Marketed CBD products with unsubstantiated drug claims including treatment of anxiety, depression, and chronic pain. Products sold as dietary supplements without required substantiation. THC content exceeded 0.3% on independent retesting.
Read FDA filing →CBD-infused foods sold in interstate commerce in violation of FD&C Act. Company claimed products could treat PTSD and opioid withdrawal symptoms. No approved new drug application on file.
Read FDA filing →Products detained at port of entry due to unapproved drug claims and failure to register manufacturing facility with FDA. Cannabidiol listed as active ingredient on labeling constitutes an unapproved new drug.
Read FDA filing →CBD tinctures marketed as treatments for Alzheimer's disease and cancer. Product labeling and website copy made structure/function claims that exceed permissible scope under 21 CFR 101.93. Inadequate current Good Manufacturing Practices.
Read FDA filing →Manufactured and distributed CBD products without adequate process controls or batch release testing. Heavy metal contaminants including lead detected above USP <232> limits. Distributor failed to maintain adequate records.
Read FDA filing →CBD pet products sold with therapeutic claims for arthritis and cancer in animals. Products are unapproved new animal drugs under 21 U.S.C. 321(v). No NADA or ANADA on file. Website testimonials cited clinical outcomes.
Read FDA filing →Source: U.S. FDA · Inspections, Compliance, Enforcement, and Criminal Investigations · openFDA API · open.fda.gov