The U.S. Food and Drug Administration is warning companies that sell products containing CBD, a compound found in marijuana and its legal cousin, hemp, to stop making claims about its medicinal benefits and warning them not to allow CBD-infused foods to cross state lines.
The letters were sent on Nov. 22 to SunFlora/Your CBD Store, a company with five stores in Emmaus, Easton, Whitehall Township, South Whitehall Township and Bethlehem where customers can purchase CBD-infused lotions, tinctures, bath bombs, gummies and pet treats.
The FDA warned that there are still unanswered questions about CBD, and retailers making medicinal claims are in violation of the Federal Food, Drug, and Cosmetic Act, according to the letter.
The FDA letters did little to stymie Lehigh Valley residents’ desire for CBD products, said Jeffrey Valera, who has opened three Your CBD Stores in the Lehigh Valley with his brother, Jonathan, since April. Their sister also opened a store in Lansdale.
“If anything, it’s actually been improving sales,” he said.
In a statement SunFlora’s leadership team said they are taking the FDA’s concerns seriously.
“We are just as committed to public safety as the Federal Government. We will continue to work with the FDA because it is our desire to fully comply with the law,” the company wrote.
A spokeswoman said the company was working with the legal team on labeling and that the website, social media and marketing materials were updated to comply. She declined to answer a question about whether the gummies would continue to be sold in stores.
In a press release, the FDA noted that one CBD-containing drug has been approved ? one used to treat two rare forms of epilepsy.
In other countries, a drug containing CBD and THC is approved for neuropathic pain, spasticity, overactive bladder and symptoms of multiple sclerosis. But it hasn’t been approved here.
The FDA plans to release more guidance on CBD in the coming weeks, FDA spokesman Peter Cassell said.
“We’re not closing the door on CBD, there are legal ways it can be on the market, but we have these outstanding questions on safety for CBD and since we have those questions that’s why we’re taking these actions,” he said.
The FDA warned potential risks associated with the compound include liver injury, drug interactions and male reproductive toxicity.
Proponents of the compound claim it helps with a variety of maladies, including anxiety and pain, although there’s little scientific data to back that up.
The CBD market exploded this year, after CBD derived from hemp was federally legalized in the 2018 Farm Bill. The collective market for CBD sales in the U.S. is expected to surpass $20 billion by 2024, according to Forbes.
CBD derived from marijuana remains illegal, as the plant is classified as a Schedule I drug.
The FDA letter is a crackdown on unverified statements of health claims, said Jeffrey Glazer, a clinical associate professor who specializes in food and beverage regulations at the University of Wisconsin Law School.
“To the extent food crosses stateliness, certainly the FDA has said, ‘We don’t think it’s appropriate,'” he said. “What we’re seeing from the FDA is a lot of finger-wagging at this point.”
Glazer said guidance on CBD will probably evolve as more research and studies into its effects are completed.
But for now, he’d recommend CBD sellers avoid making health claims, or even share health-related anecdotes.
“I would let somebody else tell the general public what the benefits or not-benefits are and just say, ‘Hey, I sell CBD,'” he said.
In addition to the five Your CBD Stores in the Lehigh Valley, there’s also Smooth Roots, a CBD store with a kiosk in the Palmer Park Mall and a storefront on Hamilton Street in Allentown. CBD can also be purchased at a variety of other locations, from gas stations to the internet.
Edward Salzman, the owner and founding member of Smooth Roots, said he’d like to see the FDA get more involved in regulating CBD than simply saying it’s not approved.
He sells products from a number of companies, including his own. He carries products from Koi CBD, which received a letter.
“I absolutely want them to regulate more,” he said. “They need to have some type of regulation on the growing, the processing, the manufacturing, the product packaging, labeling and marketing.”
There’s little federal oversight of CBD, so it can be hard for consumers to verify if a product contains the claimed amount of CBD and isn’t contaminated with anything else.
A study published in November 2017 said many CBD products had labels promising an incorrect amount of CBD. About 43% of products were underlabeled and 26% were overlabeled, according to the study.
Morning Call reporter Michelle Merlin can be reached at 610-820-6533 or at mmerlin@mcall.com.
