Source | The Associated Press

January 5, 2006

Patients taking two widely used diabetes drugs have reported blurry vision and swelling of the legs and feet, the Food and Drug Administration and manufacturer GlaxoSmithKline said Thursday.

The company said it has received “very rare” reports of new or worsening diabetic macular edema in diabetic patients who have taken Avandia or Avandamet. The swelling of the portion of the retina most important for sight can cause blurry or distorted vision.

The majority of those patients also reported peripheral edema, or swelling of the legs, ankles and feet, the company said in a letter sent last month to doctors. In some cases, stopping treatment or reducing the dose eliminated or improved the condition, it added.

Avandia and Avandamet both contain the drug rosiglitazone. More than 6 million people worldwide have taken either drug.

Source | CentralOhio.com

By John Jarvis

Investigation process too slow, says local man

A company’s promise that it will remove a chemical flavoring linked to lung disease in popcorn plant workers from its formula for making microwave popcorn could have come sooner. A Marseilles-Galion Road man who worked at ConAgra Snack Foods on Harding Highway East in 2000 and 2001 until developing bronchiolitis obliterans expressed such an opinion after hearing of ConAgra Foods Inc.’s announcement.

Keith Campbell said his former employer knew something was wrong in 2002 when he was diagnosed with the severe lung disease. “As far as ConAgra, they’ve known for five years there was a problem, they’re just now bowing to the pressure,” Campbell said. Phone messages left with local ConAgra officials were not returned before press time.

ConAgra corporate spokeswoman Stephanie Childs said the company decided in the past few months to remove the butter flavoring diacetyl from its popcorn because of the risk the chemical presents to workers who handle large quantities.

Campbell recently received an out-of-court settlement in a lawsuit of which he was part filed against the makers of flavorings containing diacetyl, the chemical tied to the lung ailment.

ConAgra Foods Inc., General Mills and American Pop Corn earlier this week said they’ll eliminate diacetyl from their butter-flavored microwave popcorn. The three companies together have more than 80 percent of the market.

Last week, ConAgra said it will change the recipe for its Orville Redenbacher and Act II brands to remove diacetyl over the next year.

The company made its announcement a day after a physician at a leading lung research hospital said in a letter to federal regulators that consumers, not just factory employees, might be in danger from fumes from buttery flavoring in microwave popcorn. The announcement came a week after another manufacturer, Weaver Popcorn Co., announced it would stop using diacetyl because of consumer concern.

Of the risk to consumers, Campbell said he wouldn’t have thought that “popping three or four bags every so often would be that big a deal,” but added that some substances seem to affect some people more than others.

Campbell eventually became part of a lawsuit filed against International Flavors & Fragrances Inc., Givaudan Flavors Corp. and Bush Boake Allen Inc., which settled with him for an undisclosed amount of money.

He said the terms of the settlement don’t permit him to reveal the amount of money he received, but “We were taken care of. I don’t have to worry.” He said the settlement enabled him to purchase his new home on a 21-acre property north of Marion.

Campbell remains on Social Security disability due to the effects of the obstructed-lung disease, which he said leaves him exhausted after routine tasks such as yardwork.

Wendy Campbell, his wife, wondered aloud about the timing of ConAgra’s announcement, as well, saying, “We’ve lived with it for the past five years. … I think they need to get rid of it because that’s what makes people sick. I guess it seems kind of funny that all of a sudden that they’re talking about it again.”

Campbell was a mixer working 12-hour shifts three and four days a week in a room where he was exposed to fumes of the microwave popcorn flavoring. ConAgra officials, he said, assured workers in the Marion plant that they were safe, and the manufacturing system was different than the one used in a Missouri plant where employee health problems were being investigated about 2001.

The National Institute for Occupational Safety and Health investigated health concerns at the plant in March 2003, announcing that it found evidence that 29 of 205 employees the agency tested showed abnormal lung function and lung disease seen in workers who mix ingredients in other microwave popcorn plants. NIOSH evaluated the employees after being requested by three employees to do so. Since the investigation, ConAgra has implemented additional safety measures recommended by NIOSH at the Marion plant, including a requirement that workers who enter the mixing room wear respirators.

