By Lena Groeger
ProPublica

Each prescription drug you take has a unique code that the government can use to track problems. But artificial hips and pacemakers? They are implanted without identification, along with many other medical devices. In fact, the FDA doesn’t know how many devices are implanted into patients each year – it simply doesn't track that data.

The past decade has seen numerous high profile cases of malfunctioning medical devices, which have lead to injury or even death. Critics say the FDA's minimal monitoring of devices contributes to these problems.

“If you’re lucky, you might find a sticker on the operating room note that was left over from the product,” said Richard Platt, who runs the Harvard Pilgrim Health Care Institute. Otherwise, there is little way of knowing what device was used.

Right now, the FDA depends mostly on voluntary reports from doctors, patients, manufacturers and hospitals to notify them of problems with devices already on the market. The agency does have some power to require manufacturers to conduct further studies or track a particular device once it is sold. But many devices don’t get that level of surveillance.

“It’s much like a patchwork of streams of information getting to the FDA,” said cardiologist Frederic Resnic of Brigham and Women’s Hospital, who has worked with the FDA on medical device safety monitoring. “The FDA is relying on anecdotal and very variable information about the safety of medical devices.”

If manufacturers get word from a doctor or hospital about a death or injury that occurred as a result of their product, they are legally obligated to investigate the event and report it to the FDA. But the process isn’t straightforward, as has become clear in the recent controversy over the malfunctioning St. Jude’s Riata defibrillator leads (wires that connect a defibrillator to the heart). The FDA said an individual doctor’s report helped alert them to the problem, but it was months before the device was recalled.

According to attorney William Vodra, a regulatory law expert and member of the Institute of Medicine panel that published a report on medical device safety last year, the number of doctors who actually contact manufacturers is small.

And after being notified of patient harm, manufacturers can minimize their own responsibility if they point the blame elsewhere, said health policy expert Diana Zuckerman, president of the National Research Center for Women & Families.

For example, if someone dies from complications in a surgery to remove an implant, the manufacturer may argue that it was the surgery – not the implant – that killed the patient.

“You have a system that is not rigorous, the standards are not always understood, and they are interpreted differently by different people,” Zuckerman said.

The FDA responds to the criticism by pointing out that while every medical device carries a potential risk, the vast majority of devices perform well and improve patient health. An FDA spokeswoman emphasized that the agency must evaluate thousands of medical devices each year, and is constantly looking for ways to better and more quickly identify problems.

While the FDA makes the adverse event reports publically available in a searchable database, it doesn't have a standardized system for reviewing reports once they are sent in, said Vodra, the attorney. A disclaimer on the site specifically states that the data is "not intended to be used either to evaluate rates of adverse events or to compare adverse event occurrence rates across devices."

“What you would normally consider the simplest kind of data analysis is not done,” said Zuckerman. Often, doctors catch a malfunctioning device before the FDA ever notices.

In one case, a group of Pennsylvania doctors noticed that several patients were showing severe complications a few years after getting an IVC filter – a device designed to capture blood clots. Bits of the filter were breaking off, causing chest pain and a dangerous build-up of fluid and pressure around the heart. In 2010 the doctors conducted their own study and found that the filter broke in a quarter of all patients who used it.

On the day that study was published, the FDA issued a warning saying it had received over 900 reports of problems with IVC filters since 2006, and that the device was meant to be removed after a few months, not left in permanently.

There have been numerous attempts at reform. Five years ago Congress ordered the FDA to set up a post-market surveillance system to track the safety of all medical projects, but a system hasn’t yet been set up for medical devices.

A year later the FDA announced the Sentinel Initiative, which would combine existing data from electronic health records and medical claims to track drugs, vaccines, and devices. Some groups of hospitals or other organizations have voluntarily set up registries to collect information about the make and model of devices.

While the FDA has made significant progress on tracking drugs, it’s not yet in a position to do the same thing for devices, according to Harvard’s Platt, who is the principal investigator of Mini-Sentinel, the FDA's pilot program for the national system. The data isn't there.

The FDA has long acknowledged the need for a unique device identifier system, and got permission from Congress to set one up five years ago. No such system of ID-tags exists yet, but after several recent high profile medical device failures, the issue getting some attention from Congress. A proposed Senate bill, which cleared the Health, Education, Labor and Pensions Committee last week, sets a timeframe for implementing a unique identification system, among other reforms.

