The Food and Drug Administration (FDA) has issued its “Guidance for Industry: Questions and Answers Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation.” Comments may be submitted at any time, although the guidance, with nonbinding recommendations for complying with a final rule that took effect in September 2009, has incorporated comments submitted after the draft guidance was published. Presented in a Q&A format, the guidance addresses compliance dates, the egg rule’s coverage, definitions, Salmonella Enteritidis prevention measures, testing, sampling, and registration requirements. See Federal Register, August 21, 2012. Noting that Americans consume 242 eggs per capita annually, New York University Nutrition Professor Marion Nestle draws attention to the guidance in her blog and cites a recent Canadian study claiming an association between the consumption of egg yolks and plaque formation in coronary arteries. She suggests that we should not “be eating so many eggs,”…
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The Food and Drug Administration (FDA) has issued a final rule that amends regulations about concentrations of compounds of carcinogenic concern in the diet of food-producing animals and residues of carcinogenic concern in specific edible tissues. The changes clarify certain definitions “to enable the Center for Veterinary Medicine to consider allowing the use of alternative procedures to satisfy the DES [Diethylstilbestrol] Proviso without requiring the development of a second, alternative, set of terminology.” The changes take effect September 21, 2012. Among other matters, the amendment will change the existing emphasis in 21 CFR Part 500 on “no significant increase in the risk of cancer to the human consumer” to an emphasis on “the specific 1 in 1 million risk of cancer to the test animals approach.” See Federal Register, August 22, 2012.
The Food and Drug Administration (FDA) has responded to Senator Dick Durbin’s (D-Ill.) letter requesting that the agency take regulatory action “to address the rising health concerns around energy drinks” purportedly containing high levels of caffeine and other ingredients such as taurine, guarana and ginseng. Among other matters, in its August 10, 2012, letter, FDA suggests that research to date shows that “even when the consumption of energy drinks is considered, most of the caffeine consumed [in the United States] comes from what is naturally present in coffee and tea.” For most healthy adults, according to FDA, caffeine intake up to 400 mg per day is not associated with untoward health effects. Additional details about Durbin’s letter appear in Issue 435 of this Update. FDA’s generally recognized as safe (GRAS) regulation for caffeine applies to cola-type beverages; the agency “has not challenged the use of caffeine in other beverages at…
A coalition of advocacy organizations has filed five complaints with the Federal Trade Commission (FTC) against companies including McDonald’s Corp., General Mills, Inc. and Doctor’s Associates, Inc., calling for an investigation into Websites they purportedly use to promote food and TV programs to children. According to the coalition, the food-related websites— HappyMeal.com, ReesesPuffs.com, TrixWorld.com, and SubwayKids. com—violate the Children’s Online Privacy Protection Act (COPPA) by encouraging children to provide their friends’ email addresses and create videos promoting branded products to send to their friends. According to the coalition, “tell-a friend,” or “viral marketing,” is profitable given the effectiveness of word-of-mouth advertising and the opportunity to create “lifetime customers.” The coalition is also requesting that FTC update existing COPPA regulations “to include data collection and storage of photographs online from children, as well as placement of cookies used for types of behavioral advertising.” Claiming that “several of the child-directed websites we…
U.K. researchers have allegedly identified raised urinary bisphenol A (uBPA) concentrations in 591 study participants “with intermediate or severe stenoses compared to those graded as having no coronary artery disease [CAD],” suggesting that “associations between uBPA and CAD may be specific to coronary artery stenosis.” David Melzer, et al., “Urinary Bisphenol A Concentration and Angiography-Defined Coronary Artery Stenosis,” PLoS One, August 2012. According to the authors, their results apparently supported the associations between uBPA and CAD reported in three previous studies but “effectively ruled out reverse causation, strengthening the evidence for causal inference.” “The mechanism by which BPA ingestion and metabolism influences vascular function and risk of cardiovascular disease has not been elaborated… We recently suggested plausible mechanisms by which BPA might increase the risk of cardiovascular disease, including reduced nitric oxide bioavailability, altered vascular reactivity to endothelin-1, oxidative stress and inflammation,” concluded the researchers, who recommended further work to…
