Recently the FDA has sent a warning letter to a California company for marketing an injectable CBD product. As reported via a variety of outlets, FDA cited multiple legal infractions and gave the company 15 days to comply with all laws and regulations. Further legal action, of any unspecified nature, was implied in the letter if compliance was not ensured by the due date.
As physicians, other clinicians, and scientists, ACS is deeply concerned about the health of our patients and the public. We are enraged by the incessant, greedy marketing of cannabinoid products in the name of healthcare without adequate research or safeguards to consumers.
While the safety and efficacy of CBD, itself, remains to be seen and needs much greater regulation, the safety of injection of non-FDA approved products is non-negotiable. As the FDA letter points out, injection deliberately bypasses several of the body’s defenses against infection and toxicity. This demands a higher level of purity and sterility than other forms of medication and is beyond the understanding and capability of most cannabis companies. Further, the risk from injections is sufficiently great that stringent regulation and oversight by FDA is mandatory.
For far too long FDA and the federal government has allowed the cannabis industry free reign to produce and market products free from ordinarily required proof of safety and efficacy. State medical and non-medical cannabis programs generally have barely adequate requirements for safety, none for efficacy, and have repeatedly shown inadequate appetite for enforcing their own regulations.
Enough is enough! The number of letters from FDA to misbehaving cannabis companies is staggering. Yet, here is yet another such company marketing obviously unsafe products to unprotected consumers. It is time for a crackdown that goes beyond letters and beyond relying on states to handle it (or not) themselves.
Make no mistake, we are not promoting another “war on drugs” nor inciting any regression to prohibition. We are not advocating for arrest or prosecution of cannabis users.
We do, however, think that warning letters to companies are insufficient to prevent their shenanigans. Clear standards and regulations must be made on a national level and then enforced even-handedly.
ACS’s position is that non-medical products must meet stringent safety standards and must not be used or implied to be used for medical purposes. Medical products, while not yet required or capable of meeting both safety and efficacy standards for FDA approved drugs, should ultimately be held to such a standard. We acknowledge that rising to such a standard will take time and therefore support an interim plan for national approval of current medical products, but with clear standards to meet for FDA approval and a clear timeline by which that standard must be met. After such time, all cannabis products must be either non-medical (safe only) or drug status (safe and efficacious).
In no case should products be allowed to be marketed that are unsafe. Non-FDA-approved injectable products are the most egregious example. Again, we call upon the FDA to exercise its authority and mission to move swiftly to enforce the law and provide clarity and safety to consumers and patients.
Sources:
https://www.sfgate.com/cannabis/article/california-injectable-cbd-gets-fda-warning-20219801.php