Draft guidance to help evaluate effectiveness of drugs to reduce pathogenic Shiga toxin-producing E. coli in cattle

The U.S. Food and Drug Administration issued today draft Guidance for Industry #229: Evaluating the Effectiveness of New Animal Drugs for the Reduction of Pathogenic Shiga Toxin-Producing E. coli (STEC) in Cattle. GFI #229 provides recommendations on study design and criteria drug manufacturers should use when evaluating the effectiveness of animal drugs intended to reduce STEC. The draft guidance addresses topics including:

supershedder.e.coliprotocol development;

study conduct;

animal welfare;

nutritional content of experimental diets;

the assessment of drug concentrations in experimental diets;

experimental parameters; and

substantial evidence of effectiveness.

The draft guidance also provides recommendations for acceptable indications, as well as study designs and analyses that sponsors should use to verify the effectiveness of drugs intended to reduce pathogenic STEC in cattle.

STEC is a foodborne pathogen found mostly in cattle, but can cause serious human illness if contracted. In the U.S., E. coli O157:H7 is the most common type of STEC associated with foodborne E. coli outbreaks, but other serotypes of STEC may also cause illness in people. Most foodborne E. coli infections can be prevented by thorough hand washing, cooking meats to the appropriate temperature, and preventing cross contamination in food preparation.

The FDA is accepting public comments on this draft guidance beginning on February 24, 2015. To submit your comments electronically to the docket, go to www.regulations.gov and type FDA-2015-D-0235 in the search box. Please note that the docket will not be open to accept comments until this date. The comment period will close 60 days after it publishes in the Federal Register. While comments are welcome at any time, you should submit them by the closing date for the FDA to consider your comments in drafting the final guidance.

ecoliO157guidance

Almost 6000 sick with 1000 dead dogs: Jerky pet treat investigation in US

The U.S. Food and Drug Administration has issued an update on its ongoing investigation into pet illnesses and deaths in animals that ate jerky pet treats.

sadie.car.10As of September 30, 2014, the FDA has received approximately 5,000 complaints of illness associated with consumption of chicken, duck, or sweet potato jerky treats, most of which involve products imported from China. The reports involve more than 5800 dogs, 25 cats, three people, and include more than 1,000 canine deaths.

These numbers include approximately 270 complaints received since the FDA’s last update in May 2014. This is a significant decrease from the previous period (October 2013 to May 2014), in which the FDA had received 1,800 complaints.

Because of the sharp reduction in complaints, the FDA is tentatively planning to shift from a biannual routine reporting cycle to issuing annual updates. This shift in reporting cycles does not mean that the FDA is reducing its effort to investigate the cause of these illnesses: the agency continues to devote significant resources to its investigation, and will post non-routine updates if notable events occur.

Although it is impossible to determine in every case whether the events reported were in fact caused by eating jerky pet treats, the FDA continues to believe that there is an association between some of the reports and consumption of jerky pet treats.

The agency continues to caution pet owners that jerky pet treats are not required for a balanced diet, and encourage them to consult with their veterinarians, both prior to feeding treats and if they notice symptoms in their pets.

Portlandia gets raw as they expose the FDA’s lies (it’s satire)

Things are about to get raw on Portlandia.

Fred Armisen, Carrie Brownstein- Photo Credit: Augusta Quirk/IFCIn the words of Candace and Toni: If you’re not outraged, you’re not paying attention to the lies that the FDA is feeding you about the joys of raw milk.

This week, Brendan (Fred Armisen) and Michelle (Carrie Brownstein) were feeling lethargic, sluggish and generally under the weather until they discovered that raw milk is a miracle cure-all. A miracle that the FDA is trying to prevent you from enjoying! Check out this clip as they storm a doctor’s (Ed Begley Jr.) office to spread the truth about raw milk.

FDA investigating Pennsylvania Asian food supplier

The United States Food and Drug Administration is investigating a food warehouse that in August had one of its trucks pulled over in Lawrence County for carrying spoiled food.

According to a letter sent Dec. 9 to NYWP Enterprise LLC, the FDA found numerous violations at its warehouse in McKees Rocks, Pa. between Oct. 15 and Oct. 30, including:

  • FDA inspectors found pests in the food plant. An apparent rodent nest was found in a plastic box containing thawing red meat.
  • Plumbing was not properly installed.
  • Rodenticides were found near food.
  • The warehouse failed to take proper precautions to reduce food contamination from chemicals.
  • The warehouse had inadequate drainage.
  • They did not properly store equipment and remove litter and waste.
  • There was inadequate workspace.
  • Improper storage of single-service items.
  • Improper lighting fixtures were found over food.
  • Employees were found using tobacco near food.

The list of violations was posted to the FDA’s website on Dec. 24. The company acknowledges the list of violations and said they are committed to maintaining and operating a facility that provides the highest quality service for its customers.

However, the FDA said the company did not provide proper documentation to detail how they would fix the violations.

 

Nine restaurants under India FDA radar for being unclean on New Year Eve

The Food and Drug Administration (FDA), Konkan division, conducted a surprise inspection of 14 hotels and restaurants in Thane and Navi Mumbai on Wednesday night during New Year celebrations.

0Nine such places came under the FDA radar that did not follow general hygiene norms. There were several complaints about the sub-standard quality of food and drinks served, owing to heavy rush.

The food safety officials collected 15 food samples, besides 13 liquor samples, in an effort to crack down on poor quality of food and drinks. The samples will be sent to Mumbai laboratory for further testing. FDA sources said that the test report was expected in a day or two, which will follow necessary action against offenders based on the Food Safety and Standards Act. 

Don’t thaw meat on melons: FDA warns Brooklyn wholesaler to clean up its act

Coral Beach of The Packer writes the U.S. Food and Drug Administration has Brooklyn wholesaler New Yung Wah Trading Co. in its sights because of unresolved food safety issues that include rodents nesting in a box of thawing meat that was stored on top of fresh melons.

melon.berriesOn Dec. 23 the FDA posted its Dec. 9 warning letter to co-owner Juan Qing Lin. FDA officials cited numerous instances of live and dead rodents, birds flying through the warehouse and landing on fresh produce and other food products during a two-week inspection of one of the company’s warehouses.

There were also plumbing problems, leaking roofs and clogged floor drains. The company had until Dec. 24 to reply to the warning letter.

Sounds like a lot of meetings: Additional actions needed to improve planning and collaboration for US food safety

A new report from the U.S. Government Accountability Office found the Department of Health and Human Services (HHS) and the U.S. Department of Agriculture (USDA) have taken steps to implement GPRA Modernization Act of 2010 (GPRAMA) requirements but could more fully address crosscutting food safety efforts. For example, GPRAMA requires agencies to describe in their strategic and performance planning how they are working with other agencies to achieve their goals.

Meeting.1HHS and USDA vary in the amount of detail they provide on their crosscutting food safety efforts. In addition, they do not include several relevant crosscutting efforts, such as the National Antimicrobial Resistance Monitoring System, which tracks whether foodborne bacteria are resistant to the antibiotics used to treat and prevent illness.

Fully addressing crosscutting efforts in individual strategic and performance planning documents is an important first step toward providing a comprehensive picture of federal food safety performance. However, individual agencies’ documents do not provide an integrated perspective on federal food safety performance. In 2011, GAO recommended that the Office of Management and Budget (OMB), in consultation with the federal agencies having food safety responsibilities, develop a government-wide performance plan for food safety. OMB has not acted on that recommendation. Without such a plan, Congress, program managers, and other decision makers are hampered in their ability to identify agencies and programs addressing similar missions and to set priorities, allocate resources, and restructure federal efforts, as needed, to achieve long- term goals. In addition, without such a plan, federal food safety efforts are not clear and transparent to the public. GAO continues to believe that a government- wide performance plan for food safety is necessary.

HHS’s Food and Drug Administration (FDA) and USDA’s Food Safety and Inspection Service (FSIS) have mechanisms in place to facilitate interagency coordination on food safety that focus on specific issues, but none provides for broad-based, centralized collaboration. For example, FDA and FSIS are collaborating with the Centers for Disease Control and Prevention through the Interagency Food Safety Analytics Collaboration to improve estimates of foodborne illness sources. However, this and other mechanisms do not allow FDA, FSIS, and other agencies to look across their individual programs and determine how they all contribute to federal food safety goals. Nearly all the experts GAO interviewed agreed that a centralized collaborative mechanism on food safety is important to foster effective interagency collaboration and could enhance food safety oversight. The Food Safety Working Group (FSWG) served as a centralized mechanism for broad-based food safety collaboration and resulted in a number of accomplishments, including improved coordination. However, the FSWG is no longer meeting.

A prior centralized mechanism for broad-based collaboration on food safety also was not sustained. Without a centralized collaborative mechanism on food safety, there is no forum for agencies to reach agreement on a set of broad-based food safety goals and objectives. Experts suggested that a centralized collaborative mechanism on food safety—like the FSWG—could provide sustained leadership across agencies over time if it were formalized in statute. Without such formalization, centralized collaborative mechanisms on food safety may continue to be short- lived.

Beware the fungus: FDA says dietary supplements containing live bacteria or yeast could cause problems in immunocompromised persons

The U.S Food and Drug Administration is warning health professionals of the risks associated with the regarding use of dietary supplements containing live bacteria or yeast in immunocompromised persons. A premature infant administered a dietary supplement, ABC Dophilus Powder (Solgar), as part of in-hospital course of treatment, developed gastrointestinal mucormycosis caused by the mold Rhizopus oryzae and died. Rhizopus oryzae mold was found to be present as a contaminant in an unopened container of the ABC Dophilus Powder, which is formulated to contain three species of live bacteria.

abc-dophilus-powderFDA, along with the Centers for Disease Control and Prevention (CDC) and the Connecticut Department of Public Health, are investigating the death of this preterm infant who developed gastrointestinal mucormycosis.  In mid-November, Solgar issued a recall for certain lots of ABC Dophilus Powder and public health warnings were issued advising customers and consumers not to use the recalled product.

