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Kamis, 27 November 2008

FTC tosses guidance on tar, nicotine in cigarettes

WASHINGTON – The cigarette industry for 42 years has made factual claims about tar and nicotine levels based on machine testing blessed by the Federal Trade Commission.

Now the FTC has dropped the test, known as the Cambridge Filter Method, like a hot rock.

The commission has rescinded guidance it issued 42 years ago, saying the test method is flawed. It also said the resulting marketing touting tar and nicotine levels could cause consumers to believe that lighter cigarettes were safer.

As a result, future advertising that lists tar levels for cigarettes won't be able to use terms such as "by FTC method."

"Our action today ensures that tobacco companies may not wrap their misleading tar and nicotine ratings in a cloak of government sponsorship," said Commissioner Jon Leibowitz. "Simply put, the FTC will not be a smokescreen for tobacco companies' shameful marketing practices."

The commission rescinded the guidance by a 4-0 vote.

Under the current system, cigarettes with a tar rate above 15 milligrams per cigarette are commonly referred to by the industry as "full flavor." Cigarettes with a tar rating of less than 15 milligrams are referred to as "low" or "light." Cigarettes with a tar rate below 6 are described as "ultra low" or "ultra light."

The National Cancer Institute found that changes in cigarette design reduced the amount of tar and nicotine measured by smoking machines using the Cambridge Filter Method. However, there was no evidence those changes reduced disease for smokers. The machine doesn't take into account the way smokers adjust their behavior, such as taking more or deeper puffs to maintain nicotine levels.

"The most important aspect of this decision is that it says to consumers that tobacco industry claims relating to tar and nicotine are at best flawed and most likely misleading," said Matthew Myers, president of the Campaign for Tobacco-Free Kids.

The commission said it originally believed in the 1960s that giving consumers uniform, standardized information about tar and nicotine yields of cigarettes would help them make informed decisions about cigarettes. At the time, most public health officials believed that reducing the amount of tar in a cigarette could reduce a smoker's risk of lung cancer. However, that premise is no longer valid.

Sen. Frank Lautenberg, D-N.J., introduced legislation this year that would prohibit companies from making claims based on data derived from the FTC's testing method, but the bill did not make it to the full Senate for a vote.

"Tobacco companies can no longer rely on the government to back up a flawed testing method that tricks smokers into thinking these cigarettes deliver less tar and nicotine," Lautenberg said.

One FTC commissioner, Pamela Jones Harbor, urged Congress to approve the regulation of tobacco by the Food and Drug Administration. The bill would authorize government scientists to track, analyze and regulate the components of cigarettes.

Tobacco companies have stated clearly over the years that there is no such thing as a safe cigarette. In a statement, Philip Morris USA, the nation's largest tobacco company, said it remains committed to working with the FTC and other federal authorities to identify and adopt testing that improves on the Cambridge method.

The FTC noted that all four major domestic cigarette makers told commissioners the 1966 guidance should be retained until a replacement test method was approved.

Philip Morris warned commissioners that elimination of the guidance could lead to a new "tar derby" in which cigarette makers would use different methods of measuring the yields in their cigarettes, thereby leading to greater consumer confusion.

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On the Net:

Federal Trade Commission: http://www.ftc.gov


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Calls for national infant formula recall spread

Disclosure that laboratory tests have detected traces of contamination in several major brands of infant formula generated concern and confusion Wednesday, with a national consumer's group and the Illinois attorney general demanding a Food and Drug Administration recall and the federal agency saying it had released inaccurate information on what chemicals were found in which top selling products.

As worried parents called manufacturers looking for guidance about the presence of melamine and a key byproduct in U.S.-made formula, the FDA reiterated its position that the baby food is safe and parents should continue feeding it to their babies, contending the extremely low levels of contamination do not present a health danger.

Also, a spokesman for one major manufacturer criticized the FDA for its release of the inaccurate information.

