Amazon sells more dietary supplements that Walmart or Target. It’s one of the largest dietary supplement vendors in the US. And, like other industries where Amazon operates, it has enormous market power.
Recently Amazon announced new rules for supplement vendors that want to distribute their products through its website. These new requirements go where the federal regulator, the Food and Drug Administration (FDA), won’t go – or more accurately, can’t go. Amazon is now forcing manufacturers to submit their products to third-party testing, something that isn’t currently required for dietary supplements sold in the country.
The low quality bar for American supplements
Before discussing the implications of Amazon’s new rules, it’s worth recalling the current standards that exist. Products labelled as dietary supplements in the United States are not subject to prescription drug manufacturing standards. The Dietary Supplement Health and Education Act of 1994 (DSHEA) established the regulatory framework for dietary supplements. It effectively excludes manufacturers of these products from virtually all regulations that are in place for prescription and over-the-counter drugs. Under DSHEA, the FDA may not approve dietary supplements for safety and effectiveness before they are marketed. The FDA can only intervene to pull products off the market, after they are marketed, and only if they are adulterated or misbranded. The goal was to eliminate barriers to sale, and it worked: Within four years of the DSHEA, supplement sales grew from $4 billion to $12 billion, and is now estimated at over $55 billion per year.
In many past posts I have identified the consequences of this legislation – ongoing reports of quality concerns with marketed dietary supplements. The absence of good product quality and labelling standards is a barrier to the science-based use of supplements. With conventional drugs, standards are rigorous and largely consistent across countries: Clinical trials are conducted to determine if a drug has meaningful effects. These clinical trials are scrutinized by regulators. Products approved are considered safe and effective based on that evaluation. Marketing claims related to drugs are permitted only as they are consistent with the evidence that supported their approval. And the manufacturing standards for any product sold must be shown to be the same as the product studied in the clinical trial. Importantly, you can trust that what’s on the label is what’s in the bottle.
Amazon’s past problems
Earlier this year I blogged about the drug galantamine, which can be extracted from plants, or synthesized in a lab. Because it can be naturally sourced, it’s available in the United States as either a dietary supplement or as a prescription medication. As a drug, galantamine is approved by the FDA for the treatment of mild to moderate Alzheimer dementia. It is also sold as a dietary supplement marketed for cognitive conditions and “memory enhancement.” In a study, researchers purchased a number of galantamine supplements from Amazon.com and compared their quality to the prescription versions of the drug. While the prescription versions all met good quality standards, the quantity of galantamine in the supplements ranged from less than 2% to more than 110% of the labeled quantity. Only one product contained galantamine within 10% of what the label stated. Frighteningly, 3 of the 10 products tested were also contaminated with Bacillus cereus sensu stricto– enterotoxin genes.
This past December, the FDA wrote to Amazon about adulterated supplements available on its website:
The United States Food and Drug Administration (FDA) purchased on your website, www.amazon.com, products that are labeled as energy enhancing supplements or food, but laboratory analyses confirmed that they contained undeclared and potentially harmful active pharmaceutical ingredients. As discussed further below, your firm is responsible for introducing or delivering for introduction into interstate commerce products that are unapproved new drugs under section 505(a) of the FD&C Act, 21 U.S.C. 355(a).
This and other investigations have led to headlines articles like this:
and
so it is perhaps understandable (and good business sense) that Amazon was forced to act.
Amazon’s new requirements
In April 2024, Amazon.com announced that some dietary supplement products now need to be verified through a third-party Testing, Inspection, and Certification (TIC) organization. It identified three organizations that sellers can work with: Eurofins, UL and NSF International. Manufacturers that use other labs to test their products must submit these test results to Eurofins, UL or NSF International who will evaluate the results. These rules cover weight management, sexual enhancement and sports nutrition products. This is not a surprise as these categories of supplements are routinely contaminated.
Previously, vendors were required to submit Certificates of Analysis (CoAs) from an accredited laboratory or show enrollment in an independent quality certification program. That is no longer sufficient. NSF says the following about its testing standards:
NSF evaluates the composition of dietary supplements and ingredients. The assessment includes testing for vitamins, minerals, herbs, botanicals, amino acids, sports supplements, concentrates, metabolites, constituents and extracts to verify the supplement facts panel reflects the product’s contents or that the certificate of analysis for the ingredient accurately depicts its identity and purity specifications.
To ensure that a safer product reaches consumers, we assess products and ingredients for the presence of contaminants that impact health, including the toxic elements lead, mercury, arsenic, cadmium and chromium (VI). We test for the presence of aerobic microorganisms, yeast and molds, and Enterobacteriaceae, and specifically for the potential pathogens Salmonella spp., Escherichia coli and Staphylococcus aureus. We analyze for mycotoxins, which are released by fungi and are hepatotoxic. We assess items that contain botanical materials for the presence of pesticides.
Amazon raises the (quality) bar?
With these new requirements, Amazon has put in place requirements that go beyond what the FDA current requires, given these quality standards must be independently verified as a condition of selling on the platform. While the third-party certification standards currently only apply to three categories of supplements, this is expected to expand to other categories (and perhaps all supplements) sold on the website over time.
This is a significant “raising of the bar” for supplements for US consumers. While there are still significant issues (like efficacy concerns) with the vast majority of dietary supplements, these new rules should provide consumers with more assurance that what is on the label is what’s actually in the bottle, and the product is free of contaminants and adulterants. Still not a great market for consumers, but it is an improvement over the current state.