Category Archives U.S. Government and Regulatory Agencies

The Federal Trade Commission (FTC) has approved a modified final order in proceedings against Phusion Projects, LLC, which markets the malt beverage Four Loko, to account for the Department of Treasury’s Alcohol and Tobacco Tax and Trade Bureau’s (TTB’s) denial of proposed changes to the company’s product labels. In re Phusion Projects, LLC, No. C-4382 (FTC, order entered July 24, 2014). Additional information about FTC’s January 2014 order and agreement with the company appears in Issue 471 of this Update. FTC alleged that Phusion and its principals “falsely claimed that a 23.5-ounce, 11 or 12 percent alcohol by volume can of Four Loko contains alcohol equivalent to one or two regular 12-ounce beers, and that a consumer could drink one can safely in its entirety on a single occasion.” The modified final order acknowledges the company’s attempt to comply with the January agreement by seeking TTB’s approval to display an…

The Center for Science and Democracy at the Union of Concerned Scientists has submitted a comment backed by more than 280 health experts asking the U.S. Food and Drug Administration (FDA) to include a percent daily value for the proposed “added sugars” declaration on food and beverage labeling. Responding to the agency’s request for comments on proposed changes to the nutrition and supplement facts labels, the letter signed by Robert Lustig, Marion Nestle and members of the Healthy Food Action network urges FDA to set a maximum daily value for added sugars at 50 grams—approximately 10 percent of recommended daily calorie intake—and to list a percent daily value on the Nutrition Facts label. “Many food and beverage manufacturers add excessive amounts of sugar to their products, including those that they market as healthy options. In our current food environment, many people are unknowingly and unavoidably consuming excess sugar,” opines the…

The U.S. Department of Agriculture’s (USDA’s) Food Safety and Inspection Service (FSIS) has denied the May 2011 petition filed by the Center for Science in the Public Interest (CSPI) seeking an interpretive rule declaring certain antibiotic-resistant (ABR) strains of Salmonella to be adulterants when found in raw ground meat and raw ground poultry. Additional information about the petition appears in Issue 396 of this Update. CSPI also asked the agency “to ensure adequate sampling and testing for these pathogens and to remove contaminated ground meat and ground poultry products from the human food supply.” FSIS essentially found insufficient data to distinguish ABR Salmonella strains from other Salmonella strains that are susceptible to antibiotics and thus stated that additional data on the characteristics of ABR Salmonella are needed to determine whether the strains identified in the petition “could qualify as adulterants under the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601…

The U.S. Department of Agriculture’s (USDA’s) Food Safety and Inspection Service (FSIS) has announced a final rule amending poultry slaughter regulations and establishing a new poultry inspection system (NPIS) for young chicken and turkey slaughter establishments. Part of USDA’s response to a presidential executive order (E.O. 13563) asking agencies to review and improve existing regulations, the final rule aims to “facilitate pathogen reduction in poultry products, improve the effectiveness of poultry slaughter inspection, make better use of the Agency’s resources, and remove unnecessary regulatory obstacles to innovation.” Optional for young chicken and turkey establishments, which can choose to retain their current inspection system, NPIS will not replace the Streamlined Inspection System (SIS), the New Line Speed Inspection System (NELS) or the New Turkey Inspection System (NTIS), as was originally proposed. FSIS has emphasized, however, that NPIS will allow inspectors “to perform more offline inspection activities that are more effective in ensuring…

A group of 17 U.S. senators has submitted a letter to the Commerce Department warning that a proposed suspension agreement imposing quotas on Mexican sugar imports would violate the North American Free Trade Agreement, “threaten the viability of American food manufacturers and raise food prices for American families.” Led by Sens. Jeanne Shaheen (D-N.H.) and Pat Toomey (R-Penn.), the group includes Sens. John McCain (R-Ariz.) and Dianne Feinstein (D-Calif.). Following petitions by members of the American Sugar Alliance, the Commerce Department launched an April 2014 investigation into allegations that Mexico’s mills are dumping subsidized sweetener in the United States, and the department is reportedly due to decide whether to impose duties on Mexican imports soon. “This mutual market access is beneficial to the United States: U.S. growers and refiners do not produce enough sugar to meet the demands of U.S. consumers, and imports are necessary to keep America’s food manufacturers…

