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Amazon Screening for Sexual Enhancement Supplements

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Amazon Screening for Sexual Enhancement Supplements

Amazon Screening for Sexual Enhancement Supplements

Overview

If you sell dietary supplements on Amazon, you must comply with all applicable federal, state, and local regulations—as well as Amazon’s own seller policies. Since December 2020, Amazon has implemented strict laboratory testing requirements for dietary supplements. These include:

  • Potency assays

  • Safety testing

  • Specialized screening for products within:

    • Sexual enhancement

    • Weight loss and weight management

    • Sports nutrition

These specialized tests help identify undeclared pharmaceutical ingredients.
Unicorn Analyticals provides compliant laboratory screening services to support sellers in meeting Amazon’s updated testing standards.

PDE5 Screening for Sexual Enhancement Supplements

Amazon requires supplements marketed for sexual enhancement to be screened for a set of banned PDE5 inhibitor drugs. These substances are frequently associated with product adulteration.

Required Test Targets (Appendix 1)

Amazon mandates testing for the following compounds:

  • Sildenafil

  • Tadalafil

  • Vardenafil

  • Sulfoaildenafil

  • Desmethyl Carbodenafil

Sellers must submit a Certificate of Analysis (CoA) from an accredited laboratory in order to maintain compliant product listings on Amazon.

Why These Tests Are Required

The dietary supplement industry has experienced ongoing issues with undeclared active pharmaceutical ingredients, particularly in sexual enhancement products. In many reported cases, prescription-only PDE5 inhibitors—such as Viagra (Sildenafil) or Cialis (Tadalafil)—have been illegally added to products marketed as “herbal” or “all-natural.”

To address these safety concerns:

  • On December 17, 2020, the FDA issued a public warning highlighting adulterated male enhancement and weight-loss supplements sold on major online marketplaces.

  • A follow-up letter was sent to Amazon on July 21, 2021.

  • The FDA’s Health Fraud Product Database continues to list products found to contain hidden drug ingredients.

Amazon's testing requirements are part of a broader effort to improve consumer safety and reduce the sale of adulterated supplements.

How Unicorn Analyticals Helps

Given the complexity of dietary supplement supply chains—especially for distributors of imported products—independent screening is essential.

Unicorn Analyticals offers Amazon-compliant laboratory testing for:

  • Sildenafil

  • Tadalafil

  • Vardenafil

  • Sulfoaildenafil

  • Desmethyl carbodenafil

We provide fully compliant CoAs and supporting documents required for Amazon seller approval.