The Food and Drug Administration (FDA) has issued a proposed rule that would add selenium to the list of nutrients required in infant formula as well as establish minimum and maximum levels for the mineral in this context. Under the proposed rule, which recognizes selenium as an essential nutrient, infant formula labels would also need to list the amount per 100 kilocalories of formula. According to FDA, the selenium content of soil varies widely by geographic region, leading to either chronic selenium toxicity or dietary deficiencies that can result in diseases such as cardiomyopathy. Recognizing that formula “is intended to be the sole source of nutrition for infants,” FDA has proposed “2.0 µm selenium/100 kcal as the minimum level for selenium in infant formulas and 7.0 µm selenium/100 kcal as the maximum level.” The agency will accept comments on the proposed rule until July 1, 2013. See Federal Register, April 16,…
Category Archives Food and Drug Administration
The Food and Drug Administration (FDA) has reportedly received “more than 30,000 comments” in response to its request for information about a petition filed by dairy-industry groups asking the agency to drop special labeling requirements for flavored milks that contain artificial sweeteners such as aspartame. The International Dairy Foods Association (IDFA) and the National Milk Producers Federation (NMPF) have asked FDA “to amend the standard of identity for flavored milk and 17 other dairy products (including nonfat dry milk, heavy cream, eggnog, half-and-half and sour cream) so that nonnutritive sweeteners are among the standard ingredients,” thus exempting the products from having to make nutrient content claims such as “reduced calorie” in a more prominent location. “If we granted the petition, a carton of chocolate milk made with nonnutritive sweeteners would simply say ‘chocolate milk,’ the same as a carton made with nutritive sweeteners, such as sugar,” said FDA Food Labeling…
The U.S. Food and Drug Administration (USDA) has proposed two new fees—a food import user fee and a food facility and inspection fee that the agency says will “enhance the safety protections for imported food and feed” as well as support “new and improved activities required by the Food Safety Modernization Act (FSMA) to modernize FDA’s inspection system.” According to FDA, programs to support FSMA are scheduled to cost $295 million next year and will apparently be 94 percent funded by user fees. “These investments will provide industry with consistent and transparent food and feed safety guidance to assure the safety of America’s food and feed supply,” the agency asserts in its budget proposal. FDA has also proposed new user fees to support its cosmetic and food contact substance notification programs. In a statement releasing the budget, FDA Commissioner Margaret Hamburg said, “These are tight budget times, and the FDA…
The Food and Drug Administration (FDA) has announced the availability of “Draft Compliance Policy Guide Sec.100.250 Food Facility Registration— Human and Animal Food” (draft CPG), which aims to “provide guidance for FDA staff regarding enforcement of the food facility registration provisions under a section [415] of the Federal Food, Drug, and Cosmetic Act .” To this end, the draft CPG outlines how FDA plans to implement provisions establishing food facility registration requirements as well as “FDA’s authority to suspend a food facility’s registration.” According to FDA, the finalized CPG “will replace ‘Compliance Policy Guide Sec.110.300 Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.’” Comments should be submitted by May 6, 2013. See Federal Register, April 4, 2013.
The Animal Legal Defense Fund (ALDF) and Compassion Over Killing have reportedly filed a complaint in a California federal court against the Food and Drug Administration, U.S. Department of Agriculture and Federal Trade Commission claiming that the agencies have failed to regulate animal-welfare labeling on egg cartons. According to ALDF, rulemaking petitions were filed in 2006 and 2007 asking for egg production methods to be fully disclosed on every carton of eggs sold in the United States. The agencies have not only allegedly failed to take action on these requests, they have also apparently failed to take action against “the often-misleading claims and deceptive imagery widely found on egg cartons.” The plaintiffs seek a court order requiring the agencies to adopt rules that would mandate that producers clearly label their egg cartons with egg production methods, including “Eggs from Caged Hens.” See ALDF News Release, March 28, 2013.
U.S. Rep. Cathy McMorris Rodgers (R-Wash.) has introduced legislation (H.R. 1249) that would amend the federal Food, Drug, and Cosmetic (FD&C) Act “to improve and clarify certain disclosure requirements for restaurants, similar food retail establishments, and vending machines.” Titled the “Common Sense Nutrition Disclosure Act of 2013,” the bill would classify a restaurant or similar retail food establishment subject to federal menu labeling laws as one “that derives more than 50 percent of its total revenue from the sale of food of the type described” by the FD&C Act. Touted as a means to lessen the regulatory burden on some retailers, the legislation would, among other things, (i) strike from the FD&C Act language requiring restaurants, retail food establishments and vending machines to list “the number of calories contained in the standard menu item, as usually prepared and offered for sale” and instead insert language specifying that these establishments must…
According to news sources, the White House Office of Management and Budget (OMB) removed some provisions from the regulatory implementation package that the Food and Drug Administration (FDA) proposed under the Food Safety Modernization Act (FSMA). Analysis of documents submitted to the rulemaking docket apparently reveals that the following requirements were removed from the draft rules submitted for OMB review: (i) company programs to monitor the environment for pathogens, (ii) finished product testing for pathogens, (iii) the assumption that pathogens found on food contact materials are also in the food, (iv) a supplier approval and verification program, (v) company review of consumer safety complaints, and (vi) FDA authority to copy company records. See Food Politics and Law360, March 25, 2013. Meanwhile, the Center for Food Safety has reportedly called on a federal court in California to impose deadlines on FDA to implement food safety regulations, arguing that the FSMA set…
According to the Food and Drug Administration (FDA), a federal court has approved a consent decree with Clifton, New Jersey-based Butterfly Bakery, Inc. over claims that it distributed misbranded food products, such as muffins and snack cakes. United States v. Butterfly Bakery Inc., No. 13-669 (D.N.J., order entered March 5, 2013). Under the agreement, the bakery will be unable to process or distribute food until it complies with the Food, Drug, and Cosmetic Act. FDA and state testing apparently showed that foods labeled as “sugar free” contained sugar, and some products contained three times the amount of declared or labeled sugar and two times the amount of fat or saturated fat. See FDA News Release, March 13, 2013.
Two agricultural organizations have filed a citizen petition with the Food and Drug Administration (FDA) seeking to ban the use of antibiotics in ethanol production so that the leftover mash, known as “distillers grains with solubles (DGS),” which is fed to livestock, does not add to the levels of antibiotics used in the production of poultry and meat in the United States and thus contribute to the development of “superbugs,” that is, bacteria resistant to multiple antibiotics. In re Ctr. for Food Safety, No. __, (FDA, filed March 15, 2013). In the alternative, the petitioners request that FDA adopt regulations that deem antibiotics sold to ethanol producers for DGS production as new animal drugs, require drug sponsors to seek FDA approval for their use and ban the sale of antibiotics that have not been approved as new animal drugs. According to the Center for Food Safety and Institute for Agriculture…
The Food and Drug Administration (FDA) recently denied a citizen petition seeking to replace “the FDA action level of 1.0 parts per million (ppm) mercury in fish with an action level, regulatory limit or tolerance no greater than 0.5 ppm mercury in fish in order ‘to protect women of childbearing age, pregnant and nursing women, children and the most vulnerable populations.’” Filed by the Center for Biological Diversity and Got Mercury, the petition also asked FDA, among other things, to (i) enforce the new limit “and/or prohibit the sale of seafood that contains mercury concentrations that exceed it,” (ii) require retailers to post point-of-sale warnings or otherwise label fish “known to be high in methylmercury,” and (iii) conduct “regular, widespread” testing for mercury and publicize the results. In denying the petition, FDA noted the agency is authorized “but not required” to set a tolerance, action level or regulatory limit for…
