Judge Finds FDA’s Rule Delays Violate Food Safety Law

Bloomberg News (4/23, Gullo) reports that a Federal judge on Monday ruled that the US Food and Drug Administration “is violating food-safety law by delaying regulations intended to help prevent outbreaks of food-borne illnesses.”

US District Judge Phyllis Hamilton “in Oakland, California, said the agency has ‘admittedly failed to comply with the mandatory rule-making schedule’ of the Food Safety and Modernization Act,” which President Obama signed into law by “in January 2011. 

The FDA had 18 months to issue new regulations. The agency said the “aggressive timelines” have “proven to be unachievable,” Hamilton said in a ruling.” She “ordered the FDA to come up with proposed deadlines for regulations by May 20.”

Agra-Net.com (4/23) reports the “final menu labeling rules are in the ‘home stretch’ and will be published this year. New legislation would be needed to charge the food industry additional fees to help pay for the FDA Food Safety Modernization Act. And FDA is doubling its comment period for the preventive controls and produce safety proposals it published in January,” according to testimony FDA Commissioner Dr. Margaret Hamburg gave recently “before the FDA-USDA appropriations subcommittee.”

FDA CVM Director Responds To Bacteria In Meat Report

In a New York Times (4/24, Subscription Publication, 1.68M) letter-to-the editor, the Food and Drug Administration’s Center for Veterinary Medicine Director Dr. Bernadette Dunham responds to an April 17 article “about the Environmental Working Group’s interpretation of government data on antimicrobial resistant bacteria in meat,” noting that the some data in the National Antimicrobial Resistance Monitoring System “may have limited direct medical relevance, and it’s important to consider which drugs are used to treat infections and which bacteria actually cause food-borne illness.”

Moreover, Dr. Dunham calls the EWG’s conclusion “that resistance in any bacterium is problematic for human health” an “oversimplication” because some “bacteria are naturally resistant to certain drugs. Also, describing bacteria that are resistant to one, or even a few, drugs as ‘superbugs’ is inappropriate” because superbugs are “pathogens that can cause severe disease and are very difficult to treat,” she notes.

Industry Groups Oppose Food Safety Tax

Food Safety News (4/22, Bottemiller) reports the President’s “FY 2014 budget released earlier this month seeks a $295 million increase” for the Food and Drug Administration’s “food program, but the vast majority of the boost would come from new fees that Congress has not mandated, including $59 million in registration and inspection fees and $166 million in import fees, to help the agency roll out the Food Safety Modernization Act.”

Prior to a “hearing late last week, a coalition of industry groups sent a letter to Sens. Mark Pryor (D-AR) and Roy Blunt (R-MO), the chair and ranking member of the Senate appropriations subcommittee on agriculture and other agencies, urging the committee to ‘appropriately fund’ food safety at FDA ‘rather than support the imposition of any new food regulatory taxes.’”

At the hearing, when Pryor asked FDA Commissioner Dr. Margaret Hamburg about the issue, she said, “I do think it’s appropriate that our budget reflect that with a combination of budget authority commitment and user fees.”

Ricardo Gomez

FDA Seeks Public Comments On Controversial Milk Labels

Several consumer groups object to a petition that groups representing the US dairy industry submitted to the Food and Drug Administration, requesting the agency to permit low-calorie chocolate milk and other flavored milk products to be sold on the market without labeling that conspicuously indicates they are reduced-calorie items.
At present, such information must be displayed prominently on the front of milk products.

In continuing coverage, The Hill (4/16, Wilson) “Regwatch” blog reports that the Food and Drug Administration “is defending new regulations for artificially sweetened milk after receiving a torrent of public criticism.” 

Regulators say the labels, which require “milk producers prominently label their products ‘low calorie’ or ‘reduced calorie’ when they contain artificial sweeteners,” could have the “unintended effect of discouraging children from trying healthier milk products” because “reduced-calorie flavored milk is a turn-off to young consumers.” 

The Hill notes that the FDA on Monday “asked for public input on whether the revised milk labels would provide enough information to consumers.” In a statement, Felicia Billingslea, Director of FDA’s Food Labeling and Standards staff, said, “The FDA recognizes the importance of this decision and is interested in hearing from the public and industry on the petition.”

Report: Supermarket Meat Contains Antibiotic-Resistant Bacteria

The New York Times (4/17, Strom, Subscription Publication, 1.68M) reports the findings in report by the Environmental Work Group illuminated Federal data that claims over half of “samples of ground turkey, pork chops and ground beef collected from supermarkets for testing by the government contained a bacteria resistant to antibiotics.”

The 2011 data collected by the National Antimicrobial Resistance Monitoring System, which is jointly run by the FDA, the USDA and the CDC, reveals “a sizable increase in the amount of meat contaminated with antibiotic-resistant forms of bacteria, known as superbugs, like salmonella, E. coli and campylobacter.” 

Dawn Undurraga, the nutritionist for the group, said the study “really raises a question about the antibiotics we are using in raising animals for meat.” The Times also mentions the report was partially underwritten by a company that sells organic and antibiotic-free meat.

Report Examines Areas In Kitchens Where Germs May Hide

The New York Times (4/12, 1.68M) “Well” blog reports that “a new report...looked at the places and appliances in household kitchens that are most – and least – likely to harbor germs like E. coli and salmonella,” finding that “some of the areas people considered most likely to be contaminated, like microwave keypads, were not, while some they had never thought of, like refrigerator water dispensers and the rubber gasket on most blenders, were among the worst.

