- At a September Food & Drug Law Institute (FDLI) conference, Mark Hartman, Director of FDA’s Office of Food Chemical Safety, Dietary Supplements and Innovation, indicated that FDA intends to revisit its previously withdrawn draft guidance on the use of fruit juice and vegetable juice as color additives.
- An additive that imparts color and meets the regulatory definition of “color additive” requires a color additive authorization, unless it is “used in a way that any color imparted is clearly unimportant insofar as the appearance, value, marketability, or consumer acceptability is concerned.” (21 CFR 70.3). Therefore, the use of fruit and vegetable juice can require a color additive authorization.
- The draft guidance document, which was issued in 2016, and withdrawn the following year after significant industry pushback, was intended to clarify which ingredients are encompassed by the color additive regulations in 21 CFR 73.250 (“Fruit juice”) and 21 CFR 73.260 (“Vegetable juice”). Among other uncertainties, the regulations include undefined terms such as “mature,” “fresh,” and “edible.”
- FDA’s now-withdrawn draft guidance interpreted the regulations in a manner that industry declared was inconsistent with the regulations and with industry practice. For example, the withdrawn draft guidance stated that only “minimal processing methods” may be used in the production of color additives from fruit and vegetable juices. However, this term is not used in either regulation, and FDA interpreted it to encompass processing techniques that were ubiquitous and important for food safety (e.g., pasteurization).
- FDA’s intention to revisit this draft guidance is also reflected on the guidance agenda for FDA’s Human Foods Program as something expected to publish by the end of December 2025.
FDA Indicates Intention to Revisit Previously Withdrawn Fruit and Vegetable Juice Color Additive Draft Guidance
