Responding to food manufacturers’ requests, the U.S. Food and Drug Administration (FDA) has published industry guidance to clarify when fruit and vegetable juices “may be used as color additives for foods without additional premarket review and approval from the agency under its color additive petition process.” Under current regulations, the agency provides that “the safety of fruit juice and vegetable juice as color additives for use in food is assured by the fact that the fruit or vegetable from which the color additive is derived has been safely consumed as food, such that there would not be safety concerns in using the juice or water soluble color components from the fruit or vegetable as a color additive.” In particular, FDA clarifies what it means by the terms “fruit,” “vegetable,” “mature,” “fresh,” and “edible,” as well as “expressing the juice” and “water infusion of the dried fruit or vegetable.” The agency…
Tag Archives artificial coloring
A California federal court has denied Kraft Food Group Inc.’s request to stay class action litigation alleging the company’s fat-free cheese product is misleadingly labeled “natural” because it contains artificial coloring, finding that the U.S. Food and Drug Administration’s (FDA’s) expected guidance on the term “natural” does not affect the issues of the case. Morales v. Kraft Foods Grp. Inc., No. 14-4387 (C.D. Cal., order entered December 6, 2016). A week earlier, the same court denied Kraft’s motion for summary judgment on the grounds that triable issues existed in the case, including (i) “whether consumers are likely to believe that ‘artificial color’ is not an artificial ingredient if it is produced by a natural product”; (ii) “whether such belief is material to customers’ purchasing decisions”; and (iii) “whether all artificial colors, regardless of source, are artificial ingredients.” Details about the certification of the class appear in Issue 570 of this…
The Center for Science in the Public Interest (CSPI) has called on the U.S. Food and Drug Administration (FDA) to require labeling on foods containing synthetic food dyes such as FD&C Green 3 and FD&C Blue 2. CSPI’s latest move follows its January 2016 publication of a report critical of FDA’s inattention to food dyes and pointing to studies allegedly linking food-dye consumption to behavioral issues in children, particularly those with Attention Deficit/Hyperactivity Disorder (ADHD). The health advocacy group’s proposed labeling would state: “WARNING: This food contains synthetic food colorings that may impair the behavior of some children.” “As long as dyes are permitted, only a warning label will provide consumers with the appropriate information to enable them to make the association between foods containing those dyes and their children’s behavioral symptoms,” CSPI said in its March 15, 2016, letter to FDA. “The FDA has mandated such labeling in the…
The Center for Science in the Public Interest (CSPI) has published a report criticizing the U.S. Food and Drug Administration’s (FDA’s) lack of action on food dyes. Titled Seeing Red: Time for Action on Food Dyes, the report points to studies allegedly linking food-dye consumption to behavioral issues in children—particularly those diagnosed with Attention Deficit/Hyperactivity Disorder (ADHD)—concluding that FDA “has failed to protect or even inform consumers of the risks of dyes to children.” “We estimate that over half a million children in the United States suffer adverse behavioral reactions after ingesting food dyes, with an estimated cost exceeding $5 billion per year, using information cited by the U.S. Centers for Disease Control and Prevention and a recent meta-analysis sponsored by an arm of the food industry,” states CSPI. “A study of food labels in one supermarket found that more than 90 percent of child oriented candies, fruit-flavored snacks, and…
A California federal court has dismissed without leave to amend several claims in a lawsuit alleging that Whole Foods Market fraudulently and misleadingly labeled its 365 Everyday Value ketchup, oatmeal and chicken broth as containing “evaporated cane juice” (ECJ) rather than “sugar.” Pratt v. Whole Food Mkt. Cal., Inc., No. 12-5652 (N.D. Cal., San Jose Div., order entered September 30, 2015). The plaintiff alleged that because Whole Foods failed to use the most common name for the ingredient—as mandated by U.S. Food and Drug Administration rules—the products were misbranded and “cannot be legally sold, possessed, have no economic value, and are legally worthless.” The court first dismissed strict liability allegations, finding that the plaintiff sought to impose a requirement inconsistent with federal law. Turning to the plausibility of the plaintiff’s allegations, the court found his reliance claims contradictory because one claim required him to know nothing about ECJ while the…
