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  1. FDA-TRACK: Agency-wide Program Performance

FDA-TRACK: Center for Food Safety and Applied Nutrition - Pre-market Review

FDA's Center for Food Safety and Applied Nutrition (CFSAN) administers the Foods Program. CFSAN ensures the safety of the human food supply, dietary supplements, and cosmetics as well as the proper labeling of foods and cosmetics. The Foods Program is responsible for a safe food supply and ensuring FDA regulations and guidance provide clear and reliable direction and assistance to industry, both inside and outside the United States, with a goal to obtain high rates of compliance with standards necessary to protect public health and meet consumer and stakeholder expectations.

FDA conducts premarket activities to ensure substances added to the food supply are safe, including reviews of food and color additive petitions, Generally Recognized as Safe (GRAS) ingredients, and new food contact substances, materials, and packaging. These activities are backed by the field-based surveillance, inspection, and compliance activities carried out to oversee imports, respond to foodborne illness outbreaks, and remove harmful products from the market.

Explore the progress CFSAN is making towards its Pre-market Review efforts below:

Food Ingredients

Any substance that is intentionally added to food is a food additive.  All new food additives must be petitioned by the manufacturer for pre-market review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use. Increasing the efficiency of review of food & color additive petition and GRAS notices:

  1. Increases consumer choices for safe packaging materials, food ingredients, and color additives;
  2. Provides consumers and industry with additional tools to mitigate or prevent microbial contamination that may lead to food borne illness; and
  3. Maximizes the use of FDA resources applied to food safety and public health protection.

FDA has the primary legal responsibility for determining the safe use of food and color additives. Before a food additive is marketed that will have technical effect in food, there must first be a regulation issued by FDA that authorizes such use. Similarly, before a color additive is marketed for use in food, drugs, cosmetics, or in certain medical devices, FDA must issue an authorizing regulation. A company that seeks a regulation for a new use of a food or color additive must submit a petition to FDA with evidence that the substance is safe for the intended use.

The Foods Program conducts an extensive review as part of its Food Additive and Color Additive Petition review process, which includes a Chemistry, Toxicology, and Environmental evaluation. The current measure is for FDA to complete review and action on the safety evaluation of direct and indirect food and color additive petitions within 360 days of receipt.

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A substance for which the use is generally recognized by qualified experts as safe is exempt from premarket approval as a food additive. "GRAS" is an acronym for the phrase Generally Recognized As Safe. The GRAS notification program is a voluntary procedure that is operating under a proposed rule issued in 1997. FDA reviews the notice and responds to the notifier by letter. In general, FDA's response has been in one of three categories: does not question the basis for the GRAS determination, concludes the notice does not provide a sufficient basis for a GRAS determination, or at the notifier's request has ceased to evaluate the GRAS notice.

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Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), many color additives intended for use in FDA-regulated products are subject to batch certification by FDA. This means that FDA chemists have analyzed a sample from the batch and have found that it meets the requirements for composition and purity stated in the regulation for that color additive. FDA strives to issue certifications within five business days.

FDA determines the need for batch certification based on whether the color additive needs this level of control to protect the public health. Some color additives, in their uncertified forms, might contain impurities at levels that pose a health concern. Certified color additives generally have three-part names consisting of a group of letters (“FD&C,” “D&C,” or “Ext. D&C”), a color, and a number. An example is “FD&C Yellow No. 5.” Using an uncertified form of a color additive that requires FDA certification makes an FDA-regulated product adulterated under the law, and FDA can take action against the product. For example, color additive violations are a common reason for import refusals of food and cosmetic products offered for entry into the United States. For additional information, visit the color certification home page.

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New Dietary Ingredients (NDIs)

The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that manufacturers and distributors who wish to market dietary supplements that contain "new dietary ingredients" (NDIs) notify the Food and Drug Administration about these ingredients.

Timely review of notification of new dietary ingredients impacts the public health by preventing substances that are not actually dietary ingredients from being used in dietary supplements, and assuring that new dietary ingredients have adequate evidence for presumption of safety. Since these statutory requirements are notifications rather than premarket approvals, it is essential that the Office of Dietary Supplement Programs (ODSP) has completed review of the information before the submitter markets the product to notify them of any safety or regulatory concerns before the product reaches consumers.

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Packaging Materials

The FD&C Act defines a food-contact substance as "any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have a technical effect in such food."  Manufacturers are required to notify the FDA prior to utilizing a new food-contact substance.

FDA has responsibility for the regulation of components of food contact materials (food contact substances) under the same authority as for direct food additives. To market a new food contact substance or an existing substance for a new use, manufacturers must notify FDA 120 days prior to marketing the substance. Notifications must establish that the proposed use is safe in accordance with the same safety standard as direct food additives. In the event safety is not established, FDA may object to the notification to prevent marketing. In addition, FDA may ask for additional information based on our review or request that a notifier withdraw a deficient notification.

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Infant Formula

Infant formula manufacturers are required to notify FDA via a new infant formula submission of a new infant formula (this includes existing infant formulas with a major change) at least 150 days prior to marketing of the infant formula. The manufacturer must provide FDA with assurances that the infant formulas meet nutrient requirements, are safe and well-tolerated, and support the two quality factors – normal physical growth and sufficient biological quality of protein. Many of these submissions are technically and scientifically complex submissions that may include large amounts of data, analyses, and preclinical and clinical studies. Because the statutory requirement is for premarket notification and not premarket approval, FDA has a 150-day review period to identify safety or regulatory issues before the product is on the market. This review period may be extended if required information is missing or substantive new information is received.

Timely review of infant formula submissions is essential for protecting the health and wellbeing of infants. Since these statutory requirements are submissions rather than pre-market approvals, it is essential that the Office of Nutrition and Food Labeling (ONFL) has completed review of the information before the submitter markets the product to notify them of any safety or regulatory concerns before the product reaches consumers.

*In January 2021, due to the increasing complexity of new infant formula submissions received in late 2020, FDA determined that it would not be able to complete its review of submissions within 90 days after the filing dates and notified industry it would be adding up to an additional 60 days (i.e., 150 days total) to the review period for new submissions moving forward. In November 2021, FDA determined that it would need an additional 30 days (i.e., 180 days total) in order to complete reviews of submissions moving forward and notified industry. This change was fully implemented during the next reporting cycle which occurred in Q2 of fiscal year 2022.

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Download FDA-TRACK CFSAN Pre-market Review Dataset

Note:  The data provided on this website are produced on an ongoing basis for performance management purposes and are subject to change due to updates of preliminary estimates, corrections, or other reasons.



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