“If UDI’s were used in a consistent way, we could use the same kinds of techniques we've developed for drugs for devices,” said Platt. “It would be a huge breakthrough.”

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Federal health officials have sent inspectors into Chinese plants that make chicken jerky pet treats to investigate potential links to illnesses and deaths in hundreds of dogs in the United States, two lawmakers say.

Staffers for Sen. Sherrod Brown, D-Ohio, and Rep. Dennis Kucinich, D-Ohio, confirmed Wednesday that Food and Drug Administration officials were conducting the inspections.

“Based on our ongoing discussions with the FDA, we are expecting important new information soon,” Vic Edgerton, a spokesman for Kucinich said in an email to msnbc.com.

It’s not clear exactly how many inspectors are involved or which plants the officials will visit as they attempt to solve the mystery behind at least 600 reports of illnesses including abrupt kidney failure after dogs have been fed chicken jerky treats made in China.

FDA officials declined to comment on the inspections.

waggintrainbrand.com

Waggin' Train Wholesome Chicken Jerky Tenders were among 13 Nestle Purina brand treats listed among 22 complaints being investigated by the Food and Drug Administration. The treats, made in China, have been tied to reports of illnesses and deaths in dogs.

Stumped by mysterious illnesses in at least 600 dogs in the U.S., federal health officials have turned to consumers for help investigating problems possibly tied to chicken jerky pet treats made in China.

A log of complaints collected from pet owners and veterinarians contains references to at least three popular brands of jerky treats that may be associated with kidney failure and other serious ailments, according to internal Food and Drug Administration documents obtained by msnbc.com.

Of 22 “Priority 1” cases listed by the FDA late last year, 13 cited Waggin’ Train or Canyon Creek Ranch jerky treats or tenders, both produced by Nestle Purina PetCare Co., the records show. 

Another three listed Milo’s Kitchen Home-style Dog Treats, produced by the Del Monte Corp. The rest listed single brands or no brand.

Priority 1 cases are those in which the animal is aged 11 or younger and medical records that document illness are available, an FDA spokeswoman said. In many cases, samples of the suspect treats also are collected.

The report, obtained through a public records request, is the first agency indication of any brands linked to illnesses that have climbed since the FDA warned pet owners about jerky treats in November. That was the FDA's third caution about the pet products since 2007.

Nestle Purina and Del Monte officials said their treats are safe and FDA regulators said repeated tests have shown no absolute tie to any brand or manufacturer.

“No specific products have been recalled because a definitive cause has not been determined,” FDA officials said in a statement.

The internal report, overseen by the FDA’s Coordinated Outbreak and Response Evaluation, or CORE, group, is one of several ongoing assignments in which FDA regulators are seeking jerky treat samples and medical records of dogs that may have developed kidney failure, liver disease or Fanconi syndrome, which can lead to serious illness and death.

The recent complaints were filed from October through December by people in cities from California to New York, but the agency will continue to accept them.

“We still invite owners and veterinarians to submit complaints and samples,” said Siobhan DeLancey, an FDA spokeswoman. “The more information we have, the more likely we can find a link.”

The move comes as the FDA is under growing pressure from consumers and lawmakers to address rising numbers of illnesses blamed on the China-made treats. Before the warning was issued in November, the agency had logged 70 reports of illnesses tied to the treats last year. Since then, more than 530 additional complaints of illnesses and some deaths have been filed, officials said.

Bella, a 2-year-old pug, died last fall after her owner, Robin Pierre, said she ate Waggin' Train chicken jerky treats.

Consumers who say their dogs were sickened or killed have launched at least three petitions demanding recalls of jerky pet treats made in China, including one begun in December that has more than 3,400 signatures from the U.S. and around the world.

“At the slightest doubt, these products should have been recalled, especially knowing there was a link or at the very least a caution/warning label put on the packaging warning the consumers,” said Robin Pierre, a co-founder of “Animal Parents Against Pet Treats Made in China.”

Pierre, 49, of Pine Bush, N.Y., believes Waggin’ Train chicken jerky treats were responsible for the sudden death last fall of her previously health 2-year-old pug, Bella, who developed kidney failure. 

“The last week of her life was nothing but misery and pain, separated from her family, she died all alone, in a cage, despite the fact that she had a family who loved her,” Pierre wrote in an email to msnbc.com. “She meant the world to me and my family.”