A recent study has reportedly concluded that school children in states with strong restrictions on competitive food sales gained less weight than their counterparts in states with weaker restrictions. Daniel Taber, et al., “Weight Status Among Adolescents in States That Govern Competitive Food Nutrition Content,” Pediatrics, September 2012. After identifying states with strong, weak or no competitive food laws, researchers analyzed data from 6,300 students in 40 states in both fifth and eighth grade (2004 and 2007). The findings evidently showed that “students exposed to strong laws at baseline gained, on average, 0.25 fewer BMI [body mass index] units… and were less likely to remain overweight or obese over time than students in states with no laws.” “Laws that regulate competitive food nutrition content may reduce adolescent BMI change if they are comprehensive, contain strong language, and are enacted across grade levels,” concluded the study’s authors. “Our results suggest that…
A recent study has allegedly linked a second artificial butter flavoring— 2,3-pentanedione (PD)—to respiratory toxicity in animals, raising concerns about the diacetyl replacement’s potential effects on factory workers. Ann Hubbs, et al., “Respiratory and Olfactory Cytotoxicity of Inhaled 2,3-Pentanedione in Sprague-Dawley Rats,” The American Journal of Pathology, September 2012. After exposing rats to either PD, diacetyl or air for six hours, researchers reported that those inhaling PD “developed necrotizing rhinitis, tracheitis, and bronchitis comparable to diacetyl-induced injury.” The study’s authors then investigated PD’s delayed toxicity on the animals, concluding that the substance caused “respiratory epithelial injury in the upper nose . . . which progressed through 12 to 14 hours after exposure,” as well as the loss of olfactory neurons and altered gene expression in the brain. “Our study demonstrates that PD, like diacetyl, damages airway epithelium in laboratory studies. This finding is important because the damage is believed to be…
The Institute for Responsible Technology (IRT) has released a new documentary, Genetic Roulette: The Game of Our Lives, that accuses the U.S. government of permitting “untested genetically modified (GM) crops into our environment and food supply.” Based on IRT founder Jeffrey Smith’s book of the same title, the film alleges that “the same serious health problems found in lab animals, livestock, and pets that have been fed GM foods are now on the rise in the U.S. population.” “Gastrointestinal disorders, allergies, inflammatory disease, and infertility are just some of the problems implicated in humans, pets, livestock, and lab animals that eat [GM] soybeans and corn,” opines IRT, which ultimately urges consumers to refrain from eating GM ingredients in an effort to ward off “the deteriorating health of Americans, especially among children.”
In the wake of an Australian High Court ruling validating regulations requiring cigarettes to be sold in plain packages, some commentators are speculating whether other products, such as alcoholic beverages and fast food, will be subject to the same types of restrictions. The opinion, penned by Patrick Carlyton, suggests that because alcoholism and obesity also purportedly have deleterious effects, government may consider imposing taxing and packaging rules on the other industries. While he questions whether these types of restrictions actually affect consumption—“will plain packaging work in reducing smoking rates? No one knows. It hasn’t been tried before”—he concludes, “One thing is certain. Plain packaging for unhealthy foods in supermarket aisles would certainly constitute a relief for every parent, and this would have nothing to do with the health benefits.” See News Limited Network, August 16, 2012.
A peer-reviewed article appearing in Preventing Chronic Disease explores how five alcohol-control policies could hold promise in addressing the obesity epidemic if used to regulate access to low-nutrient foods. Deborah Cohen & Lila Rabinovich, “Addressing the Proximal Causes of Obesity: The Relevance of Alcohol Control Policies,” Preventing Chronic Disease, May 2012. The policy interventions discussed include (i) limitations through zoning and licensing on the density of food outlets; (ii) displays and sales restrictions that focus on controlling impulse buying; (iii) regulations on portion sizes; (iv) pricing strategies, i.e., higher taxes on foods high in calories and low in nutritional value; and (v) strategic use of warning labels and ads that discourage people from overeating or consuming too many foods lacking nutritive value. According to lead author and RAND researcher Deborah Cohen, “Just as regulating alcohol accessibility has been effective in reducing problem drinking, regulating food accessibility is promising for controlling…