The U.S. Food and Drug Administration (FDA) has rejected objections filed after publishing its final rule amending “the food additive regulations authorizing the use of vitamin D2 bakers yeast as a source of vitamin D2 and as a leavening agent in yeast-leavened baked products at levels not to exceed 400 International Units (IU) of vitamin D2 per 100 grams (g) in the finished food.” According to the agency, “the objections do not provide any basis for us to reconsider our decision to issue the final rule,” and thus FDA has made no changes to it. See Federal Register, March 11, 2014. Issue 517
Tag Archives additive
The Environmental Working Group (EWG) has followed up FoodBabe.com’s Vani Hari’s petition to Subway about using azodicarbonamide (ADA)—a “chemical used to make yoga mats, shoe soles and other rubbery objects”—in its U.S. food products, by launching its own petition directed to major brands purportedly using the chemical in some 500 food products. Details about Hari’s petition appear in Issue 512 of this Update. The EWG list of food products containing ADA, ranging from bread, croutons and pre-made sandwiches and snacks to pastries, rolls, pierogies, and bagels, was derived from the organization’s database of 80,000 food products. The synthetic ingredient is apparently listed on product labels, but, according to EWG “has been largely overlooked because it is not known to be toxic to people in the concentration approved by the federal Food and Drug Administration—45 parts per million.” EWG claims that commercial bakers switched to ADA in the early 1990s to…
The U.S. Food and Drug Administration (FDA) has issued a final rule denying requests for a stay of the effective date and for a hearing on the final rule concerning the use of irradiation in food production, processing and handling. Originally appearing in the August 22, 2008, Federal Register, the rule amended food additive regulations to permit the use of ionizing radiation to control foodborne pathogens and extend the shelf life of fresh iceberg lettuce and spinach. After reviewing objections to the final rule and requests for a hearing, FDA has concluded that “the objections do not raise issues of material fact that justify a hearing or otherwise provide a basis for revoking or modifying the amendment to the regulation,” and confirmed August 22, 2008, as the effective date for the final rule. Issue 515
The U.S. Food and Drug Administration (FDA) has entered a consent decree with the Center for Food Safety, which sued the agency over its alleged failure to comply with implementation rulemaking deadlines in the Food Safety Modernization Act (FSMA). Ctr. for Food Safety v. Hamburg, No. 12-4529 (N.D. Cal., decree filed February 20, 2014). Under the agreement, FDA will withdraw its Ninth Circuit appeal and will comply with the following timeline for the adoption of final rules: (i) Preventive Controls for Human Food and Preventive Controls for Animal Food—August 30, 2015; (ii) Foreign Supplier Verification Program, Produce Safety Standards, and Accreditation of Third Party Auditors—October 31, 2015; (iii) Sanitary Transport of Food and Feed—March 31, 2016; and (iv) Intentional Contamination— May 31, 2016. The deadlines may be extended by written agreement of the parties and court approval if “FDA believes good cause exists to seek an extension.” If agreement is…
The European Food Safety Authority’s (EFSA’s) Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) has issued an opinion on formaldehyde, currently used as a feed additive and a preservative for skimmed milk intended for pigs. Concluding that “although there is no health risk for consumers exposed to the substance through the food chain,” FEEDAP cautions that inhalation of formaldehyde may cause cancer and appropriate measures should be taken to “ensure that the respiratory tract, skin and eyes of any person handling the product are not exposed to any dust, mist or vapour generated by the use of formaldehyde.” The panel also notes that formaldehyde will not accumulate in the environment and its use in animal nutrition is not expected to pose a risk for the environment. Issue 514
California EPA’s Office of Environmental Health Hazard Assessment (OEHHA) has entered a memorandum of understanding (MOU) with the state’s Department of Food and Agriculture relating to “cooperation and communication in the implementation of Proposition 65 with respect to exposure to Proposition 65 listed chemicals in food or food additives.” According to OEHHA, the agreement “describes the types of information that will be shared between the two agencies prior to public release and a mechanism by which the sharing can be accomplished.” Proposition 65 (Prop. 65) was adopted by voter initiative in 1986; it requires businesses to provide warnings when they cause an exposure to a chemical listed as known to the state to cause cancer or reproductive toxicity. The MOU applies to those chemicals listed under Prop. 65 “that are or may be found in California’s soil, food products, agricultural residues and fertilizers.” See OEHHA Press Release, February 5, 2014.…
