A bull calf sold for slaughter as food by an Ohio dairy farm was found to have higher than allowed levels of an animal drug in its edible tissues.
In a June 17 warning letter, the U.S. Food and Drug Administration said a dairy operation owned by Atlee W. Hostetler at Apple Creek, Ohio is violating the federal Food, Drug, and Cosmetic Act.
Tissue samples taken from the bull calf came back with 0.876 parts per million (ppm) of sulfamethoxazole in the muscle and 0.465 ppm of sulfamethoxazole in the liver. FDA has not established a tolerance for sulfamethoxazole in edible tissues of calves.
“Our investigation also found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply,” the warning letter said.
“For example, you failed to maintain treatment records and failed to keep an inventory system for determining the quantities of drugs used to medicate cows and calves. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the Act, 21 U.S.C. 342(a)(4).
FDA found that the Ohio dairy adulterated the new animal drugs Sulfamethoxazole and Trimethoprim. Both drugs were used in a manner inconsistent with label instructions. Such “extralabel” uses require “the lawful order of a licensed veterinarian” with the context of client/patient relationship.
“Because your use of this drug was not in conformance with its approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drug to be unsafe under section 512(a) of the Act, 21 U.S.C. 360b(a), and adulterated within the meaning of section 501(a)(5) of the Act, 21 U.S.C. 351(a)(5), the warning letter continued.
FDA gave the dairy 15 business days to respond to the violations cited in the warning letter.
Italian health officials announced Tuesday that over 70,000 mozzarella balls turned blue because of bacterial contamination during production at the German plant owned by cheese producer Milchwerke Jaeger Gmbh.
Prosecutors from Turin announced that they were looking into what type of bacteria caused the cheese to turn blue and would have results within 48 hours.
One official from the Teramo food health services said the bacteria didn’t appear to be toxic. Investigators are still looking into how the cheese became contaminated.
“Surely it happened in the production phase,” said prosecutor Raffaele Guariniello via phone interview with a national wire service.
“Those who ate the mozzarella didn’t get any type of illness,” said Teramo food official Rolando Piccioni.
Consumers have reported that it takes time for the cheese to turn blue after the package is opened. In certain cases, the mozzarella turned blue after six to eight hours, while in others it took more than two days.
Thus far, more than a ton of mozzarella in Bologna, Sardinia, Sassari, and Isola della Maddalena produced by Milchwerke Jaeger Gmbh has been confiscated by officials. The Milchwerke Jaeger Gmbh cheese is distributed under five different brand names.
Italy’s health minister urged Italian cheese distributors to remove any cheese made by Milchwerke Jaeger from their shelves.
This week, Italian police recalled and confiscated 70,000 balls of mozzarella cheese after consumers reported that the cheese quickly developed a blue tint when the packaging was opened.
Ministry laboratories were ordered by Agriculture Minister Giancarlo Galan to investigate the incident. Galan called the development “disturbing,” and no illnesses have been reported thus far.
Samples were sent to laboratories that usually deal with sport anti-doping testing to see if they could find any foreign matter in the cheese. Results are expected within the next few days.
The incident was reported after a woman in Turin notified police when she noticed that her mozzarella, which was made in Germany for an Italian company, turned blue after the package was opened and the cheese came into contact with air. Several merchants in Turin have received similar complaints.
This is not the first issue with Italy’s staple cheese made from buffalo milk. The cheese in question is of the buffalo mozzarella variety, an important part of many classic Italian dishes including pizza, panini and caprese salad.
Earlier this year, Italian agriculture authorities found that some buffalo mozzarella from an area south of Rome had fallen below standards after traces of cow’s milk were found in it.
After blue mozzarella surfaced, the Italian agriculture lobby Coldiretti lamented that many consumers don’t know that half the mozzarella sold in Italy is made from foreign-produced milk. It is pushing for legislation that would oblige producers to declare the origin of all ingredients on the label.
Magic Power Coffee, an instant coffee product marketed as a dietary supplement for sexual enhancement, contains an active drug ingredient that can dangerously lower blood pressure, the U.S. Food and Drug Administration warns.
Consumers who have Magic Power Coffee should stop using it immediately.
In a statement FDA said sexual enhancement products that claim to work as well as prescription products are likely to expose consumers to unpredictable risks and the potential for injury or even death.
Magic Power Coffee, FDA said, contains hydroxythiohomosildenafil. This is a chemical similar to sildenafil, the active ingredient in Viagra.
Hydroxythiohomosildenafil, like sildenafil, may interact with prescription drugs known as nitrates, including nitroglycerin, and cause dangerously low blood pressure. Consumers and health care professionals should be aware of this problem and the health hazard it presents.
When blood pressure drops suddenly, the brain is deprived of an adequate blood supply, which can lead to dizziness or lightheadedness.
“Because this product is an instant coffee labeled as an ‘all natural dietary supplement,’ consumers may assume it is harmless and poses no health risk,” said Deborah M. Autor, director of FDA’s Center for Drug Evaluation and Research, Office of Compliance. “In fact, Magic Power Coffee can cause serious harm.”
To date, the FDA is not aware of any adverse events associated with the use of this product.
The product is distributed on Internet sites and online auctions by multiple independent distributors participating in an online multi-level marketing scheme. It is sold in a 2-serving box and a 12-serving carton containing six 2-serving boxes.
During the past several years, the FDA has warned consumers about many products marketed as dietary supplements for sexual enhancement that contain undeclared active ingredients of FDA-approved drugs, analogs of approved drugs or other compounds that do not qualify as “dietary ingredients.”
