Highlights

  • A Beast of the Dietary Supplement Industry

  • Regulating the Market

  • Breaking Down the Requirements

A Beast of the Dietary Supplement Industry

If you are in the dietary supplement business, you understand Amazon is the behemoth.  According to Slice Intelligence, Amazon owns at least 77% of total U.S. vitamin and supplement sales dating back to 2017.  Without question, Amazon has the power to shape both industry and the marketplace.  And now, they’re flexing their muscles.  

With the New Year come new seller requirements. If you want to sell dietary supplements on Amazon and access its massive market share, you’ll have to comply with these new seller requirements. Amazon is quite clear that all supplements sold on their site must comply with Food and Drug Administration regulations governing the quality, safety, and labeling requirements of dietary supplements under the Federal Food, Drug, and Cosmetic Act (FD&C Act), and its subsequent amending statutes including the Dietary Supplement Health and Education Act (DSHEA).   

Make no mistake about it -Amazon intends for there to be no wiggle room here. As stated on their seller resource page, “all manufacturers and distributors of dietary supplements are responsible for ensuring that their products are safe before they go to market.”  The party is over for the myriad supplements that have survived in the gray area.

Regulating the Market

Dietary supplements are regulated by the FDA as food, not as drugs.  Dietary supplement firms do not need FDA approval prior to marketing their products. It is the company’s responsibility to make sure its products are safe and that any claims made about such products are true.  But, this does not mean that every supplement on the shelf is safe or effective. Historically, too many supplements have been dubious. Indeed, in this broad leeway lays the potential for misleading consumers, making unsubstantiated and hyperbolic claims sometimes to the point of fraud.  At the same time, we mustn’t overlook the many beneficial products for sale that are labeled responsibly.

Now, the behemoth has weighed in, but why the sudden concern?  Well, it is both a sign of our times and a sign of how much influence NOW Foods has.  One of the largest supplement companies, NOW, has a significant presence on Amazon. Recently NOW tested a variety of competitor products and the results were startlingly poor.  As a result, NOW impressed upon Jeff Bezos, Andy Jassy, and company the importance of maintaining the highest quality standards regarding supplements sold through the Amazon marketplace.

Consequently, effective immediately, all supplement sellers must comply with the new requirements if they wish to sell their products on Amazon.  Failure to do has resulted in products being disqualified and, in instances where they contain substances on Amazon’s prohibited list, banned from sale.

The new requirements can be categorized into several baskets revolving around 21 CFR 101.36 Nutritional Labeling of Dietary and 21 CFR Part 111.  These two sections of the federal code form the bedrock of dietary supplement regulatory compliance. It is important to note that most of these requirements are managed by the sellers themselves through documentation, pictures, details, and so on; but there are several requirements that require professional assistance such as laboratory testing and certificates of analysis (COA’s).  All in all, the Amazon requirements are reasonable and manageable. They reflect standard measures of safety and verification we’ve come to expect with other food products. However, portions of the new program are ambiguous and require elaboration. Furthermore, there may be some challenges meeting the testing requirements established in the new Amazon mandate, especially for small and mid-sized sellers. Some of these challenges may also impact large manufacturers and, as a result, reshape the product landscape.

Breaking Down the Requirements

  1.  Labeling: Amazon is quite clear that all supplements sold on their site must comply with 21 CFR 101.36 Nutritional Labeling of Dietary. There are six clear requirements stipulated by Amazon, but the full scope of 101.36 applies. Most notably, products must also contain an ingredients list and an FDA compliant Supplement Facts Panel (which may require laboratory testing to produce).  This may sound obvious, but many sellers have products that don’t yet have the required nutritional testing or labels.
  2. Claims on Product Detail Page: The devil is in the details, and Amazon elaborates strict limits on what supplement sellers may claim on their product details page. Sellers are prohibited from claiming “FDA Approval,” equivalent efficacy to prescription drugs, including FDA logo, etc.  
  3. Letter of Guarantee: The “G” word can scare smaller sellers.  In actuality, it is just a formal assurance by the supplement manufacturer that the product complies with applicable FDA regulations.

While these aforementioned requirements are straightforward and follow closely with FDA requirements laid out in 101.36, the waters are murkier regarding other requirements vis-a-vis 21 CFR Part 111.  This is where small and midsize companies may encounter a lot of challenges.  Moreover, there are technical challenges that may adversely impact even the largest manufacturers and sellers.   Consider the following…

  1. ManufacturingCFA 21 Part 111 deals broadly with current good manufacturing practice in manufacturing, packaging, labeling, or holding operations for dietary supplements.”  Let’s clarify the use of “Good Manufacturing Practice.”  Operations under GMP protocols are extremely detailed, regimented, and costly.  GMP protocols embody the strictest quality, corrective, and regulatory controls. For example, GMP protocols underpin the pharmaceutical industry by establishing an auditable system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.  For now, it remains to be seen how far Amazon will go with their interpretation of GMP as it pertains to dietary supplements.
  2. Analytical Testing:  This is where the rubber meets the road.  This levels the playing field because sellers must verify that all active ingredients in a product meet or surpass their stated levels.  This is the largest point of contention raised by NOW Foods and it is a serious problem in the dietary supplement industry. Amazon supplement sellers must now provide a certificate of analysis (CoA) that meets a number of new requirements, most notably the CoA must:
  • Provide “quantitative analysis to support the active ingredient concentration as claimed on the supplement facts panel.”  
  • Match the active ingredient name on the supplement facts panel to the active ingredient name on the CoA.   
  • Be from an ISO 17025 accredited Laboratory
  • Be no more than 6 months old

What can Mérieux NutriSciences do for you?

Contact us to learn more about how these changes could affect your product.

 

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