§7.3 Responding to Communications Received from FDA

• Jurisdiction: United States
• Publication year: 2022

§7.3 Responding to Communications Received from FDA

The FDA has taken to "rejecting" new dietary ingredient notifications on the basis that the ingredients are adulterated. Whether or not the FDA is permitted under the statute to reject notifications is an issue to be answered by the courts. However, if a communication letter from the FDA states the new dietary ingredient is adulterated, certain actions may be taken.

§7.3.1 Petition to Commissioner

Under 21 CFR §10.25, a petition may be filed with the Commissioner to refrain from taking administrative action against the new dietary ingredient.²⁶ §10.25 states the petition must take the form of a color additive petition (§71.1), a food additive petition (§171.1), a new drug application (§314.50), a new animal drug application (514.1), or a citizen petition (§10.30). A review of the various petition forms reveals that §10.30 may be the best form to use.

• §10.30(b) requires the petition to contain:
• Date—the date of submission of the petition;
• Address—the address for the Division of Dockets Management at the FDA;
• Title—"Citizen Petition";
• Statement of petition submission;
• Action requested of the FDA;
• Statement supporting petition, based on factual and legal grounds upon which the petitioner relies;
• Claim for exclusion based on §§25.30, 25.31, 25.32, 25.33, or 25.34;
• Economic impact, if requested by the Commissioner;
• Certification with signature.

One hundred eighty days later after filing the petition, a response will be forthcoming either approving, denying, or giving a tentative response.

§7.3.2 Request for Reconsideration

If the response to the petition from §7.3.1 is not favorable, a petition to reconsider may be filed with the Commissioner.²⁷ This petition must be filed within thirty days after the date of the response.²⁸ The petition for reconsideration is required to contain:

• Date;
• Address of Division of Docket Management;
• Title "Petition for Reconsideration";
• Docket Number;
• Statement of the decision of the

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