The Second Circuit has reversed a district court’s decision that ordered the U.S. Food and Drug Administration (FDA) to initiate hearings responding to a livestock antibiotics challenge from the Natural Resources Defense Council (NRDC) based on a 1977 agency finding that the use of growth antibiotics for healthy animals was unsafe. NRDC v. FDA, No. 12-2106 (2d Cir., order entered July 24, 2014). Two judges were “firmly persuaded that Congress has not required the FDA to hold hearings whenever FDA officials have scientific concerns about the safety of animal drug usage,” that FDA has discretion on proceedings to withdraw approval of animal drugs, and that the law requires “withdrawal of approval of animal drugs or particular uses of such drugs only when the FDA has made a final determination, after notice and hearing, that the drug could pose a threat to human health and safety.” In 1977, FDA planned to…

Following the recent death of an Ohio teenager whose autopsy reportedly revealed blood levels of more than 70 micrograms of caffeine per milliliter, the Food and Drug Administration (FDA) this week issued “consumer advice” warning parents that powdered pure caffeine is a “powerful stimulant and very small amounts may cause accidental overdose.” Such products are unregulated and sold as dietary supplements. According to the agency, a teaspoon of pure caffeine is “roughly equivalent” to the amount contained in 25 cups of coffee. FDA is encouraging the public as well as health care providers to report any adverse events related to consumption of powdered pure caffeine to the agency. See Associated Press, July 19, 2014; FDA Consumer Advice on Powdered Pure Caffeine, July 21, 2014.   Issue 531

The U.S. Department of Agriculture’s (USDA’s) Food Safety and Inspection Service (FSIS) has proposed a rule requiring that “all makers of raw ground beef products keep records” that would allow FSIS to conduct timelier recalls of potentially contaminated meat. The proposed rule would require retailers that mix meats from multiple sources to keep more detailed records identifying the source. According to a July 16, 2014, press release, previous FSIS efforts to encourage raw ground beef retailers’ maintenance of clear records have been insufficient in aiding the service in tracing the source of contaminated meat. “The improved traceback capabilities that would result from this proposal will prevent foodborne illness by allowing FSIS to conduct recalls of potentially contaminated raw ground products in a timelier manner,” said USDA Deputy Under Secretary for Food Safety Brian Ronholm. FSIS will accept comments on its proposed rule for 60 days following publication in the Federal…

The U.S. Department of Agriculture (USDA) has issued a final rule clarifying “the roles and responsibilities of USDA’s Office of the Assistant Secretary for Civil Rights (OASCR) and USDA agencies in enforcing nondiscrimination in programs or activities conducted by USDA.” Intended to “strengthen the agency’s civil rights compliance and complaint processing activities to better protect the rights of USDA customers,” the final rule requires OASCR and other USDA agencies to “collect, maintain and annually compile data on the race, ethnicity and gender (REG) of all conducted program applicants and participants by county and State.” To facilitate early resolution of complaints, the agency also stipulates that “OASCR shall offer Alternative Dispute Resolution (ADR) services to complainants where appropriate.” In addition, the final rule establishes two new protected bases: political beliefs and gender identity. “This amendment is meant to make explicit protections against discrimination based on USDA program customers’ political beliefs or…

Several major food companies have sent a letter to four U.S. senators and representatives urging Congress to direct Secretary of Agriculture Tom Vilsack to suspend revised country-of-origin labeling (COOL) rules on muscle cuts of meat because they discriminate against Canada and Mexico. The letter argues that if the WTO determines that the rule violates U.S. trade obligations, it could authorize retaliation from Mexico and Canada, which “has already issued a preliminary retaliation list targeting a broad spectrum of commodities and manufactured products that will affect every state in the country.” The new rules dictate that meat producers must disclose where their livestock was born, raised and slaughtered and can no longer commingle livestock from differing origins to ensure COOL accuracy. The food company coalition has also challenged the new U.S. Department of Agriculture rules in federal court, and the case is pending after an en banc rehearing in the D.C.…

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