Campbell is rankled by the regulation that requires a minimum of three employees of the employer in question to request NIOSH investigate before the agency can initiate such a probe.

“I think the process is too slow,” he said, adding that NIOSH should have been able to investigate the plant as soon as he reported his problem, and similar reports had already been received in other popcorn factories.

He questioned the motivation for the company’s decision to remove diacetyl.

“They could have done this five years ago for employee safety alone,” he said. “They didn’t know it was going to be a problem for consumers. Now, if it’s going to come down to ‘We have to do this so somebody else doesn’t get our market share,’ it’s just a marketing decision.”
 

Source | Des Moines Register

Omaha, Neb. - The nation’s largest microwave popcorn maker, ConAgra Foods Inc., said Wednesday that it would change the recipe for its Orville Redenbacher and Act II brands over the next year to remove a flavoring chemical linked to a lung ailment in popcorn plant workers.

The decision came a day after it was learned that a doctor at a leading lung research hospital said in a letter to federal regulators that consumers, not just factory workers, may be in danger from fumes from buttery flavoring in microwave popcorn.

Vogel Popcorn, a division of ConAgra Snack Foods, produces Act II and Orville Redenbacher popcorn in a Hamburg factory, as well as at other sites throughout the country, but ConAgra spokeswoman Stephanie Childs wouldn’t say whether the Iowa plant produces microwaveable products using the chemical.

Childs said the company decided to remove the butter flavoring diacetyl from its popcorn because of the risk the chemical presents to workers who handle large quantities.

Diacetyl has been linked to bronchiolitis obliterans, a rare, life-threatening disease often called popcorn lung.

Sioux City-based American Pop Corn Co., maker of Jolly Time popcorn, is also working to eliminate diacetyl from its products. The company expects to remove the chemical within 90 days, said spokeswoman Tracy Boever.

A week ago, Weaver Popcorn Co. of Indianapolis said it, too, would replace the butter flavoring ingredient because of consumer concern.

John Weimer Jr. of Wall Lake settled a lawsuit July 10 against New York-based International Flavors & Fragrances Inc. Terms were not disclosed. Weimer claimed his lungs were damaged by exposure to diacetyl while he worked as a manager at the Snappy Popcorn Co. plant in Breda.

On its Web site, Snappy Popcorn now says its microwave popcorn “contains no diacetyl,” a move that was made more than three years ago, said owner Jon Tiefenthaler.

“From a producer’s standpoint, I hope they ban (diacetyl). It is best for the industry that they do,” he said.

ConAgra doesn’t believe diacetyl in popcorn represents a safety risk to consumers, Childs said. “We’re fully confident that microwave popcorn is safe for consumers in the home,” she said.

It was reported Tuesday that a pulmonary specialist at Denver’s National Jewish Medical and Research Center had written to federal agencies to say doctors there thought they had found the first case of a consumer who developed lung disease from fumes produced by microwaving popcorn several times a day for years.

Dr. Cecile Rose sent the letter to federal officials in July.

The Flavor and Extract Manufacturers Association said Rose’s finding did not suggest a risk from eating microwave popcorn. The concern focuses on workers inhaling the chemical in manufacturing settings.

The first government study to look at what fumes are produced by microwaving popcorn at home is to be published as soon as this month, the U.S. Environmental Protection Agency said Wednesday.

Source | The Joplin Globe

By Joe Hadsall

Eric Peoples is feeling better these days. The 35-year-old Carthage resident suffers from bronchiolitis obliterans, an obstructive lung disease.

But his condition has improved. His doctors say he is up to 20 percent lung capacity, and he has been removed from the transplant list.

Peoples won a lawsuit in March 2004 against the makers of a chemical used at Jasper Popcorn Co. He alleged that his work — mixing oil containing diacetyl — caused the bronchial ailment, also known as popcorn lung.

He and others are happy to hear that Pop Weaver, Orville Redenbacher, Act II, Pop Secret and Jolly Time microwave popcorn will be made without the chemical in the future.

“It’s good to see,” Peoples said Wednesday, speaking in a gravely voice because of his condition. “I’m pleased to see Pop Weaver was the leader in doing what needed to be done years ago.”

