A warning letter sent to Amazon over the sale of tainted products sold as supplements was hailed as a step toward holding the online retail giant accountable for what is sold on its site. At least one observer, though, was troubled by the precedent that the letter might set. 

The U.S. Food and Drug Administration sent a warning letter to Amazon dated Dec. 20 in which it took the retailer to task over several sexual performance products aimed at men that were sold on Amazon’s site. The letter was posted on the FDA public portal earlier this week. 

The letter was issued by FDA’s Center for Drug Evaluation and Research (CDER), not by the Center for Food Safety and Applied Nutrition (CFSAN), which regulates dietary supplement issues. 

Products targeting a particular kind of ‘energy’ 

The letter concerned products that were referred to as “energy enhancing supplements,” but which were obviously aimed at men seeking better sexual performance. The products were branded as “MANNERS Energy Boost,” “Round 2,” “WeFun,” “Genergy,” “Big Guys Male Energy Supplement,” “Mens Maximum Energy Supplement,” and “X Max Triple Shot Energy Honey.” 

According to FDA, chemical analysis of the products revealed that they contained the undeclared APIs (active pharmaceutical ingredients) sildenafil (brand name: Viagra) or tadalafil (brand name: Cialis).  

Related:NOW tests of berberine products find none that meet label claim

These ED (erectile dysfunction) drugs have been safely used for years. But if consumers ingest them unawares, especially when the dosages are not specified, serious safety concerns can result, according to FDA. 

“[Y]our firm is responsible for introducing or delivering for introduction into interstate commerce products that are unapproved new drugs,” the warning letter states. 

The warning letter gives Amazon 15 days to address the violations cited. It does not specify what actions the company should take, however, beyond “an explanation of each step being taken to prevent the recurrence of violations.” 

Amazon has received similar warning letters in the past, including one in 2022 concerning products marketed as supplements that were found to be contaminated with an undeclared nonsteroidal anti-inflammatory drug (NSAID). 

Troubling precedent? 

Attorney Marc Ullman, of counsel with the firm Rivkin Radler, said the warning letter is interesting on several levels. 

“My first reaction was, it’s about time,” Ullman told Natural Products Insider. Dietary supplement industry stakeholders have often complained about how Amazon's apparent ability to skirt FDA enforcement concerning matters such as allowing products to be sold that were not GMP (good manufacturing practice) compliant, storing and shipping supplements in a noncompliant manner, and other issues. 

“But I’m perplexed by the approach,” Ullman added. 

He noted that the warning letter could set a precedent that would mean other online retailers might become responsible for doing independent testing on the products they sell to make sure they are not tainted with APIs. 

“Amazon is a retailer.” Ullman noted. “What does that mean for every retailer? When you look under the federal GMP regulations, retailers don’t have testing obligations. It seems like FDA is creating that type of obligation.”  

He also said that the action the warning letter calls for falls short of the mark. 

“Amazon knows the identity of everyone who bought those products. We’ve seen in the past that FDA has been reluctant to call upon Amazon to issue a recall,” he said. 

Amazon did not immediately respond to a request for comment. 

NOW responds

Dan Richard, vice president of global sales and marketing at supplement manufacturer NOW, said the episode is more evidence of a sluggish enforcement response by FDA.  NOW has done multiple rounds of testing of various types of supplements sold by lesser known brands on Amazon, and has gotten uniformly poor results, with many products found to be understrength and/or misbranded.  Yet those results have yielded little in the way of response from either FDA or Amazon.

“We saw recent letters from FDA regarding enforcement of supplements on Amazon containing illegal and undeclared drugs.  FDA conducted these tests in August 2023 and found the pharmaceutical ingredient (API) tadalafil in seven different products.  Brands seemed to take action to remove products or correct the problem as early as August 2023.  These are serious problems and need immediate attention.  However, FDA’s letter to Amazon was not until December 20, 2023, which does not seem acceptable.  Why does FDA take so long to take action when it has the test results months earlier and the problem is serious?” Richard said.

 “NOW’s testing program includes independent test results and so far, has yielded zero FDA actions that we know of.  NOW has been publishing our data and sharing this with FDA for quite a few years, yet we continue to see the same brands widely selling the same mislabeled products.  No FDA action has happened despite NOW helping FDA by doing the testing and going public with results.  FDA has never responded to NOW or asked to see our in-house or independent test results.  It is frustrating to see cheating brands prosper, without corrective attention from FDA.  Our New Year’s wish is that business-as-usual changes in 2024 and FDA holds brands accountable when appropriate,” he added.