Category Archives U.S. Government and Regulatory Agencies

The Department of Commerce has issued an affirmative preliminary determination in a countervailing duty (CVD) investigation of sugar imports from Mexico, and the United States is preparing to impose import duties as high as 17 percent on Mexican sugar. According to an International Trade Administration fact sheet, the CVD investigation was instituted in March 2014 after domestic sugar interests filed a petition seeking relief from “the market distorting effects caused by injurious subsidization of imports into the United States.” Beginning the first week of September, Commerce will instruct U.S. Customs and Border Protection to require cash deposits based on the preliminary subsidy rates calculated for different Mexican exporters. A final determination in the matter is scheduled for January 2015. An American Sugar Alliance spokesperson said that the August 26, 2014, determination “validates our claim that the flood of Mexican sugar, which is harming America’s sugar producers and workers, is subsidized…

U.S. Food and Drug Administration (FDA) researchers recently presented dietary exposure assessments for 4-methylimidazole (4-MEI) at the 248th American Chemical Society (ACS) National Meeting held August 10-14, 2014, in San Francisco. Contributing to FDA’s review of available toxicological data for 4-MEI found in Class III and IV Caramel colors produced using ammonium compounds, the scientists analyzed 4-MEI levels of caramel-containing foods and beverages using liquid chromatography-tandem mass spectrometry, then relied on intake data from the National Health and Nutrition Examination Survey (NHANES) to estimate dietary exposure levels for the following U.S. population groups: (i) “the U.S. population aged 2 years or more”; (ii) “infants (< 1 year old)”; (iii) “children aged 1 year”; (iv) “children aged 2-5 years”; (v) “children aged 6-12 years”; and (vi) “teenage boys aged 12-18 years.” According to the presentation poster, the caramel-containing food categories contributing more than 1 percent “to the cumulative dietary exposure to 4-MEI…

Discussing the expedited approval process for food additives that took effect 17 years ago, U.S. Food and Drug Administration (FDA) Deputy Commissioner for Food Michael Taylor recently told Washington Post reporter Kimberly Kindy that the agency does not have “the information to vouch for the safety of many of these chemicals.” According to the August 17, 2014, article, the number of additives in the food supply has increased to 9,000 from 800 over a 50-year span, in part because a voluntary certification system dependent on industry safety data has eclipsed FDA’s independent review process. Under the Generally Recognized as Safe (GRAS) scheme, companies need only submit a summary of their safety research to FDA, shortening time to approval even for new and novel food additives. In particular, the Post highlights how a mycoprotein marketed as “Quorn” achieved GRAS status despite one undisclosed study allegedly showing that 5 percent of test…

In its October 2014 issue, Consumer Reports will publish an analysis of the U.S. Food and Drug Administration’s (FDA’s) data that supported the agency’s recommendations for fish intake by pregnant women and children, released jointly as draft guidance with the U.S. Environmental Protection Agency (EPA) in June 2014. The magazine compiled a list of low-mercury—including haddock, trout, catfish, and crab—and lowest-mercury fish—including shrimp, tilapia, oysters, and wild and Alaska salmon—and detailed the amounts considered safe for consumption for young children and women of childbearing age. The guide includes more conservative advice than the draft guidance from FDA and EPA, such as recommending that most women and young children avoid marlin and orange roughy in addition to the listed swordfish, shark, king mackerel, and gulf tilefish. The magazine cites Deborah Rice, co-author of the EPA document that established the current limit on methylmercury consumption as 0.1 microgram per kilogram of body weight…

The U.S. Public Interest Research Group (PIRG) Education Fund has published a white paper titled “Ending the Overuse of Antibiotics in Livestock Production: The Case for Reform.” Contending that the use of antibiotics in healthy animals to accelerate their growth or “prevent disease caused by unhealthy and unsanitary conditions” has accelerated the development of antibiotic-resistant bacteria, the paper calls on the U.S. Food and Drug Administration (FDA) to act immediately to restrict the use of antibiotics in livestock production. According to the consumer-interest group’s paper, the U.S. Centers for Disease Control and Prevention has found that some 2 million Americans are sickened each year by drug-resistant bacteria, and of those, 23,000 die. The paper also states that more than “70% of antibiotics in classes used in human medicine are sold for use in food animals.” FDA data reportedly indicate that in 2011, 29.9 million pounds of antibiotics were sold in the…

