October 5, 2018 - WASHINGTON - Today, the Food and Drug Administration (FDA) amended its food additive regulations to no longer allow for the use of seven synthetic flavoring substances while also noting that the substances “do not pose a risk to public health under the conditions of their intended use.” The decision specifically removes food additive approval for six synthetic flavoring substances in response to a petition submitted by a coalition of non-governmental organizations (NGOs). The FDA also delisted styrene because it is no longer used by industry. 

Notably, the FDA states that the revocations are due to the rigid language of the Delaney Clause, and that otherwise the flavoring substances are safe: 

“Although we are amending our food additive regulations for these synthetic flavoring substances in accordance with the Delaney Clause, the FDA’s rigorous scientific analysis has determined that they do not pose a risk to public health under the conditions of their intended use. The synthetic flavoring substances that are the subject of this petition are typically used in foods available in the U.S. marketplace in very small amounts and their use results in very low levels of exposures and low risk. 

"While the FDA’s recent exposure assessment of these substances does not indicate that they pose a risk to public health under the conditions of their intended use, the petitioners provided evidence that these substances caused cancer in animals who were exposed to much higher doses. As such, the FDA is only revoking the listing of these six synthetic flavorings as a matter of law. 

The FDA has concluded that these substances are otherwise safe.”

These seven flavoring ingredients are used at extremely low levels, and are naturally occurring in foods such as grapes, pineapples, and oranges, to name just a few. The FDA’s conclusion that these substances do not pose a risk to public health under their conditions of intended use as flavorings is consistent with other global scientific and regulatory bodies, including the World Health Organization’s Joint Expert Committee on Food Additives.

FDA’s statement explains that the delisting of these flavorings is driven by an antiquated aspect of U.S. law referred to as the Delaney Clause, and not because of risk from consumption of these materials when used as flavorings. When the Delaney Clause was introduced in 1958, there was very limited understanding of animal studies and cancer. For example, it was commonly accepted that one molecule could cause cancer, and that substances causing cancer in animals undoubtedly caused cancer in humans.

Today scientists and regulators all over the world understand the difference between a potential hazard identified in a high-dose rodent study and actual risk to consumers. At various times over the last several decades, there have been concerns raised about the Delaney Clause by members of Congress, the General Accounting Office (GAO) and food safety experts, since the provision doesn’t allow FDA to consider risks based on modern day scientific understanding. It requires an act of Congress to change the 1958 Delaney Clause.

The delisting of these six flavoring substances—despite the conclusions by the FDA that these materials are safe both for use as flavorings and when they are consumed via the variety of foods that contain them (e.g. grapes, pineapples, oranges)—confirms the need for FDA to be given the latitude to assess actual risk, rather than be boxed in by an antiquated, 60-year-old statutory provision.

About FEMA

The Flavor and Extract Manufacturers Association of the United States (FEMA) is composed of flavor manufacturers, flavor users, flavor ingredient suppliers, and others with an interest in the U.S. flavor industry. Founded in 1909, it is the national association of the U.S. flavor industry. FEMA is committed to assuring a substantial supply of safe flavoring substances. More information about FEMA is available at