Entries in FDA (7)


GAO: Could Drug-Tainted Fish Be Slipping Through the Safety Net?

Jupiterimages/Thinkstock(WASHINGTON) -- The U.S. government is doing far less than other countries to keep drug-tainted fish off dinner tables.
A congressional investigation finds the U.S. Food and Drug Administration samples a tiny fraction -- just 0.1 percent -- of all seafood imports for drug residues. Inspectors visit few importers, even fewer overseas seafood processors and none of the farms. The Government Accountability Office report, written in April but just released Monday, paints the FDA’s approach to seafood safety as outdated and oversimplistic.
Americans are eating more fish and most of it -- 84 percent -- is imported from 130 countries. Half of that imported fish is raised on farms. Those crowded pens can be rough places for fish to survive. To keep them alive, farmers feed the fish antibiotics and other drugs that can remain in the meat when it shows up on your plate -- and that can lead to antibiotic resistance.
Nearly a quarter of all the fish imported to the U.S. comes from China, a country that allows fish farms to use the antibiotic tetracycline. Vietnam, the largest source of imports for farmed catfish and the third-largest source for farmed shrimp, allows use of the antibiotic neomycin. But the FDA conducts no test for either drug.
“In 2007, Japan detected excessive levels of tetracycline residues in the shrimp products it imported from China and in 2010, the EU detected excessive levels of neomycin in imported catfish from Vietnam. Because FDA does not include tetracycline and neomycin in its sampling program, it has no assurance that seafood containing these drug residues has not entered the United States," said the report.
In total, Vietnam allows the use of 38 drugs, most of which are not approved for use in the United States, in fish farms.
The United States has approved just five drugs for use in fish. But countries that send seafood to the United States use dozens of other unapproved drugs. When the FDA does look for drugs, it has a target list of 16.
“Canada tests its imported seafood products for more than 40 different drugs, select EU member countries test for 50 drugs, and Japan tests for 57.”
And the FDA has fallen short in looking for the drugs that are on the target list. The United State bans treating fish with nitrofurans, another type of antibiotic, because prolonged exposure may cause cancer. But the GAO found the FDA collecting too few samples.
When the agency does inspect fish, it can take weeks (average of three weeks) to get a result. But one sample took more than five months to come back from the lab.
The GAO also determined FDA inspectors spend much more time looking at paperwork than at fish.
Copyright 2011 ABC News Radio


Can FDA Determine Whether to Import Execution Drug?

Paul Tearle/Thinkstock(WASHINGTON) -- On Wednesday night, the Department of Justice asked a federal judge to dismiss a case brought by a death row inmate who argues that the FDA should prohibit the importation of a drug used for lethal injection executions.

Daniel Cook, who is on death row in Arizona, argues that the FDA is violating federal law and its own prior policies by allowing the importation of sodium thiopental from unapproved foreign suppliers.

Arizona and other states are scrambling to get supplies of the drug because it is no longer manufactured in the United States.

The Obama administration argues in Wednesday's filing that the FDA has full discretion whether to launch an investigation or enforcement action and the decision is "not subject to judicial review."

According to the DOJ brief: "Plaintiffs’ assertion that they are at risk of injury from defects in thiopental is pure speculation and, as a matter of law, insufficient to satisfy the standing requirement of 'injury-in-fact.'”

Copyright 2011 ABC News Radio


Delta Airlines: Rat Waste Found on Plane, FDA Sends Warning to Airline

Delta Airlines(WASHINGTON) -- Rats may have become a real-life horror story for Delta Airlines. FDA investigators say they found "rodent excreta pellets" in some Delta planes.

The Food and Drug Administration sent a warning letter on April 13 to Delta Airlines CEO Richard Anderson, citing violations found during an inspection that took place between Jan. 26 and Feb. 2 at a Delta hanger near Hartsfield-Jackson Atlanta International Airport.

