FDA – Food and Dietary Supplements
Label and Content Review
Fee: $349 / product
Food labels in the United States follow FDA’s rules in 21 CFR Part 101. A Nutrition Facts panel is required on most food offered for sale. Nine major allergens must be declared: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans and sesame. Sesame has been on this list since January 1, 2023.
Who Is Obligated?
Companies that manufacture and export packaged food to be sold in the United States.
What We Do
- We review your current label against FDA rules.
- We report the gaps in the principal display panel, ingredient list, allergen and nutrition sections.
- We prepare the corrected English label text.
What You Receive
- Review report
- Corrected label text
US Food Label and Content Review Application
Product, ingredient, and label details for the review of your food and dietary supplement labels against FDA rules.
Frequently Asked Questions
- Can I use the label from my home market in the United States?
- Generally no. A US label is prepared in English according to FDA rules; sections such as the Nutrition Facts panel and the allergen statement have their own format.
- Which allergens do I need to declare?
- The nine major allergens: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans and sesame.
- What do you need from me for the review?
- An image or the text of your current label, the ingredient list and the nutrition information are enough. If a nutrition facts calculation is also needed, we do it together with our nutrition facts calculation service.
Sources: 21 CFR 101.1; 21 CFR 101.9; 21 CFR 101.15; FDA: Food Allergies.