The release issued today concerns a warning letter issued to a marketer of CBD products called Curaleaf Inc. of Wakefield, MA. The company allegedly has been making unsubstantiated claims that its products can treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety, among other conditions or diseases.
Policing disease claims still paramount
The unusual publicizing of the warning letter (few of the warning letters issued each year receive such treatment) is intended to put the industry on notice that the agency has not fallen asleep at the enforcement switch as it considers the questions surrounding CBD, at least as far as disease claims are concerned.
“As we examine potential regulatory pathways for the lawful marketing of products containing cannabis and cannabis-derived compounds like CBD, protecting and promoting public health remains our top priority. 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,” said FDA Acting Commissioner Ned Sharpless, MD, in the statement today.
Sharpless’ statement is in line with recent FDA actions. While the agency has said there is no official enforcement discretion policy in place on CBD, it has not gone after companies marketing the ingredient if those companies refrain from making non-compliant disease treatment claims.
More information to be provided by early fall
The press release also included a statement from FDA Principal Deputy Commissioner Amy Abernethy, MD, PhD.
“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,” she said.
State AGs turn up the pressure
This restatement of the early fall timeframe (Dr Abernethy said something similar in a tweet last week) may be a response to increasing pressure for a quick resolution of the matter. That pressure was dialed up via a submission to the federal docket last week by the National Association of Attorneys General, a group of 37 state AG offices.
The AGs’ letter noted that more information is needed for them to enforce the consumer protection statutes in their states as they may relate to CBD products.
“A crucial element of FDA regulation and oversight should be an ongoing assessment of the potential risks or benefits of these products, particularly for specific populations such as pregnant women, adolescents and children, and the elderly,” they wrote.
“Currently, companies are creating a myriad of cannabinoid products largely unburdened by any oversight or testing requirements,” they noted.
Patchwork quilt already starting to develop
Attorney Ashish Talati of the law firm Amin Talati Wasserman said his firm has been bombarded with companies seeking information about how best to move forward with CBD products, and the state governments are in a similar boat.
“FDA is moving, but it is not as fast as the states might like and they are left with trying to figure out what to do in the meantime,” Talati told NutraIngredients-USA. “There is nothing good for anyone if each state comes up with its own directives.”
“We have had one client come to us with five different labels for the same product, each for a different state,” he said.
“When we met with FDA as part of the US Hemp Roundtable, FDA made it clear they want to move quickly,” Talati added.
Possible enforcement at state level
Talati also cautioned industry that in addition to warning letters from FDA, the state attorneys general are also looking closely at the category.
“Although many operational companies making cannabis and CBD products appropriately test, package, and label their products, some do not. These products should be subject to testing and manufacturing guidelines in order to keep consumers appropriately informed and safe,” the AGs wrote.
“I’m not sure what they are planning on enforcement, but they are definitely paying attention,” Talati said.
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FDA is actively exploring potential pathways to permit certain cannabis-derived compounds in food or dietary supplements, but what are the key boxes that need to be ticked to move forward with CBD products that meet the quality standards required of mainstream products?
What safety questions remain unanswered? Where do we stand on a potential NDI notification or GRAS no objection? What claims can be supported by the science? And what does the CBD space look like in five years?
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