"This clearly was an isolated incident and we cooperated with the FDA immediately to resolve it earlier this year," said Delta's director of communications, Ashley Black.

Orkin Pest Control's director of technical services, Ron Harrison, agreed it was an isolated incident. "It's vigilance. It's being sensitive and aware."

The number of reported cases, he said, was "small, but unacceptable. Airlines have to take every precaution."

To comply with FDA regulations, all places where food is prepared, served or stored -- including airline cabins -- must be kept free of flies, rodents and other vermin.

The letter mentions "rodent excreta pellets (too numerous to count)" in ceiling panels and near food preparation areas.

"We believe a recurrence is likely without adequate preventive measures in place," said the FDA, calling for action to correct the violation.

Sometimes airlines will have one prevention program while their food vendors have another. "By having more than one pest control company, you need to have deterrence and monitors in all these spaces. You need correlation programs to ensure insuring populations are in none of the places airplanes will be," said Harrison.

"Rodents usually have four ways they can come into an airplane: the airports, jet ways, food carts or food vending companies, and cargo," said Harrison. "The challenge becomes a confined space like this, a perfect habitat for rodents."

Rodents and their feces can transmit over 35 different diseases to humans, according to the Center for Disease Control and Prevention.

"The health and safety of Delta's customers and employees are Delta's top priority. We take this issue very seriously and have an established routine servicing program to inspect our aircraft," said Delta in a written statement. "The aircraft was pulled from commercial service and the issue was resolved within a few days."

Copyright 2011 ABC News Radio 


FDA Bans Milk, Vegetable, Fruits Imported from Japan after Nuclear Plant Crisis

George Doyle/Thinkstock (WASHINGTON) -- The U.S. Food and Drug Administration said Tuesday it will stop all milk products and vegetable and fruit products imported from Japan from entering the U.S. -- a response to public fears about radiation from Japan's crippled Fukushima Daiichi nuclear plant.

This announcement comes despite the agency's repeated assurances that radiation found in foods in Japan was small and posed no risk to the U.S. food supply.

Since 9/11, U.S. Customs and Border Protection and the U.S. Department of Agriculture have implemented blanket radiation screenings for nearly all U.S. imports, including food. The FDA programmed its import tracking systems to flag food shipments from Japan automatically, amid growing contamination concerns after this month's earthquake.

But the agency says it will now stop all shipments of milk products and fruits and vegetables from entering the U.S. It will not allow radiation screening of these products, according to an FDA spokesperson.

In 2010, the U.S. imported $16.5 billion worth of milk, fruits and vegetables, of which a small fraction -- $6.725 million -- came from Japan, according to the U.S. Department of Agriculture.

Most of the imported dairy products are processed foods such as casein and cheese. Imported fruits and vegetables include potatoes, frozen vegetables, citrus fruits and melons.

Japan has already placed restrictions on foods, including spinach and milk that were produced in two provinces around the Fukushima Daiichi plant. Food inspectors detected iodine and cesium in the food, two of the more dangerous radioactive byproducts that are feared to have been released from the reactors in Fukushima.

While Japanese officials said none of the produce found to be contaminated in Japan has been shipped out of the country, there might have been some contaminated produce that was not tested and could have slipped through. Many food-safety experts say that consuming food or milk that contains high radiation levels can be as dangerous as exposure to high levels in the air.

High levels of iodine that can be absorbed through the milk can accumulate in the thyroid gland and cause thyroid cancer. High levels of cesium can damage cells and put many people at higher risk of developing other kinds of cancer.

While milk, fruit, and vegetable products seem to be the highest concern for the FDA, experts say there's no need to boycott sushi or other seafood delicacies just yet. Less than four percent of food is imported to the United States from Japan, including processed and snack foods. About two percent of the seafood the United States consumes comes from Japan, according to the U.S. Department of Agriculture. Scallops are the largest seafood import from Japan to the U.S.; in 2010, nearly $64 million worth, 3,300 metric tons, came from there.

