The Food and Drug Administration (FDA) has opened the Reportable Food Registry (RFR) as a new way to head off potential cases of foodborne illness. The system requires food companies that manufacture, process or hold food for consumption in the United States to report potentially dangerous products to FDA within 24 hours “if they find a reasonable probability that an article of food will cause severe health problems or death to a person or an animal,” according to an agency news release. The reporting requirement applies to all foods and animal feed regulated by FDA except infant formula and dietary supplements, which are covered by other regulatory requirements. Under rules governing the RFR, the responsible party charged with reporting to FDA must investigate the cause of the adulteration, submit initial information and supplemental reports, and follow up with FDA as needed. The responsible party is not required to report if…
Category Archives U.S. Government and Regulatory Agencies
The Food and Drug Administration (FDA) has announced two public meetings to discuss the prevention of Salmonella enteritidis (SE) during the production, storage and transportation of shell eggs. Slated for September 30, 2009, in Chicago, Illinois, and November 5, 2009, in Atlanta, Georgia, the meetings will explain an FDA final rule that requires shell egg producers “to implement measures to prevent SE from contaminating eggs on the farm and from further growth during storage and transportation, and requires these producers to maintain records concerning their compliance.” The agency has anticipated that the rule will prevent 79,000 illnesses and 30 deaths attributed to SE, a leading bacterial cause of foodborne illness in the United States. See Federal Register, August 31, 2009.
The Food and Drug Administration (FDA) has reportedly declined to send an objection letter to Arizona-based Wisdom Natural Brands™ concerning its request for generally recognized as safe (GRAS) status for its stevia sweetener, SweetLeaf®. Considered the gold standard in GRAS rulings, the lack of an FDA objection has confirmed earlier determinations by two independent scientific panels that reviewed SweetLeaf’s® GRAS status in March 2008. The company first lodged a notification of GRAS status with FDA for a “general purpose sweetener in various food categories” in March 2009. See FoodNavigator-USA.com, September 2, 2009. In a related matter, a Los Angeles Times article titled “Sweet stuffed: We eat lots (and lots of kinds) of sweeteners. What’s in them?” offers a primer of common and not-so-common sweeteners such as sucrose, glucose, fructose, corn syrup, high fructose corn syrup, lactose, honey, and agave syrup. “America’s sweet tooth is growing,” writes Wendy Hansen. “Like many other…
The Cornucopia Institute, which represents the interests of small organic agricultural operations, has called on the U.S. Department of Agriculture (USDA) to investigate charges that Aurora Dairy’s High Plains facility is operating in violation of National Organic Program (NOP) standards. In its August 31, 2009, letter, the institute refers to a similar complaint it filed about Aurora Dairy in 2007. According to the letter, the agency assured the institute that the 2007 complaint “would be incorporated into the probation that Aurora Dairy was operating under, pursuant to a consent agreement signed with the Department. Based on freedom of information documents, obtained by The Cornucopia Institute, no scrutiny of this facility ever took place and the allegations we communicated in 2007 were never investigated.” The letter outlines how Aurora Dairy has allegedly fallen short of NOP requirements and specifically points to the planting of an annual forage crop in the animals’…
The Food and Drug Administration (FDA) has issued a request for “comments and scientific data and information on acrylamide in food,” noting that the agency is considering industry guidance on this issue. Describing acrylamide as “a chemical that can form in some foods during certain types of high-temperature cooking,” the agency is seeking information from manufacturers on how to measure and reduce acrylamide levels in food. The agency has also asked responders to provide detailed feedback about: (i) techniques for acrylamide mitigation; (ii) best monitoring practices; (iii) standard practices for the delivery, storage, temperature control, reconditioning, and screening of potatoes; (iv) changes to food packaging instructions and other measures that can reduce acrylamide levels during a product’s final preparation by consumers; (v) food types for which the agency could recommend target acrylamide levels; and (vi) achievable acrylamide levels for french fries, potato chips, breakfast cereals, coffee, cookies, and other baked goods…
U.S. Department of Agriculture (USDA) Secretary Tom Vilsack has announced the creation of a Dairy Advisory Committee that will “play an important role in building a more stable market for dairy production for years to come,” according to an agency news release. The two-year committee will specifically review farm milk price volatility and dairy farmer profitability, and offer suggestions on how USDA can best address these issues to meet the dairy industry’s needs. The 15 members will include producers and producer organizations, processors and processor organizations, handlers, consumers, academia, retailers, and state agencies involved in organic and non-organic dairy at the local, regional, national, and international levels. Nominations will be accepted through September 28, 2009. See USDA News Release, August 25, 2009.
