FDA Approves Second Embryonic Stem Cell Treatment Study

For the second time in little over a month, the FDA has approved human trials of an embryonic stem cell treatment in the US. This time, it is for a relatively rare eye condition, but the group behind the tests thinks that this could lay the foundation for treating a wide range of age-related eye conditions:

ACT's experiment will focus on Stargardt disease, which affects only about 30,000 Americans. But the company hopes the same approach will work for similar and more common eye disorders like age-related macular degeneration, which affects millions.

Stargardt is an inherited disorder that attacks central vision used for tasks like reading and recognizing faces. Some patients go totally blind, even losing peripheral vision, while others are severely impaired and can only perceive light or see their hands moving in front of their faces.

The disease typically starts in adolescence. The key problem is that impaired scavenger cells fail to remove toxic byproducts from the eye, allowing them to build up and kill other cells. There is no proven treatment.

In the new study, 12 patients will be treated with healthy scavenger cells, created in a laboratory from human embryonic stem cells. This early phase of the research is primarily to test the safety of various doses, injecting only one eye of each patient.

FDA Issues Warning Over Alcoholic Caffeinated Beverages

The FDA stopped short of banning products like Four Loko, which are fruit flavored alcoholic energy drinks that include caffeine. However, it issued warnings.

The Food and Drug Administration sent warning letters to four manufacturers of alcoholic energy drinks on Wednesday, saying that it was unsafe to include caffeine in the beverages.

The popularity of the drinks has exploded over the last few months, and there have been numerous reports of young people falling ill after drinking them. A brand called Four Loko — a fruit-flavored malt beverage that has an alcohol content of 12 percent and as much caffeine as a cup of coffee — came under particular scrutiny after students who drank it this fall at Ramapo College in Mahwah, N.J., and Central Washington University in Ellensburg, Wash., ended up in emergency rooms, some with high levels of alcohol poisoning.

On Tuesday, Phusion Projects, the Chicago company that makes Four Loko, said it would stop putting caffeine in the drink. The company’s founders said in a statement that while they still believed it was safe to blend caffeine and alcohol, they wanted to cooperate with regulators.

“We are taking this step after trying — unsuccessfully — to navigate a difficult and politically charged regulatory environment at both the state and federal levels,” the statement said.

Several states, including Michigan and Washington, have banned the drinks on their own in recent weeks, and many more were considering similar action. Last weekend, New York’s largest beer distributors agreed to stop delivering caffeinated alcoholic beverages to retailers by Dec. 10.

It's easy enough to blame the company behind this particular product, but anyone can put together a strong beverage that contains the same ingredients. After all, any number of cocktails pack more alcoholic punch than Four Loko, and high caffeine products have long been available, like Jolt Cola.

It's real easy to scapegoat Four Loko, but it ignores the responsibility of the individual drinker and those who are selling these alcoholic beverages to underage persons. The two cases that the Times cites aren't exactly definitive:

In August, an 18-year-old in Palm Coast, Fla., died after drinking Four Loko in combination with diet pills. The following month, a 20-year-old in Tallahassee, Fla., started playing with a gun and fatally shot himself after drinking several cans of Four Loko over a number of hours.

So, did the beverage cause the death or did the diet pill? Did the person shoot themselves because they were suicidal or depressed or was there something about this particular beverage that was dangerous. Based on the information at hand - there's no evidence to support that. What we can say is that neither person would have been able to purchase the alcoholic beverage because they are under 21. That means that someone was able to purchase the beverages and the store that sold those beverages did not check for ID or were given fake ID.

Moreover, binge drinking remains a problem on college campuses around the country because of a widespread and pervasive issue with alcoholic consumption in the nation that goes back to the temperance movement days. Rather than preaching moderation from an early age, we get a ban that can be easily circumvented so that people who do want to drink underage do so in a culture that doesn't respect moderation. It leads to excess and binge drinking and sends people to the hospital.

FDA Proposing Salt Limitations on Prepared Foods; Ignoring The 800 Pound Gorilla In the Room

The FDA is preparing to insert itself in to the great salt intake debate. The FDA wants to regulate the amount of sodium in prepared foods, claiming that it will reduce the levels of salt in prepared foods gradually over time because of its effect on public health.

The Food and Drug Administration is planning an unprecedented effort to gradually reduce the salt consumed each day by Americans, saying that less sodium in everything from soup to nuts would prevent thousands of deaths from hypertension and heart disease. The initiative, to be launched this year, would eventually lead to the first legal limits on the amount of salt allowed in food products.

The government intends to work with the food industry and health experts to reduce sodium gradually over a period of years to adjust the American palate to a less salty diet, according to FDA sources, who spoke on condition of anonymity because the initiative had not been formally announced.

Officials have not determined the salt limits. In a complicated undertaking, the FDA would analyze the salt in spaghetti sauces, breads and thousands of other products that make up the $600 billion food and beverage market, sources said. Working with food manufacturers, the government would set limits for salt in these categories, designed to gradually ratchet down sodium consumption. The changes would be calibrated so that consumers barely notice the modification.

