How to Submit Label Claim Petitions & Notifications

In accordance with FDA regulations (e.g., 21 CFR 101.70), hard copy originals of petitions and notifications for food and dietary supplement claims are required to be submitted to the appropriate offices. However, the required additional copies can be submitted in hard copy or electronic form (e.g., CD-ROM or email attachments). FDA encourages that copies of petitions and notifications be submitted in electronic form. Electronic submissions should be submitted in a standard format such as a Word file, or PDF if also accompanied by a Word file. Lengthy electronic submissions should be divided into easily retrievable files.

See the following links for specific information on requirements for different types of submissions:

• Health claims that meet significant scientific agreement
• Qualified health claims
• Nutrient content claims

Submissions of additional electronic copies may be emailed to: label.claims@cfsan.fda.gov.