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…
Category Archives U.S. Government and Regulatory Agencies
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The Food and Drug Administration (FDA) has published draft guidance titled “Frequently Asked Questions About Medical Foods; Second Edition” that provides additional information about the definition, labeling and availability of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.S. Department of Agriculture’s (USDA’s) Office of Inspector General (OIG) has released a July 2013 audit report examining how the Agricultural Marketing Service’s (AMS’s) National Organic Program (NOP) established the “access to pasture” rule for organic dairy cattle. Although OIG generally found that the new rules for organic milk production were “successfully implemented,” it nevertheless recommended that AMS clarify guidance for certifying agents “to ensure that all dairy producers are being treated consistently.” To this end, the audit noted that NOP (i) “had not clearly defined how producers should demarcate herds of organic milk-producing cattle, which meant that some certifying agents allowed producers to add cattle to organic herds,” and (ii) “needs to include organic feed brokers within the NOP-certification process to ensure that organic feed is not commingled or contaminated.” OIG also reported that certifying agents failed to take consistent enforcement actions “when their inspectors or reviewers identified…
University of Illinois Associate Professor of Agricultural Law A. Bryan Endres has co-authored a recently published update of the law suggesting that federal government action on a variety of agriculture- and food-related topics, moribund in the months preceding the 2012 presidential election, could increase during the next few years in light of increasing public interest in food production and safety issues. “United States Food Law Update: Shrouded by Election-Year Politics, State Initiatives and Private Lawsuits Fill in the Gaps Created by Congressional and Agency Ossification,” Journal of Food Law & Policy, Spring 2013. Funded in part by the U.S. Department of Agriculture National Institute of Food and Agriculture, the article covers a range of topics including (i) consumer fraud suits challenging the “all natural” promotions for processed food products, (ii) efforts by animal rights organizations to require the humane handling of food animals, (iii) country-of-origin and genetic modification labeling initiatives,…
The U.S. Food and Drug Administration (FDA) has filed a motion for reconsideration or stay of a court order establishing rulemaking deadlines under the Food Safety Modernization Act. Ctr. for Food Safety v. Hamburg, No. 12-4529 (N.D. Cal., Oakland Div., motion filed July 19, 2013). More information about the litigation appears in Issues 481, 487 and 489 of this Update. Scheduled to be heard on August 28, 2013, the motion contends that two of the seven rulemakings at issue, the sanitary transport rule and the intentional adulteration rule, pose challenges that preclude their issuance by the court’s deadline. Requesting that the court reconsider its order largely on the basis of arguments already rejected, the agency also asks the court to stay the order pending the Solicitor General’s determination whether to authorize an appeal and, if an appeal is authorized, while the appeal is pending.
The U.S Food and Drug Administration (FDA) has announced a public meeting of the Food Advisory Committee on September 23-24, 2013, in Silver Spring, Maryland. The committee plans to discuss detection signals for chemical hazards in foods, dietary supplements and cosmetics, and review information sources and chemical hazard data. FDA will accept comments until September 16, 2013. See Federal Register, July 23, 2013.
