The U.S. Food and Drug Administration (FDA) has issued draft guidance concerning the proper labeling of honey and honey products to ensure that such products “are not adulterated or misbranded.” In light of its earlier refusal to create a new standard of identity for honey, the agency developed the guidance to respond to labeling issues raised by a March 8, 2006, petition submitted by the American Beekeeping Federation and other honey-related associations. According to FDA, the draft guidance (i) “summarizes FDA’s legal authority over honey and honey products”; (ii) “provides a commonly used definition of honey”; (iii) “offers advice on labeling issues such as the floral source of honey, blends of honey and other sweeteners, and blends of honey and other ingredients, such as flavors”; and (iv) “describes some of the measures FDA takes to guard against honey adulterated with cane sugar, corn syrup, or residues of chloramphenicol or fluoroquinolones.”…
Posts By Shook, Hardy & Bacon L.L.P.
The U.S. Food and Drug Administration (FDA) has issued a final rule adopting the interim final rule titled “Establishment, Maintenance, and Availability of Records: Amendment to Record Availability Requirements” for recordkeeping regulations under the Food Safety Modernization Act (FSMA). The amendments made under FSMA allow FDA access to records beyond those relating to specific suspect food articles if the agency believes that other food articles are likely to be affected in a similar manner. The amendments also permit FDA to access records relating to articles of food “for which there is a reasonable probability that the use of, or exposure to, the article of food will cause serious adverse health consequences or death to humans or animals.” The expanded records-access authority is intended to improve FDA’s ability to respond to and contain safety problems with the food supply for humans and animals. FDA has also issued two guidance documents, “FDA…
U.S. Rep. Mike Pompeo (R-Kansas) has introduced legislation (H.R. 4432) that would prohibit states from implementing labeling laws for foods that contain genetically modified (GM) ingredients. Titled the “Safe and Accurate Food Labeling Act,” the bill would (i) require the U.S. Food and Drug Administration (FDA) to mandate GM labeling only if those foods “are found to be unsafe or materially different from foods produced without biotech ingredients”; and (ii) establish a federal labeling standard for foods with GM ingredients, giving FDA sole authority to require labeling on such foods if they are ever deemed unsafe or materially different from foods produced without GM ingredients. According to news sources, Pompeo contends that state campaigns to label foods containing GM ingredients are intended to scare consumers, not inform them. GM crops have made “food safer and more abundant,” Pompeo said. “It has been an enormous boon to all of humanity.” GM…
Cornell University researchers have reportedly identified five new species of Listeria that they suggest could provide new insights leading to better methods of detecting soil bacteria in food. Funded by the U.S. Department of Agriculture, the research was part of a larger study led by scientists at Colorado State University and Cornell to examine the distribution of foodborne pathogens, such as Listeria, E. coli and Salmonella, in agricultural and natural environments. Samples were taken from fields, soil, ponds, and streams in New York, Colorado and Florida. Noting that of the 10 previously known species of Listeria, only two are pathogenic to humans, the researchers claim that Listeria monocytogenes is the main cause of Listeriosis, reportedly the cause of hundreds of deaths and illnesses each year in the United States through infected deli meats, seafood and produce. According to lead study author Henk den Bakker, the study findings have implications for understanding the evolution of what makes…
A recent study has reportedly demonstrated “the protective effect of coffee on non-viral hepatitis-related cirrhosis mortality.” George Boon-Bee Goh, et al., “Coffee, alcohol and other beverages in relation to cirrhosis mortality: the Singapore Chinese Health study,” Hepatology, April 2014. Funded by the National Institutes of Health, researchers examined diet, lifestyle and medical history data from 63,275 middle aged participants enrolled in The Singapore Chinese Health Study over a mean follow-up of 14.7 years. During that time, 114 participants died from cirrhosis related to viral hepatitis (33 percent), chronic alcohol consumption (12 percent) and hepatitis C (2 percent), as well as biliary cirrhosis, autoimmune cirrhosis, and cryptogenic or unspecified cirrhosis. In addition to finding that alcohol consumption was “a strong risk factor for cirrhosis mortality,” the study evidently showed an inverse dose dependent relationship between caffeine intake and non-viral cirrhosis mortality. The study’s authors have suggested that “the benefit of coffee on…
