Phytolon Achieves Major FDA Regulatory Milestone Paving the Way for Commercialization

Phytolon Ltd. (“Phytolon”), achieved a significant regulatory milestone which is expected to materially enhance its commercial prospects in the U.S. food and beverage market. Phytolon is an Israeli biotech focused on precision fermentation of baker’s yeast to produce natural food colors, enabling vibrant hues like purple, red, orange and yellow as alternatives to synthetic dyes.

Following a color additive petition submitted by Phytolon, the U.S. Food and Drug Administration (the “FDA”) has issued an order amending its color additive regulations to allow for the safe use of beetroot red for the coloring of human foods generally, following the conclusion of the standard public comment period by the FDA.

The Beetroot Red portfolio offers unseen quality and performance compared with most natural colors in multiple food categories. Upon the effective date of the amendment, Phytolon’s beetroot red will be approved for commercialization and use across the U.S. food supply. The approval enables application in a wide range of food categories, including confectionery, dairy products, beverages, and condiments, addressing a broad and growing market demand for clean-label food coloring solutions.

In addition, the FDA has revised its guidance relating to the use of “no artificial colors” labeling[1]. Under the updated framework, food manufacturers may use this label when incorporating natural color additives, such as Phytolon’s beetroot red, provided petroleum-based synthetic dyes are not present. This regulatory change removes a significant marketing and adoption barrier, substantially improving the value proposition of natural colorants for leading food and beverage brands.

[1] https://www.fda.gov/news-events/press-announcements/fda-takes-new-approach-no-artificial-colors-claims