The Food and Drug Administration takes claims of medical benefits seriously. That’s why you’ll see a disclaimer on many supplements that the product has not been evaluated by the FDA.
The agency served Biota Biosciences with a warning letter last month. Biota claimed that their injectable CBD vials were an alternative to opioids–and that the product could even help kick an opioid habit.
FDA Must Approve All New Medications
Because it was marketed as a drug to treat a specific condition (in this case, pain), Biota’s CBD vials needed to be approved by the FDA. That’s a rigorous process that involves testing and trials. However, the process is meant to ensure that consumers can take approved medications with confidence.
The booming CBD industry skirts federal regulations easily. This is because it makes no claims to treat a specific illness or condition. However, Biota Bioservices claimed that their products could provide pain relief. This would be an alternative to opioids like codeine or fentanyl.
While CBD oil is available in topical creams, pills, gummies, tinctures, and even vape cartridges, injectable forms are rare on the market.
“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 wrote.
Lack of Instructions Could Increase Consumer Risk
These vials did not come with instructions on how to use them, posing a further potential risk to consumers. The FDA argued that the 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 agency told Biota Biosciences to stop selling the products immediately and to issue a recall. Biota complied, but they had a few things to say about their products.
Although the company complied with the FDA recall request, it’s clear that they didn’t agree with the decision. Biota responded that “no adverse or serious adverse events have been reported in relation to these products.”
What Should You Do Now?
If you purchased the Cannabidiol (CBD) Complex, Curcumin Complex, or Cannabidiol + Curcumin injectable vials from Biota Biosciences, you should not use them. Furthermore, the company marketed their products with optional “private label” services. This means that third-party vendors, including alternative health providers, could have purchased the products with a custom label.
Please ensure that you do not use any recalled drugs, even if they are marketed as “all-natural” or “organic.”