Amazon’s New Dietary Supplement Requirements are Worse Than Nothing

Posted on Jul 21st, 2021 by Norm Howe
Amazon has added new requirements for dietary supplement sellers on Amazon’s platform.  These changes are alleged to provide additional assurance to consumers that the products marketed on its platform are safe and are manufactured and labeled in compliance with Food & Drug Administration (FDA) regulations.

In fact, these changes, while well intentioned, are actually worse than nothing at all.  The reason is that they give the appearance of compliance, yet do nothing for the consumer that isn’t in most cases already in place. 

Consumers will see Amazon’s requirements and assume they are protected.  They will then stop their normal investigation of the product and press the ‘Buy’ button.  [BTW many dietary supplement users are not casual consumers.  They are concerned about their health and research any product they put into their bodies.]
 
Amazon’s new policy, if it does anything, will inhibit that deep dive research, while doing nothing to assure the quality of the dietary supplement product sold on their site.

Let’s dig into why this is true.
Amazon’s new policy requires that for each dietary supplement product, sellers must provide:
  1. A finished product Certificate of Analysis (COA) issued by an ISO/IEC 17025 accredited lab (in-house or third-party) within the past twelve months, OR
  2. A finished product Certificate of Analysis (COA) issued by an in-house laboratory that is compliant with current good manufacturing practices (cGMP) per 21 CFR 111 and 117, AND a valid GMP certificate of the manufacturing facility from a third–party:  NSF International, GRMA, UL GMP, USP GMP, Eurofins, SAI Global, SGS, Intertek, TGA, and SSCI, OR
  3. Evidence of Product/ASIN enrollment or participation in one of the following third-party quality certification programs: NSF Product Certification, NSF Certified for Sport®, BSCG Certified Drug Free®, Informed-Choice/Informed-Sport Program, USP Dietary Supplement Verification Program, UL Brand Certification Program.

An Amazon dietary supplement seller has their choice about which option to pursue, 1, 2, or 3.  We’ll come back to Option 1 in a minute.
Options 2 and 3 require audits of the actual manufacturing process by experienced inspectors, employed by globally recognized quality certification organizations.  If the Seller decides to use either Option 2 or 3, then the consumer is, in fact, getting an extra level of protection.  Why is inspection of manufacturing so important?

You cannot know whether a dietary supplement product is any good unless you know how it was made.  Simply testing the final product at the end of the production line doesn’t assure the quality of the product.  Even if you test EVERY BATCH, testing:
  • Cannot detect every possible contamination that may have creeped into the product.  You can’t test for everything.
  • Is not perfect.  The tests are run by human beings, who use instruments that were made by humans, and use methods that were developed by humans.  
  • Relies upon a sample that has to be representative of the entire finished product batch.  How do you know that the sample that went to the lab actually represents the batch unless you know that the batch is homogeneous?  And how do you know that the batch is homogeneous unless you have deep knowledge of the manufacturing process?
We could keep delving into the reasons why finished product testing of every batch does not guarantee the quality of the product.  But that’s enough for now.  The point is that Options 2 and 3 require an inspection of the plant.  Informed dietary supplement buyers know that if they see that a manufacturer is registered in one of the programs outlined in Option 2 or 3 that they are getting extra assurance of a quality product.

What if a Seller picks Option 1?
Option 1 allows the Seller to pick one batch of finished product from the past twelve months to send to an ISO certified lab.
A few questions:

  • Who picks the sample to be tested?  And how is it picked?  Did the manufacturer cherry pick a “good” batch for testing?  Was it maybe a laboratory produced batch, made up especially to be sent to the testing facility?
  • What happens if the first sample tested does not meet specifications?  Does the manufacturer pick another sample?  Did they rinse and repeat this process until they finally got one that meets specifications?
  • One sample from the past twelve months’ of production?!  What about all the other batches?
  • Who enforces these standards?  Does anyone think that Amazon is going to check how the DS manufacturer took their samples?  

Let us be clear.  The only way to know if a dietary supplement actually contains what’s on the label is to inspect the plant.  Testing one sample from the past 12 months DOES NOTHING!

Options 2 and 3 cost the Seller quite a bit of money.  Sellers who are not serious about the quality of their product will not pick Option 2 or 3.  So, which option do you think that most Sellers on Amazon will pick?
 
But US-FDA protects me because all dietary supplements sold in the US are regulated by FDA?  True, all supplements marketed in the US are regulated by US-FDA.  However, FDA has neither adequate staff, nor the legal tools to perform their job.  The buyer must beware.
What could Amazon do to mitigate this deception?  Easy, eliminate option 1.  At a minimum, they should let buyers know which option the Seller is using.  In the meantime, Let the Buyer Beware.
 
How about you?  Do you have a similar story?  What has worked best for you?  Comment below.

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