The U.S. Department of Health and Human Services (HHS) has announced the availability of draft guidance titled “Guidance for Industry: Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration [FDA].”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 The draft guidance also “reminds manufacturers that the labeling of wine beverages containing less than 7 percent alcohol by volume, such as wine coolers, diluted wine…
Category Archives Food and Drug Administration
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…
After Food and Drug Administration (FDA) investigators found rodent infestation, “insanitary” conditions, poor employee hygiene, and violations of hazard analysis critical control point regulations at a food plant in Louisiana, it dispatched U.S. Marshals to seize tuna salad sandwiches and other food products, totaling more than $72,000 in value. While no illnesses have apparently been linked to consumption of the sandwiches produced by the Bearden Sandwich Company, Inc., the FDA has reportedly pledged to act “swiftly and aggressively” against processors and manufacturers that do not comply with food safety rules. According to an agency spokesperson, “When FDA investigators find violations inside a company’s facility, we will do what is necessary to keep insanitary and potentially harmful products out of consumers’ hands.” See FDA News Release, August 7, 2009.
The Food and Drug Administration (FDA) has announced a new warning-letter system to notify food companies of safety regulation violations. Scheduled to begin on September 15, 2009, the system stems from an effort to speed up the process from the time a company receives an “FDA 483” inspection report to the issuance of a warning letter. It allows companies 15 working days to respond to the 483 form, and if they do not respond during that time, FDA will send a warning letter. If FDA does receive a response in that time, it will “conduct a detailed review of the response before determining whether to send a warning letter.” According to a Federal Register notice, many companies respond in writing once they get the 483 report by describing completed or ongoing corrective actions or promise of future corrections. “In fact, some inspected establishments submit multiple responses to FDA, sometimes over…
The Food and Drug Administration (FDA) has published three draft guidance documents, with industry input, that provide recommended practices to prevent foodborne hazards associated with fresh produce. The documents pertain specifically to tomatoes, leafy greens and melons and “provide a guide for growers and processors to follow so they may better protect their produce from becoming contaminated,” according to Health and Human Services Secretary Kathleen Sebelius. With specific suggestions ranging from clean water supplies to human hygiene, key elements include (i) an acceptable baseline standard of industry practices that help domestic and foreign firms minimize microbial contamination risks throughout the entire supply chain; (ii) specific recommendations relating to growing, harvesting, packing, processing, transporting, and distributing the product; and (iii) recordkeeping recommendations to help FDA quickly trace back to the source when an outbreak occurs. The agency is asking that comments on the drafts be submitted within 90 days from publication…
The U.S. Senate has reportedly approved a fiscal year 2010 budget for the Food and Drug Administration (FDA) and U.S. Department of Agriculture (USDA) that would increase the combined funding for both agencies by 11 percent. Similar to a House of Representatives measure (H.R.2997) passed on July 9, 2009, the $125 billion appropriations bill (S. 1406) includes financial support for farm subsidies, food safety, land conservation, and the federal food stamp program. However, the House version continues a prohibition on cooked chicken imports from China and strips out funding for a voluntary national animal identification systems (NAIS), while the Senate has outlined steps to overturn the Chinese chicken ban and would preserve one-half of the $14.6 million requested by President Barack Obama (D) for NAIS. A House-Senate negotiating panel will meet to reconcile these differences before the bill heads to both chambers for a final vote. “These projects help to…
The Food and Drug Administration’s (FDA’s) Science Board has scheduled an August 17, 2009, public meeting to review the agency’s continuing assessment of the packaging chemical bisphenol A (BPA) in FDA-regulated products and discuss plans to increase research reviews at the Center for Food Safety and Applied Nutrition (CSFAN). See Federal Register, July 28, 2009.
Acting on behalf of an apparently energized Food and Drug Administration (FDA), the Department of Justice (DOJ) has filed a complaint for injunction against a New Jersey company and its owner seeking to halt the manufacture and sale of their dietary supplement products, in part, for failure to comply with good manufacturing practice requirements. U.S. v. Quality Formulation Labs., Inc., No. 09-03211 (D.N.J., filed July 1, 2009). The complaint alleges that the defendants have caused their protein powders and other dietary supplements to be adulterated “in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth (as a result of rodent activity) or may have been rendered injurious to health (as a result of cross-contamination with a major food allergen).” The allergen at issue is milk. The complaint also alleges that one of the defendants’ articles of food is adulterated “in…
The Department of Justice (DOJ) is seeking to enjoin the operation of a cheese-processing facility in New York due to the Listeria monocytogene (L. mono) contamination of its Queso Hebra, Queso Fresco and Queso Cotija Molido cheeses. U.S. v. Peregrina Cheese, Inc., No. 09-2888 (E.D.N.Y., filed July 7, 2009). According to DOJ, state and federal inspections of the facility since at least 2004 have revealed serious sanitation problems. Because product samples and equipment surfaces tested positive for the same L. mono strain, Food and Drug Administration (FDA) analysts concluded that “the strain has formed a niche at Peregrina Cheese’s facility.” The owners have apparently refused to shut down the plant to properly sanitize it, claiming that the state food safety agency approved the “use of an antimicrobial agent as an additive in Peregrina Cheese’s Queso Fresco product.” The owners did not, however, provide “any information as to the level of use”…
