Amazon’s Seller Policies for Laboratory Screening for Banned Weight Loss Ingredients Screening In Weight Loss and Weight Management 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 clients to help them be compliant with Amazon’s requirements.
For supplements falling in the weight loss and weight management category, Amazon’s seller page states that the product must be tested for the following banned ingredients:
- Sibutramine
- Desmethylsibutramine
- Phenolphthalein
- Fluoxetine
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?
Weight loss dietary supplements have been a popular market for many years, and unfortunately, some manufacturers have been known to adulterate their products with undeclared ingredients in order to increase their effectiveness or profitability. Here’s a brief historical summary of weight loss dietary supplement adulteration with the following compounds:
Sibutramine: a weight loss drug that was approved by the US Food and Drug Administration (FDA) in 1997, but it was withdrawn from the market in 2010 due to safety concerns. Despite its withdrawal, sibutramine has been found in a number of weight loss dietary supplements sold in the US and other countries. In 2009, the FDA issued a warning to consumers about a number of weight loss products that contained undeclared sibutramine, and since then, many additional products have been identified as containing the drug.
Desmethylsibutramine: Desmethylsibutramine, is a metabolite of sibutramine that has similar pharmacological properties. Like sibutramine, it has been found in weight loss dietary supplements despite not being listed on the label. In 2011, the FDA issued a warning about several products that contained undeclared desmethylsibutramine.
Phenolphthalein: Phenolphthalein is a laxative that was once used in weight loss products, but it was withdrawn from the market in the US in 1999 due to concerns about its safety. Despite its withdrawal, phenolphthalein has been found in a number of weight loss dietary supplements sold in the US and other countries. In 2014, the FDA issued a warning to consumers about a number of weight loss products that contained undeclared phenolphthalein.
Fluoxetine: Fluoxetine is an antidepressant that has been found in weight loss dietary supplements despite not being listed on the label. In 2017, the FDA issued a warning about several products that contained undeclared fluoxetine.
Remember
When your dietary supplement falls in the weight loss or weight management category, testing for these compounds is an additional requirement on top of the core label claim testing Amazon requires for dietary supplements.
We’re Here To Help!
If you are looking to screen a weight loss dietary supplement for Sibutramine, Desmethylsibutramine, Phenolphthalein, and Fluoxetine to comply with Amazon’s seller requirements contact us to see how we can help provide you with compliant testing and documentation