The online retail giant put out the first iteration of the requirements near the end of last year. While Amazon has not responded directly to questions about the reasons for this, it appeared to be in response to criticisms that many of the dietary supplements sold on the site were of poor quality or contained questionable ingredients.
The latest update of the specifications includes a section directed at sexual enhancement and weight management products, two of the categories specifically identified as problematical by the US Food and Drug Administration (with a third being products aimed at muscle building).
Amazon will now require products in these categories to have test results that prove that they are free from specific adulterants, depending on the category.
Rogues gallery
For sexual enhancement products, Amazon now requires ‘free from’ evidence for the following adulterants, all of which are analogs of prescription erectile dysfunction drugs:
- Sildenafil
- Tadalafil
- Vardenafil
- Sulfoailenafil
- Desmethyl carbonenafil
For weight management products, the list contains a former weight loss drug and its analog as well as a laxative ingredient and an antidepressant:
- Sibutramine
- Desmethylsibutramine
- Phenolphthalein
- Fluoxetine.
Labs must have specific certifications
The tests verifying the absence of these compounds must be done annually, the specifications state.
In addition to the callouts concerning illegal weight management and sexual enhancement ingredients, the retail giant also strengthened some of the language covering Certificates of Analysis. Amazon now requires the testing to be done by labs with ISO certifications for specific tests, not a lab claiming merely to be ‘ISO certified.’
“Depending on whether you sell sexual enhancement or weight loss and weight management supplements or both, you may need to use more than one lab,” the new requirements state.
Changes in response to warning letter
Attorney Abhishek Gurnani, of the firm Amin Talati Wasserman, told NutraIngredients-USA his his firm’s view the change in the specifications had been in offing since July.
“The weight loss and sexual health requirements are a direct response to recent FDA enforcement against Amazon including the July 2021 warning letter concerning presence of undeclared drug ingredients,” Gurnani said.
“As expected, it continues to be a moving target. At some point, they should make this answerable to an Alexa command: ‘Alexa, what do you need to sell a supplement on Amazon today?’” he added.
Daniel Fabricant, PhD, president and CEO of the Natural Products Association, said the new testing requirements are reasonable considering the risks in the category. ED drug knockoffs and versions of sildenafil have been showing up in these kinds of products for years. It’s a risk for marketers of products in these categories much as listeria and e coli contamination are risks for melon farmers.
“I remember being at the agency at 2011 and (then FDA Commissioner) Dr Margaret Hamburg sent out a memo saying it’s a reasonable expectation to have some requirements around the things that typically could adulterate your products,” he said.
“I expect bodybuilding products would be next,” he said.
Amazon did not respond to a request for comment in time for publication of this article.