FDA warns Amazon over supplements containing Viagra: hundreds of cases reported over ten years | HTB

Simon Collins, HIV i-Base

On 20 December 2023, the US Food and Drug Administration (FDA) issued a significant warning letter to Amazon regarding the marketing, selling, and distribution of dietary supplements that contain undisclosed licensed pharmaceuticals, specifically the PDE-5 inhibitors Viagra and Cialis. [1]

The detailed letter outlines a series of violations pertaining to the Federal Food, Drug, and Cosmetic Act, addressing the illegal distribution of regulated medications while challenging the classification of these supplements as mere food items.

For over a decade, meticulous investigations conducted by the FDA have scrutinized the online supplement market, involving rigorous testing within their labs. Consequently, the FDA has issued hundreds of warning letters directed at manufacturers whose products contain these licensed medications without proper disclosure on ingredient labels. In various cases, other supplements have been found to contain unsafe steroids, and some of the actions taken have led to product recalls. [2]

Moreover, the FDA letter casts doubt on the marketing claims that the ingredients showcased in these supplements can significantly enhance energy levels and improve sexual health, raising serious concerns about the integrity of the product information being conveyed to consumers.

Within the jurisdiction of the United States, vitamins and supplements are classified under food regulations, meaning they typically do not necessitate prior approval from the FDA. However, for more than a decade, FDA investigations have uncovered the presence of prescription medications for erectile dysfunction hidden within a multitude of these dietary supplements. Despite this, the outcomes of each case may not be straightforward or transparent to the consumers affected.

The recent decision to formally hold Amazon accountable may indicate a shift toward more stringent regulatory practices in the supplement industry.

Amazon has been given a timeline of 15 working days to formulate a comprehensive response to the allegations noted in the letter. This response must detail the specific measures the company intends to implement to rectify any identified violations. Furthermore, Amazon must outline its commitment to prevent the introduction or distribution of “unapproved new drugs and/or misbranded products containing undeclared drug ingredients” in the future.

Currently, the FDA has not disclosed specific levels of active ingredients found in these products, nor have they assessed whether these levels would be clinically significant. This information is vital and should be made publicly accessible, alongside a thorough report addressing whether all implicated products have been recalled and discontinued.

This situation directly challenges the widespread belief that dietary supplements are inherently safe and devoid of harmful effects. Prior investigations have highlighted that vitamins and dietary supplements often contain variable levels of the purported active ingredients, and in some instances, they may contain none at all.

Among the 5 out of 25 products that advertised CBD as an ingredient, the concentrations were found to vary from 10.6 mg to 31.3 mg per serving, translating to 104% to 118% of the listed amounts. 

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