The agency said the reports it has so far received involve consumer deception, but supplements associations are also reminding their members of proper FDA procedures, to prevent the fraudulent extortion of money or information.
According to FDA’s reports, callers have enticed consumers to purchase discounted prescription drugs by wiring funds to one of several locations in the Dominican Republic. A subsequent call is received from a fraudulent ‘FDA special agent’ informing the consumer that a fine of several thousand dollars is required to be sent to an address in the Dominican Republic to prevent incarceration or other legal action.
"Impersonating an FDA official is a violation of federal law," said Michael Chappell, the FDA's acting associate commissioner for regulatory affairs.
"The public should note that no FDA official will ever contact a consumer by phone demanding money or any other form of payment. FDA officials always present identification in person when conducting official business."
The agency said the scheme probably began with the theft of personal information via credit card fraud.
It said it is investigating the situation and urged anyone with additional information or complaints to contact its Office of Criminal Investigations.
Supplements on guard
The supplements trade association United Natural Products Alliance (UNPA) sent an e-mail to its members alerting them of the scam.
“This is obvious, but to repeat, FDA does not operate this way,” wrote Loren Israelsen, executive director of UNPA.
“The clear implication is: What if somebody comes to your company posing as an FDA inspector? Unlikely as it may be, you should have an SOP to confirm identity and authenticity of anyone representing themselves as a government employee or agent.”
UNPA said this will be one of the topics it will examine at its mock FDA inspection seminar on February 5.