The U.S. Department of Agriculture’s Food Safety and Inspection Service and the Food and Drug Administration have announced a February 5, 2013, public meeting in Washington, D.C., to provide information and receive public comments on draft U.S. positions for discussion during the 23rd Session of the Codex Committee on Fats and Oils of the Codex Alimentarius Commission in Langkawi, Malaysia, on February 25-March 1, 2013. Agenda items include a proposed draft standard for fish oils, proposed draft amendment to parameters for rice bran oil in the standard for named vegetable oils, discussion paper on the revision of the limit for campesterol in the Codex standard for olive oils and olive pomace oils, and discussion paper on cold-pressed oils. See Federal Register, January 23, 2013.
Category Archives U.S. Government and Regulatory Agencies
The Food and Drug Administration (FDA) has requested public comments on the information collection provisions of regulations that “require registration for domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States.” According to FDA, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 requires food facilities to provide information via Form FDA 3537 (§1.231) or the electronic Food Facility Registration Module that will support FDA’s enforcement activities and help the agency issue notifications in the event of accidental or deliberate contamination. In 2011, the Food Safety Modernization Act amended these regulations to compel facilities to renew their registrations biennially and to submit additional information, such as “the email address for the contact person of a domestic facility and the email address of the U.S. agent for a foreign facility.” Based on the registrations received in previous years,…
The Federal Trade Commission (FTC) has issued a final decision in a complaint alleging that POM Wonderful made false and misleading claims by advertising its pomegranate juice products with health-benefit assertions that the company contended were backed by medical research. In re POM Wonderful LLC, No. 9344 (FTC, decided January 10, 2013). Additional information about the matter appears in Issue 441 of this Update. Henceforth, two randomized, controlled clinical trials (RCTs) will be required before POM can make a claim that any of its products treat, prevent or reduce the risk of heart disease, prostate cancer or erectile dysfunction (ED). Any efficacy or health benefit claims falling short of disease claims will require substantiation consisting of “competent and reliable scientific evidence . . . that must be sufficient in quality and quantity when considered in the light of the entire body of relevant and reliable scientific evidence, to substantiate that the…
The Food and Drug Administration (FDA) has recently drawn criticism over the delayed release of documents evaluating the environmental impact of genetically engineered (GE) salmon. Created by Massachusetts-based AquaBounty Technologies, the GE salmon in question evidently contain genes from Chinook salmon as well as ocean pout that allow the company to bring the fish to market in half the normal time. After a publicly contentious review process, FDA released the May 4, 2012, draft assessment and a preliminary finding of no significant impact in late December, raising questions among groups such as the Genetic Literacy Project (GLP) about whether the agency froze the application to avoid political turmoil during the election season. “The delay, sources within the government say, came after meeting with the White House, which was debating the political implications of approving the [GE] salmon, a move likely to infuriate a portion of its base,” GLP Executive Director…
The Food and Drug Administration (FDA) is seeking comments and other information, including data, to help determine whether the agency can establish regulatory thresholds for major food allergens such as milk, eggs, fish, crustacean shellfish, tree nuts, wheat, peanuts, and soybeans. In a recent notice, FDA states that although “[We have] used several risk management strategies to reduce the risk from unlabeled major food allergens, such as targeted inspections or discussions with industry organizations, we have not established regulatory thresholds or action levels for major food allergens. The establishment of regulatory thresholds or action levels for major food allergens would help us determine whether, or what type of, enforcement action is appropriate when specific problems are identified and also help us establish a clear standard… Regulatory thresholds also would help industry to conduct allergen hazard analyses and develop standards for evaluating the effectiveness of allergen preventive controls.” In particular, FDA…
The Food and Drug Administration (FDA) has proposed two new food safety rules addressing foodborne illness prevention and produce safety under the Food Safety Modernization Act. According to FDA, the first rule would require both foreign and domestic food manufacturers “to develop a formal plan for preventing their food products from causing foodborne illness” and to establish plans “for correcting any problems that arise.” The second rule proposes “enforceable safety standards for the production and harvesting of produce on farms,” including “science- and risk-based standards for the safe production and harvesting of fruits and vegetables.” Before drafting the rules, FDA apparently conducted “extensive outreach” involving the produce industry, consumers, other government agencies, and the international community. It will accept comments on both rules until May 16, 2013, and plans to issue further proposals addressing the safety and oversight of imported foods. “We know one-size-fits-all rules won’t work,” said FDA Deputy…
The Federal Trade Commission (FTC) recently adopted final amendments to the Children’s Online Privacy Protection Rule (COPPA) that aim to “strengthen kids’ privacy protections and give parents greater control over the personal information that websites and online services may collect from children under 13.” Based on the findings of a review initiated in 2010, these amendments (i) “modify the list of ‘personal information’ that cannot be collected without parental notice and consent, clarifying that this category includes geolocation information, photographs, and videos”; (ii) “offer companies a streamlined, voluntary and transparent approval process for new ways of getting parental consent”; (iii) “close a loophole that allowed kid-directed apps and websites to permit third parties to collect personal information from children through plug-ins without parental notice and consent”; (iv) “extend coverage in some of those cases so that the third parties doing the additional collection also have to comply with COPPA”; (v)…
Russian health regulators have announced a new regulation that will require imported meat to undergo testing for and be certified free of ractopamine, a hormone that has reportedly been linked to health concerns. The additive allegedly promotes animal growth and leaner meat and is added to some animal feed in the United States. According to news sources, because the U.S. Department of Agriculture (USDA) has no mechanism in place certifying meat as “ractopamine free,” the Russian requirement could effectively halt U.S. pork and beef exports to the country, profoundly affecting the more than $500 million market. Some industry analysts reportedly see the move as retaliation for American legislation punishing Russian officials linked to alleged human rights violations. In a recent press release, U.S. Agriculture Secretary Tom Vilsack stated, “The United States is very concerned that Russia has taken these actions, which appear to be inconsistent with its obligations as a…
The Food and Drug Administration (FDA) has extended for five years a 2007 food safety agreement with the General Administration of Quality Supervision, Inspection, and Quarantine of China (AQSIQ) to “enhance cooperation between the U.S. and China on food and feed safety.” The agreement includes provisions enhancing FDA’s “ability to identify high-risk food products entering the United States from China,” facilitating food facility inspections, focusing on “high-risk foods,” and creating processes for FDA to “accept relevant, verified information from AQSIQ regarding registration and certification.” See CFSAN Constituent Update, December 11, 2012.
The U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) has requested an extension of approval of an information collection associated with the regulations for the introduction of organisms and products altered or produced through genetic engineering. The regulations set forth “the permit application requirements and the notification procedures for the importation, interstate movement, or release into the environment of a regulated article and necessitate certain information and recordkeeping requirements, including APHIS issued permits, applicants’ field testing records, and the submission of protocols to ensure compliance.” APHIS is asking the Office of Management and Budget to approve its use of these information collection activities for an additional three years. The agency will consider comments received by February 11, 2013. See Federal Register, December 11, 2012.