Courtesy Susan Rhodes

Ginger, a 14-year-old family dog, sparked one of three petitions after she developed kidney failure possibly tied to chicken jerky pet treats. Her owner, Susan Rhodes, 51, of Port St. Lucie, Fla., wants the treats pulled from the market.

More than 375 people have signed a petition launched last week by Susan Rhodes, 51, of Port St. Lucie, Fla. She believes her 14-year-old dog, Ginger, may have developed life-threatening kidney failure after eating chicken jerky treats. She was stunned to hear that consumer complaints alone can’t force the FDA -- or a company -- to recall potentially tainted products.

“That is just unreal. I am not happy with that,” Rhodes said.

For their part, FDA officials said the companies are free to enact a voluntary recall at any time.

Lawmakers call for action
Lawmakers, however, are demanding stronger FDA action. Ohio Democrats Sen. Sherrod Brown and Rep. Dennis Kucinich in February called on the FDA to step up investigation of tainted pet treats.

In a response sent late last week, an FDA official told Brown the agency “continues to actively investigate” the reports and to pursue testing for chemical and microbiological contaminants.

On Monday, Brown called the agency’s response “inadequate” and urged prompt release of results of 153 pending tests on the Chinese-made treats.

“I will continue to press the FDA on this issue because Ohio consumers shouldn’t have to worry about the safety of their pet’s food,” he said in a statement.

Since 2007, FDA scientists have analyzed jerky treats for evidence of dangerous toxins, including heavy metals, melamine, melamine analogs and diethylene glycol, chemicals used in plastics and resins.

So far, they’ve found nothing convincing, a point emphasized by Keith Schopp, director of communications for Nestle Purina.  He noted that FDA officials also suggest that illnesses may be a result of causes other than eating jerky treats.

“Our chicken jerky treats are safe to feed as directed,” said Schopp. “The safety of our products -- and the pets who consume them -- are our top priorities.”

The company has a comprehensive food safety program in place, he said, including at manufacturing plants in China.

Pierre, who lost her dog, has little faith in pet food manufacturers -- or in the FDA.

“Actions speak louder than words and there has been no action from them up until now,” Pierre said. “Waggin’ Train has hid behind the technicality that the FDA cannot find the link and the FDA has let them.” 

Consumers can report illnesses to the FDA's pet food complaint site.

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In a move that highlights dilemmas plaguing the U.S. drug supply, federal regulators warned a major manufacturer about problems including bugs in vials of sterile drugs -- insects, literally -- the same day that health officials allowed the firm to ramp up scarce medications for kids with cancer.

Food and Drug Administration officials on Tuesday posted a warning letter sent to APP Pharmaceuticals LLC of Schaumberg, Ill., citing violations at a New York plant that included insects found in clean rooms and in vials of distributed drugs and failure to report defects such as vials contaminated with foreign matter and glass.

The firm also had problems with documenting sterile technique and was marketing unapproved drugs, according to the warning.

“It is apparent that APP Pharmaceuticals LLC’s has failed to implement global corrective actions,” it said.

The letter was dated Feb. 22, the same day that APP announced it had received accelerated FDA approval to market supplies of preservative-free methotrexate to help ease a critical shortage of the medication used to treat childhood leukemia.

Earlier this month, FDA officials and cancer doctors had said the drug was in such short supply, hospitals could have run out within two weeks, jeopardizing life-saving treatment for kids with acute lymphoblastic leukemia, or A.L.L., as well as patients with other illnesses.

“I am delighted that in many cases APP Pharmaceuticals has helped to minimize shortages by significantly increasing our production,” John Ducker, the firm’s president and chief executive said in a statement last week.  APP Pharmaceuticals is a subsidiary of the German firm Fresenius Kabi Pharmaceuticals Holding Inc.

The timing was not lost on Erin Fox, manager of the Drug Information Service at the University of Utah, which tracks the nation’s drug shortages.

“This is what I mean when I keep talking about quality issues,” said Fox, citing ongoing manufacturing problems at several U.S. plants, including APP. “All of these companies have had quality issues, yet they make the majority of drugs used in our country.”

The U.S. has logged record numbers of drug shortages in the past two years, fueled in part by sudden closures of drug plants because of problems with contamination, crumbling infrastructure and other issues, FDA documents show.

