Nutritional and diet supplements have always been one of the top selling categories on Amazon. And that’s not likely to change in 2021. Consumers are paying much stronger attention to their general well-being as a result of the global health crisis of 2020; and sellers on Amazon have taken notice, with many seasoned veterans now coming to realize the effective room for growth in online sales for health supplements.
But it can come at a cost. Regulations on diet supplements from the US Food & Drug Administration have been historically lax, drawing criticism from both consumer advocates as well as former FDA commissioners. As recently as 2019, Amazon suspended third party sales of a popular probiotic supplement after receiving complaints of counterfeit products from customers. And a 2013 study published in the Journal of Biomed Central found that almost half of a random selection of 44 popular supplements had been adulterated or contained contaminants.
The Council for Responsible Nutrition has estimated that 77 percent of Americans consumed some form of nutritional supplements daily in 2019—with Amazon representing a large chunk of the online supplement market (also at 77 percent.) But if federal agencies face difficulty in monitoring the legitimacy of online supplement claims, where does that leave a private sector entity like Amazon?
Federal Regulations on Dietary Supplements
The Dietary Supplement Health and Education Act of 1994 (DHSEA) defines a dietary supplement as “any product, intended to supplement the diet that contains a vitamin, mineral, herb or botanical, dietary substance, or a concentrate, metabolite or extract” so long as it isn’t deemed harmful to the general public—including the risk of adulterated substances or false and misleading advertising.
Unfortunately, that definition can be both cumbersome and broad, leading to a number of conflicting interpretations. In 2015, the New York attorney general’s office accused four major retailers—GNC, Target, Walgreens and Walmart—of selling adulterated herbal supplements in their stores, resulting in a $2.5 Million fine in one instance. But the issue isn’t confined to whether or not a retailer is selling adulterated products. The issue is one of validating claims.
The DHSEA has remained largely untouched since 1994; subsequently, so have federal regulations. While federal law dictates that all dietary supplements must be labelled clearly as such, there is no law ensuring whether or not a supplement is deemed safe by USFDA standards prior to being marketed. In fact, the only responsibility the USFDA has over diet supplements is in monitoring for adverse effects after a product enters the marketplace.
Which means retailers themselves have to establish their own regulatory guidelines to reinforce federal oversight.
Amazon, Compliance and Quality Control
Amazon is acutely aware of the drawbacks of online sales of nutritional and dietary supplements; not the least of which being the threat of widespread counterfeiting by third party sellers. But while recent changes they’ve made in official policy for diet supplement listings allow for a much more stringent documentation and compliance process, they may also restrict the current visibility for many distributors.
Perhaps the most significant change to Amazon’s policy is the requirement of all diet supplement products to provide a certificate of analysis (COA) from an ISO/IEC 17025 accredited laboratory for each dietary supplement accredited laboratory for each listing. IEC 17025 is a regulatory standard developed by the International Organization for Standardization designed to ensure technical competence and oversight in lab testing for both public and private sector industries. While not mandatory, IEC 17025 certification formalizes a standard of conformity with benchmark practices and management for testing labs.
But up until December, certification had never been required to list a supplement on Amazon. So long as manufacturers adhered to DHSEA guidelines and did not indicate FDA approval, a diet supplement could hypothetically be marketed online with no validation whatsoever. But Amazon’s change in policy ensures the validity of a supplemental product’s claim by certified quantitative analysis as well as adherence to current Good Manufacturing Practices as defined by CFR Title 21—the FDA’s code of regulatory standards in manufacturing and labelling.
In addition to certification from an accredited lab, a COA must have been issued within six months prior to listing on Amazon and include:
A letter of guarantee from the manufacturer assuring all products are lawful and safe for consumption.
Product name, batch/lot number and date code.
Name and address of the manufacturer.
Quantitative analysis to support the active ingredient concentration as claimed on a product’s label and/or fact panel.
The Impact of Amazon’s Regulatory Changes on Diet Supplements
To date, Amazon has prohibited the sale of over 3,000 dietary supplements for failure to adhere to changes in compliance. More specifically, changes in policy now state that products can no longer claim to be FDA approved or used and tested in the treatment of disease. In fact, keywords mentioning even the very name of a disease are now prohibited by Amazon’s terms of service.
Whether or not these changes will make a dramatic impact on sales of diet supplements remains to be seen. While recent estimates placed the market size at approximately $123.8 Billion in 2019, there’s every reason to expect it could easily exceed the predicted 8.2 percent CAGR over the next few years. But while consumers are growing both more health conscious in addition to shifting dramatically to digital shopping, they’ll also need assurance that any supplement can validate its claim. While FDA regulations can be sometimes vague and frustratingly open to interpretation, Amazon has helped fill the gap other retailers have otherwise ignored. It’s a step forward in a market that can be as confusing as it is profitable.
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