Last week, Weaver Popcorn Co. announced that it would no longer use diacetyl to flavor its Pop Weaver brand popcorn.

ConAgra Foods Inc., General Mills Inc. and American Pop Corn Co. followed suit Wednesday, saying their brands will use a substitute.

ConAgra makes Orville Redenbacher and Act II popcorn. General Mills sells but doesn’t make Pop Secret popcorn. American Pop Corn makes Jolly Time.

ConAgra is the nation’s largest popcorn manufacturer. Company spokeswoman Stephanie Childs said the company has no timeline for removing the ingredient, but she said it should be completely phased out within a year.

“This decision reflects two concerns of ours,” Childs said. “We want to provide our employees the safest workplace possible, and we want to address consumer concerns of the perceived risks.”

She said the change will not affect the company’s popular stovetop popcorn, Jiffy Pop, because it contains natural butter instead of the chemical.

A spokesman for General Mills said it plans to phase out diacetyl “soon.” A spokeswoman for American Pop Corn said the company has been working on a new recipe without diacetyl for several months, and that the change will be complete within 90 days.

One company that hasn’t switched is Gilster-Mary Lee Corp., which owns Jasper Popcorn Co.

Tom Welge, vice president of sales for the company, said the company may eliminate the ingredient in the future, but he did not say when.

“There is a general trend we have observed in the industry moving toward those types of flavors,” Welge said. “If the industry moves that way, we’ll certainly follow.”

More than 40 former employees and nearby residents are suing the makers of diacetyl used at the Jasper plant, alleging that the chemical caused the rare lung disease.

Forty-three other people filed lawsuits in 2004 alleging the same thing. Many of those, including Peoples and Carthage resident Angela Nally, won verdicts or reached settlements.

“Really, it’s sad that this has happened to so many people,” Nally said. “It’s hard for me to believe that I got sick from it, and I worked there only eight months.”

The plaintiffs’ attorney, Ken McClain, said the manufacturers’ decision should provide further incentive to stop using the chemical. He said the switch may affect his legal strategies.

“We are still trying to evaluate what impact this has on our case,” he said.

The decision to stop using diacetyl also pleased Jackie Nowell, a safety and health officer for the Food and Commercial Workers union.

“Anything that happens now will be very public and will increase pressure (on the manufacturers),” Nowell said. “We know there are substitutes and that there is no reason to use diacetyl.”

Consumer threat?

ConAgra’s decision came a day after a pulmonary specialist at Denver’s National Jewish Medical and Research Center said a consumer contracted the disease. The consumer popped several bags a day for several years.

Nally said the thought of somebody contracting the condition at home frightens her.

“It scares me, but it doesn’t really surprise me,” she said. “If something is that strong, why wouldn’t it be in the steam that comes out when you open a bag?”

Childs, the ConAgra spokeswoman, said the company is eliminating the chemical for the safety of its workers. She said diacetyl does not threaten anyone cooking popcorn at home.

“We’ve made the decision based on the knowledge for the potential risk to our employees,” she said. “We’re fully confident that microwave popcorn is safe for consumers in the home.”

McClain said the Colorado discovery also affects his clients’ case.

“That man made popcorn several times a day,” McClain said. “That’s just like several of the plaintiffs, who worked in quality control. Their only job is to pop popcorn, which is at a larger volume than the normal consumer.”

McClain and Nowell also continued their criticism of the U.S. Environmental Protection Agency for not releasing the results of a study on the issue.

“We have been very displeased with the Bush administration’s failure to release the study,” McClain said. “They have withheld the results, apparently because it is bad news for the butter-flavor industry.”

Suzanne Ackerman, a spokeswoman for the EPA, said the agency plans to release the results this month.

Ackerman said the study, “Emissions from Cooking Microwave Popcorn,” looks only at what chemicals may be emitted when popcorn is microwaved. It does not deal with any health effects, she said.

“Emissions testing is only a first step toward determining if health testing needs to be done,” Ackerman said. “Whether they have a health effect or not at that level is for somebody else to research.”

