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The European Food Safety Authority (EFSA) has issued a scientific opinion reevaluating the safety of silicon dioxide used as a food additive, concluding that the available information is insufficient to confirm the current acceptable daily intake. The panel reportedly found no indication of adverse effects or genotoxicity, but it questioned a long-term study indicating silicon dioxide is not carcinogenic because the description of the primary particle size was not reported. The panel recommended that the European Commission consider lowering the current limits for arsenic, lead, mercury and cadmium in the current specifications for silicon dioxide to ensure it will not be a source of exposure to those elements.

The makers of vodka infused with chemicals that purportedly reduce the risk of alcohol-related damage to DNA have filed a lawsuit against the Treasury Department and the Alcohol and Tobacco Tax and Trade Bureau (TTB) seeking to include health-related claims in product labeling and advertising. Bellion Spirits, LLC, v. United States, No. 17-2538 (D.D.C., filed November 27, 2017). Bellion Spirits asserts that it develops alcohol beverages that protect against the adverse effects of alcohol with “safe additives.” The company petitioned TTB for permission to use health-related claims for vodka containing the additive NTX, according to the complaint, but TTB referred the petition to the U.S. Food and Drug Administration (FDA). Adopting FDA’s finding that the health claims were not adequately substantiated and that the protective effects of NTX were not established, TTB denied the petition. The plaintiffs allege that TTB violated federal law by deferring to FDA, which used evaluative…

Five public advocacy groups have filed suit against the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration (FDA) seeking to vacate FDA’s “Substances Generally Recognized as Safe” (GRAS) rule, which allegedly allows “potentially unsafe food additives to be used in the food supply (human and animal) without FDA review, approval, oversight, or knowledge, in violation of the Federal Food, Drug and Cosmetic Act (FDCA).” Ctr. for Food Safety v. Price, No. 17­3833 (S.D.N.Y., filed May 22, 2017). The plaintiffs argue that the GRAS rule allows manufacturers to certify that a substance is GRAS without notice to FDA or the public, although the rule gives them the option to notify the agency about certification. However, they allege, the Food Additives Amendment to the FDCA requires food additives to go through an FDA approval process. FDA allowed manufacturers to begin using the proposed rule’s optional notification…

The U.S. Food and Drug Administration (FDA) denied a citizen petition to ban the use of perchlorates in dry food packaging while revoking regulations permitting the use of potassium perchlorate in food­-container seals, saying industry makers no longer use the chemical. FDA said it will amend food additive regulations allowing the use of potassium perchlorate as a component in sealing gaskets for food containers. Trade groups petitioned for the change, arguing that plastics manufacturers have stopped using the compound. The following day, FDA rejected a petition from public interest groups seeking to ban use of potassium perchlorate and sodium perchlorate monohydrate in dry food packaging and requesting that the agency issue new regulations prohibiting use of perchlorates in packaging. Neither request was “the proper subject of a food additive petition,” the agency stated, but the groups could petition to revoke or reevaluate the Threshold of Regulation exemption.   Issue 633

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

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

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