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

Novartis and life sciences companies commit expert…

Novartis and a consortium of life sciences companies announced an important collaboration to accelerate the development, manufacture and delivery of vaccines, diagnostics...

Amgen and the Amgen Foundation commit up to $12.5 …

Amgen (NASDAQ:AMGN) and the Amgen Foundation announced an initial commitment of up to $12.5 million to support U.S. and global relief efforts to address critical needs in...

AstraZeneca to donate 9 million face masks to supp…

AstraZeneca is donating nine million face masks to support healthcare workers around the world as they respond to the COVID-19 (novel coronavirus) global pandemic. AstraZ...

Roche response to COVID-19 pandemic

Roche Group (SIX: RO, ROG; OTCQX: RHHBY), provided an update on the various actions the company is taking to address the COVID-19 pandemic. On March 19, 2020, Roche co...

Singapore modelling study estimates impact of phys…

A new modelling study conducted in a simulated Singapore setting has estimated that a combined approach of physical distancing [2] interventions, comprising quarantine (f...

CAR macrophages go beyond T cells to fight solid t…

Chimeric antigen receptor (CAR) T cell therapy has been a game-changer for blood cancers but has faced challenges in targeting solid tumors. Now researchers from the Pere...

Consignment of 30 million hydroxychloroquine table…

Novartis announced that Sandoz, its generics and biosimilars division, has started to ship a consignment of 30 million doses of hydroxychloroquine tablets to the US Depar...

FDA approves first plasma therapy for Houston Meth…

Houston Methodist received FDA approval Saturday to become the first academic medical center in the nation to transfuse donated plasma from a recovered COVID-19 patient i...

Experimental AI tool predicts which COVID-19 patie…

An artificial intelligence tool accurately predicted which patients newly infected with the COVID-19 virus would go on to develop severe respiratory disease, a new study ...

Vivli to launch a portal for sharing data from COV…

In a visible sign of data sharing leadership, Vivli, the Center for Clinical Research Data has committed to serving the open science community through the launch of a COV...

Roche initiates Phase III clinical trial of Actemr…

Roche (SIX: RO, ROG; OTCQX: RHHBY) is working with the Food & Drug Administration (FDA) to initiate a randomised, double-blind, placebo-controlled Phase III clinical tria...

Novartis commits to donate up to 130 million doses…

Novartis announced its commitment to donate up to 130 million doses of generic hydroxychloroquine to support the global COVID-19 pandemic response. Hydroxychloroquine and...