The study already has been released to popcorn manufacturers, Ackerman said, so they could ensure that no competitive secrets were revealed.

Staff writer Greg Grisolano and the Associated Press contributed to this report.

Market share

ConAgra Foods, General Mills and American Pop Corn accounted for more than 80 percent of the market for microwave popcorn over the past 12 months, according to the research firm Information Resources Inc.

The popcorn makers said consumers who are worried about diacetyl can buy varieties of microwave popcorn that are not butter flavored because those products don’t contain diacetyl.

Source | Food Consumer

By Ben Wasserman

A chemical known as diacetyl used in microwave popcorn butter flavor was thought early to affect the workers at popcorn plants only.   But a possible case in which a 53-year Colorado man has suffering a serious lung condition caused doctors suspected by long term exposure to microwave popcorn butter flavor suggests that this chemical may harm consumers as well.

Diacetyl is a key component used in butter flavor indicated for use in microwave popcorn.   The chemical with a vicinal diketone is very reactive and in the lungs can react with proteins, potentially damaging lung tissue and enzymes and disrupting normal physiology, a scientist affiliated with foodconsumer.org suggested.

The first bronchiolitis obliterans associated with exposure to diacetyl vapor was diagnosed in former workers of a microwave popcorn plant in Jasper, Missouri. This is a serious lung disease that is irreversible. Many workers filed lawsuit against their employer and won in many cases if not all.

In the Colorado case, the furniture businessman complained to his doctors that he was becoming increasingly short of breath.   He was diagnosed as hypersensitivity pneumonitis, an inflammation of the lungs, but doctors could not identify a single risk factor in the man such as smoking, exposure to bacteria, mold or dust. No doctors initially thought that the man’s lung disease was induced by diacetyl in popcorn butter flavor.

Dr. Cecile Rose, director of the occupational disease clinical programs at National Jewish Medical and Research Center in Denver happened to have consulted to flavorings manufacturers for many years about “popcorn workers’ lung.   She found the man’s condition was similar to those induced by diacetyl in the popcorn workers, according to The New York Times.

Dr. Rose asked the man if he ate lots of popcorn. He told her that he had been eating freshly microwaved popcorn twice a day for more than ten years.   Thus exposure to diacetyl became a prime suspect for the man’s lung disease and he was advised to stop eating popcorn.   As a result, his condition was getting improved.   Dr.   Rose reported the case in a recent letter to government agencies.

The flavoring industry insists that diacetyl is safe although the U.S. government has urged both the industry and consumers to avoid or minimize use of or exposure to the chemical.  But many popcorn manufacturers are considering changing their formulae to avoid use of this dangerous chemical that.

Source | The Los Angeles Times

By Christian Miller

July 26, 2006

WASHINGTON — Emergency safety standards are needed to counter a widening outbreak of lung disease among workers exposed to a common ingredient in microwave popcorn, health experts and labor unions said yesterday.

The Teamsters and the Union of Food and Commercial Workers are planning to file an emergency petition today demanding that the Occupational Safety and Health Administration set exposure limits for diacetyl, a flavoring agent used in the manufacture of artificial popcorn butter, dog food and other products.

Diacetyl has been linked to bronchiolitis obliterans, an irreversible lung disease that has afflicted scores of workers at popcorn factories and other work sites and killed at least three people in the past few years. Consumers are not believed to be at risk, since they are exposed to far lower amounts of the chemical than plant workers.

According to the unions, the Bush administration has not acted quickly enough to stop exposure, resulting in increased health risks for thousands of workers in the multibillion-dollar flavoring industry.

“The science is there, but these agencies are sitting on their hands,” said David M. Michaels, a research professor in George Washington University’s environmental and occupational health department, who is supporting the petition. “Something needs to be done.”

OSHA officials declined to comment on the petition yesterday, but in the past the agency has indicated that current workplace protections are sufficient. OSHA requires employers to provide employees “appropriate information regarding any chemicals that meet the definition of ‘health hazard,’ ” said a spokesman, who insisted on anonymity as part of department policy.

The agency currently has no limits for worker exposure to diacetyl.

The Flavor and Extract Manufacturers Association, a trade group, said that the industry was moving aggressively to address the concern by conducting safety workshops. Glenn Roberts, its spokesman, said the group would support a safety exposure standard, so long as it was based on “sound science.”

He said the association would “continue to vigorously support any appropriate action that will protect workers in flavor and food manufacturing.”

Concerns over diacetyl have been growing since 2000, when the National Institute for Occupational Safety and Health began an investigation into reports of several workers with the lung disease at a popcorn plant in Jasper, Mo.

Investigators found that workers at the plant had chronic coughs and shortness of breath at more than twice the normal rate. The most severely affected workers underwent lung transplants.

The problem was initially believed confined to popcorn plants, where workers dumped out bags of diacetyl powder, which can damage the lungs. But this spring, California health experts reported the disease in two workers at different plants that made flavorings for dog food and other products.

Dr. Philip Harber, chief of the division of occupational and environmental medicine at the University of California, Los Angeles’ medical school, said the lung capacity in the two patients was 18 percent to 28 percent of normal.

The cases, he said, were a warning sign that workers in other flavoring-related industries who have been exposed to diacetyl may suffer from the lung disease.

“There’s no doubt that there are other cases. There have got to be a lot out there,” Harber said.

NIOSH issued an alert in December 2003 to more than 4,000 companies using the flavoring agent, warning of the danger and urging mitigation measures. Among the recommendations were using alternatives to diacetyl and improving ventilation.

But union leaders said companies have not followed the recommendations, which do not have the force of law. Jackie Nowell, the director of occupational safety and health for the food workers union, said the Bush administration needed to issue an enforceable standard to protect workers.

“This is the only administration that has failed to issue a significant standard” during its time in office, Nowell said. “This is the anti-regulatory administration.”

Michaels also raised questions over an unreleased Environmental Protection Agency study on microwave popcorn, which he said had been delayed and inappropriately reviewed by the popcorn industry.

“The public should be able to see this study,” he said.

Suzanne Ackerman, an EPA spokeswoman, said that the study was planned for publication early next year. She said the industry was allowed to review it only to make sure that no trade secrets were divulged.

Source | The Associated Press

March 15, 2004

Factory worker suffered lung damage from flavoring

JOPLIN, Mo. - A factory worker who claimed his lungs were ruined as a result of mixing flavoring oils used in microwave popcorn was awarded $20 million by a jury Monday.

Eric Peoples was the first of 30 former workers at the Gilster-Mary Lee Corp. plant in Jasper to have his suit heard against the two makers of the butter flavoring. Following a morning of closing arguments, the jury deliberated for a little more than three hours before returning the verdict.

People cried and hugged his wife, Cassandra, as the jury ruled against International Flavors and Fragrances Inc. and its subsidiary Bush Boake Allen Inc., the manufacturers of the flavoring. They were ordered to pay $18 million to Eric Peoples and $2 million to his wife for compensatory personal injury damages.

“We’re relieved that it’s over and our lives can get back to as normal as they can be,” Eric Peoples said. “At least for now, we’ll be able to spoil our children and let them forget for a while.”

Plaintiff requires lung transplant

Trial testimony showed if Peoples’ health remains stable, he could wait at least 10 years for a needed double-lung transplant; life expectancy of a lung transplant recipient is about 10 years.

The attorneys for the manufacturers left the courthouse without speaking to reporters.

The National Institute of Occupational Safety and Health also has linked exposure to vapors from butter flavoring to lung disease in popcorn factory workers Illinois, Iowa and Nebraska.

Chemical in butter flavoring to blame

Health officials insist people who microwave popcorn and eat it at home are not in danger, although the Environmental Protection Agency is studying the chemicals released into the air when a bag of microwave popcorn is popped.

Peoples’ suit charged that International Flavors and Fragrances and Bush Boake Allen knew their butter flavoring was hazardous, but failed to warn the southwest Missouri plant and its workers of the dangers or provide adequate safety instructions.

During their closing, attorneys for the two corporations told jurors their product is safe when handled properly. Information sent to popcorn plant officials warned the flavoring should be mixed in a well ventilated area and a respirator should be worn when heating it.