As early as last October, Food Safety News reported on cooperative efforts by the National Oceanic and Atmospheric Administration (NOAA) and the U.S. Food and Drug Administration (FDA) on seafood testing. That was six months before the BP oil spill.
After the Deepwater Horizon exploded in the Gulf of Mexico, Food Safety News reported from the scene on how the NOAA-FDA partnership would help ensure seafood safety as the BP oil spill threatened those once productive waters.
It makes great sense. The same tests NOAA does for science get dual use when FDA puts them to work in the name of food safety. The NOAA/FDA work received lots of media attention in the six weeks after the BP oil spill.
So it was somewhat humorous when on June 14 NOAA and FDA put out a press release coinciding with President Obama’s return to the Gulf that said “additional steps” were being taken “to enhance inspection measures designed to ensure that seafood from the Gulf of Mexico reaching America’s tables is safe to eat.”
The purpose of the press release was to let us know that the federal government, working with state regulatory agencies, “is playing an active role in ensuring the safety of seafood harvested from federal and state waters.”
If as the Gulf approached Day 60 of the BP spill the federal government found a need to say that–well, you know how bad its been going for them.
Still there were some interesting items in the NOAA/FDA Presidential return press release. It said the strategy of the two agencies was based upon fish closures, more seafood testing and inspections, and re-opening protocols.
“Closing harvest waters that could be exposed to oil protects the public from potentially contaminated seafood because it keeps the product from entering the food supply,” said Jane Lubchenco, undersecretary of commerce for oceans and atmosphere and NOAA administrator. “Combining the expertise of NOAA and FDA is the best way to use our scientific abilities to help the American people in this emergency.”
NOAA’s fish closure area, which has grown to over 80,000 square miles or 33 percent of America’s exclusive economic zone in the Gulf, is called the “first line of defense” for seafood safety by the two agencies.
The closed zone encompasses areas known to be affected by oil, either on the surface or below the surface, as well as areas projected to be affected by oil in the next 48 – 72 hours. The closed area also includes a five-nautical-mile buffer as a precaution around the known location of oil.
“FDA and NOAA are working together to ensure that seafood from the Gulf is not contaminated with oil,” said Margaret Hamburg, Commissioner of Food and Drugs. “It is important to coordinate seafood surveillance efforts on the water, at the docks, and at seafood processors to ensure seafood in the market is safe to eat.”
As Food Safety News reported, NOAA implemented a sampling and inspection plan after the spill began for both recreational and commercial fish and shellfish. It includes dockside sampling of fish products from the Gulf. Contaminated fish are reported to FDA.
FDA has enforcement jurisdiction for all fish and fishery products–except maybe for catfish. Its now targeting oysters, crab, and shrimp because those species will retain contaminants longer than finfish.
Finfish are believed to more rapidly metabolize the oil so the risk of exposure is far less than the other seafood species previously mentioned.
It was also known that the testing would be focused on seafood processors who buy from the boat captains. They watch to catch any problems in the first step of the distribution chain.
Whether it makes people in the Gulf feel any better or not, the NOAA/FDA team is thinking about re-opening the now closed areas to future fishing. That will happen “only if assured that fish products taken from these areas meet FDA standards for public health,” Lubchenco said.
NOAA’s National Seafood Inspection Laboratory in Pascagoula, MS does sensory testing and its Northwest Fisheries Science Center in Seattle does the chemical testing. NOAA had conducted 18 sampling missions through June 14 with 640 fish and shrimp samples processed for testing.
Most of this was not new to Food Safety News or any one else tracking the safety of Gulf seafood in the aftermath of the worst oil spill in U.S. history. It did show how a President can shake more information out federal agencies than anyone else can.
Possible Salmonella contamination of dog food brought a recall Friday from a California company.
Natural Balance Pet Foods Inc. recalled its Natural Balance Sweet Potato & Chicken Dry Dog Food with the “Best By” date of June 17, 2011, in 5-lb. and 28-lb. bags because of the potential it is contaminated with Salmonella.
The recall was issued after a sample in a routine test conducted by the U.S. Food and Drug Administration (FDA) came back positive for Salmonella.
No illnesses have yet been associated with the recall.
The recalled product was manufactured on Dec.17, 2009.
Salmonella in dry pet food can infect both humans and animals.
For humans, symptoms of Salmonella include nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping, and fever.
More serious ailments including arterial infections, endocarditis, arthritis, muscle pain, eye irritation, and urinary tract problems. Anyone exhibiting these signs after having contact with this product should contact their healthcare providers.
Pets with Salmonella infections may be lethargic and have diarrhea or bloody diarrhea, fever, and vomiting. Some pets will have only decreased appetite, fever and abdominal pain.
Infected but otherwise healthy pets can be carriers and infect other animals or humans. If your pet has consumed the recalled product and has these symptoms, please contact your veterinarian.
Recalled products were only distributed in pet specialty stores in the states of Alaska, Arizona, Arkansas, California, Colorado, Hawaii, Idaho, Illinois, Iowa, Kansas, Louisiana, Minnesota, Mississippi, Missouri, Montana, Nevada, New Mexico, North Dakota, Oklahoma, Oregon, South Dakota, Texas, Utah, Washington, Wisconsin and Wyoming.
Consumers who have purchased Natural Balance Sweet Potato & Chicken Dry Dog formula with the “Best By” date of June 17, 2011, are urged to return it to the place of purchase for a full refund.
For additional information, please contact Natural Balance Pet Foods Customer Service at (800) 829-4493 (8a.m. – 5p.m., PDT) or by visiting www.naturalbalanceinc.com.
