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FDA Scrutinizes Phthalates — And Sours on Evaporated Cane Juice

On May 20, 2016, the federal Food and Drug Administration announced that it had agreed to consider a petition to withdraw its approval of a number of phthalate chemicals as food additives for use in food packaging and food handling equipment. The petition was submitted by a number of non-governmental organizations, including the Natural Resources Defense Council, Environmental Defense Fund and Center for Food Safety.

Phthalates can be used in food contact applications such as coatings in articles for holding food, or as components of paper and paperboard coming into contact with foods, or adhesives. The petition identifies a number of phthalate chemicals whose approvals should be withdrawn, and seeks to prohibit altogether the use of eight phthalates as food contact substances. These include di(2-ethylhexyl) phthalate, butyl benzyl phthalate, diisononyl phthalate, and di-n-butyl phthalate, which also are on the Proposition 65 list.  The petition asserts, among other arguments, that:

  • These chemicals are in a category of chemically- and pharmacologically-related substances for purposes of evaluating safety under FDA regulations; and
  • The “intentional use of [the identified phthalates] as food contact substances are not safe” under FDA regulations.

The petition is currently under review.

In other developments, the FDA recently finalized its guidance on the use of the term “evaporated cane juice” as an ingredient in foods.  This phrase is often used in “natural” or organic products to describe a sweetener derived from cane juice. The FDA believes such sweeteners should not be called “evaporated cane juice” because the phrase does not accurately describe the basic nature of the ingredient or its characterizing properties. Further, because the phrase has the word “juice” in it, the FDA believes the term is misleading because consumers will think there is juice in the product. “Juice,” in fact, has a narrow, precise meaning under FDA regulations, and is defined as “the aqueous liquid expressed or extracted from one or more fruits or vegetables, purees of the edible portions of one or more fruits or vegetables, or any concentrates of such liquid or puree.” Cane juice, according to the FDA, is neither a fruit nor a vegetable and therefore its “juice” is not “juice” within the meaning of FDA’s definition. Instead of “evaporated cane juice,” the FDA wants food industries to change their sweetener name to “sugar,” because that term is not misleading. **


**Many thanks to Zach Thomas for his very helpful contribution to this portion of this article.

Ms. Grimaldi maintains a diverse environmental law practice focusing on chemical and product regulation and litigation defense. Her practice areas include Proposition 65, California's Safer Consumer Products Regulations, California's Rigid Plastic Packaging Container Act and the federal Toxic Substances Control Act. Ms. Grimaldi graduated from the University of California Hastings College of the Law magna cum laude and holds a Bachelor of Science Degree in Bacteriology from University of California, Davis. Prior to attending law school, she worked as a research assistant in laboratories at the University of California, San Francisco Cancer Research Institute and at the University of California, San Francisco School of Medicine.