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

Simon Collins, HIV i-Base

On 20 December 2023, the US Food and Drug Administration (FDA) issued a warning letter to Amazon about marketing, selling and distribution of supplements that include undisclosed licensed medicines, in this case the PDE-5 inhibitors Viagra and Cialis. [1]

The letter details numerous violations of the Federal Food, Drug, and Cosmetic Act. The letter relates to illegal distribution of licensed drugs and also undermines the classification of the supplements as foods.

For more than a decade, an FDA investigation has brought supplements online and tested them in their own laboratories. As a result, they issued hundreds of warning letters to manufacturers of products that include these licensed drugs without declaring them in the listed ingredients. Other supplements were found to contain steroids. Some of these letters led to product recalls. [2]

The FDA letter also challenges the marketing claims that the ingredients listed in the supplements can improve energy levels and enhance sexual health.

In the US, vitamins and supplements are categorised as food items and do not require FDA approval. However, for over ten years, FDA laboratories have identified prescription drugs used to treat erectile dysfunction in hundreds of different supplements. However, the outcomes from each of these cases isn’t easy to see.

The decision to now charge Amazon, perhaps signals a new approach.

Amazon has 15 working days to respond to the charges in the letter. Their response needs to explain specific steps you have taken to address any violations. Amazon needs to explain how they will no longer introduce or deliver “unapproved new drugs and/or misbranded products with undeclared drug ingredients”.

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The FDA notes that it doesn’t have sufficient resources to analyse all supplements, and that other supplements might have the same problems.

Although the FDA letters include a caution to the general public about using these supplements, many people might find the chance to access PDE-5 inhibitors or steroids a reason to actively buy these products.

The FDA does not appear to have published the levels of active ingredients of these drugs and whether these would be clinically relevant. These details are important and should be made available, together with a report on whether all products were recalled and discontinued.

This challenges the common perception that supplements are somehow natural and without harm. Previous investigations have reported that vitamins and supplements can contain widely different levels of the claimed active ingredients, sometimes containing none.

Last year a US NIH study reported a wide range of levels of melatonin and cannabidiol (CBD) in ‘gummies’ sold in the US. [3]

The levels of melatonin in 25 supplements ranged from 1.3 mg to 13.1 mg per dose (74% to 347% of the labelled quantity). However, doses of only 0.1 to 0.3 mg should reach the levels naturally produced by adults: the long-term effects of using higher doses on dysregulating normal production of melatonin are unknown.

In the 5/25 products listing CBD as an ingredient, the quantity ranged from 10.6 mg to 31.3 mg per serving (104% to 118%) of that listed. 

References

1. FDA warning letter. Amazon.co Inc. MARCS-CMS 66250. (20 December 2023).
   https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/amazoncom-inc-662503-12202023
2. FDA. Tainted Sexual Enhancement and Energy Products. (Undated page)
   https://www.fda.gov/drugs/medication-health-fraud/tainted-sexual-enhancement-and-energy-products
3. Cohen PA et al. Quantity of Melatonin and CBD in Melatonin Gummies Sold in the US. Research letter JAMA. 2023;329(16):1401-1402. doi:10.1001/jama.2023.2296. (25 April 2023).
   https://jamanetwork.com/journals/jama/fullarticle/2804077