Tag Archives additive

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…

The Grocery Manufacturers Association (GMA) has petitioned the U.S. Food and Drug Administration (FDA) “to approve specific low-level uses of partially hydrogenated oil (PHOs) in food products.” According to an August 5, 2015, press release, the petition seeks approval to use PHOs for color, flavor and texture when “important for the production of safe food products.” Because FDA revoked the generally recognized as safe (GRAS) status of trans fats on July 16, 2015, food manufacturers must now ask the agency to approve the ingredient for specific purposes. “Our food additive petition shows that the presence of trans fat from the proposed low-level uses of PHOs is as safe as the naturally occurring trans fat present in the normal diet,” said GMA Chief Science Officer Leon Bruner. “It’s important to know that food and beverage companies have already voluntarily lowered the amount of trans fat added to food products by more…

The U.S. Food and Drug Administration (FDA) has issued a determination revoking the generally recognized as safe (GRAS) status of partially hydrogenated oils (PHOs), “the primary dietary source of industrially-produced trans fatty acids.” To comply with the declaratory order, food and beverage companies must remove PHOs from products by June 18, 2018, or request food additive approval for specific uses of PHOs. Concluding that there is no longer expert consensus as to the safe use of artificial trans fat in human food, FDA argues that the action is “expected to reduce coronary heart disease and prevent thousands of fatal heart attacks every year.” In the wake of its November 2013 tentative decision, the agency apparently received more than 6,000 comments from individuals, industry and trade associations, consumer groups, and government officials, the majority of which purportedly supported the reduction of trans fat in the food supply. “Studies show that diet…

A June 10, 2015, petition filed by consumer and environmental groups asks the Food and Drug Administration (FDA) to ban the following synthetic substances widely used in baked goods, ice cream and beverages: (i) benzophenone (also known as diphenylketone); (ii) ethyl acrylate; (iii) eugenyl methyl ether (also known as 4-allylveratrole or methyl eugenol); (iv) myrcene (also known as 7-methyl-3-methylene- 1,6-octadiene); (v) pulegone (also known as p-menth-4(8)-en-3-one); (vi) pyridine; (vii) styrene; and (viii) trans,trans-2,4-hexadienal. Signed by the Center for Science in the Public Interest, National Resources Defense Council, Center for Environmental Health, Environmental Working Group, Center for Food Safety, Consumers Union, and Improving Kids’. Environment, the petition claims that the flavorings are not safe for use in human food under the Delaney Clause of the Food Additives Amendment Act (21 U.S.C. § 348 (c)(3)(A)) because the National Toxicology Program and other agencies have linked them to animal or human cancers. The…

An Environmental Working Group (EWG) investigation has reportedly concluded that 49 processed snack foods contain propylparaben, a preservative commonly found in cosmetic products. In light of its findings and various studies allegedly linking exposure to the chemical to decreased fertility and other hormone-related issues, EWG is urging the U.S. Food and Drug Administration to reconsider the preservative’s current “Generally Recognized as Safe” status as a food additive. “It is of great concern to us that the use of an endocrine-disrupting chemical in our food is considered safe by our own government,” Johanna Congleton, an EWG senior scientist was quoted as saying. “European Union regulators do not permit propyl paraben in food. So why do we?” EWG is soliciting concerned consumers to sign an online petition to food companies that states: “Your company uses the endocrine-disrupting chemical propylparaben in your products! Parabens are being taken out of some cosmetics and food products,…

The U.S. Food and Drug Administration (FDA) has extended the deadline for public comments about whether to expand the products included in its guidance titled “Toxicological Principles for the Safety Assessment of Food Ingredients”—also known as the “Redbook.” The agency is apparently considering this expansion “to include chemical safety assessments for all products over which FDA’s Center for Food Safety and Applied Nutrition (CFSAN) has statutory authority including regulatory contexts such as food additives, food contact substances, dietary supplement ingredients, food contaminants, and cosmetics.” According to FDA, “The Redbook would describe toxicological principles which apply across regulatory categories while still providing specific guidance for applying these principles within each particular context. The safety of foods containing microbial contaminants will continue to remain outside of the scope of the Redbook.” Comments may now be submitted until May 11, 2015. See Federal Register, February 2, 2015.

Close