APP officials said the warning letter, which focused on problems at the firm’s Grand Isle, N.Y., plant, and the company’s efforts to ease the drug shortage crisis were two different issues.

“Methotrexate is not manufactured at the Grand Island plant and, thus, is absolutely unaffected from the warning letter,” Matthias Link, a company spokesman, wrote in an e-mail to msnbc.com.

The violations followed an FDA inspection last summer, June 13 to July 8, and the company had “already begun taking actions on most of the items listed,” Link noted.

“We take all the issues listed in the warning letter very seriously and we are committed to promptly addressing these,” he wrote.

The firm has 15 days from the date of the FDA letter to respond to the problems, including how insects came to be found in an aseptic, or sterile, room used to produce crucial drugs.

“You continued to find insects in your manufacturing area, in finished product (two vials), and you received a complaint for an insect in a distributed vial,” said the letter sent by Ronald M. Pace, director of the FDA’s New York district.

Company officials told FDA inspectors the root cause of the bug problem was with the firm’s supplier of gowns, but they had not scheduled an audit of the firm until six months later, December 2011, the warning said.

FDA officials did not immediately respond to msnbc.com questions about the timing of the warning letter and the expanded approval of APP to make injection-free methotrexate.

Agency officials last week announced they’d narrowly averted two dire shortages: first, the methotrexate scarcity, and then an ongoing shortage of the drug Doxil, used to treat ovarian and other cancers.

The agency licensed a foreign firm, Sun Pharma, temporarily to supply Lipodox, a replacement chemotherapy drug, to the U.S. market.

Balancing the demand for life-saving drugs with the demand that those drugs be safe and sterile is an ongoing challenge, noted Fox.

“Between the shortages and the quality issues, it is difficult to have any kind of confidence in our drug supply,” she said.

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Government health officials have received more than 500 reports since November of illnesses in dogs who ate chicken jerky pet treats.

Amid reports of more than 500 dogs sickened by chicken jerky pet treats imported from China, government health officials are ramping up port inspections for dangerous toxins.

Food and Drug Administration officials have begun collecting and testing chicken jerky treats upon import, analyzing samples for evidence of melamine and melamine analogs and diethylene glycol, chemicals used in plastics and resins, a spokeswoman said.

Melamine-tainted imported pet food sickened and killed thousands of dogs and cats in the U.S. in 2007, leading to massive recalls and criminal indictments of Chinese and American pet food executives.

So far, FDA officials have found no evidence of harmful levels of melamine or other substances in the chicken jerky treats, said spokeswoman Tamara Ward. But the agency has increased its surveillance of the products, even as repeated chemical and microbial tests have failed to reveal a source for illnesses that continue to mount.

FDA now has received 537 reports of illnesses in dogs, including 467 reports since it issued a renewed warning about chicken jerky treats from China in November. That number includes 353 reports logged in 2011 and 184 submitted so far this year, Ward said.

Pet owners and veterinarians are reporting that animals have been stricken with a range of symptoms within hours or days of eating chicken jerky treats, including serious problems such as kidney failure and Fanconi syndrome, a condition marked by low blood sugar.

The illnesses appear tied to imported Chinese chicken jerky products, also sold as chicken tenders, chicken strips or chicken treats.

FDA scientists have worked for months to detect a source of illnesses, Ward said. Samples have been tested for drugs, poisons and mycotoxins, as well as for heavy metals and certain chemicals.

Still, the source of the problem remains a mystery and no specific brands or products have been named or recalled in connection with the illnesses, FDA officials said.

The November warning was the agency’s third alert about chicken jerky treats in four years. Previous cautions were issued in 2007 and 2008. In 2007, 156 reports of dog illnesses tied to chicken jerky were logged, but the number fell sharply, to just 41 in 2008, according to FDA reports.

Consumers can report suspicious illnesses to the FDA’s Pet Food Complaint site.

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Truckloads of medical products, tankers of bulk liquids and cartons of chemicals have been hauled to secure landfills and waste disposal centers as a Wisconsin supplier works to recover from a year-long contamination scandal blamed for illness and death.

By one account, H&P Industries and the Triad Group of Hartland, Wis., had enough potentially tainted medical prep wipes to fill a football field.

The sister firms have either destroyed or reconditioned more than $6 million of suspect products seized by federal regulators last spring, bringing them in compliance with a court order, new government documents show.