Shook attorneys Ann Havelka and Ryan Farnsworth have authored an August 18, 2014, Law360 article detailing “the first major overhaul of the nation’s poultry inspection system in nearly 60 years.” Describing the voluntary and mandatory aspects of the final rule issued by the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS), the article provides an overview of the regulations most likely to affect industry as the onus for inspection shifts from government agencies to business operators. FSIS officially published the final rule in the August 20, 2014, edition of the Federal Register. Additional information about the regulations appears in Issue 532 of this Update.   Issue 535

The U.S. Department of Agriculture’s (USDA’s) Food Safety and Inspection Service is convening a September 25, 2014, public meeting in Washington, D.C., to receive public comments about draft positions to be discussed at the 21st Session of the Codex Committee on Food Import and Export Inspection and Certification Systems of the Codex Alimentarius Commission in Brisbane, Australia, on October 13-17. Issues on the September 25 meeting agenda include (i) a discussion paper on Principles and Guidelines for Monitoring Regulatory Performance of National Food Control Systems and (ii) draft amendments to Guidelines for the Exchange of Information between Countries on Rejections of Imported Food. USDA and the Food and Drug Administration have a public meeting slated for October 23 in Washington, D.C., to provide information and receive public comments about draft positions to be discussed at the 46th Session of the Codex Committee on Food Hygiene in Lima, Peru, on November…

The U.S. Department of Agriculture’s (USDA’s) Agricultural Marketing Service has requested comments “on how a Federal standard of identity for honey would be in the interest of consumers, the honey industry, and U.S. agriculture.” Noting that the Food and Drug Administration in 2011 rejected an industry-backed citizens petition seeking such a standard, USDA as charged by the 2014 Farm Bill will produce a report examining the issue, “including any current industry amendments or clarifications necessary to update the petition.” In particular, USDA points to the existence of several standards for the inspection and grading of honey, including state-level schemes designed to prevent product adulteration. “While some are following the 2006 honey industry petition and using an amended version of the Codex Standard for Honey, CODEX standard 12-1981, Rev. 2 (2001), variations in the state standards of identity for honey are inevitable,” concludes the agency, which will accept comments until September…

The U.S. Food and Drug Administration (FDA) recently issued a consumer update warning that the lupin (or lupine) legume could cause allergic reactions in susceptible individuals, especially those with existing peanut allergies. According to FDA, the use of lupin-derived ingredients has increased in recent years because they are used in gluten-free products as a substitute for other flours. “Although lupin is a food staple for many Europeans—who may be more aware of its allergenic properties and are accustomed to seeing it listed as a food ingredient—it is relatively new to the U.S. market,” notes FDA, which “is actively monitoring complaints of lupin allergies.” To this end, the agency has asked consumers and healthcare professionals to report lupin-related adverse events through the FDA reporting system. See FDA Consumer Update, August 15, 2014.   Issue 535 

Following similar decisions from courts across the country, two California federal courts have delayed final rulings in cases accusing Kashi and Trader Joe’s of mislabeling their products by using the term “evaporated cane juice” (ECJ) in their ingredient lists rather than simply “sugar,” which the plaintiffs allege is the same substance. Gitson v. Trader Joe’s Co., No. 13-1333 (N.D. Cal., order entered August 7, 2014); Saubers v. Kashi Co., No. 13-899 (S.D. Cal., order entered August 11, 2014). In the proposed class action against Kashi, the plaintiffs accused the Kellogg-owned company of “misbranding” more than 75 different food products by listing ECJ instead of sugar on its labels to conceal its inclusion in the foods. The court found that the plaintiffs’ claims relied “heavily, if not entirely, on the premise that the [U.S. Food and Drug Administration (FDA)] has concluded that ‘evaporated cane juice’ is not the common or usual name…

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