In response to the U.S. Food and Drug Administration’s request for comments on its “Draft Guidance for Industry on Arsenic in Apple Juice: Action Level,” the Center for Food Safety (CFS) has asked the agency to “limit the public’s exposure to arsenic through a new regulatory strategy that recognizes the prevalence of arsenic in the food supply.” Stating that although individual foods containing arsenic may be safe to eat in moderation, CFS maintains that they are often consumed in combination, thereby presenting a risk of “cumulative arsenic exposure” that could reach dangerous levels. Calling FDA’s draft guidance “insufficient” to address these health hazards, CFS’s November 12, 2013, letter to FDA asks for the agency to regulate based on “cumulative arsenic exposure” rather than through product specific levels. According to CFS, FDA “must do more” to adequately protect public health. To that end, CFS suggests that, because arsenic is present in…
Category Archives Food and Drug Administration
The U.S. Food and Drug Administration (FDA) has issued a request for comments on proposed revisions to its “Guidance for Industry: Studies to Evaluate the Utility of Anti-Salmonella Chemical Food Additives in Feeds.” With the aim of helping sponsors design efficacy studies to support the submission of food additive petitions (FAPs) related to preventing Salmonella in food for animals, FDA noted that a revision is necessary because science, technology and FDA policy have changed since the guidance was last revised. Because current guidance addresses only chemical food additives intended to maintain feeds or feed ingredients as Salmonella-negative, the agency intends to expand the scope to address other categories of food additives beyond chemical food additives and to cover all food for animals, including pet food. Among other things, FDA seeks comment on the following questions: (i) what intended technical effects will the agency see in FAPs for anti-Salmonella use of…
The U.S. Food and Drug Administration (FDA) has issued a request for comments regarding a proposed information collection about food labeling regulations. According to FDA, current approval periods for information collection requests regarding (i) third-party disclosure burdens about the amount of trans fatty acids present in a food, and (ii) voluntary declarations of the quantitative amount and the percent of Daily Value of a dietary ingredient on a “per day” basis in addition to the required “per serving” basis, have expired. To remedy the oversight, to most appropriately streamline these information collections, and to eliminate redundancy in its information collection requests, FDA seeks to revise the collection to “include these third party disclosure elements and have included them in the burden estimates and discussion.” Comments will be accepted until December 31, 2013. See Federal Register, November 1, 2013.
The U.S. Food and Drug Administration (FDA) has issued a request for comments concerning a proposed information collection for a Food Safety Survey. Specifically, the agency seeks comment on the following questions: (i) is the information collection necessary and will it provide practical utility; (ii) is the estimate of the burden of the information collection, including the validity of the methodology and assumptions used, accurate; (iii) can the quality, utility and clarity of the information be enhanced; and (iv) how can the burden of the information collection on respondents be minimized. The Food Safety Survey, which the agency notes will contain many of the same questions and topics as previous Food Safety Surveys, will also be updated to explore emerging consumer food safety topics and expand understanding of previously asked topics. New topics to be explored include the increase in listeriosis rates in people older than age 60; consumer understanding of…
The U.S. Food and Drug Administration (FDA) “has tentatively determined that partially hydrogenated oils (PHOs), which are the primary dietary source of industrially produced trans fatty acids, or trans fat, are not generally recognized as safe (GRAS) for any use in food based on current scientific evidence establishing the health risks associated with the consumption of trans fat, and therefore that PHOs are food additives.” If the agency finalizes this determination, “food manufacturers would no longer be permitted to sell PHOs, either directly or as ingredients in another food product, without prior FDA approval for use as a food additive.” It would not, however, affect the trans fat that occurs naturally in small amounts in meat and dairy products. Announcing the initiative, FDA Commissioner Margaret Hamburg said, “The FDA’s action today is an important step toward protecting more Americans from the potential dangers of trans fat. Further reduction in the…
The U.S. Food and Drug Administration (FDA) has issued a statement cautioning people older than age 40 about eating too much black licorice—2 ounces per day for two weeks. FDA experts explain that black licorice contains glycyrrhizin, a sweetening compound that can cause the body’s potassium levels to plummet, leading to an irregular heart rhythm, high blood pressure, edema, lethargy, and possibly heart failure, said FDA. The agency also warned that black licorice can interact negatively with some medications and supplements. According to FDA Director of Cosmetics and Colors Linda Katz, potassium levels are usually restored with no permanent health problems when black licorice consumption stops.
The U.S. Food and Drug Administration (FDA) has released a draft of its spice risk report, which calls attention to the most common microbial hazards and filth in imported spices, along with possible sources of contamination. The report, “Pathogens and Filth in Spices,” also evaluates current mitigation techniques, recommends options and identifies research needs and data gaps. According to FDA, a notice about the report will be published in the November 4, 2013, Federal Register. Calling the findings a “wake-up call” to spice producers, FDA revealed that of the products tested between 2007 and 2010, (i) spices are twice as likely to be contaminated as other types of imported food; (ii) 12 percent of spices imported into the United States were contaminated with insect parts, excrement, rodent hair and other materials; (iii) 7 percent of the shipments contained Salmonella; and (iv) spices imported from Mexico and India apparently have the highest rate of contamination.…
The U.S. Food and Drug Administration (FDA) has issued a proposed rule that would establish current good manufacturing practice (CGMP), hazard analysis and risk-based preventative controls for animal food. According to an October 29, 2013, Federal Register notice, FDA is taking this action to provide greater assurance that animal food is safe and will not cause illness or injury to animals or humans and is intended to build an animal food safety system for the future that makes modern, science and risk-based preventive controls the norm across all sectors of the animal food system.” Billed as “part of the Food Safety Modernization Act’s larger effort to modernize the food safety system for the 21st century,” the proposed rule would require domestic and foreign animal-food manufacturing facilities registered under the Federal Food, Drug, and Cosmetic Act to develop a formal plan to prevent foodborne illness as well as respond to “any…
Three days after the U.S. Food and Drug Administration (FDA) filed a motion for emergency stay pending appeal before the Ninth Circuit, the federal district court that had established November 30, 2013, as the deadline for the agency to publish notices of proposed rulemaking (NPRM) for specific food safety rules under the Food Safety Modernization Act denied the motion for stay pending appeal that FDA filed before it in September. Ctr. for Food Safety v. Hamburg, No. 12-4529 (N.D. Cal., order entered October 21, 2013). Details about the emergency stay request based on delays attributable to the federal government shutdown appear in Issue 501 of this Update. According to the district court, FDA failed to show that it would be irreparably injured absent a stay. The court recognized that the agency was unprepared to issue a final rule on the intentional adulteration of food by the November 2013 deadline, “But…
The U.S. Food and Drug Administration (FDA), currently under a district court timeline for completing the implementing regulations required under the Food Safety Modernization Act (FSMA), has filed an emergency stay pending appeal before the Ninth Circuit Court of Appeals, arguing that the 16-day government shutdown in October makes compliance “not only unsound but impossible.” Ctr. for Food Safety v. Hamburg, No. 13-16841 (9th Cir., filed October 18, 2013). Details about the district court’s refusal to amend the deadlines appear in Issue 494 of this Update. FDA specifically requests relief from the November 30 deadline for the publication of a proposed rule “addressing novel requirements for preventing the intentional adulteration of food.” The agency claims that compliance would “threaten[] to waste scarce agency resources and risk results inconsistent with the public interest by requiring FDA to spend the next several weeks completing and publishing a proposal that does not take…