The firm’s $4 million penal bond has been canceled and the seized products have been returned to H&P’s jurisdiction for disposal, possible steps toward reopening, according to new Food and Drug Administration documents obtained through an msnbc.com open records request and appeal.

The discarded products included 50 truckloads of finished goods, 13 truckloads of raw chemicals and five bulk tank-trailers of in-process materials, according to Shelly Burgess, an FDA spokeswoman.

"The firm will not be permitted to resume operations until FDA is satisfied that it can do so with full compliance with the decree and the law," Burgess said.

It took H&P Industries three tries to gain FDA approval of a reconditioning plan that outlines an overhaul of manufacturing, monitoring, inspection and reporting procedures to correct problems with contamination and sterilization. Previous plans were not detailed enough to satisfy FDA’s concerns, the documents posted online late Tuesday showed.

“Because of both micro- and cross-contamination concerns, FDA has no [good manufacturing process] assurance and is uncomfortable with introducing any potential risk back into the market,” said Tamara Ely, an FDA compliance officer, according to an account of a November 21, 2011 meeting.

Only unopened, factory-sealed raw chemicals will be allowed to be “reconditioned” so that they’re safe for use either by H&P Industries or by a vendor who agrees to accept returned product, the documents showed. The reconditioning procedure requires sampling, testing and approval to verify that no microbial contamination exists.

Everything else — finished products, in-process products, materials in tanks and drums, raw chemicals, bulk chemicals and other open, used components  — was destroyed. The firm is still prohibited from manufacturing drugs or devices, Burgess noted.

H&P’s compliance comes more than a year after FDA officials urged the company to issue the first of several global recalls of alcohol and iodine prep products potentially contaminated with at least two kinds of bacteria because of inadequate manufacturing and sterilization procedures.

FDA officials had known for years about problems with the Wisconsin plant, but had failed to adequately enforce regulations, an msnbc.com investigation found.

The move also comes nearly a year after parents of a 2-year-old Houston boy first filed a lawsuit claiming that contaminated alcohol pads made by H&P Industries were responsible for the bacterial infection that killed their son.

Since then, at least a dozen lawsuits have been filed by patients and their families in several states who claim that tainted prep wipes led to infections, illnesses and, in some cases, deaths.

H&P Industries officials did not respond to msnbc.com requests for comment, but the firm consistently has denied that its products could be directly tied to those events.

Burgess, the FDA spokeswoman, confirmed the number of truckloads of finished medical products, tanker trucks of bulk liquids and containers of chemicals that the company was forced to destroy.

But by another estimate, the volume of returned alcohol and iodine prep products alone would have filled an area “the size of a football field,” according to a lawyer representing the Triad Group.

“There are billions of these pads produced a year, millions in a day, believe it or not, so it is massive what has been returned,” lawyer Alana Bassin told U.S. District Court Judge Lynn Hughes during a July briefing, a court transcript shows.

The medical products have been transferred to secure landfill and destruction sites that operate under regulatory jurisdiction. Some of the material may have to be processed as hazardous waste, the documents noted.

H&P Industries' plans for the future remain unclear. The firm’s 285,000-square-foot plant at 700 W. North Shore Drive , Hartland, Wis., is for sale for $14.2 million, real estate listings show.

Related: Tracking tainted wipes: an msnbc.com special investigation

The ShoulderFlex massager was recalled this summer following the death of one woman, but it is still available for sale at some online sites.

If you think you’ve found the perfect gift for Grandma, and it happens to be a ShoulderFlex massager, buy her something else quick. It turns out to be a device that can lull users into a relaxed state -- and then strangle them.

The Food and Drug Administration issued an alert on Wednesday warning that hair and necklaces can get caught in the massager and cause strangulation. One person has died and another nearly did, according to the FDA.

Dr. Michelle Ferrari-Gegerson, a 37-year-old Florida woman, was found dead by her husband last Christmas Eve after her leather necklace got tangled in the device, reported the Miami Herald.

“The ShoulderFlex Massager poses serious risks,” said Steve Silverman, director of the Office of Compliance in the FDA’s Center for Devices and Radiological Health, in a statement. “Consumers should stop using this device, health care providers should not recommend it to their patients and businesses should stop distributing and selling the device.”

The device was recalled in August, but the manufacturer, King International, went out of business and the FDA discovered that it didn’t properly alert stores that sell the massager. A quick Internet search reveals that the product is still available at several online web sites.

