Earlier this summer, dozens of people reported that their boxes of Foot Loops and Apple Jacks contained strange odors and tastes. Some complained of nausea and diarrhea after consuming the cereal. The complaints prompted Kellogg to recall 28 million boxes of the iconic breakfast treats.

Kellogg subsequently blamed the problem on elevated levels of 2-methylnaphtalene, while adding that its experts found “no harmful material” in the cereals.

2-Methylnaphthalene may not be harmful, but it’s hard to know for sure. The FDA has no information about its impact on human health. Neither does the EPA, even though it has been asking the chemical industry to provide health information about 2-methylnaphtalene since 1994.

The EPA made the request 16 years ago because the chemical was being produced in massive quantities and finding its way into dozens, if not hundreds of consumer products.

The cereal recall has refocused attention on huge gaps in Federal regulators’ knowledge about chemicals in consumer products including food, children’s toys and clothing. According to the Washington Post, regulators don’t know squat about “the health risks posed by most of the 80,000 chemicals on the market today.”

The knowledge gap can be traced to the 1976 passage of the Toxic Substances Control Act which exempted 62,000 chemicals, including 2-methylnaphthalene, from regulatory oversight and stipulated that chemicals developed since then need not be tested for safety. Instead, manufacturers were encouraged to volunteer information concerning the health effects of their compounds and required to hand-over any data showing that a chemical harms health.

That created an enormous disincentive for manufacturers to test their chemicals.

Congress is working on legislation that would require companies to undertake health and safety assessments of existing chemicals and prove that new ones are safe before using them. The chemical industry thinks such laws could hamper innovation and competitiveness.

Pizaazz thinks it’ll take a US version of China’s melamine scandal before this legislation makes it to the President’s desk.

So-called pay-for-delay settlements involving generic and branded drug makers are becoming more common and costing consumers $3.5 billion each year, according to FTC Chairman John Liebowitz, who testified before Congress that he wanted to eliminate such agreements altogether.

These deals allow branded drug makers to sell their expensive products without generic competition for a period longer than the duration of the patents they hold on their drugs.

In the first 9 months of fiscal 2010, drug makers entered into 21 patent litigation settlements.  That’s more than the entire previous year.

“That’s almost an epidemic,” Leibowitz told BurrillReport. “Every single FTC Commissioner, going back through the Bush and Clinton administrations, has supported stopping these unconscionable agreements.”

The FTC supports legislation designed to halt pay-for-delay settlements. At the moment, this legislation is tucked into a Senate spending bill.

Both branded and generic drug companies would prefer to leave things just as they are. “The FTC’s testimony fails to present the whole story regarding patent settlements,” according to a statement released by the Generic Pharmaceutical Association. “Over the past 10 years, patent settlements have enabled dozens of first-time generics to come to market many months before patents on the counterpart brand drugs expired.”

The Pharmaceutical Research and Manufacturers of America, which represents branded drug makers, agreed. “A blanket ban could decrease the value of patents, remove an important option for a patent-holder’s defense of intellectual property, and reduce the incentives for future innovation of new medicines,” it said.

A Senate panel has already recommended banning pay-for-delay deals, but narrowly. Pennsylvania Democrat Arlen Specter introduced an amendment to remove the ban from the spending bill, but that amendment did not pass. The ban must pass the full Senate and House before becoming law.

Last week, 2 Iowa-based egg producers recalled more than half a billion eggs after federal investigators traced a recent salmonella outbreak to their production facilities. The outbreak began in May. So far, it has not been linked to any deaths.

The two companies are Wright County Egg, which recalled 380 million eggs that had been distributed across the nation, and Hillandale Farms, which recalled 170 million eggs that had been distributed to 14 states in the West and Midwest. According to the Washington Post, the companies use some of the same suppliers of feed and young chickens, a fact that may help investigators trace the source of the outbreak.

