Legal & Regulation
Biota Biosciences Recalls Its Intravenous CBD Oils for Noncompliance with FDA Regulation
Upon a summons by the FDA, Biota Biosciences recalled three of its products launched by its proprietary Sterile Vial line. The three recalled intravenous CBD products were Cannabidiol (CBD) Complex,” “Cannabidiol+Curcumin,” and “Curcumin Complex.” The company claimed that these injectable CBD products managed chronic pain and treated opioid addiction. According to the FDA, the two claims qualified the products as drugs and therefore had to meet all the Federal drug regulations and approval procedures. Biota had skipped these procedures and hence the cause of having to recall the products from the market.
The online marijuana community claims that teenage kids are now injecting weed directly into their blood veins like heroin. With the saturation of these products in the CBD market, competition has stiffened, prompting Biota Biosciences to develop the unconventional intravenous cannabis-based product. However, these products have now been recalled for breaching federal regulations.
On 21st May 2020, the FDA posted on Twitter that the company had recalled the three intravenous CBD products. The cease-and-desist letter served by the FDA last month outlined the reasons for the recall. Biota Biosciences had made unfounded claims of medical benefits on the product packaging. The company claimed that the products could treat chronic pain, autoimmune disorders, and opioid addiction. The FDA further charged the startup for not including precise instructions for safe injection of the CBD products.
Biota Biosciences Issues Voluntary Nationwide Recall of Cannabidiol (CBD) Complex, Curcumin Complex, and Cannabidiol + Curcumin Injectables Because They Were Marketed Without FDA Approval https://t.co/hAYSW5IxDX pic.twitter.com/QxxoD8pCNI
— U.S. FDA Recalls (@FDArecalls) May 21, 2020
The company issued a voluntary nationwide recall of Curcumin complex, Cannabidiol (CBD) Complex, and Cannabidiol + Curcumin Injectables for being sold without the approval of the FDA. Subject to federals laws, any product purporting to treat medical conditions is classified as a drug. For a company to legally market such a drug, the product must pass through clinical trials approved by the FDA. Biota Biosciences failed to subject the three products it claimed to have medical benefits, to the stringent legal process.
On 22nd May, the company announced on its website stating Sterile Vial’s recalls. The report also highlighted the hazards the company had introduced into the CBD market. The report noted that,
“Unapproved drugs projected to be administered through direct injection into blood veins poses grave risks of harm to users since they will bypass the body’s defenses against toxins that may lead to terminal conditions such as sepsis and septicemia.”
However, there are controlled medical studies that employ injectable THC formulations. Nevertheless, such formulations are pharmaceutical standard, and administered only by licensed medical doctors. With the recent trend of people injecting themselves with homemade marijuana broths. This could trigger a potentially fatal health condition known as “Intravenously Injected Marijuana Disorder.” The condition causes attacks of severe muscle pain, vomiting, and heart complications.
To date, the Food and Drug Administration has approved just one CBD drug to be used medically. Epidiolex is the only FDA-approved CBD drug and was approved back in 2018 for the treatment of extreme seizure disorders. However, the Drug Enforcement Administration (DEA) recently removed Epidiolex from the drug scheduling, and the products can be prescribed for off label use.
Biota Biosciences is one of the CBD companies that has recently crossed the FDA regulation laws and faced its wrath. The FDA had been serving warnings to dishonest CBD manufacturers from the moment the US federal government legalized hemp and CBD, towards the end of 2018. Other unscrupulous CBD medical claims highlighted by the federal agency include CBD companies marketing products as cures for COVID-19 and cancer.