04.23.20
The U.S. Food and Drug Administration has issued warning letters to two companies, charging them with illegally selling unapproved products containing cannabidiol (CBD) in ways that violate the Food and Drug Cosmetic Act. Each of these companies marketed their CBD products for serious diseases, in spite of the fact that making disease claims for CBD products is illegal.
BIOTA Biosciences received a warning letter following the marketing of its injectable CBD products, as well as an injectable curcumin product, both of which were marketed for serious diseases and as an alternative to opioids. BIOTA Biosciences markets private label CBD and wholesale CBD extracts, and their products include beverages, bulk CBD extracts, and water soluble CBD, as well as injectable curcumin.
Homera Corp DBA Natures CBD Oil Distribution was also issued a warning letter for marketing and distributing CBD products as a treatment to opioid addiction as well as other serious diseases. The firm is an own label distributor for CBD products and a retailer for Green Roads CBD Products.
“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,” FDA principal deputy commissioner Amy Abernethy said. “CBDE 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.”
FDA has not approved any CBD products, other than one prescription human drug product, Epidiolex, which is used solely to treat rare, severe forms of epilepsy. FDA has not evaluated whether CBD products are effective for their intended use, what the proper dosage might be, how they could interfere with FDA-approved drugs, or whether they have dangerous side effects or other safety concerns. In addition, FDA does not review the manufacturing of any CBD products. The agency continues to express concern that American consumers believe that CBD products are tested and/or approved by the federal government when this is not the case. Additionally, the agency continues to express concern over unanswered questions regarding the overall safety of CBD use in the short and long term.
BIOTA Biosciences received a warning letter following the marketing of its injectable CBD products, as well as an injectable curcumin product, both of which were marketed for serious diseases and as an alternative to opioids. BIOTA Biosciences markets private label CBD and wholesale CBD extracts, and their products include beverages, bulk CBD extracts, and water soluble CBD, as well as injectable curcumin.
Homera Corp DBA Natures CBD Oil Distribution was also issued a warning letter for marketing and distributing CBD products as a treatment to opioid addiction as well as other serious diseases. The firm is an own label distributor for CBD products and a retailer for Green Roads CBD Products.
“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,” FDA principal deputy commissioner Amy Abernethy said. “CBDE 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.”
FDA has not approved any CBD products, other than one prescription human drug product, Epidiolex, which is used solely to treat rare, severe forms of epilepsy. FDA has not evaluated whether CBD products are effective for their intended use, what the proper dosage might be, how they could interfere with FDA-approved drugs, or whether they have dangerous side effects or other safety concerns. In addition, FDA does not review the manufacturing of any CBD products. The agency continues to express concern that American consumers believe that CBD products are tested and/or approved by the federal government when this is not the case. Additionally, the agency continues to express concern over unanswered questions regarding the overall safety of CBD use in the short and long term.
