The Colorado company known for the “Charlotte’s Web” cannabidiol-rich extract and three other businesses that make CBD products were put on notice by the FDA for illegally making unsubstantiated health claims.
The U.S. Food and Drug Administration on Wednesday issued warning letters to four firms: Stanley Brothers Social Enterprises LLC, which does business as CW Hemp, of Colorado Springs, Colo.; That’s Natural Marketing & Consulting, of Pueblo, Colo.; Green Roads Health, of Pembroke Pines, Fla.; and Natural Alchemist, of El Dorado Hills, Calif.
In a statement, FDA officials said they’ve becoming increasingly concerned about the “proliferation” of products that claim to treat or cure diseases such as cancer.
“Substances that contain components of marijuana will be treated like any other products that make unproven claims to shrink cancer tumors. 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,” FDA Commissioner Dr. Scott Gottlieb said in the statement.
The companies subject to the FDA’s warning letters did not respond Wednesday to requests by The Cannabist for comment.
The CBD products in question have not been subject to FDA review or approval, officials said.
In the warning letters, the FDA rejected claims that the products could be classified as dietary supplements, citing the Investigational New Drug Applications submitted for CBD-containing pharmaceutical drug candidates Sativex and Epidiolex.
At the beginning of October, Gottlieb indicated that additional actions against cannabis companies could be in the works. His agency would be looking into the rules around the marijuana plant and claims made by companies that, “marijuana has anti-tumor effects in the setting of cancer,” Gottlieb said at an Oct. 3 hearing before Congress.
The FDA issued similar warning letters to CBD product makers in 2015 and 2016.
In the respective warning letters, the FDA cited many examples of what the agency considers illegal claims by each company. They included:
- Website lists testimonials relating to therapeutic effects for diseases and conditions such as cancer, depression, traumatic brain injury, autism, diabetes, and Alzheimer’s.
- Website directs visitors to the webpage for Realm of Caring, which provides CBD dosing instructions for child cancer patients.
- Facebook and Twitter posts extolling the benefits of CBD for athletes with Chronic Traumatic Encephalopathy (CTE).
- Social media responses to customers questions advising, “…you do not need a RX to buy Charlotte’s Web.”
Read the FDA’s letter to CW Hemp.
- Website includes testimonials about CBD products killing of cancer cells and leveling off of blood sugar.
- Social media posts touting benefits of cannabinoids for treatment of cancer, autism and heart issues.
- Website section defining CBD oil makes statements that, “CBD makes cancer cells commit ‘suicide’ without killing other cells.”
Read the FDA’s letter to That’s Natural.
- Product descriptions on webpage claim they’re intended for treatment of one or more diseases and their labels do not provide directions for intended use.
- The company’s alleged sale of food products containing added CBD across state lines, which the FDA considers illegal.
- Website includes claims and phrases such as: “Adding CBD oil as part of your daily Alzheimer’s medicine routine has a good chance at delaying the progression of the disease…”
Read the FDA’s letter to Green Roads.
- Website claims “[C]annabis plant, enriched with CBD, can be used for treating diseases like rheumatoid arthritis, colitis, liver inflammation, heart disease and diabetes.”
- Testimonial on webpage that stated: “I was pleasantly surprised to find that CBD helped my arthritis…I have shared with my son and he states he is a big believer in CBD for . . . TBI [traumatic brain injury] after being acquainted with military personnel who have tried it.”
Read the FDA’s letter to Natural Alchemist.
The FDA has requested that the companies correct the noted violations, FDA spokesman Michael Felberbaum told The Cannabist via email. Failure to correct the violations promptly could trigger legal actions such as product seizures or a court-filed injunction.
“When a product is in violation of the Federal Food, Drug, and Cosmetic Act, the FDA considers many factors in deciding whether or not to issue warning letters,” he said. “Those factors include, among other things, agency resources and the threat to the public health.”
Following the FDA’s announcement on Wednesday, phones were “ringing off the hook,” said attorney Bob Hoban, managing partner at Denver-based Hoban Law Group, a firm specializing in cannabis business law. The firm is representing the hemp industry in cannabinoid-centric lawsuits against the U.S. Drug Enforcement Administration.
“I don’t believe alarm bells should be sounding,” Hoban said, “but I think this requires that the industry should be looking at itself.”
Manufacturers of CBD-rich extracts and products derived from cannabis, notably hemp, should take a self-policing approach to ensure that what they’re selling falls in line with requirements for food or dietary supplement products, he said.
While Hoban disagrees with the FDA’s position that hemp-derived, cannabinoid-rich products cannot be dietary supplements, he said he agrees with the agency on how these products are allegedly marketed.
“At the end of the day, you can’t make these claims,” he said.
Catch up on all the cannabidiol news with The Cannabist’s special report: CBD, TBD
Part I – Forbidden medicine: Caught between a doctor’s CBD advice and federal laws
Part II – How advocates are inspiring congressional action on CBD legalization
Part III – With DEA digging in its heels on “marijuana extracts,” legality of CBD oil on trial in federal courts
Part IV – CBD research is going to the dogs in quest to legitimize pet products
Part V – CBD on the international stage: WHO committee delving into science, control status of cannabis compound
Part VI – Race for CBD medication breakthrough: Is pharma firm’s boon the hemp industry’s doom?