Observers question adverse event reporting compliance for products sold on Amazon

By Hank Schultz

- Last updated on GMT

Observers question adverse event reporting compliance for products sold on Amazon
Some industry observers are starting to question how many of the thousands of supplements sold on Amazon and other high volume online platforms comply with adverse event reporting requirements and other rules pertaining to the sales of these products.

Industry consultant Scott Steinford, who operates Trust Transparency Center, has assembled some data on the scope of the issue. Steinford did some research on the number of different products sold on Amazon’s platform and the hoops the retailer allegedly asks (or doesn’t ask) a potential seller to jump through.

According to federal law, the manufacturer or brand holder is responsible for the product’s compliance, not the retailer. What Steinford and others have alleged is that while Amazon bears no responsibility per se, its vast reach could create a climate in which non-compliant brand holders can more easily flourish. Steinford said it could be an opportunity for Amazon to lead on the issue by being more proactive.

Amazon outdoes all others in reach

Steinford is also the executive director of both the Natural Algae Astaxanthin Association (NAXA) and the CoQ10 Association. Part of the remit of both of these trade groups is to monitor where the products are sold and to purchase products for independent testing.

He came up with some staggering results. According to Steinford, other online platforms, such as Costco, Walgreens or Vitamin Shoppe, ranged from a low of 36 brand listings to as many as 921.  Dedicated online supplement sales platforms such as iHerb and Lucky Vitamin had more, ranging up to more than 2,500.

Amazon’s reach blew them all away. Steinford found the site lists more than 13,000 different supplement products, more than all of the other sites he surveyed combined.

Supply chain dedicated to online selling

As far as Steinford could ascertain, many of these sellers sell only on Amazon.  And in many cases, these small contractors source their products via a supply chain of contract manufacturers that specialize in feeding this pipeline. It all adds up to an industry within an industry, one which doesn’t seem to play by all the same rules, he said.

“The vast selling power of Amazon is changing the marketplace. The real problem I see developing in this marketplace is that increasingly dietary supplements are looked at in the same light as all of the other widgets they sell are,”​ Steinford told NutraIngredients-USA. “Selling supplements is not the same as selling a book, or a shoe, or a belt.”

“These sellers are taught by Amazon how to sell on Amazon,” ​he said. “Of those 13,000 products, only a few hundred are sold by companies that other people in this industry would recognize.”

Amazon’s vetting process

Amazon is not without a vetting process. Steinford did say the company does have a list of banned ingredients. But in pulling products off the virtual shelf for testing, Steinford alleged that he found that many products had labeling errors. In particular, a number had no adverse event reporting information.

“I don’t think this was done with malicious intent,”​ Steinford said. “I think this has gone unrecognized by Amazon, and I’m sure many of the sellers are ignorant of these requirements.”

Amazon did not respond to repeated inquiries from NutraIngredients-USA for comment for this article. The US FDA was also contacted for this article, but was unable to respond before publication.

Dietary supplement manufacturers are required by federal law to have a procedure in place so that consumers can report adverse events. The manufacturer is supposed to collate and hold these, and is required to report to FDA any events that rise to the ‘serious’ level.  Steinford said he found evidence that some of these requirements are not being followed for products sold on Amazon.

For example, Steinford said through his associations’ testing programs he had found products labeled with a company’s Delaware address (where it was located in titular fashion for tax purposes) when it clearly had its operations elsewhere. It’s a small sample size, Steinford admitted, about 150 products in total — or just more than 1% of all supplements sold on Amazon. But he said he’s unaware of any other testing having been done on Amazon-sold products looking at similar questions.

Safety monitoring as a differentiator

Rick Kingston, PharmD, is a clinical professor at the University of Minnesota School of Pharmacy and is an expert on adverse event reporting. Kingston, who is also the president of scientific and regulatory affairs for the firm SafetyCall International, agreed the problem is potentially a big one, and he said it’s not restricted to just Amazon.

“Some of these small brands may not be as up to speed on adverse event reporting as they should be,”​ Kingston said. “The barrier to entry can be low for some of these virtual companies, and I think some of these small companies may not be familiar with the adverse event reporting requirements.”

Kingston said that the present situation might be an opportunity for any one of the online retailers to lead on the issue.

“At the end of the day it is the brand holders, not the retailer, who are responsible for complying with these requirements.  But if they could guarantee their customers who buy products on their site that they have systems in place to make sure that their clients are monitoring the safety of the products, I think that could be a big selling point. It could be an opportunity for some of the big name retailers to have a substantial impact on the safety of these products,” ​he said.


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