SHB Pharmaceutical & Medical Device Practice Chair Madeleine McDonough and Associate Lael Awong have co-authored a chapter in a Food and Drug Law Institute (FDLI) primer titled FDA’s Regulation of Veterinary Drug Products. Researched, referenced and edited by experienced professionals, FDLI primers are designed to be practical and user-friendly. McDonough and Awong contributed to the “Human Food Safety” chapter, which addresses Food and Drug Administration (FDA) regulations aimed at ensuring that food is safe for human consumption regardless of the use of an animal drug in a food-producing animal. They explain how veterinary drug sponsors can meet FDA requirements for the analysis of drug residues in food-producing animals in the preparation of new animal drug applications. The primer is available for purchase on FDLI’s website.
Category Archives Other Developments
In response to evidence that British children appear to be getting fatter, the Academy of Medical Royal Colleges in London has reportedly recommended imposing a 20 percent tax on sugary soft drinks for one year as an experiment to see whether it reduces consumption by kids. The group has also called for a ban on TV ads for foods high in saturated fats, sugar and salt until 9 p.m., and has suggested that the government develop “formal recommendations on reducing the proximity of fast food outlets to schools, colleges, leisure centers and other places where children gather.” Meanwhile, the British Soft Drinks Association and other industry groups have publicly opposed such steps, claiming that most soda sold in Britain does not contain added sugar and that a new tax would hurt consumers who can “ill afford it.” The country’s Food and Drink Federation has also contended that existing restrictions on TV ads…
A recent New York Times report has claimed that the failure of a new computer system used by meatpacking and processing plant inspectors did not stop untested shipments of beef, poultry, pork, and lamb from reaching consumers. According to an August 17, 2013, article by Ron Nixon, the U.S. Department of Agriculture (USDA) acknowledged the August 8, 2013, system failure but “played down the threat to public safety and insisted that the breakdown of the $20-million computer system had not compromised the nation’s meat supply.” Designed to speed up the inspection process, which involves sending meat samples to laboratories to test for E. coli and other contaminants, the new computer system is an important piece of USDA’s plan “to provide real-time information about the conditions at meat processing plants and make it easy for the agency to track food safety problems before they led to outbreaks.” But Nixon notes that…
Although the typical energy drink user is reportedly young and male, a recent news source indicates that a new demographic is emerging as a top consumer of these beverages—busy, young mothers. Recent data from Nielsen reveal that busy mothers and their households—categorized as “Young Bustling Families”—are more likely to drink energy drinks than the average U.S. household, with a purchasing index of 150, higher than both “Young Transitionals” or young adults just out of college, and “Independent Singles” in their 20s and 30s. In response to these new consumption patterns, some energy drink makers have developed “women-friendly” energy drinks, including a pink lemonade-flavored beverage from which a portion of sales are donated to the Avon Foundation Breast Cancer Crusade, and a beverage with no sugar or calories that apparently features a sweeter, more refreshing flavor, and is packaged in a white can with “feminine design elements.” See Convenience Store News,…
The Center for Science in the Public Interest, Consumers Union and Food Animal Concerns Trust have sent a letter urging U.S. delegates to an upcoming U.N. food standards agency meeting about residues of veterinary drugs in food to ask other countries to stop using drugs that have long been prohibited for use in the United States due to “human health concerns, particularly carcinogenicity and mutagenicity.” The drugs in question include carbadox, nitrofural, furazolidone, chlorpromazine (thorazine), stilbenes (e.g. diethylstilbestrol, DES), olaquindox, dimetridazole, ipronidazole, metronidazole, and ronidazole, and according to Food Animal Concerns Trust Director Steven Roach, they are “not needed for animal health” and most countries have adopted safer alternatives. “We urge the U.S. delegation to insist on a recommendation that other countries prohibit use of these drugs, as the U.S. itself does,” said Roach. See Consumerist, August 21, 2013.