The U.S. Department of Agriculture (USDA) and U.S. Department of Justice (DOJ) have announced a series of public workshops “to explore the competition issues affecting the agricultural sector in the 21st century and the appropriate role for antitrust and regulatory enforcement in that sector.” Organized in response to “concerns about changes in the agricultural marketplace, including increasing processor concentration in some commodities,” these meetings will focus on “the dynamics of competition in agricultural markets, including, among other issues, buyer power (also known as monopsony) and vertical integration.” The workshops will also address (i) “the impact of agricultural concentration on food costs”; (ii) “the effect of agricultural regulatory status and other applicable laws and programs on competition”; (iii) “issues relating to patent and intellectual property affecting agricultural marketing and production”; and (iv) “market practices such as price spreads, forward contracts, packer ownership of livestock before slaughter, market transparency, and increasing retailer…
The U.S. Department of Health and Human Services (HHS) has announced the availability of draft guidance titled “Guidance for Industry: Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration [FDA].” The agencies have issued the document “in light of the recent ruling by the Alcohol and Tobacco Tax and Trade Bureau (TTB) (formerly The Bureau of Alcohol, Tobacco and Firearms (ATF)) clarifying that certain beers do not meet the definition of a ‘malt beverage’ under the Federal Alcohol Administration Act (FAA Act).” According to HHS, beers that do not fall under FAA Act jurisdiction “are subject to the labeling provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA).” The draft guidance also “reminds manufacturers that the labeling of wine beverages containing less than 7 percent alcohol by volume, such as wine coolers, diluted wine…
The Food and Drug Administration (FDA) has announced that it will decide by November 30, 2009, whether the chemical bisphenol A (BPA) is safe for use in food packaging. FDA Acting Deputy Commissioner and Chief Scientist Jesse Goodman has reportedly told the agency’s Science Board that a group of FDA scientists will conduct a new review of more than 100 studies on BPA and that the review will be assessed by a group of government scientists not affiliated with FDA. Commissioner Margaret Hamburg will review the science and recommendations, and then determine whether BPA is safe when used in food containers. Scientific evidence on whether the levels of BPA in products are harmful has been hotly disputed. Last year, FDA said the chemical was safe because the small amounts that leach from food containers do not threaten children or adults. But its Science Board rejected that decision, apparently claiming that…
The Third Circuit Court of Appeals has determined that federal food labeling law does not preempt the state law-based claims filed by a consumer who challenged Snapple’s designation of beverages containing high fructose corn syrup (HFCS) as “natural.” Holk v. Snapple Beverage Corp., No. 08-3060 (3d Cir., decided August 12, 2009). The appeals court reversed a lower court ruling dismissing the claims on the basis of implied preemption. The complaint, originally filed in state court, but removed to federal court in 2007 under the Class Action Fairness Act, initially asserted that Snapple products were not “All Natural” because they contained HFCS; they were not “Made from the Best Stuff on Earth”; and Snapple falsely labeled some beverages, naming them after fruit-juice varieties that were not actually in the beverages. The plaintiff alleged unjust enrichment and common law restitution, breach of express and implied warranties and violations of the New Jersey…