The FDA is so concerned about the device that it recommends not just throwing it away, but dismantling it before you do so that no one else could ever use it. “The massage fingers should be removed and disposed of separately from the device,” according to the alert. “The power supply should be disposed of separately, as well.”

A California man is vowing to continue his do-it-yourself sperm donor operation, despite efforts of federal health officials to crack down on the free service.

Trent C. Arsenault, 36, of Fremont, Calif., told msnbc.com that he has fathered 14 children -- with four more on the way -- and donated sperm to between 60 and 75 families since he started the online operation in 2006.

“Every time I log into Facebook, I’m overwhelmed with all the pictures from the families,” said Arsenault, who regards his donations as a way to help low-income people struggling with infertility.

Last year, federal Food and Drug Administration officials delivered a letter ordering Arsenault to “cease manufacturing,” or halt his service, because the computer security expert had not followed regulations governing safety precautions for transmission of human cells or tissues through donor clinics.

“We have legitimate concerns,” said Shelly Burgess, a spokeswoman for the FDA.

But Arsenault was allowed to continue the operation while the agency decided whether to grant him a hearing on the matter, according to his lawyers.

The lawyers, who work for the nonprofit legal firm Cause of Action in Washington, D.C., argue that Arsenault shouldn’t be held to clinic sperm donor standards because his contracts with recipients are individual intimate partner arrangements allowed under the law.

No hearing has yet been scheduled, Burgess said. Arsenault could face penalties including court action if the agency concludes that his acts were a violation of federal regulations. 

Federal health experts say Yaz and other widely-used birth control pills should carry stronger labeling information that emphasizes recent evidence that the drugs have a slightly higher risk of blood clots than older drugs.

The Food and Drug Administration's panel of experts voted 21-5 Thursday that labeling on the popular drugs made by Bayer is inadequate and should be updated with information from several recent studies.

Yaz, its predecessor Yasmin and related prescriptions use a manmade hormone called drospirenone, which mimics the naturally occurring female hormone progesterone.

Panelists spent more than nine hours discussing often conflicting data on the blood clot risk of drospirenone-containing drugs compared with older medications. While the group disagreed on the quality of the evidence, the overwhelming majority said it should be made more explicit in the label, including the potentially fatal nature of blood clots.

"Clearly the wording is inadequate and incomplete," said Dr. Richard Bockman of New York's Hospital for Special Surgery. "Adverse events have to be made graphic so physicians and patients are aware of the consequences."

In an earlier vote, panelists voted 15-11 that the pills remain a beneficial option for preventing pregnancy. The majority opinion amounts to a vote of confidence that the drugs should remain on the market, though well over a third of panelists voted against the drug's overall benefit, especially given numerous other oral contraceptives available.

"I can see no real group of patients that this drug benefited over existing alternatives," said Mark Woods of New York University School of Medicine. "Without any clear benefit, and given the potentially catastrophic risk, I voted no."

Approved in 2006, Yaz grew into the best-selling birth control pill in the U.S. by 2008, backed by hundreds of millions of dollars in TV and magazine advertising that emphasized its ability to clear up acne and other hormonal side effects. But prescriptions have fallen more than 80 percent in the last two years amid safety concerns and a consumer backlash against misleading advertisements that regulators said overstated the drug's benefits.

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Chocolate ice cream is a frequent catch-all for botched batches of other flavors, which are doled out in small amounts and mixed with the dark, rich treat in order to avoid waste and expense. Reworking food is a common practice, industry experts say.

When a school lunch supplier repackaged moldy applesauce into canned goods and fruit cups, it drew a sharp warning from federal health regulators last month -- and general disgust from almost everyone else.

“I was appalled that there were actually human beings that were OK with this,” said Kantha Shelke, a food scientist and spokeswoman for the Institute of Food Technologists. “This is a case of unsafe food. They are trying to salvage that to make a buck.”

But even as Food and Drug Administration officials prepare to re-inspect Snokist Growers of Yakima, Wash., to ensure that the applesauce maker keeps toxin-tainted fruit off store shelves, federal officials and industry experts acknowledge that Snokist is not alone in “reworking” faulty food.

Turning imperfect, mislabeled or outright contaminated foods into edible -- and profitable -- goods is so common that virtually all producers do it, at least to some extent, sources say.

