Amazon announced sweeping new specifications for dietary supplements in December. NutraIngredients-USA was the first industry publication to report the specifications, which can be found HERE.
To summarize, the key aspects required by Amazon are:
1. A Certificate of Analysis (CoA) from an ISO/IEC 17025 accredited laboratory (in-house or third party) for each dietary supplement you are applying to list OR product enrollment in an Independent Quality Certification Program
2. A Letter of Guarantee from the brand owner of the product that guarantees compliance with current Good Manufacturing Practices (21 CFR Part 111); assurances that the products only contains lawful and safe ingredients (as defined in section 402 (f) of the FD&C Act); and that labels are accurate.
However, the Letter of Guarantee does not cover a couple of key issues, said Aaron Secrist, Executive Vice President of Quality, R&D and Operations, NOW Health Group.
“I think there are some other things that Amazon should require in their Letter of Guarantee,” Secrist told us, “such as assurance that the facility(s) used to manufacture, hold and distribute the product are registered with the FDA under the FDA Food Safety Modernization Act (FSMA) and assurance that the product is not only manufactured, but packaged, tested, labeled and held under current Good Manufacturing Practices as listed in 21 CFR Part 111.
“I believe they should also ask for assurance that the brands are in compliance with the Dietary Supplement and Nonprescription Drug Consumer Protection Act which requires companies to submit Serious Adverse Event Reports (SAER) to the FDA.”
Adverse event reports (AERs)
The Dietary Supplement and Nonprescription Drug Consumer Protection Act was signed into law on December 22, 2006, with compliance effective one year later.
Under the law, the manufacturer, packer, or distributor whose name appears on the label of a dietary supplement marketed in the US must report all serious adverse events to the FDA.
The label must include a domestic address or domestic phone number for the responsible person to receive an SAER. A clear, prominent statement telling consumers that they may report serious adverse events to the address or phone number can also be included on the label, although this is a recommendation and not a requirement.
In the online space, where consumers may choose to communicate about a product by writing reviews, the AER issue is significant, said Dr Rick Kingston, President, Regulatory and Scientific Affairs, SafetyCall International and Clinical Professor of Pharmacy, University of Minnesota.
Dr Kingston, who is also affiliated with the National Center for Natural Products Research at the University of Mississippi, told us: “Amazon is understandably interested in ensuring the quality of products before they are offered for sale to customers. And, continued work on that front where Amazon partners with their vendors makes sense.
“But one area that is equally important relates to monitoring what actually happens with products once they are put in the hands of consumers. This is where post market surveillance becomes so vital as the final safety net to ensure product safety.
“We have heard from some clients that they have requested the opportunity to reach out directly to consumers alleging adverse events, but Amazon would not facilitate communication between the parties,” he said.
Dr Kingston sees this as a unique opportunity for Amazon to engage the manufacturer in investigating any reports of adverse effects involving a given supplement.
“Why is it important? The manufacturer is best positioned to investigate the reports and determine if some nature of mitigation is warranted,” he said. “This is especially true if some type of adulteration or manufacturing breach is involved.
“It should also be emphasized that manufacturers have a regulatory obligation to document all adverse event reports and submit to the FDA those that meet the definition of serious adverse events. To exclude the manufacturer in any investigations actually puts customers at risk as it could delay immediate action should it be necessary.”
Dr Kingston said that there are two simple things that Amazon – or any other retailer, for that matter – might do:
- Facilitate communications between manufacturer and consumer including posting/providing the manufacturer’s contact information.
- Allow, and require manufacturers to reach out directly to consumers that make any allegations of adverse events so that the reports can be properly vetted.
Consumers also have an obligation to be part of the safety equation, said Dr Kingston. “If they suspect something is wrong or a product is causing unexpected effects, they should be willing to say something to the manufacturer,” he said.
What is a "serious adverse event?"
According to the FDA, a serious adverse event is one that:
Results in death, a life-threatening experience, inpatient hospitalization, a persistent or significant disability or incapacity, or a congenital anomaly or birth defect; or
Requires, based on a reasonable medical judgment, a medical or surgical intervention to prevent an outcome described above.
For FDA’s guidance on adverse event reporting, please click HERE.
NutraIngredients-USA’s Spotlight on Amazon
This is part 3 in our series of articles about Amazon’s new dietary supplement specifications. Please click the links below to read parts 1 and 2: