FDA Keeps Checking the Colors in Your Food, Drugs, and Cosmetics
Published Date: 10/28/2026
Notice
Summary
The FDA is asking for approval to keep collecting info on color additives used in food, drugs, cosmetics, and medical devices. This helps ensure every batch meets safety and purity rules before hitting the market. If you’re involved in making or using these color additives, you can comment by November 27, 2026, but no new fees or big changes are expected.
Analyzed Economic Effects
5 provisions identified: 1 benefits, 4 costs, 0 mixed.
Estimated annual time burden for firms
FDA estimates 67 respondent firms submit a total of 7,504 certification requests per year. FDA estimates 0.22 hour per certification request (total 1,651 hours) and 0.25 hour per recordkeeping entry (7,504 records; total 1,876 hours). The combined annual estimated hours are 3,527 across all respondents.
Pre-market batch certification required
If you make color additives that are listed in 21 CFR part 74 or provisionally listed in 21 CFR part 82, you must submit a request for certification and a representative sample for each batch so FDA chemists can analyze it before that batch may be used in FDA-regulated foods, drugs, cosmetics, or many medical devices. Batches that fail certification are rejected; certified batches receive a certification lot number.
Certification fees based on batch weight
FDA charges a user fee for color additive certification, and the fee is calculated based on the batch weight. These fees support FDA's color certification program.
Mandatory recordkeeping and disposal records
Manufacturers must keep complete records showing distribution and disposal of all color additive material covered by a certification, consistent with 21 CFR part 80 recordkeeping requirements.
Web-based system and electronic certificates
FDA provides a web-based color certification information system so manufacturers can request certification online, track submissions, and get electronic certification results. FDA returns certification results electronically, and submitters may sell certified color before receiving a hard copy certificate.
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Key Dates
Department and Agencies
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