FDA issues warning about fake letters that may be linked to extortion scam

The US Food and Drug Administration (FDA) has issued a warning to consumers about criminals who are forging warning letters, as though they have been written by the agency, in efforts to target individuals who are trying to purchase medicines online or over the phone.

There have been concerns raised by the agency, as a result of previous experience with these sorts of criminal activities, that these fake warning letters are linked to an international extortion scam. The agency has stated that it does not issue warning letters to individuals who purchase medicines online.

“While warning letters are a common compliance tool used by the FDA, we typically send them directly to companies and individuals involved in the manufacturing or distribution of FDA-regulated products,” iterated FDA Commissioner Dr Scott Gottlieb. “Consumers who aren’t involved in manufacturing or distributing FDA regulated products should be on alert that if you get an FDA warning letter, it’s probably fake, and probably a scam. We know the confusion and concern that these fake warning letters may cause and want to assure consumers that we generally don’t take action against individuals for purchasing a medicine online, though we regularly take action against the owners and operators of illegal websites. With that said, as a public health agency, we must remind consumers of the dangers of purchasing medicines from illegal online pharmacies. These risks range from receiving unapproved and potentially counterfeit medicines to unknowingly making themselves targets to scams like these. Many of these illegal websites appear legitimate, and it can be hard to tell the difference between a legally operating online pharmacy and a rogue website. We understand the temptation to buy online, and there are ways to do it safely, including only buying from US-licensed pharmacies that require a prescription.”

These fake letters have been brought to the attention of the FDA as a result of the agency’s surveillance efforts, which revealed that consumers who had made a purchase online actually received an official-looking letter instead of their purchased products. The letters purport to be from the FDA or the FDA and the Federal Trade Commission and claim that the agency has determined drug violations based on a review of the parcel and social media accounts.

Generally, the letters are addressed to ‘Sir/Ma’am’ but have been found to be addressed to consumers by name in some instances. There is also a warning in the letters to the consumer that an investigation is ongoing that may lead to legal action is ‘suspicious activity’ is found to have been performed.

The FDA has urged any consumers who believe they may have been sent one of these fake letters to email the task force that deals with these issues, including as much information as possible about the package and letter, such as photos or scanned documents, to help with this investigation.