Marijuana businesses are well used to run-ins with federal regulators. Now some are encountering a whole new area of friction with the government: The claims they make about the health benefits of their products.
On November 1, the U.S. Food and Drug Administration announced that it sent letters warning four companies--Greenroads Health, Natural Alchemist, That's Natural!, and Stanley Brothers Social Enterprises--about making unsubstantiated claims on their websites and on social media that their products can treat, and even cure, cancer. The claims related to items that contain cannabidiol, an active chemical in marijuana known as CBD.
FDA commissioner Scott Gottlieb said in a statement that the agency won't stand for health claims not backed by clinical trials.
"We don't let companies market products that deliberately prey on sick people with baseless claims that their substance can shrink or cure cancer, and we're not going to look the other way on enforcing these principles when it comes to marijuana-containing products," Gottlieb said.
All four companies have removed cancer-cure claims from their websites and social media pages. The FDA had threatened to take legal action--including product seizure, fines, and injunctions--if the businesses did not take corrective steps within 15 days.
Shawn Hauser, a senior associate at Colorado law firm Vincente Sederberg who helps marijuana businesses navigate FDA guidelines, says unsubstantiated health claims are not good for the industry.
"In the past, FDA has stayed out of marijuana regulations, but as more states legalize and more products are out there, the government is paying attention," says Hauser. "Making unfounded health claims is not legal and it is risky."
Hauser says that according to the United States Federal Food, Drug, and Cosmetic Act, any product intended to cure, mitigate, or prevent a disease is considered a drug by the FDA and is legally required to go through clinical testing to make sure it's safe and effective.
There are marijuana-related products that have gone through the FDA pipeline. Dronabinol, an FDA-approved medication that contains a synthetic form of THC, the psychoactive chemical found in cannabis, is prescribed to cancer patients to relieve nausea and vomiting from chemotherapy, as well as to AIDS patients to stimulate appetite. And GW Pharmaceuticals is running FDA clinical trials on CBD as a treatment for certain types of epilepsy.
In 29 states, plus Washington, D.C., if you have cancer, HIV or AIDS, Parkinson's disease, and a range of other conditions, you can get a medical marijuana recommendation from a doctor. But that doesn't mean marijuana and other cannabis products are proven treatments or cures.
The National Academy of Sciences, Engineering, and Medicine has found substantial evidence that cannabis and cannabinoids can help with chronic pain, chemotherapy-induced nausea and vomiting, and reduce spasticity in multiple sclerosis patients, but said in its report that conclusive data regarding the short- and long-term health effects of cannabis use "remains elusive." NASEM also found that there is no evidence that cannabis or cannabinoids cure, or treat, cancer.
Stanley Brothers Social Enterprises, and its sister company CW Hemp, did not return calls for comment. But, a company spokesperson told Bloomberg that they take "regulatory compliance very seriously."
Tisha Casida, the CEO of That's Natural, which makes CBD All-Natural Hemp Oil, told The New York Times that her company would comply with the FDA's warning under protest. In a letter to customers on the company's website, Casida says she believes in the potential health benefits of CBD and other cannabinoids published in dozens of peer-reviewed medical studies over the past 40 years. She also mentions that the U.S. government has a patent on CBD for use as an antioxidant drug.
Tom Downey, an attorney who specializes in government regulations at Ireland Stapleton Pryor & Pascoe, says the federal government has been following a non-enforcement policy as long as marijuana businesses comply with state law. Health claims are a consumer-protection issue, however, which may make the FDA more likely to crack down.
"Forget the fact that it's marijuana--think about your product as a vitamin supplement," Dowey says. "If I stood up and said this vitamin cures cancer, the question if I can say this or not is answered with a 'No.'"