Constituent Update

November 6, 2023

The U.S. Food and Drug Administration (FDA) is announcing an update to its online submission module to improve communication for industry who send regulatory submissions to FDA’s Office of Food Additive Safety (OFAS). 

The CFSAN Online Submission Module (COSM), is a web-based tool that walks users through a step-by-step process to assemble and send fully electronic regulatory submissions directly to OFAS, eliminating the need for printing and mailing of paper submissions. The update to COSM introduces three new features:

1. Users can submit documents directly to the OFAS via COSM, eliminating the need to use the FDA’s Electronic Submission Gateway (ESG), email or mail/
2. COSM allows for secure communication between the FDA and users for submissions and amendments to submissions created in COSM/
3. Dynamic user dashboard displays the status of the submissions.

Submitters will use the same link to log into COSM as they have in the past and follow the same step-by-step process to assemble their submissions following the established question-and-answer form. The form guides users through developing and organizing the documents in the appropriate order for submission directly to OFAS, or to send through other traditional means. Information on how to register, use COSM, and send submissions is provided in the updated help guides on the COSM webpage.

Communication with submitters through COSM is available for the following OFAS submission types:

• Biotechnology Notification File (BNF)
• Color Additive Petition (CAP)
• Food Additive Petition (FAP)
• Food Contact Notification (FCN)
• Generally Recognized as Safe Notice (GRN)
• New Protein Consultation (NPC)
• Pre-Notification Consultation (PNC) for a food contact substance

For questions regarding food ingredient and packaging material submissions, please contact the Office of Food Additive Safety by email at Premarkt@fda.hhs.gov or call 240-402-1200.

Additional Resources

• Food Ingredients & Packaging
• Food Additives & Petitions
• Generally Recognized as Safe (GRAS)
• Submissions on Bioengineered New Plant Varieties
• Guidance for Industry: Preparation of Food Contact Notifications (Administrative)