Category Archives U.S. Government and Regulatory Agencies

A budget plan passed to fund the U.S. government until September 2017 reportedly includes $3 million to pay for an information campaign about genetically modified organisms (GMOs) in food. As a partnership between the U.S. Food and Drug Administration (FDA) and the Department of Agriculture, the campaign will apparently seek to counter "misinformation about agricultural biotechnology." “It is not the responsibility of the FDA to mount a government-controlled propaganda campaign to convince the American public that genetically modified foods are safe,” Rep. Nita Lowey (DN.Y.) said. See The Washington Post, May 3, 2017.   Issue 633

The U.S. Food and Drug Administration (FDA) denied a citizen petition to ban the use of perchlorates in dry food packaging while revoking regulations permitting the use of potassium perchlorate in food­-container seals, saying industry makers no longer use the chemical. FDA said it will amend food additive regulations allowing the use of potassium perchlorate as a component in sealing gaskets for food containers. Trade groups petitioned for the change, arguing that plastics manufacturers have stopped using the compound. The following day, FDA rejected a petition from public interest groups seeking to ban use of potassium perchlorate and sodium perchlorate monohydrate in dry food packaging and requesting that the agency issue new regulations prohibiting use of perchlorates in packaging. Neither request was “the proper subject of a food additive petition,” the agency stated, but the groups could petition to revoke or reevaluate the Threshold of Regulation exemption.   Issue 633

The U.S. Food and Drug Administration (FDA) has extended the compliance date for calorie-­count menu labeling from May 5, 2017, to May 7, 2018, and is inviting public comment on the issue. The menu-­labeling rule applies to restaurants with 20 or more locations, as well as “grab-­and-­go” foodservice vendors such as supermarkets, coffee shops and bakeries, concession stands at movie theaters and amusement parks. While the rule is supported by the National Restaurant Association and many restaurant chains have already posted the required information, other trade groups say that the FDA underestimated the costs of compliance and that the rule is an unnecessary regulatory burden on businesses.   Issue 633

A federal court has ruled that three environmental groups lack standing to intervene in a lawsuit to block implementation of the Seafood Import Monitoring Program. Alfa Int’l Seafood v. Ross, No. 17­0031 (D.D.C., order entered April 17, 2017). The court held that the Natural Resources Defense Council, Oceana and the Center for Biological Diversity failed to establish concrete or particularized injuries “fairly traceable” to the possible vacating of the proposed program, known as the Seafood Traceability Rule. Even if they could, the court found, the groups still had not made a minimal showing that defendant U.S. Department of Commerce was unable to adequately represent their interests in the case. The groups argued that the new administration “might adopt policies that negatively affect the force of the Rule,” but Commerce reported that it supported the program. The court also dismissed the groups’ disagreements with Commerce about the program’s scope and timing…

After reviewing a challenge by the maker of Gerber baby foods, the National Advertising Division (NAD) has recommended that Beech-­Nut Nutrition discontinue several advertising claims but rejected complaints that Beech-­Nut’s ads implied its baby foods are fresh. NAD warned Beech­-Nut against use of the term “coldpuree” unless it “conspicuously” explains that foods are cooked after they are pureed cold. It also recommended that Beech-­Nut stop making unsupported claims that “glass is the ultimate in sustainability” and that “glass is nature’s safest container.” Beech-­Nut challenged NAD’s jurisdiction, arguing that most of the ads are no longer used, but NAD rejected the challenge and noted that the challenged claims continued to appear on Beech­-Nut’s website, in a YouTube video and on product packaging.   Issue 632

The U.S. Food and Drug Administration (FDA) has announced an extension to its comment periods for information on the use of genome editing techniques in animals and in plant varieties used for human or animal food. Comments on FDA's draft guidance, "Regulation of Intentionally Altered Genomic DNA in Animals," and on the use of genome editing techniques to produce new plant varieties will be accepted until June 19, 2017.   Issue 631

The Securities and Exchange Commission (SEC) and the Department of Justice (DOJ) have reportedly ended their investigations into Hampton Creek's alleged sales­-inflation buyback operation, in which employees purchased jars of the company's Just Mayo product then sold the jars back to the company. Bloomberg initially reported that the company had expensed $1.4 million for "Inventory Consumed for Samples and Internal Testing” while reporting $1.9 million in sales during the same period, but a forensic consulting team with an accounting firm commissioned by Hampton Creek apparently found that the company spent less than half of one percent of sales on the buyback program. Additional information on the Bloomberg report appears in Issue 613 of this Update. See Fortune, March 24, 2017.   Issue 629

The Senate Agriculture Committee has approved Sonny Perdue's nomination to lead the U.S. Department of Agriculture (USDA), with Perdue receiving support from all members of the committee except Sen. Kirsten Gillibrand (D-­N.Y.), along with an abstention from Sonny Perdue's cousin, David Perdue (R-­Ga.). The full Senate vote has not yet been scheduled. See Politico, March 30, 2017. After criticism over potential conflicts of interest, nominee for commissioner of the U.S. Food and Drug Administration (FDA) Scott Gottlieb has promised to recuse himself for one year from agency decisions involving more than a dozen companies. Gottlieb faces a Senate confirmation hearing on April 5, 2017. See The New York Times, March 29, 2017.   Issue 629

The U.S. Department of Justice (DOJ) has obtained a consent decree against Valley Milk Products LLC prohibiting the sale of more than four million pounds of milk powder products and preventing the company from manufacturing the products in the future. U.S. v. All 50 pound high heat nonfat dry milk powder (Grade A), No. 16-­0076, (W.D. Va., order entered March 17, 2017). DOJ seized dry milk and dry buttermilk products at the company’s Strasburg, Virginia, facility in November 2016 after FDA inspections found unsanitary conditions and confirmed samples of Salmonella and Listeria. According to the U.S. Food and Drug Administration, the Salmonella strains were “nearly identical” to strains found at Strasburg in 2010, 2011 and 2013, indicating “the existence of persistent/resident strain and harborage” of the bacteria at the facility. DOJ also alleged the products were “contaminated with filth” after inspectors found dark brown droplets forming on metal surfaces of…

Sen. Jon Tester (D-­Mont.) and Rep. Rosa DeLauro (D­-Conn.) have urged the federal government to act in response to a Brazilian investigation allegedly finding that more than 100 of the country's health inspectors allowed the sale of rancid meat, falsified export documents or failed to inspect meatpacking plants. Tester introduced a bill in the U.S. Senate purporting to temporarily ban Brazilian beef imports. "A 120-­day ban will provide the U.S. Department of Agriculture time to comprehensively investigate food safety threats and to determine which Brazilian beef sources put American consumers [at] risk," Tester's March 21, 2017, press release asserts. In a March 22 press release, the U.S. Department of Agriculture's (USDA's) Food Safety and Inspection Service announced additional pathogen testing of all raw beef and ready-­to-­eat products from Brazil. "Keeping food safe for American families is our top priority,” Acting Deputy Secretary of Agriculture Mike Young was quoted as saying.…

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