Hinda Mitchell, a spokesperson for Wright County Egg told the Post that her company “recognizes the significant consumer concern about the potential incidence of Salmonella Enteritidis…we continue to work cooperatively with FDA after our voluntary recall. This is consistent with our commitment to egg safety.”

It turns out that the Iowa-based DeCoster family owns or has close ties with both egg producers.

For what it’s worth, the Post reported yesterday that the family has a long history of run-ins with federal officials. In 1996 for example, another DeCoster-owned egg farm was dunned $3.6 million for health and safety violations after inspectors found employees handling dead chickens and manure with their bare hands.

Then, in 2001, Iowa’s Supreme Court cited the family as a “repeat violator” of its environmental laws, singling-out violations involving DeCoster’s hog-farms. Later that year, the family settled a complaint that company supervisors subjected 11 female workers to a “sexually hostile work environment,” including assault and rape.

What is more, in 2002 and again in 2008, OSHA cited the family for several violations that resulted in the exposure of workers to dangerous conditions.

Of course none of this is directly relevant to the salmonella outbreak…

An FDA advisory panel has voted to allow ongoing sales of the diabetes drug Avandia despite the fact that Glaxo’s former blockbuster poses a “significant safety” concern by increasing the risk of cardiovascular events.

The FDA is not required to follow the recommendations of its panels, although it usually does.

Nearly one-third of the 33-member panel voted to ban Avandia. Most panelists who voted to keep the drug on the market called for increased restrictions on its use, and said it should be used only as a second- or third-line drug for the treatment of diabetes.

For example, David Oakes, a statistics professor at the University of Rochester, told the Wall Street Journal that his vote for continued sales of Avandia should not be construed a “vote of confidence,” but rather that he was concerned about the quality of studies which link Avandia to heart attack risk.

Janet Woodcock, who heads-up the FDA’s drug division, said her agency will decide on the matter within the next few weeks.

Avandia sales have plummeted since a 2007 article in the New England Journal of Medicine reported a 43% bump in heart attack risk with the drug. Q1, 2010 world-wide sales of Avandia were reported to be $245 million, off 10% year-over-year.

The FDA panel also concluded that Avandia posed a greater heart attack risk than Actos, a rival drug made by Takeda. Both drugs were approved in 1999 for blood-glucose control in patients with Type 2 diabetes.

In the wake of the panel’s announcement, Glaxo’s Chief Medical Officer Ellen Strahlman defended the safety record of Avandia. She said the drug would remain on the market pending the FDA’s decision.

The Affordable Care Act has catapulted the US Preventive Services Task Force from an obscure agency which produced unenforceable guidelines about screening and preventive services into one whose recommendations directly impact reimbursement.

The health reform law requires insurers to pay in full for services receiving an A or B recommendation from the Task Force. The flip-side is that insurers may not have to pay at all for services that are not recommended by the Task Force. As a result, the Task Force’ new best friends include lobbyists and disease advocates who want their priorities – things like screening for Alzheimer’s disease, HIV and diabetes or HIV – to get covered.

The American Diabetes Association, for example, is advocating that insurers be required to cover a broader population than current Task Force recommendations suggest. Current recommendations are that only patients with high blood pressure should be screened.

The HIV Medicine Association has made a similar argument to the Task Force. It claims that a key reason why 20% of people infected with HIV are unaware of that fact is because most insurers don’t cover the costs of testing.

“If you want to be evidence-based, lobbying doesn’t fit,” Ned Calonge, the chairman of the Task Force told the Washington Post. “My charge to members would be to stay true to the methods and the evidence.”

The Task Force, by the way, is the same one that caused a stir before the 2008 presidential election when it recommended that women should start receiving screening mammograms at the age of 50, rather than 40. That move was eventually trumped by an amendment to the Affordable Care Act which required insurers to cover mammograms for women in their 40s.

An FDA advisory panel has voted to allow ongoing sales of the diabetes drug Avandia, even though it expressed concern that Glaxo’s former blockbuster increases the risk of cardiovascular events like heart attacks.