Meanwhile, a group of retired military personnel warn of an ongoing obesity epidemic in the country that threatens national security because the pool of people who are medically and physically fit to serve in the US Armed Forces is being reduced because too many people are incapable of handling the physical rigors of doing their service.

This points to the real nexus of the obesity epidemic and public health that the nanny staters ignore.

It isn't the food that most people eat or the beverages they consume.

It is the sedentary lifestyle, where people act like sediment and exercise nothing more than a fickle finger on their remote control.

Exercise is the key to public health, but you can't tax that. You can't regulate and demand exercise, but you can tax sugared and carbonated beverages and you can tax and regulate salt intake.

So, even with all the food and beverage choices that people have, they still choose the easiest options, and they'll choose not to exercise (just as they haven't done for years on end). As the nation moved into a service-based economy, the physical demands for work have declined and that means that people are simply not exercising as they once did. The problems are prevalent in public schools as well, despite designing meals that are supposed to give the necessary daily allowances for calories, vitamins and minerals.

FDA Sets Melamine Levels For Baby Formula

Days after claiming that they were unable to do so, the FDA has announced that they've set levels for melamine.

Food and Drug Administration officials on Friday set a threshold of 1 part per million of melamine in formula, provided a related chemical is not present. They insisted the formulas are safe.

The development comes days after The Associated Press reported that FDA tests found traces of melamine in the infant formula of one major U.S. manufacturer and cyanuric acid, a chemical relative, in the formula of a second major maker. The contaminated samples, which both measured at levels below the new standard, were analyzed several weeks ago.

The FDA had said in early October it was unable to set a safety contamination level for melamine in infant formula.

Dr. Stephen Sundlof, the FDA's director of food safety, said Friday the agency was confident in the 1 part per million level for either of the chemicals alone, even though there have been no new scientific studies since October that would give regulators more safety data. He had no ready explanation for why the level was not set earlier.

The standard is the same as the one public health officials have set in Canada and China, but is 20 times higher than the most stringent level in Taiwan.

It's a chemical that mimics protein and can be toxic and fatal to children in sufficient dosages; it's the chemical responsible for injuring thousands of Chinese children after Chinese manufacturers spiked baby formula and milk products with melamine to increase the protein counts for tests.

What's curious about the level set by the FDA is how it was seemingly set in such an arbitrary manner. It's as though the FDA chose to show action merely by positing a level, and that they'll eventually get around to figuring out what is a reasonable level after additional tests. I'd be interested in knowing how Taiwan set its level, which also could be an arbitrary response to how China flooded the market with melamine-tainted products.

The FDA mandated-level is well below the level of melamine found in the tainted Chinese products.

It doesn't inspire confidence either that the FDA admitted errors in its testing:

After saying it made an error in its data, the FDA on Wednesday produced these results: Nestle's Good Start Supreme Infant Formula with Iron had two positive tests for melamine on one sample; Mead Johnson's Infant Formula Powder, Enfamil LIPIL with Iron had three positive tests on one sample for cyanuric acid.

Separately, a third major formula maker, Abbott Laboratories, told the AP that in-house tests had detected trace levels of melamine in its infant formula.

Also, what exactly is considered a trace level? That's left unstated by the reports.

FDA Finds Traces of Melamine in US Infant Formula

The FDA says that these are just trace amounts and that they do not rise to the level of a need for recall. Yet, there's something here that has me wondering about how the melamime entered the manufacturing process and why it was considered acceptable.

The Food and Drug Administration said last month it was unable to identify any melamine exposure level as safe for infants, but a top official said it would be a "dangerous overreaction" for parents to stop feeding infant formula to babies who depend on it.

"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."

Melamine is the 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.

Previously undisclosed tests, obtained by The Associated Press under the Freedom of Information Act, show that the FDA has detected melamine in a sample of one popular formula and the presence of cyanuric acid, a chemical relative of melamine, in the formula of a second manufacturer.

Separately, a third major formula maker told AP that in-house tests had detected trace levels of melamine in its infant formula.

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

The FDA and other experts said the melamine contamination in U.S.-made formula had occurred during the manufacturing process, rather than intentionally.

The FDA and the manufacturers have a potential mess on their hands, and they need to deal with this judiciously, swiftly, and openly. In sufficient quantities, melamine can kill - toxicity is always in the dosage, and the FDA believes that the trace amounts found in the US infant formula don't pose a hazard.

This is the same chemical that injured thousands of Chinese infants and killed several Chinese children when melamine was purposefully added to baby formula to bolster the protein content. The chemical was also found in milk products and even chocolates that were sold outside China. The Chinese government for its part engaged in a coverup to avoid coverage of the story during the Beijing Olympics.

I think the FDA will need to revisit that position and clarify exactly whether any melamime is acceptable or set limits.

Spotlight on Salsa?

Scientists aren't quite sure what's caused the salmonella outbreak that has sickened nearly 1,000 people around the country. The FDA originally considered the culprit to be certain types of tomatoes, but now they think it may be foods involved in making salsa, including cilantro.

