FDA warns of imposters sending consumers fake warning letters

FDAThe U.S. Food and Drug Administration is warning consumers about criminals forging FDA warning letters to target individuals who tried to purchase medicines online or over the phone. Based on the agency's experience with criminals posing as FDA employees, the FDA is concerned that these fake warning letters are linked to an international extortion scam. The FDA generally 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," 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."

Any consumers who believe they may have received a fake warning letter should email This email address is being protected from spambots. You need JavaScript enabled to view it. with as much information as possible about the letter and its packaging, including sending photos or scanned documents to help aid in the FDA's ongoing investigation of the scam.

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.

Most Popular Now

Cannabis extract helps reset brain function in psy…

Research from King's College London has found that a single dose of the cannabis extract cannabidiol can help reduce brain function abnormalities seen in people with psyc...

For first time in 40 years, cure for acute leukemi…

Acute myeloid leukemia is one of the most aggressive cancers. While other cancers have benefitted from new treatments, there has been no encouraging news for most leukemi...

New cancer treatment uses enzymes to boost immune …

Researchers at The University of Texas at Austin have developed a new approach to treating cancer using enzyme therapy. The enzyme, PEG-KYNase, does not directly kill can...

Bayer accelerates six new startups

Changing the experience of health: that's the focus of the six startups which the Bayer G4A team has included in the Accelerator program this year. The young companies fr...

Novartis receives European Commission approval of …

Novartis today announced that the European Commission (EC) has approved Kymriah® (tisagenlecleucel, formerly CTL019). The approved indications are for the treatment of pe...

Shire completes sale of oncology franchise

Shire plc (LSE: SHP, NASDAQ: SHPG) announces today that it has completed the sale of its Oncology franchise to Servier S.A.S. for $2.4 billion. The franchise includes the...

Antioxidant reduces risk for second heart attack, …

Doctors have long known that in the months after a heart attack or stroke, patients are more likely to have another attack or stroke. Now, a paper in the Journal of the A...

Novartis to divest the Sandoz US dermatology busin…

Novartis today announced it has agreed to sell selected portions of its Sandoz US portfolio, specifically the Sandoz US dermatology business and generic US oral solids po...

New tablet production facility in Ingelheim: Cente…

Boehringer Ingelheim held a groundbreaking ceremony for the construction of a new production facility for innovative drugs. This new Solids Launch facility will focus on ...

SOLAR-1 trial of Novartis investigational alpha-sp…

Novartis today announced the global Phase III SOLAR-1 trial evaluating the investigational alpha-specific PI3K inhibitor BYL719 (alpelisib) has met the primary endpoint s...

Tezepelumab granted Breakthrough Therapy Designati…

AstraZeneca and its partner Amgen Inc. (Amgen) today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for tezepelumab...

Pfizer terminates domagrozumab (PF-06252616) clini…

Pfizer Inc. (NYSE: PFE) announced that it is terminating two ongoing clinical studies evaluating domagrozumab (PF-06252616) for the treatment of Duchenne muscular dystrop...