A recent study has purportedly claimed that “both low sodium intakes and high sodium intakes are associated with increased mortality,” raising questions about sodium consumption guidelines set by the Centers for Disease Control and Prevention (CDC) and other health authorities. Niels Graudal, et al., “Compared with Usual Sodium Intake, Low- and Excessive-Sodium Diets are Associated with Increased Mortality: A Meta-Analysis,” American Journal of Hypertension, April 2014. After analyzing data from 23 cohort and two followup studies involving 274,683 individuals, Danish researchers reported that the risks of all-cause mortality and cardiovascular disease events “were decreased in usual sodium vs. low sodium intake… and increased in high-sodium vs. usual sodium intake,” a result “consistent with a U shaped association between sodium intake and health outcomes.” In particular, the main findings apparently showed that “2,645-4,945 mg of sodium per day, a range of intake within which the vast majority of Americans fall, actually results…
A recent New York Times article highlighting the apparent fragility of the lime harvest has blamed a recent shortage on “weather, disease and even Mexican criminals,” warning that increased wholesale prices have only compounded the problem. According to citrus researcher David Karp, a citrus greening disease known as huanglongbing (HLB) has already infiltrated groves in Mexico, which supplies 95 percent of the limes consumed in the United States. In addition to reducing the Key lime harvest by one-third in the past three years, the presence of HLB in Colima has stoked fears that the disease will spread to Persian limes located in Veracruz and other Mexican states. In addition, as industry leaders told Karp, the current shortfall has not only induced farmers to strip their trees early “to cash in on sky-high prices,” but attracted the attention of criminal cartels that have reportedly started “plundering fruit from groves and hijacking…
“Today many plastic products, from sippy cups and blenders to Tupperware containers, are marketed as BPA-free. But [George Bittner’s] findings—some of which have been confirmed by other scientists—suggest that many of these alternatives share the qualities that make BPA [bisphenol A] so potentially harmful,” writes Mariah Blake in a new investigative report examining the purported effects of BPA-free plastic on human health. Published in the March/ April 2014 issue of Mother Jones, the report relies on research conducted by CertiChem, a laboratory founded by University of Texas-Austin Neurobiology Professor George Bittner, whose previous work in Environmental Health Perspectives claimed that “almost all” store-bought food containers “tested positive for estrogenic activity,” including those marketed as BPA-free. In particular, the report points to these findings as evidence that the independent studies used by industry and regulatory authorities are unreliable. “Many of the same scientists who were involved in doing tobacco industry research are…
A South Dakota court has determined that most of the claims filed by the makers of lean finely textured beef (LFTB) against ABC News, certain news correspondents, including Diane Sawyer, and former U.S. Department of Agriculture (USDA) employees may proceed. Beef Prods., Inc. v. Am. Broadcasting Cos., Inc., No. 12-292 (Union Cty. Cir. Ct., S.D., order entered March 28, 2014). Information about the lawsuit appears in Issue 453 of this Update. While the court found the plaintiffs’ claims for common law disparagement preempted by a state statute addressing the elements of a disparagement cause of action, available relief and statute of limitations, it limited its dismissal with prejudice to those alleged tortious statements expressly stating or implying that the product is not safe for human consumption. As to the defamation claims, the court found that the three plaintiffs were appropriate parties because the complaint sufficiently alleged that people who heard the…
Diageo Americas Supply, Inc. has filed a declaratory judgment action against the Tennessee Alcoholic Beverage Commission director challenging the constitutionality of a 1937 law that requires licensed alcohol beverage makers in the state to store their products “only within the county authorizing the operation or in a county adjacent to the county authorizing the manufacturing operation, and such possession shall be limited to storage facilities of such manufacturer” (Storage Law). Diageo Americas Supply, Inc. d/b/a George A. Dickel & Co. v. Bell, No. 14-0873 (M.D. Tenn., filed March 28, 2014). Alleging that the law has never been enforced, the complaint includes the defendant’s March 20 letter warning the company that it was in violation of the Storage Law because it “is storing product (manufactured/distilled alcoholic beverages) produced at its Tullahoma, Tennessee, distillery in warehouses located in Louisville, Kentucky.” According to the company, most of its distilled alcohol beverages are stored on-site…