Amazon's GMP policies not perfect, but praised by supplement stakeholders

Recent policies adopted by Amazon require dietary supplements have been tested and offer an assurance from the manufacturer that the products meet FDA regulations. Amazon’s actions last year drew praise from many industry stakeholders who feel the changes could promote transparency for consumers and improve the quality of supplements sold through the e-commerce giant.

Amazon in November 2020 notified its sellers and vendors of the policy changes, which require production of three major pieces of documentation in order to sell dietary supplements: a certificate of analysis (CoA) from an ISO/IEC 17025-accredited laboratory for each supplement; product images; and a letter of guarantee from the product manufacturer, including an assurance that the supplement is produced under FDA’s cGMPs (current good manufacturing practices) incorporated in 21 CFR Part 111.

“I applaud the new requirement for supplement testing because it’s a long time coming,” said Blake Ebersole, president and founder of NaturPro Scientific LLC, a scientific and regulatory consulting firm for dietary supplement companies and others, in an interview. “It could be one of the major opportunities to impact standards for supplement quality in the U.S., considering how many supplements Amazon sells.”

Amazon’s reputation in the supplement space hasn’t been exactly stellar. For example, NOW Health Group Inc. has identified many products of inferior quality, based on third-party lab tests as well as testing conducted by the company, a family-owned manufacturer of natural products since 1968.

“We have seen products with virtually zero potency, and a very high percent of suspicious products tested below legal labeled potencies,” disclosed Dan Richard, NOW’s vice president of global sales and marketing and the youngest son of NOW’s founder, Elwood Richard.

Dan Richard lauded Amazon for its new policy changes.

“Amazon is taking a very big step to try to rein in bad quality products and deserves applause for this effort,” he said in an email.

The quality of products sold on Amazon varies widely, agreed Elan Sudberg, CEO of Alkemist Labs, a contract testing laboratory specializing in plant authentication, botanical ingredient identification and quantitative analytical services to the food and beverage, nutraceutical and cosmeceutical industries.

“It’s been the wild, Wild West on that platform for many years,” Sudberg groused. “Anyone could have sold anything with very little adequate oversight, and they did.”

That reality has vexed established supplement firms that invest heavily in science and regulatory compliance.

Amazon declined a request for an interview to discuss its new dietary supplement policies, including how it intends to enforce them, but the company issued a brief statement.

“Selling partners are required to comply with all laws and regulations, as well as Amazon’s policies including compliance and testing requirements,” an Amazon spokesperson said. “We have proactive measures in place to prevent suspicious, noncompliant or prohibited products from being listed, and we continuously monitor the products sold in our stores.”

Amazon’s new policies, Sudberg agreed, “will improve the quality of products” purchased on Amazon.

“Ever heard someone try to pronounce GMPs as if it’s a single word with no vowels?” Sudberg asked. “We have, and honestly it freaked us all out that these big companies that sold a ton of products didn’t even know that they are required by law to adhere to regulations.”

Many supplement brands selling on Amazon have never seen a CoA and are poised to “get a crash course on the realities of product testing and quality assurance,” Ebersole said.

He hailed the requirement for independent lab testing, but said he anticipated it will “expose some flaws” in supplement brands who “fully trust their manufacturer” for cGMPs but are unfamiliar with independent lab testing or confirming their products are tested correctly.

Michael McGuffin, president of the American Herbal Products Association (AHPA), is pleased Amazon is requiring sellers to produce images of the product label.

“It’s just time to show the label,” McGuffin said in an interview. “So many times, I need to see a product label, and I know which retailers will show me the whole label. Amazon’s not been one of them.”

He suggested Amazon has a mixed record of showing the entire label. Its new policy reflects “progress” of a retailer demonstrating a “gatekeeper function,” McGuffin said.

Among Amazon’s requirements: All sides of the product label must be visible; the Supplement Facts panel and ingredient list must be clearly shown; and the product image must contain the product name, as well as the name and address of the company.

Through its new policies, Amazon is seeking to ensure supplements sold via its website comply with federal regulations, said Dean Cirotta, president of EAS Consulting Group, a regulatory consulting firm for the supplement sector and other industries. In an interview, he explained, “What they’re asking for is, ‘Hey, if you’re going to sell a dietary supplement in the United States, there are regulations they must meet, and we just want some documentation to show that we’re selling products that are compliant.’”

Asked to comment on Amazon’s supplement policies, an FDA spokeswoman said the agency was not familiar with the specific details of the retailer’s program. But “in general, we applaud all efforts by industry stakeholders to enhance the level of overall compliance and ensure that products meet the applicable legal requirements,” she said.

Despite overall support for the changes, several sources interviewed for this story aren’t thrilled with all the fine details of Amazon’s new policies. For example, they questioned the wisdom of some of the CoA provisions, including the requirement that the document must come from an ISO/IEC 17025-accredited lab. Aaron Secrist is executive vice president of quality, research and development (R&D) and operations with NOW Health Group, and he was the first auditor for the Natural Products Association (NPA) cGMP certification program.

Secrist described ISO 17025 accreditation as “robust” yet “very limited” in “scope.”

“This means that a contract laboratory might have ISO accreditation for testing fats in milk but certainly not for testing ginsenosides in ginseng root,” he explained by email.

McGuffin said many legacy supplement brands have no reason to obtain the above accreditation because they operate their own in-house labs. Amazon’s requirement, he suggested, is imposing a superfluous obligation on legacy brands that already possess scientifically-valid tests and produce high-quality products.

McGuffin also identified concerns with some other CoA requirements imposed by Amazon, including a requirement that the CoA contain a “quantitative analysis to support the active ingredient concentration as claimed on [the] Supplement Facts panel.” Quantitative analysis is not the only way to demonstrate the finished product meets specifications, and FDA’s cGMP regulations, McGuffin explained, were “deliberately flexible.”

Some of Amazon’s nomenclature also strikes industry veterans as odd, including use of the terms “active ingredient”—a term applicable to drugs, not dietary supplements—and “concentration units.”

And at least one consultant—Ebersole—suggested Amazon may be overly reliant on artificial intelligence rather than human beings to review and approve documents.

Many experienced professionals in the dietary supplement industry “are left scratching our heads sometimes” regarding Amazon’s requests, Ebersole said. “The process does sometimes reject sellers for doing the right things, while accepting suppliers who have figured out how to game the system.”

Amazon’s new documentation requirements also have obvious limitations. Full audits of facilities, Dan Richard explained, are significantly more comprehensive and able to ascertain whether a supplement company is actually in compliance with cGMPs.

“My fear is that some cheater brands may be savvy enough to cheat on documents,” he said.

Still, industry sources interviewed for this article are mostly pleased with Amazon’s new policies. And if McGuffin had a say at Amazon, he would have made a bigger splash publicly about the documentation requirements.

“I’d be bragging …, ‘We’re declaring ourselves to be a retailer with a strong commitment to being a gatekeeper.’”