FDA: Food Program Guidance Under Development
(Expected to be published as drafts or finals by the end of December 2023.)
Introduction
The following list of guidance topics includes possible new topics for guidance documents or revisions to existing guidance documents that the FDA Foods Program is considering.[1] We currently intend to develop guidance on each topic; however, the FDA Foods Program is neither bound by this list of topics, nor required to issue every guidance document on this list. Several factors may impact FDA’s ability to issue the listed guidance, including, for example, new Administration priorities, emerging public health issues, or other extenuating circumstances. We are not precluded from issuing guidance documents on topics not on this list.
Comments should be submitted to www.regulations.gov at Docket FDA-2022-D-2088.
FDA: Aspartame and Other Sweeteners in Food
FDA Response to External Safety Reviews of Aspartame
The FDA is aware of the International Agency for Research on Cancer (IARC) and Joint FAO/WHO Expert Committee on Food Additives (JECFA) conclusions about aspartame issued July 14, 2023. Aspartame being labeled by IARC as “possibly carcinogenic to humans” does not mean that aspartame is linked to cancer.
The FDA disagrees with IARC’s conclusion that these studies support classifying aspartame as a possible carcinogen to humans. FDA scientists reviewed the scientific information included in IARC’s review in 2021 when it was first made available and identified significant shortcomings in the studies on which IARC relied. We note that JECFA did not raise safety concerns for aspartame under the current levels of use and did not change the Acceptable Daily Intake (ADI).
Aspartame is one of the most studied food additives in the human food supply. FDA scientists do not have safety concerns when aspartame is used under the approved conditions. The sweetener is approved in many countries. Regulatory and scientific authorities, such as Health Canada and the European Food Safety Authority have evaluated aspartame and also consider it safe at current permitted use levels.
Some consumers may rely on products with aspartame and other sweeteners to help reduce their sugar consumption. We recognize that navigating different information from health organizations is challenging. We will continue to provide reliable, science-based information on aspartame and other sweeteners on the FDA’s web site to help consumers make informed choices.