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 warning letter to Amazon concerning the marketing and distribution practices of certain supplements that contain undisclosed licensed medications, particularly involving the PDE-5 inhibitors Viagra and Cialis. [1]

In this crucial correspondence, the FDA outlined numerous breaches of the Federal Food, Drug, and Cosmetic Act. The implications of this letter extend beyond mere regulatory oversight; it highlights significant concerns regarding the illegal sale of licensed pharmaceuticals, further complicating the classification of these supplements as food items.

Over the last decade, the FDA's extensive investigation has scrutinised supplements sold online, employing laboratory tests to uncover hidden medicinal ingredients. This rigorous examination has led to the issuance of hundreds of warning letters directed at manufacturers whose products included these potent drugs without proper declaration on the ingredient lists. Additionally, other supplements have been found to contain anabolic steroids. Some of the enforcement actions taken following these findings resulted in voluntary product recalls. [2]

Moreover, the FDA's letter casts doubt on the marketing assertions claiming that the ingredients in these supplements can significantly boost energy levels or enhance sexual health. Such unverified claims pose a risk to consumers who may be misled about the efficacy and safety of these products.

In the United States, dietary supplements are classified as food items and, as such, are not subject to the same stringent approval process as pharmaceuticals; however, the FDA has identified prescription medications aimed at treating erectile dysfunction in a variety of these supplements for more than a decade. The complexities of each individual case, however, remain challenging to navigate for regulatory bodies.

The decision to initiate formal charges against Amazon may indicate a shift towards a more aggressive regulatory stance.

Amazon has been given a period of 15 working days to respond to the allegations presented in the FDA's letter. In its response, Amazon must outline the specific measures that have been undertaken to remedy any violations cited. Furthermore, they are required to clarify how they intend to prevent the introduction or distribution of “unapproved new drugs and/or misbranded products containing undeclared drug ingredients” in the future.

Significantly, the FDA has not released data regarding the concentrations of active ingredients within these problematic supplements, nor has it provided clarity on whether these levels are clinically relevant. This information is vital for consumers and healthcare providers alike and should be disclosed alongside findings about whether all questionable products were indeed recalled and discontinued.

This situation challenges the prevalent belief that dietary supplements are inherently natural and devoid of harmful substances. Previous investigations have underscored that vitamins and dietary supplements can vary tremendously in their claimed active ingredient levels, with some products containing none at all.

Among the 5 out of 25 products that listed CBD as an ingredient, the concentrations varied from 10.6 mg to 31.3 mg per serving (104% to 118% of that declared). 

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