Amerikan lääkeainevirasto FDA varoittaa kannabistuotteiden epäasiallisesta markkinoinnista USAssa

FDA warns companies not to promote CBD for opioid addiction
The U.S. Food and Drug Administration is warning companies for illegally selling cannabidiol (CBD) by
claiming that the product can treat opioid addiction or be used as an alternative to opioids. These claims
violate the law, and the warning letters are a continuation of the FDA’s efforts to pursue companies that
illegally market CBD products with claims that they can treat medical conditions.
“The opioid crisis continues to be a serious problem in the United States, and we will continue to crack
down on companies that attempt to benefit from selling products with unfounded treatment claims,” said
FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., in sending the warning letters in late

“CBD has not been shown to treat opioid addiction. Opioid addiction is a real problem in our
country, and those who are addicted need to seek out proper treatment from a health care provider. There
are many unanswered questions about the science, safety, effectiveness and quality of unapproved
products containing CBD, and we will continue to work to protect the health and safety of American
consumers from products that are being marketed in violation of the law.”

The two warning letters were issued to:
• BIOTA Biosciences LLC of Washington state for marketing and distributing injectable CBD
products as well as an injectable curcumin product. These products are marketed for serious
diseases and as an alternative to opioids. BIOTA Biosciences markets privatelabel CBD and wholesale CBD
extracts, and their products include beverages, bulk CBD extracts, and water-soluble CBD, as well as injectable curcumin.

• Homero Corp DBA Natures CBD Oil Distribution of New Hampshire for marketing and distributing CBD products
as a treatment for opioid addiction as well as other serious diseases. The firm is an own-label distributor for CBD
products, as well as a retailer for Green Roads CBD products. Unlike drugs approved by the FDA, these
unapproved products have not gone through any FDA evaluation of whether they are effective for their intended use,
what the proper dosage might be, how they could interact with FDAapproved drugs, or whether they have dangerous
side effects or other safety concerns, the agency said.

In addition, the manufacturing process of unapproved CBD drug products has not been subject to FDA review
as part of the human or animal drug approval processes. Consumers may also put off getting important medical care,
such as proper diagnosis, treatment, and supportive care, due to unsubstantiated claims associated with CBD products.
For that reason, it’s important that consumers talk to a health care professional about the best way to treat diseases or
conditions with existing, approved treatment options.

In March, the FDA provided updates on its work related to CBD products, with a focus on protecting
public health and providing market clarity. The FDA continues to be concerned that some people wrongly
think that the myriad of CBD products on the market have been evaluated by the FDA and determined to be safe,
or that using CBD “can’t hurt.” 
Under the Federal Food, Drug, and Cosmetic Act , any product intended to treat a disease or otherwise
have a therapeutic or medical use, and any product (other than a food) that is intended to affect the
structure or function of the body of humans or animals, is a drug. The FDA has not approved any CBD
products other than Epidiolex, which the FDA approved in 2018 to treat rare, severe forms of epilepsy (see
CPU, August 2018).
This action by the FDA doesn’t even begin to address the many products touted to contain CBD that
you can find in health food stores, supermarkets, and so on — some quite expensive, and none approved
for medical use or any other use. •
For more information, go to
ref: Alcoholism & Drug Abuse Weekly DOI: 10.1002/adaw (11.5.2020)