Amazon Screening for Weight Loss Supplements

Understanding Amazon’s Compliance Rules

To sell weight-loss or weight-management supplements on Amazon, sellers must follow all applicable laws and meet Amazon’s strict product-testing requirements. Since December 2020, Amazon has expanded its compliance standards to include:

• Potency testing

• Safety and purity testing

• Mandatory screening for banned substances in specific supplement categories such as:

  • Sexual enhancement

  • Weight loss & weight management

  • Sports nutrition

These specialized screens identify undeclared pharmaceutical ingredients, a recurring issue in the supplement industry.
Unicorn Analyticals performs all required testing to keep sellers compliant and listings active.

Required Testing for Weight-Loss Supplements

Amazon requires weight-loss and weight-management supplements to be analyzed for the following prohibited substances:

• Sibutramine

• Desmethylsibutramine

• Phenolphthalein

• Fluoxetine

A valid Certificate of Analysis (CoA) from an accredited laboratory must be submitted to Amazon to maintain listing approval.

Why Amazon Mandates These Tests

The weight-loss supplement category has long been associated with product adulteration. Some manufacturers have illegally enhanced “all-natural” products with pharmaceutical-grade compounds to boost results—putting consumers at risk.

Here’s a brief overview of why these specific ingredients are targeted:

Sibutramine

Originally approved by the FDA in 1997, Sibutramine was removed from the U.S. market in 2010 due to cardiovascular risks. Despite the ban, it continues to appear—undeclared—in many weight-loss products. The FDA issued multiple warnings starting in 2009 highlighting supplements containing this hidden drug.

Desmethylsibutramine

A metabolite of Sibutramine with similar effects, it has been repeatedly detected in weight-loss supplements without disclosure. The FDA issued warnings in 2011 after identifying numerous products containing this ingredient.

Phenolphthalein

Once used as a laxative and occasionally added to older weight-loss formulas, Phenolphthalein was removed from the U.S. market in 1999 due to carcinogenic concerns. Yet it continues to surface in imported supplements. In 2014, the FDA warned consumers about products containing undeclared Phenolphthalein.

Fluoxetine

An antidepressant not approved for use in weight-loss supplements. In 2017, FDA alerts identified multiple products spiked with hidden Fluoxetine—posing serious health risks.

Important Reminder

For products in the weight-loss or weight-management category, Amazon requires this banned-substance screening in addition to routine label claim verification and standard supplement testing.

Partner With Unicorn Analyticals

If you need Amazon-compliant testing for weight-loss supplements, Unicorn Analyticals provides accurate screening and certified documentation for:

• Sibutramine

• Desmethylsibutramine

• Phenolphthalein

• Fluoxetine

We help keep your listings compliant, active, and safe.

Contact Us Today

Need compliant Amazon testing? Get in touch to learn how Unicorn Analyticals can support your product approval and quality assurance needs.