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.
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:
CW Hemp
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.”…
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.
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