A federal court in New Jersey has, for a second time, requested supplemental briefing before approving a stipulated final order for permanent injunction and other equitable relief in the Federal Trade Commission’s (FTC’s) action against a company that allegedly marketed açai-berry weight-loss products with “fake” news reports and deceptive claims. FTC v. Circa Direct LLC, No. 11-2172 (D.N.J., order filed June 13, 2012). Among other matters, the court seeks FTC’s views on whether the agency has shown it was likely to succeed on the merits “without an admission of liability by the Defendants and with no evidentiary submissions before the Court.” The court also requests additional briefing on whether it “may consider the lack of an admission by the defendants in its public interest analysis under the [FTC Act].” When the parties submitted their first supplemental briefs, FTC Commissioner J. Thomas Rosch submitted a letter indicating that, in his view,…
Category Archives Legislation, Regulations and Standards
The U.S. Government Accountability Office (GAO) has issued a report highlighting the need for improved performance information and cost analysis for environmental, health and safety (EHS) research as they relate to nanotechnology. As part of its analysis, GAO reviewed nanotechnology research conducted in 2010 by seven National Nanotechnology Initiative (NNI) member agencies, including the Food and Drug Administration. According to the 84-page report, EHS research funding grew from $38 million in 2006 to $90 million in 2010. GAO found several problems in 2010, however, that “raise concerns about the quality of EHS funding data reported.” It also discovered, among other things, that although the member agencies most frequently focused on carbon nanotubes, nanosilver and nanoscale titanium dioxide, NNI had not prioritized nanomaterials for EHS research. GAO recommends that the Office of Science and Technology Policy (i) “coordinate development of performance information for NNI EHS research needs and publicly report this…
A federal court in Florida has denied the Federal Trade Commission’s (FTC’s) request that it modify a stipulated final order resolving a 2006 dispute with Garden of Life, Inc. over purportedly unsubstantiated representations that its products could treat a range of serious diseases and their symptoms. FTC v. Garden of Life, Inc., No. 06-80226 (S.D. Fla., filed May 25, 2012). The parties had agreed that the company could make such claims if supported by “competent and reliable scientific evidence,” defined in the stipulated final order as “tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area, that has been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results.” Claiming that the company was continuing to deceive consumers and that “the Stipulated Final Order has failed to…
The New York City Board of Health and Mental Hygiene (DOHMH) has called a July 24, 2012, public hearing to gather feedback on Mayor Michael Bloomberg’s recommendation to limit the size of sugar-sweetened beverages sold at local food service establishments. The 11 member board reportedly voted unanimously at a June 12, 2012, meeting to publish the proposal, which would amend Article 81 of the Health Code to establish a maximum serving size of 16 ounces for sugary non-alcoholic drinks and all self-service cups. If adopted by DOHMH on September 13, the amendment would apply to restaurants, food carts, delis, movie theaters, stadiums, and arenas while also imposing a $200 fine for each violation of the code. According to the notice of public hearing, the proposal seeks to address rising obesity rates among city residents by “reacquainting New Yorkers with more appropriate portion sizes.” The plan has apparently drawn support from…
California Secretary of State Debra Bowen (D) has reportedly certified that enough valid signatures were gathered to allow a genetically modified organism (GMO) food-labeling initiative on the state ballot during the November 6, 2012, general election. In May, the Committee for the Right to Know obtained 971,126 signatures, of which 555,236 had to be proven valid. The ballot initiative, aka California Right to Know Genetically Modified Food Act, was covered in Issue 438 in this Update. “We’re thrilled that Californians will have the opportunity this November to vote for the right to know what’s in our food,” said Stacy Malkan, a committee spokesperson. “It’s about our fundamental right to make informed choices about the food we eat and feed our families.” See California Secretary of State Debra Bowen Press Release, June 11, 2012; Law360, June 12, 2012.
According to news sources, Philippine Department of Justice Secretary Leila de Lima issued an opinion in May 2012, upholding a Department of Health (DOH) memorandum that prohibited multinational companies that make infant milk and other nutritional products from using registered trademarks that contain health and nutrition claims which may undermine breastfeeding and breast milk. The companies were not prohibited from selling or advertising their products as long as their marketing materials, including product labels, comply with DOH rules. DOH apparently took the action on the basis of data showing that the country has a weak breastfeeding culture. In issuing her ruling, de Lima rejected the companies’ contention that preventing a trademark owner from the right to use its own registered mark on its products constituted a deprivation of property without due process of law. She reportedly said, “deceptive marks and misdescriptive marks are absolutely unregistrable.” See Business Mirror, June 13,…
Health Canada recently issued “Guidance for the Food Industry on Reducing Sodium in Processed Foods” as part of its effort “to help Canadians achieve the average sodium intake goal of 2300 mg per day by 2016.” According to Health Canada, which developed the voluntary guidance after receiving “significant input” from stakeholders, the benchmark sodium levels aim to help food manufacturers gradually reformulate their products to meet the nation’s sodium-reduction goals. To that end, the agency calculated the Sales Weighted Average (SWA) sodium content in milligrams per 100 grams “using the sodium levels of the products within a category weighted by their Canadian volume market share in kilograms (kg).” The 2016 proposed SWA sodium levels were then established “by reducing the baseline SWA sodium content by approximately 25% to 30%.” “The phased levels typically represent, respectively, 1/3 and 2/3 of the reduction required to meet the 2016 guiding benchmark SWA levels…
The Food and Drug Administration (FDA) has notified Representative Edward Markey (D-Mass.) that it has accepted his petition seeking to prohibit the use of bisphenol A (BPA) in canned infant formula. If the agency is able to complete its scientific review, it will file his petition in the Federal Register within 90 days seeking public comment on whether the industry has actually abandoned this use of the chemical, the ground on which Markey sought the ban. As noted in Issue 433 of this Update, while FDA has confirmed the chemical’s safety for continued use in food-packaging materials, the American Chemistry Council has asked the agency to prohibit its use in polycarbonate bottles and sippy cups, contending that industry no longer uses BPA in these products. Markey’s petition echoed that rationale in relation to infant-formula packaging. According to a news source, the “abandonment” focus allows government to “sidestep the debate over…
The U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) has extended until June 14, 2012, the comment period for a proposed rule that would amend regulations governing the importation of live bovines and other animal products with regard to bovine spongiform encephalopathy (BSE). Under the proposed rule, APHIS would adopt World Organization for Animal Health criteria that identify a country’s BSE risks as negligible, controlled or undetermined, bringing U.S. import regulations in line with international health standards. APHIS has pushed back the deadline to allow “interested persons additional time to prepare and submit comments.” Additional details about the proposed rule appear in Issue 432 of this Update.
A federal court in New York has determined that the Food and Drug Administration (FDA) arbitrarily denied petitions filed by advocacy organizations in 1999 and 2005 requesting the initiation of proceedings to withdraw approval from certain uses of antibiotic drugs in livestock. Nat. Res. Defense Council v. FDA, No. 11-3562, (S.D.N.Y., decided June 1, 2012). The ruling follows the court’s March 2012 grant of summary judgment to the plaintiffs on their first claim for relief. Additional information about that ruling appears in Issue 432 of this Update. The most recent ruling relates to the third claim for relief, that is, whether FDA violated the Administrative Procedure Act when it denied the two petitions “requesting that the FDA withdraw approval of certain uses of certain classes of antibiotics in food-producing animals.” The court first determined that it had subject matter jurisdiction over the claim, disagreeing with FDA’s assertion that its November 2011 decision…
