5204602349_c87b204860_z

FDA cautions consumers on fake warning letter scam

pharmafile | July 17, 2018 | News story | Manufacturing and Production FDA, fake, letter, scam, warning 

The FDA has warned that criminals have been targeting customers who bought medicines online or over the phone with “official-looking, but fake, warning letters”.

Customers who had ordered drug products online or over the phone instead received fake warning letters, purported to be from the FDA, which state that the US regulator had determined the customer in question had violated drug law and that they were under investigation.

The agency has expressed concern that the fake warning letters are linked to an international extortion scam adding that they do not generally issue warning letters to individual consumers.

“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” he continued. “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.”

The forged letters, which contain incorrect grammar and strange phrasing, warn consumers that the FDA: “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 have been asked to email FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov with as much information as possible. The agency have requested that customers who received the forgeries send photos or scanned documents to help aid the FDA’s ongoing investigation.

Louis Goss

Related Content

GSK’s Jemperli accepted for FDA review for endometrial cancer treatment

GSK has announced that the US Food and Drug Administration (FDA) has accepted its supplemental …

FDA approves ImmunityBio’s Anktiva bladder cancer treatment

ImmunityBio has announced that the US Food and Drug Administration (FDA) has approved Anktiva (N-803, …

Roche’s Alecensa approved by FDA as lung cancer treatment

Roche has announced that the US Food and Drug Administration (FDA) has approved Alecensa (alectinib) …

Latest content