The Food and Drug Administration (FDA) has apparently signaled its intent to proceed with an experimental study of consumer responses to nutrient content claims on fortified foods by issuing a notice of the proposed collection of information to the Office of Management and Budget. First announced in the August 15, 2012, Federal Register, the study would involve 7,500 adults asked to complete a 15-minute web-based survey designed to gauge their responses “to expressed and implied nutrient content claims on the labels of snack foods such as cookies, carbonated beverages, and candy.” “The study is a part of the Agency’s continuing effort to enable consumers to make informed dietary choices and construct healthful diets,” concludes FDA, which has estimated the total burden of this information collection at 3,099 hours. “Results of the study will be used primarily to inform the Agency’s understanding of how claims on the packages of fortified food…
Category Archives Legislation, Regulations and Standards
The Food and Drug Administration (FDA) has announced plans to prepare an environment impact statement (EIS) for a proposed rule that would establish standards for the growing, harvesting, packing, and holding of produce for human consumption. According to an August 16, 2013, FDA press release, the agency determined that an EIS was necessary based on public feedback and its own analysis, and will now begin a scoping process “designed to determine relevant issues that will influence the scope of the environmental analysis.” FDA will accept comments on the EIS scoping process until November 15, 2013. Additional details about the proposed produce standards appear in Issue 466 of this Update. See Federal Register, August 19, 2013.
The Food and Drug Administration (FDA) has announced an upcoming public meeting slated for September 19-20, 2013, in Washington, D.C., to discuss regulations proposed under the Food Safety Modernization Act (FSMA) that would establish Food Supplier Verification Programs as well as new rules for accrediting third-party auditors and certification bodies. Intended to ensure “that imported food meets the same safety standards as food produced domestically,” the proposed rules would (i) require importers “to verify that their foreign suppliers are implementing the modern, prevention-oriented food safety practices called for by [FMSA],” and (ii) “strengthen the quality, objectivity, and transparency of foreign food safety audits on which many U.S. food companies currently rely.” FDA will accept advanced registrations from individuals who wish to participate in person by September 10, 2013. Additional details about the proposed rules appear in Issue 492 of this Update. See Federal Register, August 16, 2013.
The Federal Trade Commission (FTC) has issued a request for comments concerning a proposed parental consent method submitted by AssertID, Inc. under the Voluntary Commission Approval Processes provision of the Children’s Online Privacy Protection Rule. Amended December 19, 2012, and effective July 1, 2013, the Children’s Online Privacy Protection Rule requires certain websites to post privacy policies and obtain verifiable parental consent before collecting, using or disclosing personal information from children younger than age 13 and provides approved methods for obtaining the consent. Interested parties may, however, submit requests for commission approval of additional consent methods. Regarding AssertID, Inc.’s proposal, the commission seeks comment on the following questions: (i) is this method already covered by existing methods listed in Section 312.5(b)(1) of the rule; (ii) does the proposed method meet the requirements for parental consent laid out in 16 C.F.R. § 312.5(b)(1)—is it reasonably calculated to ensure that the person…
Four years after filing a citizen petition with the U.S. Food and Drug Administration (FDA) seeking a prohibition on the use of partially hydrogenated oils containing artificial trans fat in food for human consumption, 98-year-old University of Illinois Emeritus Professor of Comparative Biosciences Fred Kummerow has filed a lawsuit seeking an order compelling an agency response to his petition and a declaration that its failure to ban trans fats violates the Food, Drug, and Cosmetic Act. Kummerow v. Hamburg, No. 13-2180 (C.D. Ill., filed August 9, 2013). The complaint details the history of the ingredient’s invention and research, including the plaintiff’s own, demonstrating its “harmful effects,” including inhibition of an enzyme necessary to prevent blood clots in the arteries and veins. The plaintiff also distinguishes between artificial and natural trans fats, noting that he does not seek a ban on the latter. According to the complaint, Kummerow learned in 2004…
The Food and Drug Administration (FDA) has published draft guidance titled “Frequently Asked Questions About Medical Foods; Second Edition” that provides additional information about the definition, labeling and availability of medical foods—“foods formulated to be consumed or administered orally or enterally under the supervision of a physician.” The first edition of this guidance was issued in May 2007. Comments will be accepted until October 15, 2013. See Federal Register, August 13, 2013.
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.”…
The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) has extended the comment period for a proposed rule that would require “mechanically tenderized” labeling for raw or partially cooked needle- or blade-tenderized beef products, “including beef products injected with marinade or solution.” According to FSIS, the rule would also require the labels of mechanically tenderized beef products destined for consumers, hotels, restaurants, or similar establishments to include “validated cooking instructions” to ensure safe handling and reduce the risk of foodborne illness. Acting at the request of two trade associations, the agency will now accept comments on the new labeling scheme until October 8, 2013. Additional details about the proposed rule appear in Issue 486 of this Update. See Federal Register, August 9, 2013.
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…
The U.K. Advertising Standards Agency (ASA) has ruled that pasta manufacturer NAH Foods, Ltd. cannot use a magazine ad for its “Slim Pasta” that features the heading “Zero Calorie Pasta?” and the subheading “UK & Ireland’s No.1 Best Selling Zero Calorie Pasta, Noodles & Rice” because tests of the product revealed that it actually contains 7.7 calories per 100 grams. In its defense, the company pointed out that the advertisement’s heading, “zero calorie pasta?”, contained a question mark and argued that it had not claimed “zero calorie pasta,” but ASA, while noting the question mark, decided that “consumers would infer that the advertiser was selling zero calorie pasta.” According to European regulation, a food can claim to be energy-free if it contains no more than 4 calories per 100 ml, and to make a low-energy claim, a food must contain no more 40 calories per 100 g for solid foods,…
