FDA Approval for Color and Food Additives
*Procedure for FDA Approval of Color and Food Additives:
- A new petition is received.
- OFAS (Office of Food Additive Safety) evaluates the petition for the adequacy of filing (if adequate, a filing notice is published in the Federal Register).
- The need for review outside CFSAN is determined (Center for Food Safety and Applied Nutrition).
- Then, the Consumer Safety Officer distributes appropriate parts of the petition to experts for evaluation.
- Decisions are made when:
- A tentative safety conclusion is reached
- An advisory committee input is received, if necessary
- The final safety evaluation is made
- The administrative record is compiled, and
- A Federal Register final rule is drafted
- The final Agency review is completed. The final regulation is published in the Federal Register. The regulation appears in the Code of Federal Regulations.
- A food additive or color additive cannot be used until a regulation is in effect that allows the use, as announced in the Federal Register. For food additives, the regulation is effective when the final rule is published. For color additives, the final rule becomes effective 31 days after the final rule is published.
*List of Documents for Color and Food Additives' Approval
A petition has to be submitted if the additive is not already regulated by the FDA. The following elements have to be mentioned in the petition:
It should specify the basic elements, which are as follows:
- Probable exposure
- Evaluation of safety
- Limitations of conditions of use (may be necessary to ensure safe use)
In addition to that, an administrative record has to be produced, which includes:
- Data is submitted by the petitioner.
- There is communication between FDA and the petitioner.
- FDA reviews the data as clarified by the communication and prepares memoranda.
- FDA publishes a final regulation, which authorizes a specific use of the additive. It must withstand legal challenge and bear the FDA's credibility.
In addition to the same, the following may be provided for in consonance with Section 409(b)(2) of the Act:
- The identity and composition of the additive
- Proposed use
- Use level
- Data establishing the intended effect
- Quantitative detection methods
- Estimated exposure from the proposed use (in food, drugs, cosmetics, or devices, as appropriate)
- Full reports of all safety studies
- Proposed tolerances (if needed)
- Environmental information (as required by the National Environmental Policy Act (NEPA), as revised (62 FR 40570; July 29, 1997)
- Fee (for color additive petitions only)
- Ensure that consistent information is presented throughout all sections of the petition, including those about:
- Environmental science, and
- Any other pertinent studies (e.g., microbiology)
*Fee for Color and Food Additives:
- Food use new listing ($3,000)
- Non-food use new listing ($2,600)
- Food use amendment ($1,800)
- Non-food use amendment ($1,600)
*Mode of Filing:
Electronic OR Physical