“We know beyond a shadow of doubt that if you use basic hygiene practices, you don’t have a problem in this plant,” said attorney Mike Patton, who represents New York-based International Flavors and Fragrances.

Gilster-Mary Lee, which was not named in the suit, remodeled the plant after government investigators in 2001 linked a chemical in the butter flavoring, diacetyl, to the workers’ illnesses. There have been no reports of illness since the ventilation was improved and workers began wearing respirators, Patton said.

Source | CNN

Tuesday, March 2, 2004

JOPLIN, Missouri (AP) — A jury was selected Monday to hear the claim of an ailing factory worker who says his rare lung disease was caused by the artificial butter vapors at a microwave popcorn plant.

A panel of 12 and four alternates was chosen. Opening statements were set for Tuesday; lawyers for both sides agreed not to speak to the media until the trial is over.

Eric Peoples, 31, who is awaiting a lung transplant, is one of 30 former workers at the Gilster-Mary Lee Corp. plant in Jasper suing two makers of artificial butter flavoring. He was selected to have his case heard first because he is among the sickest.

Peoples is seeking unspecified damages from International Flavors and Fragrances Inc. and a subsidiary. Gilster-Mary Lee is not a defendant; its Jasper plant employs about 130 people.

The trial is considered a landmark legal battle aimed at linking bronchiolitis obliterans, also known as popcorn packers’ lung, to vapors from butter flavorings in the popcorn mixing room at the plant. The disease restricts and obstructs the functioning of the lungs.

The suit alleges the manufacturers knew, or should have known, the butter flavorings were hazardous and that they failed to warn workers of the dangers or to give instructions on safe use of the product.

The National Institute for Occupational Safety and Health has said it suspects exposure to a chemical in butter flavoring, diacetyl, caused the health problems.

Health officials have said there is no danger to people who microwave the popcorn and eat it at home.

Source | The Wall Street Journal

October 5, 2001

Responding to a lawsuit, International Flavors & Fragrances Inc. said its butter flavors meet Food and Drug Administration rules and are safe for handling and use by workers.

The company said the lawsuit, which alleges respiratory injuries linked to artificial butter flavoring, is without merit.

The Wall Street Journal reported in its Friday edition that the National Institute for Occupational Safety and Health issued a report that eight employees at Gilster-Mary Lee Corp. in Jasper, Missouri developed a permanent type of lung disorder, bronchiolitis onliterans, after being exposed to artificial flavoring while mixing and packaging microwave popcorn.

Investigators suspect a chemical in the butter flavoring, possibly diacetyl, caused the damage.

The institute said an additional 21 of the plant’s 117 workers also showed signs of lung problems.

Based on the preliminary report from the institute, International Flavors said it believes any injuries suffered by the plaintiffs are related to inadequate workplace conditions and not its butter flavors.

In a filing with the Securities and Exchange Commission Friday, International Flavors said it doesn’t expect the litigation to materially hurt its financial condition, results of operations or liquidity.

The company also is cooperating fully with the government agencies investigating the cause of the health complaints.

New York Stock Exchange-listed shares of International Flavors recently traded at $26.64, up $1.20, or 4.7%, on composite volume of 585,400 shares. Average daily volume is 468,907 shares.

Kim Dixon with Reuters reported today, Thursday September 13 that Cephalon Inc. (NasdaqGS:CEPH - News) has warned doctors about deaths that have been linked to its Fentora pain drug for cancer patients.

According to the The U.S. Food and Drug Administration (FDA), Cephalon issued two Dear Healthcare Professional Letters to inform prescribers and other healthcare providers of important safety information regarding Fentora.

Fentora is indicated only for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.

Serious adverse events, including deaths, have occurred in patients treated with Fentora. These deaths occurred as a result of improper patient selection (e.g., use in opioid non-tolerant patients), improper dosing, and/or improper product substitution. The healthcare professional letters provide key points regarding appropriate patient selection and proper dosing and administration of Fentora to reduce the risk of respiratory depression.

[September 10. 2007 - Dear Doctor Letter - Cephalon]
[September 10, 2007 - Dear Healthcare Professional Letter - Cephalon]
[March 2007 - Label with Medication Guide - Cephalon]

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