FDA excoriates a chain of suburban Philadelphia pain clinics for 'egregious’ claims about CBD
The FDA will also form a "high-level internal agency" to explore how CBD products can be legally marketed. They also fired off a number of warning letters to companies making "egregious" claims for the compound.
A regional chain of 27 pain clinics in South Jersey and the Pennsylvania suburbs was singled out by the Food and Drug Administration on Tuesday for making “unsubstantiated” and “egregious medical claims" for a line of CBD patent medicines it sells at its clinics and online to “vulnerable populations.”
Relievus, which is headquartered in Mount Laurel, N.J., made dozens of outlandish claims for its Relievus-branded CBD oils and tinctures, the FDA said. The company also is known as Advanced Spine and and Pain, LLC.
CBD, or cannabidiol, is a substance derived from cannabis plants, though it may also be synthesized in a lab. Unlike THC, the psychoactive ingredient in marijuana, CBD will not get anyone high.
Update: Relievus president Young J. Lee said after receiving notice from the FDA he had removed CBD products from his company’s website, stopped posting ads on social media, and was stopping the sales of CBD effective Wednesday.
“We will communicate closely with FDA regarding the rules and regulations on CBD products,” Lee said in an emailed statement to the Inquirer.
The FDA last year approved a highly purified marijuana-derived CBD drug, Epidiolex, to treat some rare forms of childhood epilepsy. But the federal agency has not granted any other drug approvals for CBD and it forbids the use of CBD in cosmetics and as an ingredient in foods.
Yet on its website Relievus touted its CBD products as near cure-alls for scores of ailments for humans — and for dogs.
Although removed by late Tuesday afternoon, the Relievus website had stated its CBD was good for illnesses as diverse as depression and cervical cancer, Crohn’s disease and schizophrenia, inflammation and PTSD, substance use disorders and diabetes.
There is no clinical proof that CBD is effective for any of those maladies, a point the FDA underlined in a warning letter to Relievus.
"Your ‘CBD Salve’ and “CBD Oil’ products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are ‘new drugs,’” wrote the director of the FDA’s Office of Compliance in a letter to Lee. “FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.”
The company also claimed its canine CBD product could treat anxiety, cancer pain, arthritis, and tumors in dogs. The FDA said CBD has not been approved for those illnesses in animals and was therefore “unsafe.”
The federal agency threatened legal action if Relievus did not take “prompt action.”
CBD this year has become a wildly popular nutritional supplement and food additive despite the fact there is no evidence it is useful for anything other than rare varieties of pediatric seizures.
In a notice released by the FDA on Tuesday, the agency said it had scheduled public hearings for May 31 to gather information about CBD and product safety.
The FDA also announced it had formed a “high-level internal agency” to explore ways that CBD supplements and products could be legally marketed.
“This is a positive development,” said William Roark, a Philadelphia-area attorney who co-chairs the Pennsylvania Bar Association’s Committee on Cannabis and Hemp. “Stakeholders were looking to the FDA for clarity on how it would be enforcing regulations about CBD products, and that’s greatly needed when you have CVS and Walgreens about to put CBD on their shelves.”
In addition to Relievus, FDA fired off warning letters to two additional companies citing unsubstantiated advertising claims. Nutra Pure, of Washington state, manufactures and sells CBDPure brand softcaps and oils. PotNetwork Holdings, of Fort Lauderdale, manufactures and sells Liquid Gold Gummies.
In Tuesday’s release, the FDA said that even approved CBD products could pose some safety risks, including the potential for liver injury, and therefore should be taken under medical supervision. There “are also unresolved questions regarding the cumulative exposure to CBD if people access it across a broad range of consumer products.”
Researchers and advocates have warned that with the exception of Epidiolex, there are no established doses for the substance and that interactions with prescription drugs are a very real possibility.
“This [CBD] is a complicated topic and we expect it could take some time to resolve fully,” said outgoing FDA commissioner Scott Gottlieb in a statement. He said that without a drug approval process, unregulated use could diminish “commercial incentives for further clinical study.”
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