Pubdate: Thu, 02 Nov 2017
Source: New York Times (NY)
Copyright: 2017 The New York Times Company
Author: Sheila Kaplan


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

"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.

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.''

Some of the other companies did not respond to requests for comment.
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MAP posted-by: Matt