"We're getting inundated by calls from moms confused about the situation," said Pete Paradossi, a spokesman for Mead Johnson, one of the three major manufacturers of U.S.-made formula involved in the problem detections.

Melamine is the industrial chemical found in Chinese infant formula — in far larger concentrations — that has been blamed for killing at least three babies and making at least 50,000 others ill.

The FDA and other experts said the melamine contamination in U.S.-made formula had occurred during the manufacturing process, rather than intentionally as was done in Chinese production. The manufacturers insist their products are safe.

"The levels that we are detecting are extremely low," said Dr. Stephen Sundlof, director of the FDA's Center for Food Safety and Applied Nutrition. "They should not be changing the diet. If they've been feeding a particular product, they should continue to feed that product. That's in the best interest of the baby."

Part of the confusion Wednesday stemmed from the FDA's own statements.

While proclaiming that the very low concentrations detected of melamine and a similar compound called cyanuric acid pose no health danger to infants, the FDA has maintained it is unable to identify any exposure level of melamine in infant formula "that does not raise public health concerns."

Further complicating the situation was inaccurate data that FDA released to The Associated Press, which was first to disclose the formulas' brand names and other details in an investigative report Tuesday.

A spreadsheet the AP obtained from the FDA under a Freedom of Information Act request stated that Mead Johnson's Infant Formula Powder, Enfamil LIPIL with Iron contained traces of melamine.

On Wednesday, FDA spokeswoman Judy Leon said that spreadsheet contained an error — that the FDA had incorrectly switched the names of the Mead Johnson product with Nestle's Good Start Supreme Infant Formula with Iron. That meant, Leon said, that the Nestle's Good Start had melamine while Mead Johnson's Enfamil had traces of cyanuric acid.

The FDA said last month that the toxicity of cyanuric acid is under study, but that in the meantime it is "prudent" to assume that its potency is equal to that of melamine.

Problems with melamine-spiked formula surfaced this fall in China, where unscrupulous manufacturers intentionally dumped it into watered-down milk to falsely elevate protein levels. The concentrations in China were as much as 2,500 parts per million — about 10,000 times greater than what the FDA found in the U.S.

The FDA said there have been no reports in the United States of human illness from melamine. The chemical, which legally can be used in product packaging and a solution to clean manufacturing equipment, can bind with other chemicals in urine, potentially causing damaging stones in the kidney or bladder and, in extreme cases, kidney failure.

Mead Johnson spokesman Paradossi said he was frustrated that the FDA had provided inaccurate information for worldwide distribution by the AP. He said the FDA informed his company of the test results, as well as the inaccurate disclosures only Wednesday, during an emergency conference call the agency staged with major manufacturers and the industry's trade group. During a similar call Monday, the FDA told the industry about the upcoming AP investigative report.

Nestle did not returns calls seeking comment Wednesday.

At the same time, Illinois Attorney General Lisa Madigan called on the state's public health department and the FDA to recall both the Nestle and Mead Johnson products — and urged the companies to take that step regardless of what any government agency does.

Madigan also criticized the FDA's handling of its test results.

"The agency apparently withheld the results of its testing from the public for over three weeks, and then only disclosed the information in response to a FOIA request by The Associated Press," she wrote in a letter to Michael Leavitt, the secretary of the U.S. Department of Health and Human Services, which oversees the FDA.

As for possible consideration of a recall, the FDA's Leon said: "The agency would only seek to remove a product on the basis of a risk, based on scientific evidence. That's not what we're talking about here."

Consumers Union said that the FDA's assurances are of small comfort to parents and caregivers.

"The FDA originally said there was no safe level for these contaminants in infant formula. So this formula is contaminated," said Jean Halloran, the group's director of Food Policy Initiatives. "It is very disturbing to us that no recall has been requested."

She urged the FDA "to immediately make public all of the results of its tests for melamine contamination in food," even those with levels below what would trigger agency action."

Rep. Bart Stupak, D-Mich., a frequent critic of the FDA, also has called for recalls.

