"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," said FDA Commissioner Scott Gottlieb, M.D. "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 U.S.-licensed pharmacies that require a prescription."
The FDA has become aware through its surveillance efforts that instead of receiving the drug products they attempted to purchase from a website or over the phone, consumers received official-looking, but fake, warning letters. These fake warning letters, purporting to be from the FDA or the FDA and the Federal Trade Commission, claim the FDA has determined that there are drug violations based on a review of their parcel and their social media accounts. The letters are addressed generally to a "Sir/Ma'am" but in some instances may include a specific name. The letters also warn consumers that "we are still investigating the root of this delivery & necessary legal steps will be taken if we found [sic] out any suspicious activity on your end."
In addition to being the target of scams like these, consumers who buy medicines from illegal online pharmacies may be putting their health at risk. The products purchased from illegal online pharmacies, while marketed as authentic, may be counterfeit, contaminated, expired or otherwise unsafe.
Most illegal online pharmacies lack adequate safeguards to protect personal and financial information and some intentionally misuse consumers’ information. These websites may infect computers with viruses or sell consumers' personal information to other illegal websites and internet scams. If a consumer buys medicine from an illegal online pharmacy, they also risk being harassed by repeated emails and phone calls or being charged for products they never ordered or received.
The FDA's BeSafeRx campaign seeks to educate consumers and health care professionals about the health risks of buying prescription medicine through fake online pharmacies and to help current and potential online pharmacy consumers to make informed purchasing decisions.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.