Selling non-approved FDA stem cell treatments, particular those involving transport of the stem cells across state lines?
I’d be very scared if I were you right now. You may get a visit from the FBI shortly.
If you are a scientist or physician affiliated with a company that does stem cell transplants, I think you might consider stopping or at the very least start asking questions about the company’s relationship or lack thereof with the FDA.
While the FDA has at times seemed unsure of what to do about non-approved stem cell treatments and apparently is in litigation on this issue, things now seem to have taken a dramatic change for the better. Reportedly, the FBI has been quietly gearing up to take real action against those peddling non-FDA approved stem cell treatments that in some cases involve violations of federal law.
I hear that the FBI has been talking to senior scientists in the stem cell field about this.
Importantly, note the recent action by the FDA arresting and convicting an Arizona women (through a plea deal) of the following charge:
introducing an unapproved new drug into interstate commerce.
You can read more about this incident on the FBI’s own website here. If you think this is not serious, consider that the party who was convicted faces up to a $10,000 fine and up to three years of hard time in federal prison!
Look for more arrests and convictions by the FBI for this same or related charges in the coming weeks or months.
According to the FBI this first conviction “arises from the introduction into interstate commerce of stem cells derived from umbilical cord and cord blood tissue for non-research purposes without FDA approval.”
It appears the FDA via the FBI is going to be far more bold starting now and we can expect far more convictions in this area of stem cells as non-approved drugs.
One of the agents in charge of the Arizona-related case, Special Agent Cory B. Nelson in Charge of the FBI’s San Antonio Field Office, is quoted as follows:
As evidenced by this investigation, protection of the public takes many forms, not the least of which is the aggressive pursuit of individuals or corporations who intentionally risk the public’s health for profit.
Happily, the problem for the folks out there trying to make big bucks by selling non-FDA approved stem cell drugs (yes, again, reminder that the FDA considers stem cells a drug) is that it would be very difficult for them to do so without their product crossing state lines and hence violating federal law. Even if they do not transport the stem cells across state lines they may still very well be violating federal law in other ways by selling non-FDA approved drugs.
This is an incredibly positive development for protecting people from potentially life-threatening illegal treatments.
Way to go, FBI and FDA!