The Food and Drug Administration (FDA) has issued industry guidance concerning the “administrative detention of human or animal food.” Providing information about FDA’s authority under the Food Safety and Modernization Act to hold adulterated or misbranded food and prevent it from reaching the marketplace, the guidance explains who can approve an administrative detention order, what food may be subject to detention, who receives a copy of the order, and the appeals process. See Federal Register, October 25, 2011.
Category Archives Food and Drug Administration
The Food and Drug Administration (FDA) recently opened a docket pertaining to a petition filed by Philadelphia seeking to exempt from preemption a menu labeling ordinance that requires chain restaurants and retail food facilities in the city to provide calorie, fat and sodium information for the food and beverage products they sell. According to the petition, the ordinance meets three requirements under the Federal Food, Drug, and Cosmetic Act allowing FDA to grant an exemption from preemption: the ordinance “was designed to address a particular local need for information which need is not met by the requirements” of federal labeling law, the exemption from preemption “would not unduly burden interstate commerce,” and the exemption “would not cause any food to be in violation of any applicable requirement under federal law.” Philadelphia contends that while Congress required uniformity in chain restaurant menu labeling as part of the Patient Protection and Affordable…
The Food and Drug Administration (FDA) has announced changes to its bottled water quality standard “by establishing an allowable level for the chemical di(2-ethylhexyl)phthalate (DEHP).” Effective April 16, 2012, the final rule establishes “in § 165.110(b)(4)(iii)(C) (21 CFR 165.110(b)(4)(iii)(C)), which includes allowable levels for pesticides and other synthetic organic chemicals, an allowable level for DEHP at 0.006 mg/L.” It also requires manufacturers to monitor their products “for DEHP at least once each year under the current good manufacturing practice (CGMP) regulations” and to monitor their source water “as often as necessary, but at least once every year unless they meet the criteria for source water monitoring exemptions under the CGMP.” According to FDA, the amended rule brings bottled water standards in line with those set by the Environmental Protection Agency (EPA) for public drinking water. The two comments opposing the rule change evidently did not provide enough evidence to challenge…
The Food and Drug Administration (FDA) has submitted a proposed information collection to the Office of Management and Budget (OMB) to conduct an experimental study designed to evaluate the public’s risk perceptions after a foodborne-illness-related recall. Produce growers, food retailers and consumers will be asked to participate in the study “to help FDA better understand whether the magnitude and duration of the decline in commodity consumption following food recalls can be partly explained by grower and retailer speculations and projections about consumers’ attitudes.” Using a hypothetical fresh spinach recall, the study will test whether “‘attribution error’—the tendency people have of overestimating others’ negative response to situations compared to their own response”—contributes to unnecessarily prolonging the economic effects of a food recall. The study will involve 900 participants (180 growers, 180 retailers and 540 consumers) assigned to either an ‘‘anger’’ scenario, ‘‘fear’’ scenario or ‘‘control’’ scenario. After reading a news article…
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.
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…