The U.S. Department of Agriculture’s Food Safety and Inspection Service and the Food and Drug Administration have announced a February 11, 2014, public meeting in Washington, D.C., to provide information and receive comments on agenda items and draft U.S. positions for discussion during the 46th Session of the Codex Committee on Food Additives of the Codex Alimentarius Commission in Hong Kong, China, on March 17-21, 2014. Agenda items include (i) endorsement and/or revision of maximum levels for food additives and processing aids in Codex standards; (ii) food additive provisions for grape wine and its sub-categories; (iii) descriptors and food additive provisions for milk and buttermilk and their sub-categories, and dairy-based drinks, flavored and/or fermented (e.g., chocolate milk, cocoa, eggnog, drinking yoghurt, whey-based drinks); (iv) proposals for provisions of nisin in meat and meat products, including poultry and game; and (v) proposed draft amendments to the International Numbering System for food…
The U.S. Food and Drug Administration (FDA) has issued two final guidance documents for industry on distinguishing liquid dietary supplements from beverages. Titled “Distinguishing Liquid Dietary Supplements From Beverages” and “Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements,” the documents update 2009 draft guidance intended “to help dietary supplement and beverage manufacturers determine whether a liquid food product is properly classified as a dietary supplement or as a beverage, and to remind the industry of legal requirements regarding the substances that may be added to either type of product.” In “Distinguishing Liquid Dietary Supplements from Beverages,” FDA describes the factors characterizing liquid products deemed dietary supplements and those characterizing beverages deemed conventional foods. These include product claims, names, packaging, serving size, recommended daily intake, conditions of use, and product composition, as well as statements or graphic representations in labeling, advertising and other marketing practices, including promotional websites,…
The European Food Safety Authority’s (EFSA’s) Panel on Food Additives and Nutrient Sources Added to Food (ANS) has published its full risk assessment on aspartame, concluding that the food additive is safe at current levels of exposure. In addition to noting that aspartame’s breakdown products— phenylalanine, methanol and aspartic acid—occur naturally in other foods, EFSA’s experts found that aspartame’s acceptable daily intake (ADI) of 40 mg/kg bw/day “is protective for the general population,” with the exception of those individuals with phenylketonuria, a medical condition that necessitates a diet low in phenylalanine. At the request of the European Commission, the ANS Panel analyzed “all available information” in an effort to resolve uncertainties related to the re-evaluation of aspartame as a food additive. In particular, the panel’s final scientific opinion assessed both human and animal studies submitted in response to public calls for data; previous evaluations; and additional literature that became available during…
Texas and California residents have filed a putative class action against Whole Foods Market Services, Inc. in a Texas federal court, alleging that the company’s private label lines include falsely labeled additive-laden and genetically modified (GM) foods, despite promises that its products contain “nothing artificial” and that it enforces “strict quality standards.” Gedalia v. Whole Foods Mkt. Servs., Inc., No. 13-3517 (S.D. Tex., filed November 28, 2013). Among purported transgressions are (i) organic infant formula containing 25 ingredients “prohibited from being in organic foods” as well as 30 artificial ingredients, and (ii) organic soy and almond milk containing “ingredients not permitted in organic foods.” The complaint also alleges that the company reneges on its promise to avoid ingredients grown from genetically engineered seed and relies on a Cornucopia Institute study purportedly showing that Whole Foods’ 365 Everyday Value® products “were contaminated with high levels of genetically engineered ingredients,” citing, in particular,…
