FDA Releases List of Chemicals Not Allowed in Foods and Chemicals Under Review

The 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.
 

This week, FDA issued Warning Letters to a number of companies that were selling products with Delta-8 Tetrahydrocannabinol (Delta-8 THC), an isomer of Delta-9 THC, the intoxicating component found in marijuana. many of these products look like snacks or candies and can be an issue for children mistakenly eating. 

This is a good reference for chemicals in question.

Post-market Determinations that the Use of a Substance is Not GRAS

• 4-androstenedione
• Arimistane
• Betel nut (Areca catechu)
• Caffeinated alcoholic beverages (CABs)
• Cannabidiol (CBD)
• Delta-8-tetrahydrocannabinol  (THC)
• 1,3-dimethylamylamine  (1,3-DMAA)
• Ginkgo biloba
• Kava
• Melatonin
• Picamilon

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

• Authorized PFAS: Certain Short-Chain Per- and Polyfluoroalkyl Substances (PFAS) Food Contact Substance
• Authorized PFAS: Uses of other Per- and Polyfluoroalkyl Substances (PFAS) in food contact applications Food Contact Substance
• Brominated-Vegetable-Oil (BVO)  - Food Additive
• Irgafos 168 - Food Contact
• Partially Hydrogenated Oil (PHO) - food additive
• Phthalates - Food contact
• Red Dye No. 3 - Color Additive
• Titanium Dioxide - Color Additive

List of Select Contaminants Currently Under FDA Review

• Arsenic - Environmental Contaminant
• Cadmium - Environmental Contaminant
• Lead - Environmental Contaminant
• 4-MEI Methylimidazole CAS Number 822-36-6 - Process contaminant in some caramel colors and flavors, and in some foods and beverages during the normal cooking process
• Mercury - Environmental Contaminant
• 3-Monochloropropane-1,2-diol (MCPD) esters and Glycidyl Esters (GE)  - Process contaminants that can occur in refined edible oils, such as vegetable oils, and foods made with these oils, including infant formula
• Per- and Polyfluoroalkyl Substances (PFAS) - Environmental Contaminant
• Thallium - Environmental Contaminant

https://www.fda.gov/food/cfsan-constituent-updates/fda-update-post-market-assessment-certain-food-ingredients
FDA Update on Post-market Assessment of Certain Food Ingredients

Constituent Update

July 12, 2023

Today, 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 Conversations 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 on the FDA’s post-market assessments.

In addition to the FDA’s pre-market programs, the agency’s active post-market monitoring of new safety information related to food ingredients is also essential to the safety of the U.S. food supply. Under the Federal Food, Drug, and Cosmetic (FD&C) Act, any ingredient used or intended for use in food must be authorized by the FDA for use as a food additive unless that use is Generally Recognized As Safe or GRAS by qualified experts or meets a listed exception to the food additive definition in the FD&C Act. An unapproved food additive is deemed to be unsafe under the FD&C Act.

The inventory includes some of the FDA’s post-market assessments of food ingredients and may include links to some activities related to such an ingredient since 2004. 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.

The lists that were also made available today, include select ingredients considered GRAS, food and color additives, food contact substances, and contaminants currently under FDA review. These represent some of the chemicals of interest to the agency and those that are of high interest among stakeholders who have asked the FDA to review their safety. The FDA anticipates updating the inventory and these lists periodically.

Lastly, the Conversations with Experts features Dr. Kristi Muldoon-Jacobs, acting Director of the Office of Food Additive Safety, sharing her insight about the FDA’s current post-market assessment of ingredients and food contact substances and how we envision enhancing our approach to support this work.

The FDA’s assessment of chemicals in the food supply is part of our commitment to food safety.