Selling supplements on Amazon has become more difficult. Back in January, the retailer tightened its quality assurance requirements for supplement products. Amazon will fully enforce these requirements on June 7, which means brands will need to re-submit active-ingredient products.
Will I really have to re-submit documentation for all of my supplement products?
If a supplement product has an active ingredients list, then yes. An active ingredient is defined by the FDA as “any component of a drug product intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of humans or other animals.”
Here at Netrush, our team is supporting our brand partners by gathering documentation to re-submit on their behalf. We’ve been working since January to get ahead of this shift to mitigate any impact on our partners.
Is this a good thing?
These changes needed to happen. It was too easy for counterfeiters and sketchy sellers to access the marketplace and sell unverified supplements to shoppers. Not only was this creating a sub-optimal customer experience issue, but more importantly, it was also creating a customer safety issue.
Amazon’s new requirements aren’t outlandish. Many brick-and-mortar retailers already require similar documentation.
What are Amazon’s new requirements?
Here’s a quick breakdown:
Certificate of Analysis (CoA):
- Must contain lot number and manufacture date
- Expiration date must not be in the past (documents with dates in the past will not be reviewed)
- Include the name and address of the manufacturer or distributor
- Must be issued by an ISO 17025 or GMP certified laboratory
- CoA issued within the last six months
- CoA must contain quantitative analysis to support the active ingredient concentration as claimed on the supplement factors pane
- Must include product name
Product Packaging Picture (PPP):
- Six images that display all sides of the product
- The product’s nutrition panel and active ingredients list must be clearly visible in one of the pictures
- Images can’t be digitally edited — we find the most successful images are taken from a phone without any further editing
- Images must contain the name and address of the manufacturer
- Images must include the product name
For a full list of requirements, see Amazon’s guidelines.
Letter of Guarantee from the Manufacturer (LoG):
- Must be printed on your company letterhead
- LoG must contain the complete product name as listed on the label
- LoG must contain an assurance that the product is manufactured under current Good Manufacturing Practices
- LoG must contain an assurance that only lawful and safe, as defined in section 402(f) of the FD&C Act, ingredients are utilized
- LoG must contain an assurance that concentration of active ingredient(s) as stated on the label and labeling is safe for consumption
Important note: Amazon has announced that starting June 7 brands will no longer need to provide a Letter of Guarantee. However, Amazon is constantly updating its policies, and as of right now, LoGs are still required in the submission process. We’re suggesting that brands be prepared to submit an LoG with the understanding that it may not end up being needed.
How long does it take to get approved?
If everything has been submitted correctly, our team has found that approval typically takes 48 hours. Getting everything organized and submitted is the more difficult part. Each submitted piece of documentation needs to match Amazon’s exact requirements, so brands should take care that they follow guidelines to the letter.
What happens if I don’t submit documentation?
Amazon will remove products that aren’t re-submitted, and those products will remain inactive until documentation is provided. Submitting documentation is the only path to reinstatement.