Other safety alerts
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| The United States: FDA warns companies illegally selling CBD products to treat medical conditions, opioid addiction |
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The US Food and Drug Administration (FDA) announces that it has issued warning letters to two companies for illegally selling unapproved products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug and Cosmetic Act (FD&C Act). This action is a continuation of the FDA’s efforts to pursue companies that illegally market CBD products with claims that they can treat medical conditions, including opioid addiction or as an alternative to opioids. 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. The affected products include “Canabidiol (CBD) Complex,” “Cannabidiol+Curcumin,” and “Curcumin Complex.”
- Homero Corp DBA Natures CBD Oil Distribution of New Hampshire for marketing and distributing CBD products as a treatment to opioid addiction as well as other serious diseases. The affected products include all strengths and varieties of “Natures Pure CBD Oil”, various topical CBD products and CBD edibles.
The FDA has not approved any CBD products other than one prescription human drug product to treat rare, severe forms of epilepsy. Unlike drugs approved by the FDA, there has been no FDA evaluation of whether these unapproved products are effective for their intended use, what the proper dosage might be, how they could interact with FDA-approved drugs, or whether they have dangerous side effects or other safety concerns. 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.
Please refer to the following website in FDA for details:
http://www.fda.gov/news-events/press-announcements/fda-warns-companies-illegally-selling-cbd-products-treat-medical-conditions-opioid-addiction
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Friday, Apr 24, 2020
Issued at HKT 15:00
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