The U.S. Food and Drug Administration (FDA) has issued a final rule allowing “the safe use of mica-based pearlescent pigments prepared from titanium dioxide and mica as color additives in certain distilled spirits.” Mica-based pearlescent pigments are currently approved as color additives in many foods and beverages, including distilled spirits containing “not less than 18 percent and not more than 23 percent alcohol by volume.” Effective November 5, 2015, the new rule permits the use of these pigments at a level of up to 0.07 percent by weight in distilled spirits containing not less than 18 percent and not more than 25 percent alcohol by volume, while finding that “certification of mica-based pearlescent pigments prepared from titanium dioxide is not necessary for the protection on the public health.” “Regarding cumulative exposure from the current and petitioned uses of mica-based pearlescent pigments, we note that in our recent final rule that…
A consumer has filed a putative class action against Kraft Foods Group Inc. alleging that the company’s fat-free cheese is mislabeled as “natural” because it contains artificial or synthetic ingredients, including “artificial color.” Quiñones-Gonzalez v. Kraft Foods Grp., Inc., No. 15-1892 (D.P.R., filed July 27, 2015). The plaintiff asserts that she relied on the “natural” label to mean that the product, “at a minimum, has no artificial ingredients or characteristics. The public is further led to believe the Product will be healthier, safer and/or produced to a higher standard.” She seeks class certification, an injunction, restitution and damages for allegations of deceptive and unfair marketing and unjust enrichment. A class was certified in June 2015 in a similar lawsuit pending in California federal court; details about the ruling appear in Issue 570 of this Update. Issue 573
A California federal court has certified a class of consumers challenging the “natural” label on Kraft’s fat-free cheddar cheese product but limited the class only to consumers who relied on that labeling when purchasing the product. Morales v. Kraft Foods Grp., Inc., No. 14-4387 (C.D. Cal., order entered June 23, 2015). The complaint had asserted that artificial coloring in the product precluded Kraft from labeling the cheese as “natural.” The court found that the proposed class met the numerosity, commonality, typicality and adequacy of representation standards, then focused on whether the common issues predominate over any individual issues. Kraft argued that the plaintiffs could not show that every member of the proposed class relied upon the “natural” representation because the term “natural” may mean different things to different people. The court disagreed but noted that Kraft could make that argument later in the legal process. Kraft also challenged the ascertainability of…
Consumer advocacy watchdog Environmental Working Group (EWG) has issued a new iteration of its “Dirty Dozen Guide to Food Additives.” Reportedly based on hundreds of studies and information culled from EWG’s Food Scores database, the resource purports to cover “food additives associated with serious health concerns, ingredients banned or restricted in other countries, and other substances that shouldn’t be in food.” The substances that EWG deems the “dirty dozen” include nitrites and nitrates; potassium bromate; propyl paraben; butylated hydrosyanisole (BHA); butylated hydroxytoluene (BHT); propyl gallate; theobromine; secret flavor ingredients; artificial colors; diacetyl; phosphate-based food additives; and aluminum-based food additives. See EWG Press Release, November 12, 2014. Issue 545
After revisiting a prior safety assessment, the European Food Safety Authority (EFSA) has established an acceptable daily intake (ADI) of 4 mg/kg bw/day for the food coloring known as Sunset Yellow. EFSA’s Panel on Food Additives and Nutrient Sources Added to Food (ANS) recommended raising the ADI—previously set at 1 mg/kg bw/day—in light of a 28-day study report, a 2011 evaluation conducted by the Joint FAO/WHO Expert Committee on Food Additives and additional toxicological information made available since the 2009 assessment. “Exposure estimates for Sunset Yellow FCF based both on the currently authorized MPLs [Maximum Permitted Levels] and reported use levels are well below the new ADI of 4 mg/kg bw/day for all population groups,” noted the ANS Panel. “Overall, the Panel concluded that, using data provided by the food industry and Member States, the reported uses and use levels of Sunset Yellow FCF (E 110) would not be of…
