The Panel of Food Additives and Nutrient Sources added to Food, a branch of the European Food Safety Authority (EFSA), has conducted a reassessment on the effects of acacia gum used in food products and reportedly found 30,000 milligrams per person per day to be well-tolerated. The scientific opinion apparently found no carcinogenic or other adverse effects of acacia gum, which is "unlikely to be absorbed intact and is slightly fermented by intestinal microbiota," at the refined exposure assessment for the reported uses of the ingredient as a food additive. Issue 631
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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…
A study commissioned by the International Food Additives Council (IFAC) has claimed that when used as a gelling or thickening agent in foods, carrageenan (CGN) causes no adverse effects in human cells. James McKim, Jr., et al., “Effects of carrageenan on cell permeability, cytotoxicity, and cytokine gene expression in human intestinal and hepatic cell lines,” Food and Chemical Toxicology, July 2016. After testing three forms of carrageenan in vitro to evaluate “intestinal permeability, cytotoxicity, and CGN-mediated induction of proinflammatory cytokines,” researchers evidently concluded that intestinal cells did not absorb CGN, which, in turn, was not cytotoxic and did not induce oxidative stress or inflammation. “This study was unable to reproduce any of the previously reported in vitro findings. As a result, it is unlikely that CGN causes inflammation or that it disrupts insulin signaling pathways reported by Bhattacharyya et al. (2012),” note the study’s authors. “This work also demonstrates that…
The U.S. Food and Drug Administration (FDA) has filed an opposition to a petition for a writ of mandamus seeking a response to several consumer groups’ petition to prohibit perchlorate, an additive currently approved for limited use in food packaging. Breast Cancer Fund v. FDA, No. 16-70878 (9th Cir., petition filed July 8, 2016). The groups’ petition urged the Ninth Circuit Court of Appeals to compel FDA to respond to their December 2014 food additive petition, arguing the agency was required to respond by June 2015. Details about the petition for a writ of mandamus filed by the groups—which include the Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Environmental Working Group and the Natural Resources Defense Council—appear in Issue 599 of this Update. FDA’s response first challenges the group’s standing to sue. “Even if petitioners could demonstrate that perchlorate poses some risk…
The U.S. Food and Drug Administration (FDA) has approved folic acid fortification of corn masa flour in response to a 2012 petition from the March of Dimes Foundation, National Council of La Raza and other groups. FDA’s action allows manufacturers to voluntarily add up to 0.7 milligrams of folic acid per pound of corn masa flour. Used in tortillas, tamales and other foods, corn masa flour is a dietary staple for many people of Mexican and Central American descent, and the petitioners sought the voluntary fortification to increase the folic acid intake for U.S. women of childbearing age who regularly consume such products. Folic acid is a synthetic form of folate, a B vitamin linked to the decreased incidence of neural tube defects. See Federal Register, April 15, 2016.
The U.S. Court of Appeals for the Federal Circuit has affirmed a Patent Trial and Appeal Board ruling that a method of enzymatic hydrolysis of soy fiber for use in creating food additives is not patentable because it would have been obvious in light of previous inventions. In re Urbanski, No. 15-1272 (Fed. Cir., order entered January 8, 2016). The plaintiffs challenged the U.S. Patent and Trademark Office’s denial of a patent for their technique of creating food additives from soy fiber, which the examiner found to be “readily combinable” from two prior inventions. The Federal Circuit agreed with the examiner’s and appeals board’s determinations that a person of ordinary skill would have expected that adjusting the process as the plaintiffs did would have yielded the results they reached. Accordingly, the court affirmed the prior dismissal. Issue 590
The U.S. Department of Agriculture’s Office of the Under Secretary for Food Safety and the U.S. Food and Drug Administration are convening a February 16, 2016, public meeting in College Park, Maryland, to discuss draft U.S. positions for consideration at the 48th Session of the Codex Committee on Food Additives (CCFA) in Xi’an, China, on March 14-18. Among other things, CCFA is responsible for establishing or endorsing permitted maximum levels of individual food additives, proposing risk assessments to the Joint FAO/WHO Expert Committee on Food Additives and recommending labeling standards for food additives. Agenda activities for the February 16 meeting will include discussion of a paper about the use of specific food additives in wine production; draft revisions to the food category 01.1 “Milk and dairy-based drinks”; and use levels for paprika extract. See Federal Register, January 11, 2016. Issue 590
The Center for Science in the Public Interest (CSPI) has filed a lawsuit against the U.S. Food and Drug Administration (FDA) to compel the agency to act on the advocacy group’s 2005 citizen petition requesting regulations about the use of salt as a food additive. Ctr. for Sci. in Pub. Interest v. FDA, No. 15-1651 (D.D.C., filed October 8, 2015). The petition called for FDA to revoke salt’s status as generally recognized as safe, amend prior approvals of salt use, require food manufacturers to reduce sodium levels in processed foods, and mandate labeling messages about the health effects of salt in foods containing more than half an ounce of the substance. The complaint alleges that while “[n]early all Americans consume more sodium than is safe,” “[c]onsumers can exert relatively little control over their sodium intake by adjusting discretionary use of salt” because such use amounts to only 5 to 10…
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…
The U.S. Food and Drug Administration (FDA) has published a July 31, 2015, warning letter targeting the use of whole stevia leaf in food and beverages. Issued to Ten Ren Tea Co. of San Francisco, Ltd., the letter claims that tea products containing “Stevia leaf, tea bag cut” are adulterated under the Federal Food, Drug, and Cosmetic Act “because they bear or contain an unsafe food additive.” “Any substance added to a conventional food, such as your Ten Ren Chrysanthemum Tea and Hibiscus Spice Tea, must be used in accordance with a food additive regulation, unless the substance is the subject of a prior sanction or is generally recognized as safe (GRAS) among qualified experts for its use in foods [21 CFR 170.30(g)],” notes the agency, which has only permitted highly-refined stevia preparations in specific applications. “[W]e are not aware of any basis to conclude that Stevia leaf is GRAS…