During a series of calls with formula manufacturers starting Monday — put together hurriedly, according to several participants, as the AP was preparing to publish its story — the FDA has told manufacturers it has taken 230 samples of various products, including pediatric supplements and ingredients used in infant formula. Leon said that 87 of those samples are of infant formula, and that 77 of those have been analyzed.

Under the corrected information she relayed Wednesday, the results were:

• Nestle's Good Start Supreme Infant Formula with Iron had two positive tests for melamine on one sample, with readings of 0.137 and 0.14 parts per million.

• Mead Johnson's Infant Formula Powder, Enfamil LIPIL with Iron had three positive tests for cyanuric acid, at an average of 0.247 parts per million.

Separately, a third major formula maker — Abbott Laboratories, whose brands include Similac — told AP that in-house tests had detected trace levels of melamine in its infant formula. Those levels were below what FDA found in the other formulas, an Abbott spokesman said, and below any nation's safety guidelines.

The three firms — Abbott Laboratories, Nestle and Mead Johnson — manufacture more than 90 percent of all infant formula produced in the United States.

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Associated Press Writer Ricardo Alonso-Zaldivar contributed to this report from Washington, D.C.

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On the Net:

The FDA's melamine guidance: http://www.fda.gov/oc/opacom/hottopics/melamine.html


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Brain scans show root of memory glitch with aging

NEW YORK – Brain scans of older people in a noisy lab machine give biological backing to the idea that distraction hampers memory with aging, researchers reported Wednesday.

The finding bolsters a theory about one reason why memory weakens with age: older people have more trouble remembering some things because they're more easily distracted when they try to learn them.

The memory exercise reported in the latest issue of the Journal of Neuroscience dealt with recognizing faces, but the findings apply to the more general task of trying to remember something a person sees or hears, said lead author Dale Stevens.

Stevens, a postdoctoral researcher at Harvard University, did the work while at the Rotman Research Institute at Baycrest, which is affiliated with the University of Toronto.

Older people who have to learn something should do all they can to focus on that task and eliminate potential distractions, he advised.

The study compared 10 healthy people in their 60s and 70s to a dozen younger volunteers, ages 22 to 36. Their brains were scanned while they looked at photographs of people they did not know. As each photograph was displayed for one second, the volunteers were asked if they'd seen it before in the study.

In all they saw 180 different faces, of which 120 showed up a second time. The older participants failed to recognize a face they'd already seen 43 percent of the time, compared to 26 percent for the younger volunteers.

Researchers went back to see what was going on in the brains of the volunteers when they first saw a face that they later failed to recognize. Why didn't those faces get planted in memory?

In both groups, a brain area called the hippocampus, which is involved in memory, was less active when a face failed to stick in the memory than when it did. That was no surprise. More interestingly, the older group also showed heightened activity in certain other brain areas while the younger volunteers did not.

Those areas included the auditory cortex, which plays a role in analyzing sound, and several areas involved in directing attention, Stevens said.

So what was going on? The brain-scanning machine was noisy, with lots of knocking, buzzing and banging like a jackhammer, Stevens said. Even with the earplugs the volunteers wore, "it's a little distracting," he said.

The brain activity in the older volunteers shows that the noise was more distracting to them than to the younger participants, and reveals the brain circuits involved, researchers concluded.

The study could not address when a person's brain starts to act up this way. But Cheryl Grady of the Rotman institute, another author, said she suspects it may begin between ages 40 and 60.

Dr. Barry Gordon, a neurology professor and memory expert at The Johns Hopkins Medical Institutions in Baltimore, called the work "an appreciable advance." A next step could be seeing whether older people will do better on a memory test if they're warned about the distraction problem, said Gordon, who wasn't involved in the new study.

In any case, he said, "if you want to remember something, it's more important if you're older than younger not to be listening to your iPod."

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On the Net:

The Journal of Neuroscience: http://www.jneurosci.org/

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