FDA issues new MAPP on reviewing color additives
The US Food and Drug Administration’s Office of Pharmaceutical Quality (OPQ) issued a new Manual of Policies and Procedures (MAPP) describing the agency’s internal procedures for reviewing color additives and flavors in new drug applications, supplements, and Type IV drug master files and how these reviews will be coordinated with the Office of New Drugs (OND).The 12-page MAPP identifies the responsibilities of quality assessors in conducting these reviews and addresses when a request for an OND evaluation is necessary.
The MAPP states that for these submissions, OPQ will confirm that the color additives listed in the regulations governing color additives under 21 CFR Parts 73, 74 or 82 and that their use complies with the conditions in these listing regulations.
For flavors, OPQ will determine whether the flavor preparation has been previously reviewed for use in food or drug products and is under maximum daily exposure (MDE) limits. If the flavor preparation is new to FDA or the newly proposed use exceeds levels previously reviewed by FDA, the preparation will need a safety assessment by OND pharmacology and toxicology reviewers.
For color additives, it is the role of the product quality assessor to determine that these are also under MDE limits based on the information provided in the DMF. If the MDE cannot be justified in the Inactive Ingredient Database, OPQ should request a safety evaluation from the OND nonclinical review team.
The MAPP does not cover generic drug applications or their supplements because the Office of Generic Drugs already evaluates the acceptability of color additives and flavors for these products.
The MAPP will go into effect on 18 June.
FDA MAPP
