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Amazon receives FDA warning letter for supplements with undeclared ingredients

fda.gov

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Re: Amazon receives FDA warning letter for supplements with undeclared ingredients

#2

Post by kayodelycaon »

I’m glad the conclusion says the products lists are not the only ones to which this letter applies. Otherwise Amazon could just remove the products mentioned and make the FDA play wack-a-mole.

As a side note, this letter is exactly why I think a regulatory agency like the FDA is absolutely necessary. This stuff can kill people and it is impossible for the average person to protect themselves.

Re: Amazon receives FDA warning letter for supplements with undeclared ingredients

#3

Post by toomuchtodo »

kayodelycaon wrote: post #2

I’m glad the conclusion says the products lists are not the only ones to which this letter applies. Otherwise Amazon could just remove the products mentioned and make the FDA play wack-a-mole. As a side note, this letter is exactly why I think a regulatory agency like the FDA is absolutely necessary. This stuff can kill people and it is impossible for the average person to protect themselves.

The FDA likely needs a data team if they don’t have one already to monitor Amazon for ongoing compliance. Similar to the SEC’s data team that monitors capital market data flows for anomalies that would indicate illegal behavior.

My two cents: good market to be looking for good data folks who might want a (potentially remote) federal agency data job with shakiness in tech.

https://usajobs.github.io/microsite-data-science/

Re: Amazon receives FDA warning letter for supplements with undeclared ingredients

#5

Post by throw__away7391 »

Nothing bought on Amazon should be consumed or applied topically or otherwise come into prolonged contact with your body. I learned this the hard way a few years back with some counterfeit shampoo that severely burned my scalp after a single use.

Re: Amazon receives FDA warning letter for supplements with undeclared ingredients

#6

Post by Sanzig »

> FDA confirmed through laboratory analyses that the “MANNERS Energy Boost,” “Round 2,” “Genergy,” and “X Max Triple Shot Energy Honey” products, purchased on www.amazon.com, contained the active pharmaceutical ingredient (API) tadalafil; and the “WeFun,” “Big Guys Male Energy Supplement,” and “Mens Maximum Energy Supplement” products, also purchased on www.amazon.com, contained the API sildenafil. These ingredients are not declared on the products’ labeling. Sildenafil and tadalafil are phosphodiesterase type-5 (PDE-5) inhibitors and the active ingredients in the FDA-approved prescription drugs Viagra and Cialis, respectively, used to treat erectile dysfunction (ED).

So Amazon was literally selling Viagra and Cialis disguised as a supplement. Wow.

Re: Amazon receives FDA warning letter for supplements with undeclared ingredients

#9

Post by EA-3167 »

Sanzig wrote: post #6

> FDA confirmed through laboratory analyses that the “MANNERS Energy Boost,” “Round 2,” “Genergy,” and “X Max Triple Shot Energy Honey” products, purchased on www.amazon.com, contained the active pharmaceutical ingredient (API) tadalafil; and the “WeFun,” “Big Guys Male Energy Supplement,” and “Mens Maximum Energy Supplement” products, also purchased on www.amazon.com, contained the API sildenafil. These ingredients…

Not just Amazon, every time these "ED supplements" are tested, most of them turn out to have actual pharmaceuticals in them.

Here's a similar article from 5 years ago: https://www.wired.com/story/dietary-supplements-can-contain-...

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