The Food and Drug Administration (FDA), Centers for Disease Control and Prevention, Food Safety and Inspection Service (FSIS), Agricultural Research Service, and Center for Nutrition Policy and Promotion have announced a public meeting to discuss approaches to reduce sodium consumption. The November 10, 2011, public meeting in Silver Spring, Maryland, will provide a forum for the agencies to hear directly from interested parties and will help inform possible future regulation. Comments are requested by November 29. FDA and FSIS had previously requested “comments, data, and evidence relevant to the dietary intake of sodium as well as current and emerging approaches designed to promote sodium reduction.” Additional details about the open dockets on dietary sodium intake appear in Issue 409 of this Update. See Federal Register, October 12, 2011.
Category Archives U.S. Government and Regulatory Agencies
The Food and Drug Administration (FDA) has determined that text included in the preambles to three regulations adopted over the past 10 years and purporting to preempt state law “are not legally justified.” The agency reviewed all of its regulations in response to President Barack Obama’s (D) May 20, 2009, memorandum outlining the administration’s preemption policy. The three affected regulations involve labeling rules for prescription drugs, biological products and medical devices. FDA also clarified the preemption language in other regulations, including those on food labeling and specifically cited “74 FR 2443, January 15, 2009,” which proposed amending the labeling for yogurt products. According to the agency, the preamble, which discusses the rule’s “pre-emptive effect, in that it would preclude states from issuing any … requirements … that are not identical to those required by the final rule,” failed to “acknowledge the applicability limitation set forth in section 6 (c) (2)…
According to a news source, the Food and Drug Administration (FDA) is poised to prohibit the use of bisphenol A (BPA) in baby bottles and sippy cups in response to a petition filed by the American Chemistry Council. A council spokesperson apparently stated during an October 7, 2011, press briefing that while scientific data and government assessments have declared the chemical safe and U.S. manufacturers ceased making these products with the plasticizer in response to market demand, the council took the action because of “quite a bit of legislative activity around a product that doesn’t exist” and “[c]onfusion about these products has become an unnecessary distraction to consumers, legislators and state regulators.” An environmental advocate reportedly characterized the council’s petition as a “stunning reversal,” noting that the “industry spent millions this year fighting efforts in California and other states to ban BPA in baby bottles and sippy cups.” The Environmental…
The Center for Food Safety (CFS) has filed a legal petition on behalf of the “Just Label It” campaign with the Food and Drug Administration (FDA), “demanding that the agency require the labeling of all food produced using genetic engineering [GE].” Representing health-care, consumer, agricultural, and environmental organizations, the campaign has urged the public to submit comments on the petition to FDA and to question why GE foods are patented for novelty but remain unlabeled. The petition specifically calls on FDA to rescind its 1992 Statement of Policy: Foods Derived from New Plant Varieties, which evidently determined that GE foods do not require special labeling because they “are substantially equivalent to foods produced through conventional methods.” Instead, the petitioners want FDA to issue “a new policy declaring that a production process is ‘material’ under FFDCA [the Federal Food, Drug and Cosmetic Act] section 201(n) if it results in a change…
The Food and Drug Administration (FDA) has issued industry guidance concerning new fee provisions under the Food Safety Modernization Act. The guidance aims to provide answers to common questions about FDA’s plans for implementing the fees in fiscal year 2012. In particular, the guidance addresses such topics as fees for import re-inspections and non-compliance of a recall order, and FDA’s process for requesting fee reductions. FDA will accept comments at any time. See Federal Register, October 6, 2011.
The Food and Drug Administration (FDA) recently announced the availability of its draft Foods and Veterinary Medicine Strategic Plan 2012 – 2016, which takes into account “all of the activities within the jurisdictions of the Center for Food Safety and Applied Nutrition and the Center for Veterinary Medicine and includes activities supported by the Office of Regulatory Affairs.” According to the executive summary, the Foods and Veterinary Medicine (FVM) Program aims to protect the American food supply by securing high rates of compliance with science-based food safety and labeling standards as well as implementing “integrated, prevention-oriented and risk-based programs.” To this end, the 2012-2016 plan identifies one cross-cutting goal—to “improve effectiveness and efficiency across all levels of the FVM program”—as well as seven program goals: (i) “Establish science-based preventive control standards across the farm-to-table continuum”; (ii) “Achieve high rates of compliance with preventive control standards domestically and internationally”; (iii) “Strengthen…
The Food and Drug Administration (FDA) has issued a report as part of a transparency initiative offering eight draft proposals “to make FDA’s publicly available compliance and enforcement data more accessible and user-friendly.” Based on public comments, an initiative task force will recommend specific draft proposals for FDA Commissioner Margaret Hamburg to consider by January 31, 2012. In particular, the report recommends that FDA explore (i) “different ways to improve data quality and facilitate more timely data disclosure,” (ii) “how to present its compliance and enforcement data graphically and better utilize mobile web applications,” (iii) “whether posting additional data compilations or analysis… would increase transparency,” and (iv) “ways to better utilize social media.” FDA requests comments by December 2, 2011. See Federal Register, October 4, 2011.
The U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) has issued a proposed rule that would amend and republish “the list of selected agents and toxins that have the potential to pose a severe threat to animal or plant health, or to animal or plant products.” The Agricultural Bioterrorism Protection Act of 2002 requires APHIS to review the list on a biennial basis and submit revisions as necessary. Among the criteria APHIS considers when determining the status of an agent or toxin are (i) the effects of exposure on animal or plant health and on the “production and marketability” of an animal or plant product, (ii) the pathogenicity of the agent or toxin, (iii) the ability to treat or prevent any illness caused by the agent or toxin, and (iv) any other factors deemed essential for the protection of animal and plant health. The agency requests comments…
The Federal Trade Commission (FTC) has entered a 20-year consent order with Phusion Projects, LLC, the maker of Four Loko®, an alcoholic beverage that has generated significant controversy for its “super-size” container and previous inclusion of caffeine, which some allege has led to binge-drinking and adverse health effects. In re: Phusion Projects, LLC, No. 112-3084 (FTC). According to an FTC news release, “The marketers of Four Loko have agreed to re-label and repackage the supersized, high-alcohol, fruit-flavored, carbonated malt beverage, to resolve Federal Trade Commission charges of deceptive advertising.” FTC alleged that the company’s advertisements, packaging and promotional material misrepresented the amount of alcohol in its products and, in fact, implied that a 23.5-ounce can of the beverage contains the alcohol equivalent of just one or two regular 12-ounce beers. The product actually contains alcohol equivalent to 4.7 regular beers, according to FTC. “As a result, consuming a single can…
The Office for the Under Secretary for Food Safety, the U.S. Department of Agriculture and the Food and Drug Administration have announced an October 4, 2011, public meeting in Washington, D.C., to provide information and receive public comments on draft U.S. positions to be discussed at the 19th session of the Codex Committee on Food Import and Export Inspection and Certification Systems (CCFICS) on October 17-21 in Cairns, Australia. CCFICS is responsible for such things as “harmonizing methods and procedures which protect the health of consumers, ensure fair trading practices and facilitate international trade in foodstuffs.” Agenda items include relevant activities of the World Health Organization and draft guidelines for national food-control systems. See Federal Register, September 27, 2011.
