US FDA Update on Post-market Assessment of Certain Food Ingredients

The U.S. Food and Drug Administration (FDA) released a public inventory of certain food ingredients that the agency has determined to have unsafe uses in food because they are unapproved food additives and lists of select chemicals currently under the agency’s review. The FDA also released a Conversation with experts about the agency’s work to enhance the assessment of ingredients in foods on the market. These resources are intended to provide more insight into the FDA’s post-market assessments.

When the FDA becomes aware of an ingredient for which there is no authorization as a food additive, the FDA reviews the regulatory status of this ingredient, including whether the publicly available data and information show the use is safe and meets the GRAS standard. This determination informs the agency’s actions to protect public health, including enforcement actions and other post-market activities that warn manufacturers and the public of unsafe food additives and can result in the removal of unsafe products from the market.

This inventory is not intended to be a complete list of food ingredients that may be unlawful if used in food and may not include all post-market activities the agency has taken with respect to unsafe food additives. Specifically, the inventory includes the name of the unsafe food additive, information about some post-market activities and public communications, and the FDA’s memo that describes reviews in which the agency concluded the use of the ingredient did not meet the GRAS standard. The post-market activities include warning letters, import alerts, seizures, and injunctions.

List of Select Food Ingredients and Food Contact Substances Currently Under FDA Review: