WASHINGTON
— Everyday Advanced Hemp Oil, Bosom Lotion and CBD Edibles Gummie Men
may have their fans, but the Food and Drug Administration is not among
them.
Four
companies selling those and dozens of other marijuana-derived dietary
supplements have been warned by the F.D.A. to stop pitching their
products as cures for cancer, a common but unproven claim in the
industry.
“Substances
that contain components of marijuana will be treated like any other
products that make unproven claims to shrink cancer tumors,” said Dr.
Scott Gottlieb, the agency’s commissioner, in a news release
on Wednesday. “We don’t let companies market products that deliberately
prey on sick people with baseless claims that their substances can
shrink or cure cancer.”
The
businesses — Stanley Brothers Social Enterprises, Green Roads of
Florida, That’s Natural and Natural Alchemist — each sell products that
falsely claim to cure cancer, Alzheimer’s disease or other illnesses,
the agency said.
The
supplements allegedly contain cannabidiol (CBD), a component of the
marijuana plant that is not approved by the F.D.A. for any use. Unlike
medical marijuana, CBD contains only a fraction of the
tetrahydrocannabinol, known as THC, needed to cause a high, according to
the manufacturers.
The
companies sell CBD over the internet in a wide range of oil drops,
capsules, syrups, teas and creams. The websites feature endorsements
from people — generally identified only by first names and last initials
— who claim that they or their loved ones have been miraculously cured
of terminal diseases and other illnesses.
“There
are a growing number of effective therapies for many cancers,” said Dr.
Gottlieb, a cancer survivor himself. “When people are allowed to
illegally market agents that deliver no established benefit, they may
steer patients away from products that have proven, anti-tumor effects
that could save lives.”
Stanley
Brothers, a leading marijuana product company based in Colorado, notes
on its website that other cannabis companies have also gotten F.D.A.
warning letters. As of Wednesday afternoon, there were no references to
its products as cancer cures on the website.
Dara
Kaplan, a spokeswoman for CW Hemp, one of the names under which Stanley
Brothers operates, said the company would work with the F.D.A. to
better monitor third-party testimonials.
“We take regulatory compliance
very seriously,” Ms. Kaplan said.
But
the F.D.A. also took issue with a previous claims for the company’s
Everyday Advanced Hemp Oil. One testimonial said: “A patient of mine
uses this for cancer and it gives lots better relief than prescription
drugs!’’
“My
dear ex-mother-in-law has been diagnosed with late stage pancreatic
cancer,” said another testimonial. “This is the only thing that gives
her relief.”
The
F.D.A. said that other claims on the website of the company’s
affiliated nonprofit group, called Realm of Caring, show that Stanley
Brothers recommends using its products as drugs, which would require the
company to go through the normal drug approval process.
John
Hudak, a senior fellow at the Brookings Institution and the author of
“Marijuana: A Short History,” said companies that sell traditional
cannabis products and those derived from hemp often skirt the edges of
the law or violate it outright.
“I
think it’s a very difficult argument to say that they are not working
in a way that is in violation of F.D.A. standards and practices,’’ Mr.
Hudak said. “Having one disclaimer on a website and then having other
claims elsewhere on a website is not what the F.D.A. allows.”
The
businesses have 15 days to submit evidence to the F.D.A. that they have
corrected the violations or to explain why more time is needed.
Tisha
Casida, the chief executive of That’s Natural, which markets CBD
All-Natural Hemp Oil, said she would comply with the F.D.A.’s request,
albeit under protest. One of the company’s claims, according to the
F.D.A., was that the hemp oil contained an ingredient that “makes cancer
cells commit suicide.’’
“All
free people have a right to experience health and wellness from
naturally derived cannabinoids,” she wrote in an email. ‘‘We should not
have to only take F.D.A.-approved synthesized drugs.
We should be able
to experience natural plant-based medicine in its truest form.’’
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