The FDA is not required to follow the recommendations of its panels, although it usually does.

Nearly one-third of the 33-member panel voted to ban Avandia. Most panelists who voted to keep the drug on the market called for increased restrictions on its use, saying it should be used only as a second- or third-line drug for the treatment of diabetes.

For example, David Oakes, a statistics professor at the University of Rochester, told the Wall Street Journal that his vote for continued sales of Avandia should not be construed a “vote of confidence,” but rather as reflecting his concerns about the quality of studies which link Avandia to heart attacks.

Janet Woodcock, who heads-up the FDA’s drug division, said her agency will decide on the matter within the next few weeks.

Avandia sales have plummeted since a 2007 article in the New England Journal of Medicine reported a 43% bump in heart attack risk with Avandia. Q1, 2010 world-wide sales of Avandia are reported to have been $245 million, off 10% year-over-year.

The FDA panel also concluded that Avandia posed a greater heart attack risk than Actos, a rival drug made by Takeda. Both drugs were approved in 1999 for blood-glucose control in patients with Type 2 diabetes.

In the wake of the panel’s announcement, Glaxo’s Chief Medical Officer Ellen Strahlman defended the safety record of Avandia. She said the drug would remain on the market pending the FDA’s decision.

The Australian government has unveiled a new set of antismoking measures that includes removal of brand images and colors on cigarette packages.

According to the new rules—which have yet to be approved by Parliament—cigarette products would have to be marketed in packaging that is devoid of logos and includes promotional text that is presented in uniform color, font, positioning and point size.

The packaging—in the words of the Australian government—was “one of the last remaining frontiers for cigarette advertising.”

Cigarette boxes in Australia already feature explicit health warnings and photos that depict some of the consequences of smoking, like mouth cancer and gangrenous extremities.

Also included in the proposed rules is a 25% increase in the excise tax on cigarettes. The tax will bump the price of a box of 30 cigarettes by roughly 2.16 Australian dollars, to nearly 16.70 Australian dollars ($15.40).

The increased excise tax will itself cut cigarette smoking by 6%, according to government projections. Approximately 17% of Australians over age of 14 smoke cigarettes. 

The World Health Organization hailed the measures as “a new gold standard for the regulation of tobacco products.”

Tobacco companies questioned the effectiveness of the new measures and said they would encourage counterfeiting.

“There is no evidence to support the government’s notion that this will reduce consumption,” Imperial Tobacco said in a statement. “Plain packaging would seriously harm our brands and infringe the intellectual property rights in which both Imperial Tobacco and its shareholders have invested.”

By a 3-2 vote, the board of supervisors in Santa Clara County, California has passed an ordinance prohibiting free giveaways of promotional toys associated with child-sized meal-deals at fast-food outlets, unless the meals meet certain nutritional standards.

The ban will apply to cheeseburgers, chicken nuggets and other fare containing excessive calories, sodium, fat or carbohydrates.

“What we’re trying to do is de-link the connection between unhealthy food and toys,” said Ken Yeager, the board president, who believes that many kids select their meal based on the toy that accompanies it.

“It’s the toys that they want,” Yeager, who does not have children, told the New York Times. “This ordinance does not attack toys. Toys, in and of themselves, do not make children obese.”

The ban takes effect this month in a county in which 25% of the children are obese. Nationally, between 11% and 18% of children are overweight or obese, with low-income residents affected disproportionately.

In adults, the problem is even more widespread: two-thirds of adults are overweight or obese, according to the National Center for Health Statistics.

McDonald’s spokesperson Walt Riker expressed disappointment with the board’s decision. “Our Happy Meals provide many of the important nutrients that children need,” including zinc, iron and calcium, he said.

A congressional investigation into the FDA’s handling of the 2008 outbreak of deaths and anaphylactic reactions caused by contaminated heparin from China has revealed that the agency failed to pursue “specific, credible leads” that could have fingered the culpable organizations.

