Sexual Enhancement Supplements

Amazon’s Seller Policies for PDE5 Screening of Sexual Enhancement Dietary Supplements

If you list products on Amazon, you must comply with all federal, state, and local laws and Amazon’s seller policies applicable to those products and product listings. As of December 2020, Amazon introduced a number of lab testing requirements for Dietary Supplements including potency assay and safety testing. Amazon also introduced some specific testing requirements for dietary supplements falling in the sexual enhancement, weight loss and weight management and sports nutrition. These tests are intended to screen for undeclared ingredients. Vivariant presently performs this testing for the sexual enhancement category and is working on launching the screening tests for weight loss and weight management and sports nutrition.

For sexual enhancement supplements, according to Amazon.com’s seller page:

“[…] each dietary supplement product that is intended for sexual enhancement or weight loss and weight management must also submit the following documentation:

A finished product Certificate of Analysis (COA) for the compounds listed in Appendix 1, issued by an ISO/IEC 17025 accredited laboratory.

Appendix 1 lists the following test targets for sexual enhancement supplements:

  • Sildenafil
  • Tadalafil
  • Vardenafil
  • Sulfoaildenafil
  • Desmethyl carbodenafil

Sellers are required to submit the certificate of analysis from the testing lab to Amazon in order to keep their listing in good standing.

Why?

There have been issues in the dietary supplement industry with undeclared ingredients. In cases of adulteration a product, often an active pharmaceutical ingredient, is added to the formulation without appearing on the ingredient list. For sexual enhancement supplements adulteration usually involves a class of drugs called PDE5 Inhibitors. Popular brand names of PDE5 inhibitors include Viagra (Sildenafil) and Cialis (Tadalafil). These are prescription-only drugs yet the active ingredient is sometimes illegally added to “herbal” products labelled as sexual enhancers to increase the marketed effect.

On December 17, 2020 the FDA published a news article “FDA Warns Consumers to Avoid Certain Male Enhancement and Weight Loss Products Sold Through Amazon, eBay and Other Retailers Due to Hidden, Potentially Dangerous Drug Ingredients“. An additional letter was sent to Amazon on July 21, 2021. The FDA’s Health Fraud Product Database contains listings of all products that their laboratories have discovered undeclared ingredients.

Amazon introduced these seller requirements to improve the safety profile of dietary supplements sold on their platform. Testing for these substances is intended to screen for undeclared PDE5 inhibitors. Given the complexities of the supply chains in dietary supplements this type of testing is particularly important for companies who act as distributors of foreign-manufactured products. If you are looking to screen a sexual enhancement dietary supplement for Sildenafil, Tadalafil, Vardenafi, Sulfoaildenafil and Desmethyl carbodenafil to comply with Amazon’s seller requirements contact us to see how we can help provide you with compliant testing and documentation.

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