https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cali-botanicals-llc-575320-06112019
They overstepped their bounds, trying to make claims for kratom. FDA loves cracking down on companies that claim nutritional supplements "are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease." Kratom, though, is not legally marketed in the United states as a dietary supplement.[1]
"Mitragyna speciosa (Korth.) Havil."by Ahmad Fuad Morad is licensed under CC BY-NC-SA 2.0
This specific instance they had claims on their website, Facebook page, and Twitter that kratom can be used for treating opiate addiction and withdrawal.
Another interesting point they nail them on is that "it fails to bear adequate directions for its intended use(s)." Which if kratom is intended to be used for opiate withdrawal it can only be done under a doctor's direction. Also there is no FDA-approved application for kratom.
[1]https://www.fda.gov/news-events/press-announcements/fda-issues-warnings-companies-selling-illegal-unapproved-kratom-drug-products-marketed-opioid
No comments:
Post a Comment