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…
Category Archives U.S. Government and Regulatory Agencies
POM Wonderful LLC has filed a petition seeking review in the D.C. Circuit Court of Appeals of a Federal Trade Commission (FTC) order requiring two randomized, controlled clinical trials before the company can make a claim that its pomegranate juice products treat, prevent or reduce the risk of heart disease, prostate cancer or erectile dysfunction. POM Wonderful LLC v. FTC, No. 13-1060 (D.C. Cir., filed March 8, 2013). In its January ruling, FTC found that the company made false and misleading claims by advertising its products with health-benefit assertions that POM contended were backed by medical research. Additional information about the FTC rulings in the case appears in issues 441 and 467 of this Update.
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 U.S Department of Agriculture (USDA) and U.S. Environmental Protection Agency (EPA) have scheduled a March 28, 2013, public meeting in Arlington, Virginia, to address draft U.S. positions for discussion at the 45th Session of the Codex Committee on Pesticide Residues of the Codex Alimentarius Commission during a May 6-13 meeting in Beijing. Agenda items include (i) a report by the 2012 joint Food and Agriculture Organization and World Health Organization meeting on pesticide residues; (ii) a discussion paper on principles and guidance for estimating maximum residue limits for pesticides; and (iii) a discussion paper on guidance for establishing maximum residue limits for pesticides for minor and specialty crops. See Federal Register, March 14, 2013.
The U.S. Department of Agriculture (USDA) has issued a proposed rule that would revise Country of Origin Labeling (COOL) requirements for muscle cuts of meat and amend the definition of “retailer” to include “any person subject to be licensed as a retailer under the Perishable Agricultural Commodities Act.” Under the proposed rule, “origin destinations for muscle cut covered commodities derived from animals slaughtered in the United States would be required to specify the production steps of birth, raising, and slaughter of the animal from which the meat is derived that took place in each country listed on the origin designation.” According to USDA, the proposed rule would also “eliminate the allowance for any commingling of muscle cut covered commodities of different origins.” The proposal does not change “existing country of origin labeling of imported muscle cuts derived from animals slaughtered in another country.” The agency said that it “expects that…
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…
The Food and Drug Administration (FDA) has reopened the comment period for its 2005 interim final rule on the “Use of Materials Derived From Cattle in Human Food and Cosmetics,” which prohibited the use of certain cow components to prevent the potential risk of bovine spongiform encephalopathy (BSE) in human food and cosmetics. The interim final rule stated that a cow’s small intestine was safe for use in human food and cosmetics provided the distal ileum was removed. According to the agency, new scientific data confirms the presence of low levels of BSE in other parts of the cow’s intestine, including the proximal ileum. Interested parties can comment on the new studies until May 13, 2013. See Federal Register, March 4, 2013.
According to a news source, the Food and Drug Administration (FDA), which has released for public comment just two of five major proposed rules to implement the Food Safety Modernization Act (FSMA), will allow the public to comment on all of them once they have all been made available. FDA spokesperson Shelly Burgess said, “We have received some feedback regarding this and FDA will adjust the comment periods to allow the opportunity for the public to comment as a package.” Thus, no comment period will close until all five rules have been published. Information about the initial proposals appears in Issue 466 of this Update. See Law360, March 5, 2013.
The Food and Drug Administration (FDA) has released for public comment a report on pilot projects established under the Food Safety Modernization Act (FSMA) “with the food industry to explore and evaluate methods for rapid and effective tracking and tracing of foods.” The report includes the recommendations of the Institute of Food Technologies, the agency’s project partner, on improving tracking and tracing of food, and FDA will use public comments on those recommendations in finalizing its report to Congress on the matter. Electronic or written comments are requested by April 4, 2013. See Federal Register, March 5, 2013.