Yale University’s Rudd Center for Food Policy and Obesity and the Robert Wood Johnson Foundation’s (RWJF’s) Bridging the Gap research program recently published a study in the American Journal of Preventative Medicine concluding that the food and beverage industry “still spends the bulk of its money to promote unhealthy products” to children and teens. Lisa Powell, et al., “Food Marketing Expenditures Aimed at Youth: Putting the Numbers in Context,” American Journal of Preventative Medicine, August 2013. Seeking to contextualize a Federal Trade Commission (FTC) report that found food and beverage companies spent less on youth-focused marketing in 2009 than in 2006, the study suggests that the expenditure trends highlighted by FTC ultimately fail to account for changes in the marketing landscape that allegedly negate the overall decrease in spending. In particular, according to a concurrent issue brief, Rudd Center and Bridging the Gap researchers reported that “the vast majority of…
Citing a shortage of naturally raised beef due to last year’s drought, Chipotle Mexican Grill Inc. has apparently told media sources that it may allow its restaurants to begin using beef treated with antibiotics. Although Chipotle only reached its goal to use antibiotic- and hormone-free meat a few years ago, the company reportedly said that it plans to review its “never-ever” antibiotic policy and possibly allow suppliers to sell animals that have been treated with antibiotics “when necessary.” The policy change would still bar the use of beef from animals given antibiotics to prevent disease or promote weight gain. “Many experts, including some of our ranchers, believe that animals should be allowed to be treated if they are ill and remain in the herd,” Chipotle founder and co-CEO Steve Ells was quoted as saying. “We are certainly willing to consider this change, but we are continuing to evaluate what’s best…
The Pew Charitable Trusts’ Food Additive Project has published a paper in Reproductive Toxicology claiming that gaps in the toxicity data for food additives raise questions about the Food and Drug Administration’s (FDA’s) safety assessments for these substances. Thomas Neltner, et al., “Data Gaps in Toxicity Testing of Chemicals Allowed in Food in the United States,” Reproductive Toxicology, August 2013. Comparing data from FDA’s Priority-based Assessment of Food Additives database, the Accelrys Toxicity Database of chemical studies and the U.S. National Library of Medicine’s TOXLINE database, the study’s authors apparently determined that “almost two-thirds of chemical additives appear to have been declared safe for use in food without the benefit of being fed to an animal in a controlled toxicology study,” while approximately 78 percent of additives lack adequate data to estimate a safe level of exposure and 93 percent lack reproductive or development toxicity testing. They also reported that, according to…
A coalition of U.K. dairy groups, including Dairy UK, the National Farmers Union and British Cheese Board, has published an August 1, 2013, letter in The Daily Telegraph, urging the European Commission (EC) to tighten regulations governing country-of-origin labeling (COOL). Stating that current regulations permit imported dairy products to be stamped with “UK marks,” the coalition has requested that only dairy products made in “this country, from milk produced by Britain’s dairy farmers should be labeled as British.” “Unlike other food products . . . country of origin labeling is not mandatory on dairy products and we think that it should be,” said a spokesperson for the coalition. “Many consumers want to buy British dairy products and support British dairy farmers. The current labeling arrangements don’t ensure that they have the information to be able to do that.” According to news sources, of particular concern to the coalition are dairy…
National and local health groups have sent an August 1, 2013, letter to U.S. Department of Agriculture (USDA) Secretary Tom Vilsack, urging the agency to allow demonstration projects “designed to promote healthier food and beverage purchases” under the Supplemental Nutrition Assistance Program (SNAP). Organizations such as the American Heart Association, American Medical Association and Center for Science in the Public Interest (CSPI) have asked USDA to approve SNAP pilot projects as part of an effort to provide the agency and Congress with the data needed “to make an informed decision concerning ways to improve the nutritional quality of purchases through the SNAP program.” According to a concurrent CSPI press release, these projects “might include curbs on purchases of soda and other sugar drinks or unhealthful foods.” “Most Americans’ diets, including the diets of low-income folks served by SNAP, are overflowing with soft drinks and woefully deficient in whole grains and…
