Process Authority Letters
Process Authority Letters
A Process Authority (PA) Letter is a document required by the FDA for certain regulatory categories of food, including acidified foods, low-acid canned foods, and food produced using certain novel processes. These letters must be filed on the FDA website along with the formula and manufacturing process of the corresponding product. A related document, called an Exemption Letter, may be provided in the event that the product is exempt from this filing. The PA or Exemption Letter is issued after review by a food safety authority.
Request a Process Authority Letter
To request a Process Authority Letter, please visit the Request Services and Document Submission tab. Follow instructions on the downloadable Process Authority Letter Request Form and submit the documents, then wait for a team member to reach out.
What is a Process Authority Letter?
To obtain a Letter, a recognized expert reviews the product’s formula, process, packaging, and storage. The Process Authority then determines if the formula, processing method, and storage conditions are sufficient to mitigate the risk of pathogenic bacteria. If so, he or she issues a letter that you must file with the FDA, along with information about your formula, process, container, storage, and log books. Filing this “scheduled process” is like telling the FDA, “As long as we use this formula and follow this process, there is no risk of harm to consumers.”
Services
More pricing information can be found here.
Process Authority Letter/Exemption Letter
Our team will assess your formula, process, and packaging and determine whether it is appropriate for a Process Authority Letter, or needs additional testing or adjustments. Any testing we need to complete the assessment is done by us and included in the price of the letter, so you do not need to submit a separate Food Analysis Request Form. If the product is suitable, we issue the letter. Your letter then has to be filed with the FDA. You can submit that filing yourself, or we can guide you through it for an additional cost per letter as noted on our Pricing page.
Resources
The Food Innovation Center has a variety of resources, equipment, and references available to our partners. Connect with us to learn more.
More Process Authority Letter Resources
- 21 CFR 114 Acidified Foods
- 21 CFR 113 Low Acid Canned Foods
- 21 CFR 117 Current GMPs and Preventative Controls for Human Food
- 21 CFR 108 Subpart B Emergency Permit Control
- Portal for Electronic Submissions to FDA
- Instructions for Electronic Submission of Scheduled Processes Form 2541 to Register your Facility
- Process Filing for Acidified Foods (AF) and Low-Acid Canned Foods (LACF)
- FDA Guidance Documents (nonbinding recommendations) for Acidified Foods (AF) and Low-Acid Canned Foods (LACF)
- Info on Scheduled Processes from NC State Extension
- Info on Scheduled Processes from Virginia Tech Extension
- Info on Scheduled Processes from Oklahoma State Extension
- Info on Scheduled Processes from Washington State Extension
- Better Process Control School Online