The FDA never did say who was responsible for the outbreak, which caused at least 80 deaths and several hundred severe reactions, according to Joe Barton, the ranking Republican on the House Energy and Commerce Committee.

Nearly all the world’s heparin comes from Chinese farms, where ingredients for the widely-used blood thinner are derived from pig intestines. China-based pharmaceutical companies process the raw ingredients and export them around the world.

In February 2008, US hospitals and dialysis centers began reporting severe allergic reactions and deaths associated with heparin. Six weeks after the outbreak began, the FDA announced it was caused by a contaminant, chondroitin sulfate, that had been added to the raw product to stretch supplies.

In one instance cited by Barton, a foreign “respectable regulatory government agency” tipped-off the FDA that a Chinese company was producing tainted heparin. The FDA never pursued the lead.

A letter penned by Barton also cites an internal FDA memo from April, 2008 indicating the agency was aware that one company, Chongqing Imperial Bio-Chem, was supplying tainted heparin to the US.

Although the FDA subsequently banned US imports from Chongqing, Barton’s letter accuses the FDA of failing to explore more thoroughly the possibility that the company was centrally involved in the scam. In an inspection of the facility later in the year, the letter said, the FDA relied on the company’s president to translate.

A Chinese embassy spokesperson responded that Chinese officials “provided full cooperation to the US in the whole process.”

The Food and Drug Administration wants to reduce salt consumption by Americans in an effort to cut morbidity and mortality from cardiovascular disease.

The unprecedented move would be implemented over a decade or more.

It would begin by quantifying salt content in processed foods and progress to the establishment of salt limits in various food categories. Subsequently, these would be ratcheted down over years so that consumers wouldn’t take notice.

At the moment, FDA classifies salt as “generally recognized as safe,” meaning that food producers can add as much as they want. All they have to do is report salt content on nutrition labels.

Americans’ salt consumption has risen steadily for 3 decades as they consume more processed foods and eat out more frequently. Most of us consume twice as much as the government’s daily recommended limit.

Scientists at Stanford and Columbia recently published a study showing that reducing salt intake by 3 grams per day could prevent tens of thousands of strokes and heart attacks per year.

The feds had heretofore tried to coax the food industry to voluntarily reduce salt and educate consumers about its risk. However, a recently released report by the Institute of Medicine has found these approaches have failed.

The FDA’s challenge is that, “historically, consumers have found low-sodium products haven’t been of the quality that’s expected,” according to Todd Abraham, an SVP of research and nutrition at Kraft Foods.

Meanwhile, Morton Satin, who directs technical and regulatory affairs for the Salt Institute, a trade group representing salt producers, believes regulation “would be a disaster for the public.” He added that the scientific evidence linking salt consumption to cardiovascular disease is mixed and that salt intake is not necessarily associated with health problems.

Camel Orbs, a flavored Tic Tac-like tobacco-containing pellet introduced last year by R.J. Reynolds,  poses a threat to children, according to a new study published in Pediatrics.

The smokeless tobacco product is supposed to be used by smokers when they can’t light up. It contains 1 mg of nicotine, about half that received by smoking one cigarette.

This amount can cause nausea and vomiting in a small child (a lethal dose of nicotine for an infant is about 1.0 mg/kg body weight). The problem is made worse by the fact that the Orb contains a highly bio-available form of nicotine.

To reach these conclusions, Hillel Alpert and colleagues from the Harvard School of Public Health  reviewed 13,705 tobacco product ingestion cases by children under 6 years of age that were reported to 61 regional poison control centers between 2006 and 2008.

The scientists counted 13,705 cases of tobacco product ingestion, more than 70% of which involved infants less than 1 year of age. Orbs came in second only to cigarettes themselves as the substance ingested by the kids. There was one death.

In an accompanying editorial, Marisa Cruz and Lawrence Deyton of the FDA Center for Tobacco Products said their agency has requested information from RJR and will be seeking “research around the impact of marketing for dissolvable tobacco products on young people, how adolescents and young adults perceive such products, and whether dissolvable tobacco products may lead to initiation or persistence of tobacco use in this population.”