FDA is informing healthcare providers that dietary supplements, including those that are formulated to contain live bacteria or yeast, are generally not regulated as drugs by the FDA.  As such, these products are not subject to FDA’s premarket review or approval requirements for safety and effectiveness, nor to the agency’s rigorous manufacturing and testing standards for drugs, including testing for extraneous organisms.

 

 

Over 300 sickened: State knew Chobani yogurt was tainted months before recall, FDA says

Whether it’s food, automobiles, consumer goods, whatever – selling deficient product and trying to cover it up usually backfires.

chobani.yogurtPeople and corporations are found out over time: so suck it up and go public early and often.

In response to continual mold problems, Chobani, the Greek yogurt people, made staff changes at its Twin Falls plant and corporate headquarters in New York, hired one new public relations firm and one advertising firm during the recall, and fired Nicki Briggs and “other in-house PR staffers” in November after “a broad refocusing of its resources.”

Chobani official said those PR changes had nothing to do with the mold outbreak and resulting recall.

Chobani may have been focusing on the wrong problem.

MagicValley.com reports the Idaho Department of Agriculture saw moldy yogurt during a routine inspection at Chobani two months before the company issued a voluntary recall, says a U.S. Food and Drug Administration report obtained by the Times-News under a Freedom of Information Act request.

The state denies the FDA claim.

More than 300 people got sick after consuming the moldy Greek yogurt from Twin Falls.

The state inspection was conducted in July. But not until September did Chobani issue a voluntary recall of 35 varieties of its tainted yogurt, advising the public it was contaminated with Mucor circinelloides, a mold commonly associated with yogurt production.

A report summarizing five separate inspections by the FDA in September gives this account of the state’s inspection:

“In July the routine Grade A sampling and testing samples taken by the Idaho Department of Agriculture (ISDA) from the Chobani Idaho Inc. production were visually noted, by the laboratory technician, that surface defects were present and additional testing was conducted noting a yeast like growth developing in the yogurt samples.”

chobani-recall-2013-updateThe FDA inspections also prompted Chobani to clean various pieces of equipment at the Twin Falls facility. After some “minor deficiencies” were reported, the FDA did not issue a mandatory recall or take further action.

ISDA spokeswoman Pamela Juker said state regulators never took note of any mold during the July inspections, and she’s unsure where the FDA got its information.

“All of the raw and finished product-testing results met the requirements of the Pasteurized Milk Ordinance,” Juker said. “All of the tests we’ve done met the requirements.”

Chobani repeatedly has declined to provide details on the issue. But Weber Shandwick, a third-party public relations firm, emailed a company response Wednesday.

“Our goal is to ensure our Idaho facility is not just a leader in size, but also in cleanliness, quality and safety,” a Chobani official wrote. “To accomplish this, we have brought in significant resources and are working with internal as well as outside experts to put together one of the most advanced food safety and quality systems in our industry.”

Uh-huh.

And I prefer science as an enhancement of nature.

Neptune (me, not exactly as shown) to halt production until FDA documents correction of unsanitary practices

Neptune Manufacturing prepares, processes, packs, holds and distributes ready-to-eat smoked and salt-cured (pickled) fish and fishery products including pickled herring, smoked steelhead trout, smoked turbot/halibut, smoked whitefish, smoked salmon and smoked mackerel. The company sells its ready-to-eat products wholesale to customers located in southern California and Las Vegas.

neptuneThe U.S. Food and Drug Administration has conducted seven inspections of the facility since 2006. Each time, FDA investigators found similar unsanitary conditions. (The Act refers to unsanitary conditions as insanitary.) FDA investigators found the pathogenic bacterium Listeria monocytogenes (L. mono) on four occasions at the facility. FDA investigators also found a failure to control for Clostridium botulinum (C. bot) growth and toxin formation on at least three occasions.

L. mono is a foodborne pathogen that can cause serious illness or even death in vulnerable groups such as newborns, elderly adults and those with impaired immune systems. C. bot, a bacterium that can grow in seafood products, causes botulism, which is rare but can cause paralysis and death without prompt treatment. The purpose of food safety regulations is, in part, to prevent the growth and spread of L. mono, C. bot and other microorganisms that cause foodborne illness.

“When a company and its owners repeatedly violate the same food safety procedures, their failure to improve their processes and clean up their facility endangers the public,” said Melinda K. Plaisier, the FDA’s associate commissioner for regulatory affairs. “The FDA will take necessary action to protect the food supply from adulteration.”

No illnesses have been reported to date associated with Neptune Manufacturing, Inc. products. Consumers can report problems with FDA-regulated products to their district office consumer complaint coordinator.

poseidon neptuneOn December 1, a federal judge from the U.S. District Court for the Central District of California entered a consent decree of permanent injunction against Neptune Manufacturing, Inc., of Los Angeles, and its owners, Alexander Goldring, Peter Oyrekh and Semyon Krutovsky.

The consent decree requires Neptune and its owners to stop processing and distributing their smoked and pickled seafood products until they have taken specific steps to bring their operation into compliance with the Federal Food, Drug, and Cosmetic Act (“the Act”).