FDA issues warning to CBD company for ‘unsubstantiated’ health claims

Posted at 11:50 AM, Jul 23, 2019
and last updated 2019-07-23 13:50:21-04

In a move to crack down on the marketing of cannabis-related products, the US Food and Drug Administration has issued a warning letter to the company Curaleaf for selling some unapproved cannabidiol products with “unsubstantiated” health claims that the products treat cancer and Parkinson’s disease, among other health conditions.

Cannabidiol, also known as CBD, is the ingredient in marijuana and hemp touted to have many medicinal benefits. It’s different from tetrahydrocannabinol, or THC, the main psychoactive component of cannabis.

“Selling unapproved products with unsubstantiated therapeutic claims — such as claims that CBD products can treat serious diseases and conditions — can put patients and consumers at risk by leading them to put off important medical care. Additionally, there are many unanswered questions about the science, safety, effectiveness and quality of unapproved products containing CBD,” Dr. Ned Sharpless, acting FDA commissioner, said in the agency’s news release on Tuesday.

The warning letter, sent on Monday, included some examples of how Curaleaf Hemp products have been marketed on the company’s social media accounts. The FDA said the products are considered drugs because they are “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” or “intended to affect the structure or any function of the body.”

Curaleaf noted in a written statement on Tuesday that the FDA’s letter is “currently under review” by the company’s legal counsel.

“We will respond to the letter within the 15 business-day timeframe that FDA provides. We intend to work collaboratively with FDA to address the issues in the letter. Curaleaf is fully committed to complying with FDA requirements for all of the products that it markets. Compliance is a top priority for Curaleaf. We can reaffirm that nothing in the letter raises any issues concerning the safety of any Curaleaf product. Curaleaf products are all derived from hemp and meet the requirements of the Farm bill,” the statement said.

‘The industry is exploding’

The letter indicated that Curaleaf has 15 working days to respond with either details on how the company has corrected violations or with information as to why the company believes its products are not in violation. Failure to correct the violations promptly may result in legal action, including the seizure or ban of a product, according to the FDA.

This latest move by the FDA comes just months after the agency held its first hearing to assess the safety and efficacy of CBD products.

As states have liberalized the use of marijuana, CBD-related products such as oils, lotions, chocolates and even dog food have stormed the market. Market analysts expect the hemp-derived CBD market alone to hit between $15-20 billion in the next five to six years.

“The industry is exploding. It’s growing in popularity every day. It’s so important for the FDA to get a regulatory handle on this,” Jonathan Miller, general counsel for the US Hemp Roundtable, an industry-backed advocacy group said in May.

“There are bad products out there. There are products that make false claims. It’s important that FDA develop standards,” he said.

Earlier this year, FDA sent warning letters to PotNetwork Holdings in Florida, Nutra Pure in Washington state and Advanced Spine and Pain in New Jersey for “making unsubstantiated claims related to more than a dozen different products and spanning multiple product webpages, online stores and social media websites.” These companies made claims that CBD could help with cancer and dementia.

Miller said in May that the industry wants regulation. “Our biggest enemy isn’t the FDA or the DEA, but CBD companies making false claims,” he said.

‘Potential opportunities and significant interest’ in CBD

The FDA noted in its news release on Tuesday that it plans to continue to take an agency-wide approach to addressing the regulation of CBD products that fall under its jurisdiction.

“We will continue to work to protect the health and safety of American consumers from products that are being marketed in violation of the law,” Dr. Amy Abernethy, the FDA’s principal deputy commissioner of food and drugs, said in Tuesday’s news release.

“At the same time, we also recognize the potential opportunities and significant interest in drug and other consumer products containing CBD,” she said. “We understand this is an important national issue with public health impact and of interest to American hemp farmers and many other stakeholders. The agency has a well-established pathway for drug development and drug approvals, and we remain committed to evaluating the agency’s regulatory policies related to other types of CBD products. We plan to report our progress by early this fall as we expedite our work to address the many questions about CBD.”