Male Enhancement Products Found with Drug-Spiked Ingredients

FDA has issued two drug-spiked product warning letters this year! This is the type of action I appreciate seeing the FDA do, as this small number of bad actors in the market gives the dietary supplement industry a bad name.

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FDA tested these products and found them to contain active ingredients in Viagra and Cialis.

The company's product claims about erectile dysfunction likely triggered FDA to test these products, and several ED claims are cited in the warning letters. Erectile dysfunction may be considered a disease claim and should be avoided. But how about libido, sexual performance, and aphrodisiac claims? Do you think these types of statements are structure-function statements? In my opinion, libido-type claims attract FDA attention and require additional testing on Amazon, but they, if substantiated, are likely in the lower-risk category as long as companies are testing to ensure there are no unintentional drug-spiked ingredients.

I rarely tell jokes on Warning Letter Wednesday, but I can’t help this one.
“Why did the lizard go to the doctor?... He had reptile dysfunction.”

In this warning letter, the timeline is perplexing. FDA inspected the manufacturer and conducted a website review in June 2022. FDA tested a product and found the presence of sildenafil which is the active ingredient in Viagra. Then in August 2022, the company issued a recall for one lot of the seven-count product. Two months later FDA issued a public notification warning consumers about these products, and now in January 2023, the company was issued a warning letter. What can we do to help get these drug-spiked products off the markets sooner?

This warning letter from yesterday also has an even more bizarre timeline. FDA reviewed the website and potentially tested products in May 2022. In July 2022 FDA issued a public notification warning consumers about the presence of tadalafil in these products. Then, just last month FDA re-reviewed their website and found the company apparently still selling these products, which led to this warning letter.

Again I ask, ‘What can we do to help get these drug-spiked products off the markets sooner?’

Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading.