In response to a petition filed by the U.S. Pharmacopeial Convention, the U.S. Food and Drug Administration (FDA) has issued a final rule that amends select food-additive regulations referring to “food-grade specifications from prior editions of the Food Chemicals Codes (FCC) to incorporate by reference food-grade specifications from the FCC 7th Edition.” The rule took effect November 29, 2013, but objections and requests for hearing may be filed until December 30. See Federal Register, November 29, 2013.
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A recent study has reportedly linked high phosphorus consumption to increased all-cause mortality in a healthy adult population, raising concerns about the use of inorganic phosphorus additives in processed food. Alex Chang, et al., “High dietary phosphorus intake is associated with all-cause mortality: results from NHANES-III,” American Journal of Clinical Nutrition, November 2013. Relying on 24-hour dietary recall surveys from 9,686 participants in the National Health and Nutrition Examination Survey – III, researchers noted an association between high phosphorus intake and all-cause mortality for individuals who consumed more than 1,400 milligrams of phosphorus per day. “The relation between increasing absolute phosphorus intake and mortality appeared flat until a threshold of ~1400 mg/d, which is an amount of phosphorus consumption that is twice the adult US RDA [recommended daily allowance],” reported the study’s authors. Although they acknowledged that their results did not distinguish between organic and inorganic sources of phosphorus, they…
The U.S. Food and Drug Administration (FDA) has issued a request for comments on proposed revisions to its “Guidance for Industry: Studies to Evaluate the Utility of Anti-Salmonella Chemical Food Additives in Feeds.” With the aim of helping sponsors design efficacy studies to support the submission of food additive petitions (FAPs) related to preventing Salmonella in food for animals, FDA noted that a revision is necessary because science, technology and FDA policy have changed since the guidance was last revised. Because current guidance addresses only chemical food additives intended to maintain feeds or feed ingredients as Salmonella-negative, the agency intends to expand the scope to address other categories of food additives beyond chemical food additives and to cover all food for animals, including pet food. Among other things, FDA seeks comment on the following questions: (i) what intended technical effects will the agency see in FAPs for anti-Salmonella use of…
India’s Supreme Court has reportedly accepted a government scientific panel’s finding that the chemical additives in soft drinks— e.g., artificial sweeteners, phosphoric acid, carbon dioxide, coloring agents, benzoic acid, and caffeine—are well within safety levels and do not pose a health hazard to citizens. According to a news source, the Union government insisted that the Food Supply and Standards Act, 2006, along with its rules and regulations, constituted a “vigorous regulatory regime and [was] being implemented meticulously.” At the same time, however, the court ordered the Food and Safety Standards Authority of India to monitor and conduct regular checks of all carbonated soft drinks sold in the country, indicating that the matter relates to citizens’ fundamental right to life guaranteed under the Constitution. The order was passed by a bench composed of Justices K.S. Radhakrishnan and A.K. Sikri, who were hearing a public interest litigation (PIL) seeking the establishment of an independent…
A federal court in California has granted in part and denied in part the motion to dismiss filed by Dole Food Co. in a putative nationwide class action alleging that the company misbrands a number of its fruit products by making certain “all natural,” “fresh,” nutrient content, antioxidant, sugar-free, and health claims, as well as failing to disclose that the products contain artificial additives, chemical preservatives and other artificial ingredients. Brazil v. Dole Food Co., No. 12-1831 (N.D. Cal., order entered September 23, 2013). According to the court, the plaintiff has standing at this stage of the proceedings to bring claims as to products he did not purchase, ruling that he may proceed with “substantially similar claims based on both products he purchased and substantially similar products he did not purchase” on behalf of unnamed class members. The court dismissed with prejudice claims based on the company’s website statements because the…
The European Commission (EC) has issued a draft rule amending Regulation 1169/2011—a food information and labeling rule adopted in 2011—with regard to use of the term “nano” to describe food additives. The amended rule requires adherence to the definition of “engineered nanomaterial” provided in Recommendation 2011/696/EU, because this rule “reflects the technical and scientific progress to date.” The revised rule further states that the definition of a nanomaterial should be “linked” to the International Organization for Standardization’s definition that an engineered nanomaterial is “a nanomaterial designed for a specific purpose or function.” According to the revised regulation, some food additives, which had been registered as “nano,” may no longer be categorized as such. Noting that it would be “unsuitable” and confusing for certain food additives to be preceded by the word “nano,” the revision states that “food additives included in the [Union lists] should not be mandatorily qualified as ‘nano’ in the…
The Pew Charitable Trusts’ Food Additive Project has published a paper in Reproductive Toxicology claiming that gaps in the toxicity data for food additives raise questions about the Food and Drug Administration’s (FDA’s) safety assessments for these substances. Thomas Neltner, et al., “Data Gaps in Toxicity Testing of Chemicals Allowed in Food in the United States,” Reproductive Toxicology, August 2013. Comparing data from FDA’s Priority-based Assessment of Food Additives database, the Accelrys Toxicity Database of chemical studies and the U.S. National Library of Medicine’s TOXLINE database, the study’s authors apparently determined that “almost two-thirds of chemical additives appear to have been declared safe for use in food without the benefit of being fed to an animal in a controlled toxicology study,” while approximately 78 percent of additives lack adequate data to estimate a safe level of exposure and 93 percent lack reproductive or development toxicity testing. They also reported that, according to…
The Food and Drug Administration (FDA) has issued a final rule providing “for the safe use of spirulina extract made from the dried biomass of the cyanobacteria Arthrospira platensis (A. platensis), as a color additive in candy and chewing gum.” According to FDA, “Spirulina is a blue-green filamentous cyanobacteria that occurs naturally in freshwater and marine habits.” Its extract primarily contains “the water soluble components of spirulina, namely phycocyanins and other proteins, polysaccharides, lipids, and minor amounts of components such as vitamins, minerals, and moisture.” FDA has also determined that “there is no need for a specific upper limit for the color additive or phycocyanin content,” although the extract must abide by limits for lead, arsenic and mercury, in addition to testing negative for the microcystin toxin, “which is produced by some species of cyanobacteria that could be potentially present in the water where A. platensis is grown and harvested.”…
A recent study published in JAMA Internal Medicine has faulted the Food and Drug Administration’s (FDA’s) process for declaring food additives “generally recognized as safe” (GRAS), citing alleged financial conflicts of interest among those chosen by companies to verify the safety of new additives. Thomas Neltner, et al., “Conflicts of Interest in Approvals of Additives to Food Determined to Be Generally Recognized as Safe: Out of Balance,” JAMA Internal Medicine, August 2013. Led by Thomas Neltner, director of the Pew Health Group’s Food Additive Project, researchers used the Institute of Medicine’s conflict of interest criteria to analyze “451 GRAS notifications voluntarily submitted to FDA between 1997 and 2012.” In particular, they sought to determine (i) “the likelihood that a decision by an individual making a [GRAS] determination would be unduly influenced by the financial interests of a manufacturer of an additive,” and (ii) “the seriousness of possible harm if a GRAS…
A federal court in California has issued an order preliminarily certifying a nationwide class for settlement purposes and approved the class settlement in a case alleging that Barbara’s Bakery misled consumers by labeling its products as “all natural” with “no artificial additives,” “no artificial preservatives,” or “no artificial flavors,” when they contained genetically modified (GM), artificial or synthetic ingredients. Trammell v. Barbara’s Bakery, Inc., No. 12-2664 (N.D. Cal., order filed June 26, 2013). Under the proposed terms, the company would create a $4 million non-revertible fund to pay class member claims, an incentive award for the named plaintiff, attorney’s fees, and costs of notice and administration. Class members would able to recover up to $100 for the purchase of products including cereals, cereal bars, cheese puffs, fig bars, granola bars, Snackanimal® animal cookies, organic mini-cookies, snack mixes, and crackers. The settlement would also require the company to modify the labeling and…
