Automate FDA Prior Notice Submissions for Food / Beverages to USA

Shopify Apps
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Topic summary

A Shopify merchant selling beverages to the USA needs to submit FDA Prior Notices for each shipment but is facing critical operational issues.

Current Problem:

  • Previously used PriorNotify app, which has been non-functional for 3 weeks
  • Unable to file submissions, causing severe order delays
  • Had to remove beverage products from US market due to inability to process Prior Notices quickly enough

Manual Submission Challenges:

  • Direct FDA website submissions are too time-consuming for their sales volume
  • Cannot manually complete Prior Notices fast enough to maintain operations

Seeking Alternatives:
The merchant is looking for recommendations on:

  • Other Shopify apps for generating and submitting FDA Prior Notices
  • Third-party brokerage solutions
  • Any alternatives to PriorNotify (which appears to be the only app listed in the Shopify App Store)

The discussion remains open with no solutions or recommendations provided yet.

Summarized with AI on November 3. AI used: claude-sonnet-4-5-20250929.
1

Hi there, we are looking in to alternate apps and solutions to submit prior notices to the FDA. We sell beverage items to the USA and need to provide a FDA Prior Notice with each shipment. Going directly through the FDA website for submission takes a very long time per submission for the volume we sell.

We had been using an app called PriorNotify up until this point, however for the past 3 weeks we have been unable to file anything through this app, which is severely holding up orders. We have since had to remove our beverage products from being sold on our USA market, as we are unable to manually fill out the Prior Notices quickly enough for the volume of orders.

I am wondering if anyone else is selling Food / Beverage items to the USA, and which app or brokerage you would recommend for generating and submitting Prior Notices? PriorNotify seems to be the only one listed on the App Store, however I am hoping there are other solutions out there.

Thank you for any suggestions!

1 Like
2

Our sister company developed the PriorNotify app. Their systems were down for a while in late 2024 when the USA FDA completely revamped its PNSI system, and they had to scramble to adapt to the change.

Since then, they got the submission process working with a separate USA Customs agency system. And they also got the app working again with the USA FDA’s PNSI system. Now both systems work great!

We are able to submit our prior notices automatically and very quickly. And you have the option to use the USA FDA’s PNSI system (which is good, if your carrier wants to see the official government confirmation document that is usually not required), or you can use the separate USA Customs agency system (which is faster, but only provides the PN Confirmation Number that is required, and a non-official confirmation document).

It works great for us!

3

Please check out NoticeFlow.ca! A direct Shopify integration is in the works but in the meantime it is incredibly easy to use. Simply download Invoices, packing slips or any doc that shows whats in a box (Include the recipient details) and the team at NoticeFlow will create and FILE IT with the FDA through a Subaccount setup during onboarding. Only pay for what you use. Works Wonderfully!

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4

We are exclusively food and bev to the US from BC Canada and have been using noticeflow.ca. Been working great and we have very high volumes.

1 Like