FDA’s First Warning Letter of the Year Highlights the Impossibility of Regulating Online Pharmacies
(Thursday, January 5, 2023) Online pharmacies, particularly those based in other countries, have been a constant headache for the FDA. These pharmacies sell drugs, both approved and non-approved to the US consumers and there is practically nothing FDA can do about it as is highlighted by one of FDA’s first warning letters of the year. The warning letter highlights the nature of these pharmacies and the clear inability of the FDA to even identify the individuals behind them, forget taking any punitive action. This letter was issued to globalpharmacyplus, a company presumably based in Canada. FDA could not identify a specific person or even a physical address in the Warning Letter. In the letter, FDA listed several unapproved drugs sold by this pharmacy to the US consumers, and several prescription drugs sold without adequate prescription or instructions for use. The website claims to be in operation for about 18 years (since 2004) and sells 607 prescription drugs, many of which belong to the illegal categories described by the FDA in its letter. Although the pharmacy seems to be based in Canada, according to the FDA letter, there is no way for anyone to ascertain the real location of the suppliers of these drugs. The website ownership is anonymized and the drugs sold on the site could have been sourced from various locations across the globe. More importantly, it is not possible to determine how many of these drugs could be counterfeit, fake, expired, unstable or contain dangerous ingredients. Many of such pharmacies also ship their products under false or misleading labels and use anonymized shipping, making it very hard for US customs and mail to correctly identify and interrupt their shipping. In the end, the onus of making sure that the products purchased online are safe is on the consumers. It is not fair to expect the FDA to regulate all these businesses operating in foreign countries. The consumer must take responsibility to check the sources before placing orders. Otherwise, such online pharmacies will keep operating and potentially hurting the consumers. ![]() AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: [email protected] Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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