The U.S. Food and Drug Administration has signaled concern as CBD products started flooding the consumer market in the past year, and warned a handful of companies for illegally selling those products in ways that violate federal law.
Last week the agency got more specific, updating a consumer advisory to say that the compound derived from hemp or marijuana that does not cause a high still “has the potential to harm you” — and issuing warning letters to 15 more companies.
“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,’ ” FDA Principal Deputy Commissioner Dr. Amy Abernethy said.
“Aside from one prescription drug approved to treat two pediatric epilepsy disorders, these products have not been approved by the FDA and 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.”
It is currently “illegal to market CBD by adding it to a food or labeling it as a dietary supplement,” according to the agency.
It also noted that there “are many important aspects about CBD that we just don’t know,” including the effects of taking it daily for long periods of time, how it affects developing brains, how it interacts with herbs and botanicals, and whether it could negatively affect a man’s fertility.
Abernethy said the FDA recognizes “the significant public interest in CBD and we must work together with stakeholders and industry to fill in the knowledge gaps about the science, safety and quality of many of these products.”
Responses from industry
No area firms were among those warned last week, but two companies with a significant local presence provided comments to LNP on the FDA’s actions.
Floyd’s of Leadville is a Colorado-based CBD company with a growing presence in Lancaster because of founder and county native Floyd Landis. Its products, ranging from creams to gummies to drinks, are sold in stores including Rutter’s and Sheetz.
Jake Sitler, director of business for Floyd’s, said intense scrutiny is part of the process of getting into major retailers, and the company has embraced the need to do everything by the book and self-regulate as the industry develops, from ensuring clean soil conditions to accurate labeling.
He noted that Floyd’s products include a QR code that show detailed batch testing information. And he said that at, for instance, 50 milligrams per gummy, Floyd’s products have lower concentrations of CBD than the epilepsy drug the FDA approved.
“We look forward to regulations,” he said.
Heather J. Kreider is a registered nurse and co-owner of Lancaster-based Hempfield Botanicals, which makes oral and topical CBD oils.
In an email, she noted a preliminary World Health Organization review released last year.
The review reported no evidence of “any public health related problems associated with the use of pure CBD” but noted that, “Reported adverse effects may be as a result of drug-drug interactions between CBD and patients’ existing medications.”
Kreider wrote, “Until the government can fully figure out how to profit from something, they’ll release statements of the risks.”