If you sell supplements on Amazon, you may be tired of trying to compete against low-priced competitors that thumb their noses at good manufacturing practices and supplement quality control. While your prices must reflect the costs of providing fully-dosed ingredients and doing things right, their prices do not.
Good news: The Amazon supplement policy update that went into effect this spring is helping to eliminate this unfair competition. While the initial roll-out of Amazon’s new rules for compliance for dietary supplements is focused on the sexual enhancement, weight management and sports nutrition/body building categories, eventually the rules will most likely apply to all vitamins and dietary supplements.
What’s the goal of the new Amazon supplement seller guidelines?
The new guidelines are aimed at creating dietary supplement transparency, ensuring that dietary supplement products sold on Amazon meet key safety standards, especially regarding ingredients. Although the cost of compliance may be problematic for small businesses and start-ups, in the long run this change may be good for the dietary supplement industry overall – provided consumers are made aware of the new standards.
What does Amazon now require for compliance for dietary supplements?
A key aspect of the new guidelines is that each year sellers must verify compliance through an approved third-party testing, inspection and certification organization. This third-party organization is responsible for validating a variety of Amazon supplements safety standards testing requirements, including:
• GMP Manufacturing – The product is made at a facility that is compliant with the FDA’s Good Manufacturing Practice (GMP) regulations.
• Ingredients – All ingredients listed on the product’s label are present in the product in the claimed amounts. If the product is classified as sexual enhancement, weight management or sports nutrition/bodybuilding (i.e., the initial focus on the new rules), it does not contain any undeclared active pharmaceutical ingredients (APIs).
• Contaminants – Testing as per NSF ANSI 173 2022 standards verifies that the product does not contain heavy metals, pesticide residues, microbial contaminants, THC or other contaminants.
• Label claims – Disease treatment claims are not made on the dietary supplement’s product label or detail page.
In addition, be aware that it is your third-party testing, inspection and certification organization that must provide all relevant documents to Amazon – you are not permitted to do so. These documents include test results, certificates of analysis, GMP certifications, evidence of product enrollment or participation in a third-party quality certification program, and more.
What if we have already done third-party testing?
If you already have test reports from a third-party ISO 17025 accredited lab that is not on Amazon’s list of approved vendors, you can provide these reports to the approved vendor that you will now be working with for verification.
How do we know if these Amazon supplement seller guidelines apply to us?
Amazon will notify you if any of your supplements require compliance verification and provide the associated due dates.
Who is responsible for ensuring all this third-party testing takes place?
The brand is. You must contract with and pay for an approved third-party vendor, ensure the tests are completed, provide any requested information, track the process in your Compliance Dashboard in Amazon’s Seller Central or Vendor Central, etc.
What costs will compliance entail?
In addition to the cost of the product testing, which is estimated to be $5,000 to $7,000 annually for each product, you will also incur costs for the rest of the inspections. This includes inspecting labels, GMP certifications and documentation for any claims that you make about the product, such as Kosher, Halal, vegan, vegetarian, non-GMO, etc.
What happens if we do not comply with this Amazon supplement policy update?
Once Amazon notifies you that you must take these steps, you risk having your products removed or suppressed if you do not comply. Only products that meet the standards are eligible for sale on Amazon.
How can CapsCanada help?
CapsCanada’s empty capsules are manufactured to the highest standards, in cGMP compliant facilities. Our capsules are Kosher and Halal certified, as well as free of starches, preservatives, common allergens and GMOs. These facts are important, because it’s not just your formulations that must meet the updated Amazon supplement safety standards testing requirements – the capsules in which your product is contained must be in compliance, too.
