August 28, 2015

FDA Publishes Draft Guidance on Mandatory Recall Authority

FDA

The Food and Drug Administration (FDA) has published draft guidance for industry on mandatory food recall authority. The draft contains nonbonding recommendations. The mandatory food recall provisions are part of the Food Safety Modernization Act of 2011 (FSMA). Section 423 of the FD&C Act gives authority to the government to order a responsible party to recall food when FDA determines there is a reasonable probability that the food is adulterated or misbranded, and that use of the food will cause serious adverse health consequences or death to humans or animals. Before FSMA was enacted, FDA had to rely on corporations to voluntarily recall food products. This authority lets FDA force a recall when the responsible party chooses not to conduct a voluntary recall. The items that fall … [Read more...]

FDA Releases 2012 NARMS Retail Meat Annual Report

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The FDA has released two reports that measure antimicrobial resistance in certain bacteria isolated from raw meat and poultry. The data is collected through the National Antimicrobial Resistance Monitoring System (NARMS). The 2012 Retail Meat Report summarizes key findings in bacterial resistance related to raw chicken, ground turkey, ground beef, and pork chops collected at retail stores around the country. The 2013 Retail Meat Interim Report is also being released today, which focuses only on Salmonella. These reports detail antimicrobial resistance in Salmonella, Campylobacter, E. coli, and Enterococcus. The reports find that there was a decrease in third-generation cephalosporin resistance amount poultry meats in 2012 and 2013, although current cephalosporin resistance levels are … [Read more...]

EWG Launches Petition to Remove Propyl Paraben

FDA

Environmental Working Group (EWG) has launched a petition to remove propyl paraben, an endocrine disruptor, from the country's food. This ingredient is in 49 processed foods, including Sara Lee cinnamon rolls, Weight Watchers cakes, Energy Club nuts and chocolate blend, Entenmann's Coconut Crunch Donuts, Setton Farms' trail mix, and La Banderita corn tortillas. Propyl paraben is on EWG's Dirty Dozen Guide to Food Additives. The FDA has listed propyl paraben as GRAS, or "generally recognized as safe." But there is evidence that propyl paraben disrupts the endocrine system, which regulates metabolism, sexual function, sleep, reproduction, and mood. A 2010 study at the CDC found that 92.7% of Americans tested had propyl paraben in their urine. Researchers at the Tokyo Metropolitan … [Read more...]

Fourth Quarter 2014 Recall Results

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According to Stericycle, products recalled by the FDA were down, although units recalled were up, and the USDA recalls were the highest since Q1 2012. The company keeps track of food recalled in the U.S. for allergens, foreign material contamination, and bacterial contamination. The FDA recalls numbered 105 in the last three months of 2014, which is the lowest number all year. But 13.8 million units of product were recalled, which is a 142% increase from the third quarter. Undeclared allergens were the main reason for recall, at 50% of the total number. Manufacturers need to be more aware of ingredients sources and the supply chain to keep track of these ingredients. USDA issued 31 recalls for meat, poultry, and processed egg products, which is an increase of 48% from the third … [Read more...]

Senator Schumer Wants FDA to Crack Down on Unsanitary Warehouses

FDA

Senator Chuck Schumer (D-NY) called on the FDA this week, asking for more inspections on food warehouses. Last year the FDA found "squalid" conditions in 90 warehouses that hold food that is shipped to consumers. In a press release, Schumer said, "at the end of 2014, the FDA quietly revealed hundreds of food safety violations at food processing facilities over the course of the year, and everyone from restaurant-goers to owners are appalled by some of the disgusting conditions at warehouses that supply our food. Reports of the filthy conditions at some of these warehouses sound like a page straight out of Upton Sinclair's 'The Jungle'." Some of the issues in those warehouses were dead and alive rats and birds, and rodent feces next to the food. The FDA inspects "high risk" facilities … [Read more...]