The largest perceived danger may be around raw seafood that is used to make sushi. Tuna is the second largest seafood import from Japan, with nearly 350 metric tons and nearly $4 million worth of imports, according to the U.S. Department of Agriculture. But that is about a tenth of scallop imports.

Also, radiation levels become diluted in large bodies of water, so officials said seafood caught from the ocean should have only trace amounts of radiation, if any.

Copyright 2011 ABC News Radio


CDC, FDA Investigating Multi-State Salmonella Outbreak

Photo Courtesy - Getty Images(ATLANTA) -- The Center for Disease Control announced that it will work with the FDA and state public officials in several states and Washington, D.C. to investigate an outbreak of Salmonella infections.

Eighty-nine individuals in 15 states and Washington, D.C have reportedly been infected with a strain of Salmonella serotype I 4,[5],12:i: between Nov. 1 and Dec. 21 in Connecticut (1), Washington, D.C. (1), Georgia (1), Hawaii (1), Iowa (1), Illinois (50), Indiana (9), Massachusetts (1), Missouri (14), New York (1), Pennsylvania (2), South Dakota (1), Tennessee (1), Texas (1), Virginia (1) and Wisconsin (3), respectively.  Infected patients range in age from one to 75, with a median age of 28. 

Though no deaths have been reported, 23 percent of documented cases have been hospitalized.  The CDC says that patients generally experience illness for four to seven days, with most patients recovering without any treatment.

Preliminary results of the ongoing investigation have linked eating alfalfa sprouts at a national food chain to some reported cases of exposure.  The CDC advises consumers with weakened immune systems (children, elderly, pregnant women and those with immune deficiencies) to avoid eating raw sprouts of any kind (alfalfa, clover, radish and mug bean sprouts).  Consumers should cook sprouts thoroughly to kill harmful bacteria and request that raw sprouts not be added to food at restaurants or otherwise. 

Copyright 2010 ABC News Radio


Eighty-Thousand Eggs Recalled

Photo Courtesy - ABC News(JACKSON, MI) -- The largest producer and seller of eggs in the U.S has recalled 80,000 eggs because they may be contaminated with Salmonella.  Cal-Maine Foods of Jackson, Mississippi says it bought the eggs from Ohio-Fresh of Croton, Ohio and they were distributed to food wholesalers and retailers in Arkansas, California, Illinois, Iowa, Kansas, Missouri, Oklahoma and Texas.

The potential contamination was discovered during what Cal-Maine calls routine environmental sampling at one of Ohio-Fresh’s plants.  There have been no reported illnesses because of the eggs. 

Cal-Maine says it is cooperating with the federal Food and Drug Administration in issuing the voluntary recall.  Brands involved include Sunny Meadow, Springfield Grocer, Sun Valley and James Farm.  Cal-Maine advises consumers who believe they have tainted eggs to either throw them out or return them to the store where they bought them. 

Copyright 2010 ABC News Radio


Cheese Warning for Gouda Sold at Costco in Five States

Image Courtesy - Bravo Farms(SILVER SPRING, Md.) -- The Centers for Disease Control and the Food and Drug Administration are warning people not to eat a certain kind of cheese sold at Costco stores in five states.  It may be linked to a small E. coli outbreak that has sickened about two dozen people in five western states.  Costco is working with the federal government to track the possible outbreak.

People in Arizona, California, Colorado, New Mexico and Nevada have been affected and authorities suspect the Bravo Farms Dutch Style Gouda cheese sold and offered as samples at Costco stores in those states.  It's listed as Costco item 40654 and if you have any of it, you are advised to take it back to the place you bought it or dispose of it in a sealed container.

Most people infected with this strain of E. coli develop diarrhea and abdominal cramps, but some illnesses may last longer and can be more severe. While most people recover within a week, some may develop a severe infection.

Copyright 2010 ABC News Radio

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