, which was also identified as an issue with GW Pharmaceuticals’ Epidiolex, an FDA-approved drug for treating epilepsy.
But despite the new round of warning letters, there are no signs that the FDA is turning against CBD–rather, it merely appears anxious that the burgeoning industry not be allowed to go too far, and that consumer sentiment does not get carried away by excitement.
The FDA continues to stress that it acknowledges “significant public interest” in CBD and is exploring regulatory possibilities.
As Principal Associate Commissioner for Policy Lowell Schiller put it earlier this year, “we don’t hold a grudge against [cannabis products], but we also don’t hold them to a lower standard of safety or absolve them of other requirements. Recently, we’ve seen an enormous surge of interest in this substance, and the level of excitement is palpable.”
“At FDA, we’re excited too. We see significant potential in this substance, including potential clinical uses,” said Schiller.
Lowell, who was speaking to a National Industrial Hemp Council event in August and co-chairs an internal FDA working group on CBD, particularly focused on the question of cumulative exposure, which has been little studied.
“For example, how much CBD is safe to consume in a day? What if someone has a CBD coffee in the morning, applies a topical CBD lotion, consumes some CBD oil, eats a CBD snack, and maybe has a CBD beer? How much is too much, and how is a person to know? How will the CBD interact with other drugs the person might be taking? What if she’s pregnant or nursing? What if children access CBD products like gummy edibles? What are the long-term effects of regular use and consumption?”
CBD-Intel (www.CBD-Intel.com) provides impartial, independent, and premium market and regulatory analysis, legal tracking, and quantitative data for the CBD sector.
We provide our clients with the tools to navigate this fast-moving sector, tailor their business strategy, optimize resources, and make informed decisions. In addition, we offer customized research and consultancy support.