The findings suggest that many people who try to keep a tidy kitchen may be overlooking some of the more problematic areas, said Lisa Yakas, a microbiologist with NSF International, a nonprofit public health group that published the report.” According to the Centers for Disease Control and Prevention, approximately 20% of food-borne illness outbreaks trace their origins to foods prepared and eaten at home.

Physicians, Health Experts Urge FDA To Restrict Caffeine In Energy Drinks

The New York Times (3/20, Meier, Subscription Publication, 1.68M) reported, “A group of 18 doctors, researchers and public health experts” in a letter (pdf) sent Tuesday to FDA Commissioner Dr. Margaret A. Hamburg, “argued that energy drink makers had failed to meet the regulatory burden placed on them to show that the ingredients used in their beverages were safe,” especially for use by children. Therefore, the group urged the agency to “restrict caffeine content in the products and to require manufacturers to include caffeine content on product labels.” The Times notes that energy-drink makers “have insisted their products are safe” and the FDA has “said that it is safe for adults to consume about 400 milligrams of caffeine daily, though many experts say that most adults can consume 600 milligrams or more of caffeine without ill effect.”

Energy Drinks Changing Aisles To Avoid Federal Regs. In a front-page story, the New York Times (3/20, A1, Meier, Subscription Publication, 1.68M) reports, “Fans of Monster Energy, the popular high-caffeine energy drink, may not notice the change: its ingredients will be the same and its familiar label bearing a green, clawlike monogram will change only slightly. But the drink’s maker has decided after a decade of selling it as a dietary supplement to market it as a beverage, a switch that will bring significant changes in how it is regulated.” For one, the move from the supplement aisle to the beverage aisle in the grocery store means Monster Beverage “will no longer be required to tell federal regulators about reports potentially linking its products to deaths and injuries.” Monster’s move “follows a similar regulatory makeover by another brand, Rockstar Energy,” and comes “amid intensifying scrutiny of energy drink safety.”

Tree Fruit Farmers Worry About Costs To Meet FDA Safety Rules

The Washington Post (4/9, Dennis, 489K) reports that the US Food and Drug Administration, “wrestling to put in place a massive overhaul of the nation’s food safety system, drew a line this year when proposing which fruits and vegetables would be subject to strict new standards” under the 2010 Food Safety Modernization Act. 

Growers, who are “subject to the new produce rules could face a variety of new responsibilities, including regular testing of irrigation water, sanitizing canvas fruit-picking bags and keeping animals away from crops.” Many tree fruit farmers, who are concerned “about the cost” of meeting the new standards “argue that the FDA should focus more on foods that have caused deadly outbreaks, such as spinach and cantaloupes, and less on fruits that have a virtually flawless safety record, grow above the ground and, in some cases, have protective skins or rinds.”

Columnist Takes Issue With Genetically Modified Food Bill

In the syndicated “Alternative Health with Dr. Lind” column in the Washington Times (3/28, 76K), Dr. Peter Lind, who practices metabolic and neurologic chiropractic at his wellness clinic in Salem, OR, wrote, “President Barack Obama signed a spending bill, HR 933, into law, the ‘Monsanto Protection Act,’ that strips federal courts of the authority to immediately halt the planting and sale of genetically modified (GMO) seed crop regardless of any consumer health concerns.”

In voicing his opposition to the bill, Lind quoted several studies and group statements pointing to potential safety issues with genetically modified foods, including one from the American Academy of Environmental Medicine, which concluded, “There is more than a casual association between GM foods and adverse health effects. There is causation, ‘as defined by recognized scientific criteria.”

Lind urged readers to educate themselves about genetically modified foods and seeds and to get in touch with elected officials on all levels of government to voice their concerns.

GMO Food Labels Would Increase Transparency For Consumers

The Minneapolis Star Tribune (3/31, 335K) editorialized Minnesota officials should craft legislation that informs consumers about genetically engineered foods. The editorial board writes, “As Americans awaken in greater numbers to the link between nutrition and health, they’re demanding transparency on food labels in order to make the best choices for their diets, whether because of allergies, diabetes, vegetarianism, religion or other reasons.”

The board believes that American consumers “have a right to know what’s in the food they’re buying, and that’s currently not the case with genetically engineered ingredients, which are in the majority of processed foods in US supermarkets.” The board also warns that “the nation’s most powerful biotech, agribusiness, chemical and packaged-food companies are spending millions to prevent change,” and what at stake is not about “food safety, but basic consumer information.”

The Roll Call (4/2, Rojas, Subscription Publication) “Heard on the Hill” blog reports that on April 8, “food activists opposed to genetically modified crops will take their fight to the US Food and Drug Administration...sponsoring an old school eat-in at the agency’s College Park, Md., campus staged around a truly historic meal.”

An all-day “anti-GMO protest is scheduled for April 8 outside the FDA’s Center for Food Safety and Applied Nutrition and will feature a full day of activities. It will include the preparation and consumption of a massive cauldron...of all-inclusive ‘stone soup.’” According to the blog, “Occupy Monsanto organizer Adam Eidinger told HOH that the event is geared toward one simple goal: a clear understanding of what we are all eating.”