An RJR spokesperson said the company hadn’t known of any pediatric adverse events caused by Orbs ingestion before the article was published. He added that Orbs taste like tobacco despite the candy-like flavorings and that the packaging meets government standards for child resistance.

The FDA has announced plans to review the safety of triclosan, an antibacterial agent found in hundreds of consumer products including soap, toothpaste, toys and clothing. The stepped-up regulatory scrutiny was prompted by recent lab studies showing that bacteria can evolve resistance to the chemical using a mechanism that would help them resist antibiotics as well.

In making the announcement, the FDA said there is no evidence that triclosan is directly harmful to humans or that bacteria in nature have become resistant to triclosan.

The “FDA does not have sufficient evidence to recommend changing consumer use of products that contain triclosan at this time,” the agency said.

The new development did not satisfy Massachusetts Democrat Edward Markey, who called for a ban on the substance. “There are many troubling questions about triclosan’s effectiveness and potentially harmful effects, especially for children,” Markey told MSNBC.

The Soap and Detergent Association has consistently said triclosan is safe. It has been used to reduce bacterial loads in consumer products for nearly 30 years.

An environmental group, the Natural Resources Defense Council, hailed the FDA’s announcement.

“It’s about time FDA has finally stated its concerns about antibacterial chemicals like triclosan,” said the Council’s Sarah Janssen.

“The public deserves to know that these so-called antibacterial products are no more effective in preventing infections than regular soap and water and may, in fact, be dangerous to their health in the long run.”

Experts agree that that triclosan-containing soap does little or nothing more to remove bacteria from the skin than plain soap. Washing hands physically removes excess bacteria from the skin. Soap helps this, with or without triclosan.

Approximately 3 million Americans consume unpasteurized milk each year. They believe “raw” milk contains enzymes, vitamins, beneficial bacteria and disease-fighting nutrients that are lost during pasteurization.

These beliefs persist despite the unanimous opinion of public health officials that the risks of unpasteurized milk outweigh any benefits, and that pasteurization—in which milk is heated to kill disease-causing bacteria—is by far the best way to assure milk is safe.

According to the CDC, there were 85 outbreaks of bacterial infections caused by raw milk consumption between 1998 and 2008. These outbreaks were associated with 1,614 reported cases of illness, 187 hospitalizations and 2 deaths. Deaths have also been caused by ingestion of fresh cheese made from raw milk, the CDC reports, especially the Queso Fresco cheeses which are favored by many Hispanic people.

Pregnant women, the elderly and children are particularly vulnerable to bacterial infections associated with raw milk, but healthy young adults can also be stricken.

The FDA bans interstate sales of unpasteurized milk for human consumption, but 28 states allow it to be sold, and others are considering doing so. These states impose their own laws regarding milk processing. Some require in addition that warning labels be affixed to milk containers.

In the aftermath of some recent outbreaks associated with unpasteurized milk, the FDA and CDC are ramping-up efforts to warn consumers about its dangers, and urging states to strengthen what regulatory controls they currently enforce. 

Pasteurization was widely adopted in the US around 1938. Before then, cow’s milk caused nearly 25% of all food- and water-borne disease outbreaks. “People don’t remember the bad old days,” Robert Tauxe, the CDC’s deputy director of food-borne and bacterial diseases division told the Wall Street Journal.

US physicians wrote 4.4 million prescriptions last year for nitroglycerin (TNG) tablets, those tiny pills in the tiny bottle that dissolve under the tongue and act in minutes to relieve chest pain associated with coronary artery disease.

TNG has direct vasdilatory effects on the coronary arteries. It also reduces blood pressure and cardiac “preload.” Patients take TNG when they first feel angina. They can take up to 3 if the first one doesn’t work. After that, they call 911.

TNG has been around forever, and it turns out that’s a problem. The pills predate the Food and Drug Administration itself, and were grandfathered-in as safe and above regulatory review in 1938 when the agency was formed.

