Biota Biosciences Issues Recall Following Warning from FDA

Following a warning letter from the U.S. Food and Drug Administration (FDA), injectable CBD manufacturer Biota Biosciences has agreed to voluntarily recall three of its products.

The FDA warned the company that advertising the products as a treatment for opioid addiction makes them subject to FDA rules governing the marketing of drugs. As a result, the FDA says the products are in violation of FDA regulations since they have not received FDA approval.

CBD is cannabidiol, a chemical compound found in marijuana and hemp. Another major chemical compound is THC, the psychoactive compound in marijuana that gets you high. CBD, however, is reportedly not psychoactive, though research into its potential benefits and side effects is still ongoing.

“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,” the FDA noted in its warning letter.

And because Biota Biosciences made claims about the effectiveness of its injectable CBD products in treating opioid addiction, the FDA says fall under the Federal Food, Drug, and Cosmetic (FD&C) Act.

Under the FD&C Act, the FDA said, claims made about Biota Biosciences products on its website are of serious concern.

Biota Biosciences Warning Letter

The FDA cited several examples of the claims in its warning letter, such as: “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.”

The agency cited another claim about a “vision” of an “opioid-free future.”

“Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction,” the FDA warned.

In response, Biota Biosciences issued a recall of three of its injectable CBD products: Cannabidiol Complex, Curcumin Complex, and a product that combines the two.

“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. “CBD has not been shown to treat opioid addiction.”

Indeed, the FDA’s warning to Biota Biosciences is just one example of dozens in recent months as the agency attempts to crack down on CBD producers making unfounded health claims about their products. Some CBD companies may even be trying to capitalize on the ongoing coronavirus pandemic—on April 7, the FDA warned two CBD companies about making claims that its products are capable of treating or curing COVID-19.

The FDA’s recent push over CBD regulation stems from the concern that consumers may not be aware that CBD products have not been determined to be safe by the FDA.

“We are concerned that some people wrongly think that the myriad of CBD products on the market have been evaluated by the FDA and determined to be safe, or that using CBD ‘can’t hurt,’” the FDA said.

Filing a CBD Lawsuit

If you purchased CBD supplements, the product may not have the health benefits advertised, or may not contain the amount of active ingredient advertised. You may qualify to join this class action lawsuit investigation and pursue compensation.

Filing a lawsuit can be a daunting prospect, so Top Class Actions has laid the groundwork by connecting you with an experienced attorney. Consulting an attorney can help you determine if you have a claim, navigate the complexities of litigation, and maximize your potential compensation.

Join a Free CBD Supplements Class Action Lawsuit Investigation

If you purchased one of the CBD supplements listed above in California or New York between 2016-2020, you may qualify to join this CBD supplement class action lawsuit investigation.

Get a Free Case Evaluation Now

This article is not legal advice. It is presented
for informational purposes only.