“Any food can be reconditioned,” said Jay Cole, a former federal inspector who now works as a senior consultant with The FDA Group, a firm that specializes in helping manufacturers comply with industry regulations.

“It’s how people do their business,” added Shelke, founder of Corvus Blue, a Chicago-based packaged goods consulting firm.

It may be something benign, such as misshapen pieces of pasta that are re-ground into semolina, or something unexpected, like a batch of mislabeled blueberry ice cream mixed in with chocolate to avoid waste.

It might be something unappetizing, such as insect parts sifted out of cocoa beans or live bugs irradiated -- and left behind -- in dried fruits like dates and figs.

Or it could be something alarming, such as the salmonella Tennessee bacteria detected last year in huge lots of hydrolyzed vegetable protein, or HVP, a flavor enhancer used in foods from gravy mix and snack foods to dairy products, spices and soups. 

Some 177 products were recalled in 2010, but bulk HVP products from Basic Food Flavors Inc. of Las Vegas, Nev., were allowed to be reconditioned by heat-treating the foods to kill the salmonella, according to the FDA. The reprocessed foods were then distributed and sold.

No question, FDA regulations do permit foods to be reconditioned, said William Correll, the agency’s acting director of compliance.  That leeway can avoid both waste and expense, he explained.

“Some things can be adulterated and fixed, and you’re not throwing out food that would otherwise be OK,” Correll said.

That’s why chocolate ice cream becomes the catch-all when other flavors aren’t quite right, said Shelke. If a producer accidentally botches a batch of blueberry, small amounts of the mistaken treat can be mixed into future bins of chocolate, where the dark color and rich flavor mask any error.  

The key, however, is that the process must render the food safe for consumption. 

That’s why Snokist Growers drew such a strong warning. In the case of the moldy applesauce, there are a couple of problems, Correll said. Mold is tricky because when contamination is extensive, it’s not enough to simply remove the obviously tainted parts and then zap the food with heat.

Snokist officials claim that their heat process kills patulin, the most common toxin produced by mold in apples, and renders the food commercially sterile. But FDA officials counter that the firm’s thermal process is not adequate to ensure that other heat-stable mycotoxins are eradicated from the food.

“Mold is not an easily reconditionable product,” Correll said. “It’s not OK to take moldy tomatoes and make them into tomato paste.”

Not that some food firms don’t try. It’s no secret that the FDA allows certain levels of expected contaminants to remain in foods, simply because a zero-tolerance standard would be impossible to meet, officials said.

The agency’s “defect action levels” are used to define the point at which food becomes adulterated and subject to enforcement. Below that level, however, some unappetizing substances make it through.

The FDA allows, for instance, an average of 225 insect fragments or 4.5 rodent hairs per 8 ounces of macaroni or noodle products. An average of 20 or more maggots of any size is permitted per 3.5 ounces of drained canned mushrooms, or per half-ounce of dried mushrooms. When it comes to mold, an average count of 15 percent is OK for canned cranberry sauce.

Because such levels are permitted, some food producers propose to combine faulty and sound products to lower the overall level. An apple-juice maker might ask to mix juice with high counts of mold with a batch with low counts, for instance. But, Correll said, that’s not allowed.

“Dilution is not the solution,” he said.

Similarly, companies that propose to eliminate a serious contaminant without addressing the source are turned down. He recalled a seafood firm with faulty bathroom practices that led to canned crab contaminated with fecal E. coli bacteria. Heat-treating would have eradicated the bugs -- but not the problem, Correll said.

“If food is adulterated in an unacceptable way, reconditioning won’t fix it,” he said. “You can’t cook the poop out of it.”

FDA officials couldn’t provide an estimate of the number of reconditioning requests received from food firms each year. But in 2009, the agency started a new Reportable Food Registry, which requires notification of hazards to human health. At least 2,240 reports were logged in the registry’s first year, including the salmonella-tainted vegetable protein.

Many producers faced with faulty food simply want to minimize their losses without harming public health, said Peter Quinter and Jennifer Diaz, lawyers with the Florida firm Becker & Poliakoff, which represents importers of foreign food.

Such firms want to avoid having product refused, so they go to great expense to salvage products such as insect-infested rice for future consumption, Diaz said. Grain products can be sifted, re-inspected, repackaged – and sent on to grocery stores.

“Taking the ick factor away is that the product is no longer contaminated,” she added.

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