The result is that 80% of the TNG prescribed in the US has never been tested for safety, potency or effectiveness. The only form of TNG that has received FDA approval is Nitrostat, which is made by Pfizer.

Amazingly, doctors just found this out last month. It’s possible that millions of patients may have been taking substandard or ineffective forms of the drug. Some of them may have been harmed by the oversight.

“If it’s not approved and no one has tested it, we can’t be sure that it’s safe and effective,” Harry Lever, a cardiologist at the Cleveland Clinic told the New York Times.

Late last month, the FDA warned the 2 other TNG makers to cease marketing their unapproved products. The companies, Konec Inc. of Tucson and Glenmark Generics Inc. of Mahwah, NJ have been given 90 days to halt production, and 180 days to stop shipping them.  Spokespeople from these companies said they’d comply, but insisted their products were safe.

Meanwhile Pfizer has ramped-up production of Nitrostat and claims it can handle the windfall.

Amid an unfolding nationwide outbreak of salmonella that has been linked to salami made with tainted black and red pepper,  officials from the Food and Drug Administration met recently with spice industry representatives to figure out how to prevent future outbreaks. 

People agree that spices need to be treated with either irradiation, steam heating or fumigation with ethylene oxide to rid them of bacteria. But the FDA cannot currently require such action.

Last year, the House overwhelmingly approved legislation that would require domestic spice producers to take these steps and spice importers to assure the safety of foreign supplies, but the bill is stalled in the Senate.

The outbreak of salmonella-tainted salami has been linked to 249 illnesses in 44 states. There have been no deaths.

Although salmonella is more commonly associated with poultry, meat and vegetables, the bacterium can survive in dried spices for years. And since spices have a long shelf-life, it becomes difficult for health officials to link diseases to particular spices.

With the exception of garlic, onions and red chili peppers, most spices consumed in the US are imported from countries like Brazil, China, Egypt, Grenada, India, Indonesia, Morocco, Spain, Sri Lanka, Turkey and Vietnam, developing nations where pollution and water problems create contamination hazards.

About half the nation’s spices are irradiated, but these end up being sold to industrial customers. Retail spice companies don’t irradiate spices because federal law requires that this be disclosed on the label. The industry believes consumers won’t buy such products.

“If the labeling issue would go away, there would be a high interest (in) irradiation,” said Steve Markus, director of food safety and commercial products at Sterigenics, the nation’s largest food irradiation company.

Lately, the Food and Drug Administration has been receiving increased numbers of reports describing  problems with insulin pumps, those small devices used by diabetics to deliver insulin without the need for injections.

The FDA noted that various hardware and software issues have resulted in 18 device recalls during the last 5 years.

“Device problems…exist across manufacturers,” the agency noted. 

In response, FDA has convened an advisory panel to recommend actions to “minimize risks associated with the devices in these recall situations,” according to its Web site.

Insulin pumps are typically used by patients with Type I diabetes, in which the pancreas produces little or no insulin. Type 1 diabetics rely on exogenous insulin for survival.

According to the FDA, the number of people in the US who used insulin pumps increased from 130,000 in 2002 to 375,000 in 2007.

The FDA requires pump makers to report problems and potential problems associated with the devices. The agency received 17,000 such reports in the 3-year period ending September 30, 2009. Such reports don’t necessarily mean the pump caused a problem but usually merit further investigation. Patients can misuse a properly functioning pump, for example.

Roughly 12,000 reports to the FDA were associated with a patient injury (which typically involved gyrating blood glucose levels). Deaths occurred 310 times.

In these instances, the FDA said information provided by pump makers “was typically incomplete.” In 225 of these reports, the manufacturer listed the device problem as “unknown.” In many of these cases, the device wasn’t returned to the manufacturer for follow-up investigation.

In 41 reports involving a patient death, the circumstances included diabetic coma and other problems typically associated with severe abnormalities in blood-sugar levels, which suggests possible device malfunctioning.