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Docket No 99F-09253 Indirect Foo - FDA

Docket No 99F-09253 Indirect Foo - FDA 2025

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The document is a draft guidance from the FDA aimed at assisting industry stakeholders in submitting abbreviated new drug applications (ANDAs) in electronic format. It outlines the requirements and organization for electronic submissions, including necessary components, file formats, and procedures to ensure consistency with existing new drug application guidelines. The guidance emphasizes the importance of providing both archival and review copies electronically, as well as specific instructions for organizing submission folders and documents.

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Does the FDA regulate direct but not indirect food additives?

Direct food additives are those that are added to a food for a specific purpose. For example, xanthan gum used in salad dressings, chocolate milk, bakery fillings, puddings and other foods is a direct additive used to add texture. Most direct additives are identified on the ingredient label of foods.

What is a citizen petition for the FDA?

A citizen petition is a way for individuals, regulated industry representatives, or consumer groups to petition FDA to issue, amend, revoke a regulation, or to take other administrative action. The requirements for a citizen petition are set out in 21 CFR 10.30.

What are the indirect additives FDA?

Indirect Food Additive - In general, these are food additives that come into contact with food as part of packaging, holding, or processing, but are not intended to be added directly to, become a component, or have a technical effect in or on the food.

What are the 5 types of additives?

The different types of food additive and their uses include: Anti-caking agents stop ingredients from becoming lumpy. Antioxidants prevent foods from oxidising, or going rancid. Artificial sweeteners increase the sweetness. Emulsifiers stop fats from clotting together. Food acids maintain the right acid level.

What are indirect additives?

Indirect food additives are those that become part of the food in trace amounts due to its packaging, storage or other handling. For instance, minute amounts of packaging substances may find their way into foods during storage.