Senators Question Antibiotic-Resistant Bacteria Task Force

Senators Elizabeth Warren (D-MA), Dianne Feinstein (D-CA) and Kirsten Gillibrand (D-NY) have sent a letter to Secretaries Chuck Hagel, Tom Vilsack and Sylvia Burwell of the Interagency Task Force for Combating Antibiotic-Resistant Bacteria to ask how gaps in the FDA's plan to combat antibiotic-resistant bacteria will be addressed. President Obama issued an executive order on September 18, 2014 to set up that Task Force. The first guiding principle of the national strategy is that "misuse and over-use of antibiotics in health care and food production continue to hasten the development of bacterial drug resistance, leading to the loss of efficacy of existing antibiotics." But almost 75% of the antibiotics sold every year in this country are used in food animal production, in a way that … [Read more...]

FDA Shuts Down Hawaiian Bean Sprout Operation

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The U.S. Food and Drug Administration (FDA) has taken action to shut down RZM Food Factory, a Hawaiian bena sprout producer for unsanitary conditions. The company has which prepared and distributed mung bean, alfalfa, radish and clover sprouts in Hawaii has ceased operations and cannot resume until it hires an independent sanitation expert and develops a program to eliminate unsanitary conditions at the facility. “The FDA repeatedly advised RZM Food Factory of unsanitary conditions at the facility,” said Melinda K. Plaisier, the FDA’s associate commissioner for regulatory affairs in a statement. “If and when the company is permitted to resume operations, the FDA plans to continue monitoring its operations and may require the company to recall products or cease production if the agency … [Read more...]

CSPI: FDA Should Ban Retail Sale of Bulk Caffeine

The Center for Science in the Public Interest is saying that the FDA should ban the retail sale of bulk caffeine as a dietary supplement. Parents of two young men who died after ingesting this product met with FDA officials and senators to press their cause. CSPI is formally petitioning the FDA over this issue. >Katie and Dennis Stiner of Ohio lost their 18 year old son Logan in May of this year. James and Julie Sweatt of Alabama lost their 24 year old son Wade in July 2014 after he ingested caffeine powder for the first time. One teaspoon of powdered caffeine is equivalent to 25 cups of coffee. It is very difficult to determine the difference between a safe dose and a deadly dose when caffeine is used in this form. Serving sizes are between 1/32 and 1/16 of a teaspoon - amounts that … [Read more...]

PEW Criticizes Gaps in FDA’s Antibiotic Policy

PEW Charitable Trusts is criticizing the U.S. Food and Drug Administration's policy on antibiotic use in food animals, saying there are gaps in the law that promote the growth of antibiotic resistant bacteria. The organization wants the FDA to remove indications for "feed efficiency" and "weight gain" from the labels of animal antibiotics and require vets to oversee the use of the drugs. FDA issued a new policy on antibiotic use in farm animals called Guidance for Industry #213 that was intended to reduce antibiotic misuse. They removed the use of sub-therapeutic additions of antibiotics for feed efficiency and weight gain, but kept the use for disease prevention. PEW reviewed labels of all of the 287 antibiotic products identified by #213 and looked for overlap in the areas of … [Read more...]

CSPI Asks FDA to Label Sesame an Allergen

Regular readers of this site know that recalls are often issued in Canada for sesame seeds, but those types of recalls are not issued in the U.S. The Center for Science in the Public Interest (CSPI) is asking the FDA to require that sesame be disclosed on food labels in the same manner as the other major food allergens, which include milk, eggs, fish, shellfish, tree nuts, peanuts, what, and soy. When Congress passed the Food Allergen Labeling and Consumer Protection Act in 2004, the "Big 8" allergens account for 90% of allergic reactions caused by food. But experts think that sesame is an emerging cause of severe allergy. About 300,000 to 500,000 Americans are allergic to sesame. CSPI filed the petition earlier this month, asking that the agency raise awareness among food service … [Read more...]

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