A Food and Drug Administration (FDA) letter warning a company about its marketing of injectable CBD products has led to a voluntary recall that the federal agency announced on Wednesday.
Biota Biosciences received the letter last month, with FDA directing the firm to cease sales of its line of CBD vials, which it markets as a pain reliever that serves as an alternative to opioids and can help with detoxification.
The agency said the company was violating federal statutes both by engaging in interstate commerce of an unapproved new drug and failing to properly label the products by neglecting to include directions for use.
“Injectable drug products can pose a serious risk of harm to users because they are delivered directly into the bloodstream and bypass many of the body’s natural defenses against toxic ingredients, toxins, or dangerous organisms that can lead to serious and life-threatening conditions such as septicemia or sepsis,” FDA wrote.
In a public response published on Friday, the company told consumers that “we would like to convey that the executive and management team at Biota Biosciences take full responsibility for these observations and understand the gravity of the risk to consumers by posting these unapproved claims and intended use on our website.”
Products subject to the recall include formulations of Cannabidiol (CBD) Complex, Curcumin Complex, and Cannabidiol + Curcumin. “All customers who received this product will have the choice to keep any remaining product or receive a full refund for returning unused products,” the firm said.
Since receiving FDA’s warning letter, the company says has pulled all the products, provided the agency with a “root cause and corrective action plan” and launched a voluntary recall of the vials.
According to the original warning letter, the CBD products meet the definition of a drug subject to FDA regulation because “they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body,” the letter continues.
FDA identified several examples of medical claims Biota Biosciences made about their CBD vials in advertising:
“Fighting the opioid epidemic… BIOTA Biosciences produces and distributes effective all-natural alternatives with no side-effects. Join the growing ranks of pain, oncology, psychiatry, naturopathy healthcare professionals utilizing BIOTA Sterile CBD Vials.”
“VISION: OPIOID-FREE FUTURE… Our goal is to supply the world with pharmaceutical grade, all natural products containing cannabidiol and other natural compounds. We believe strongly that pharmaceutical grade hemp oil will drastically reduce the need for opioid-based pain relief and eliminate the global opioid epidemic by providing a safe and natural alternative.”
“Instant relief for patients that are symptomatic of inflammatory auto-immune diseases”
While the products lack directions for use, the company has claimed that they bypass liver absorption and deliver CBD “directly into your bloodstream.”
Further, FDA stressed that even if the labels did contain usage information, they would still be in violation.
“New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA,” the letter states. “FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.”
The injectable CBD vials “are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes.”
“The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your marketed products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. According to your website, you manufacture many other types of CBD containing products. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.”
FDA gave Biota Biosciences 15 days within the receipt of the letter to notify them about corrective steps they’ve taken. Failure to resolve the issues could have resulted in “legal action without further notice, including, without limitation, seizure and injunction.”
In its public statement, Biota Biosciences said that so far “no adverse or serious adverse events have been reported in relation to these products.” FDA is urging consumers may have such experiences to report them to its MedWatch Adverse Event Reporting program.
This is one of the latest statements FDA has made about CBD companies that are not meeting its standards.
Earlier this week, the agency publicized a voluntary recall of another CBD product from a different company, notifying consumers about potentially high levels of lead in a batch of tinctures.
FDA has said that it is currently targeting companies that make especially outlandish and unsanctioned claims about the therapeutic potential of their cannabis products.
For example, it sent a warning letter to a CBD company owned by a former NFL player after advertisements it displayed suggested its products could treat and prevent a coronavirus infection.
FDA has previously issued warnings to other CBD companies that have made unsubstantiated claims about the therapeutic potential of their products.
Although the agency does not currently approve of CBD as a food item or dietary supplement, it is in the process of developing regulations that may allow for such marketing.