But the U.S. Food and Drug Administration appears no closer to finding the source of a mysterious salmonella outbreak that has sickened more than 900 people nationwide. It's not even certain that tomatoes are the cause.

And, as the FDA continues looking for the source of the salmonella, it is looking at jalapeno peppers and salsa ingredients, such as cilantro and Serrano peppers.

Investigators with the Centers for Disease Control and Prevention have interviewed people sickened in June to find out what they ate and to compare their diets with those of healthy relatives and neighbors.

Officials have not revealed early findings, except to say they supported the investigation's new move.

Among the possibilities FDA has said it was exploring is whether tomatoes and other produce are sharing a common packing or shipping site where both might become contaminated, or whether multiple foods might be tainted while being grown on adjoining farms or with common water sources.

Officials have said some patients have told the CDC they ate raw tomatoes in fresh salsa and guacamole.

As of Friday, 943 people infected with salmonella with the same genetic fingerprint have been identified in 40 states, the District of Columbia, and Canada, according to CDC. The illnesses are thought to have begun in early April. There have been 225 cases reported since June 1 - evidence that the source likely has not been contained.

The Tomato Crisis Hits the NYC Metro Area

It seems that the FDA is playing catchup once again, as the salmonella outbreak from tomato consumption has spread to the New York City metro area. No one quite knows the source of the contamination, so prudence is a wise course of action.

In addition to New York, cases were also reported in Florida, Georgia, Missouri, Tennessee and Vermont.

There are 228 illnesses reported to the government across those states. Officials learned of five dozen previously unreported cases on Thursday, and they said it is possible the food poisoning contributed to a cancer patient's death.

The Food and Drug Administration has not pinpointed the source of the outbreak. With the latest known illness striking on June 1, officials also are not sure if all the tainted tomatoes are off the market.

"As long as we are continuing to see new cases come on board, it is a concern that there are still contaminated tomatoes out there," said Dr. David Acheson, the agency's food safety chief.

Government officials have said all week they were close to cracking the case, but ``maybe we were being too optimistic,'' Acheson acknowledged.

How much longer? ``That's impossible to say.''

On the do-not-eat list are raw red plum, red Roma or red round tomatoes, unless they were grown in specific states or countries that the FDA has cleared because they were not harvesting when the outbreak began or were not selling their tomatoes in places where people got sick.

People who have compromised immune systems are especially at risk as the illness can be fatal as one person has died and several dozen others have been hospitalized.

The FDA is trying to track down the source of the particular strain of salmonella, but has had little luck so far.

A problem for consumers is identifying where a tomato is from. It is a hurdle and criticism the FDA is grappling with as it tries to find the source of the rare strain of the bacterium salmonella St. Paul.
"There are plenty of tomatoes on the market that are safe," Dr. David Acheson, the FDA's associate commissioner for foods, said in the conference call.
Consternation is mounting among tomato growers in Florida and Mexico, who are worried about lost sales. Both are large suppliers of tomatoes in the U.S.
While 19 Florida counties are safe to ship their tomatoes again, some top-producing counties, such as Collier and Dade, still are under investigation.

New Jersey tomatoes do not appear to be at risk at this time since they have yet to come to market.

FDA Issues Colgate Toothpaste Recall

Five-ounce tubes of toothpaste labeled Colgate and sold in discount stores in four states are being recalled because they may contain a poisonous chemical, according to the importer.

A Food and Drug Administration official, Doug Arbesfeld, confirmed that testing had found the chemical in a product with the Colgate label. But he said the agency is unsure if it is really Colgate or a counterfeit.

"We are aware that toothpaste is something that's been counterfeited in the past," he said. "We don't want to alarm people unnecessarily."

There was no immediate reply to an e-mail message left with a Colgate-Palmolive spokesman Wednesday evening.

MS USA Trading, Inc. of North Bergen, N.J., said the toothpaste may contain diethylene glycol, a chemical found in antifreeze.

The company said the toothpaste, imported from South Africa, was sold in discount stores in New Jersey, New York, Pennsylvania and Maryland.

The FDA can't quite tell whether the affected toothpaste is counterfeit or not. They're trying to track it down, along with how exactly the chemical entered the manufacturing process. While this incident appears to be involving imports from South Africa, similar concerns exist over imports from China that have been contaminated with the same chemical.

These items keep popping up in low-cost or dollar stores.

Yet More Pet Food Recalled

Menu Foods continues to add to the items already being recalled. The problem is that the recall now extends to products sold even earlier than first acknowledged.

A recall of pet food tainted with melamine, a chemical used to make plastic products, has been widened to include 22 types of dog biscuits, the Food and Drug Administration said yesterday.

The biscuits, made by Sunshine Mills Inc., contain wheat gluten imported from China that contained melamine, said Stephen F. Sundlof, director of the Center for Veterinary Medicine at the F.D.A.

Sunshine Mills, of Red Bay, Ala., manufactures branded and private label dry pet food and biscuits. The recalled biscuits include Nurture Chicken and Rice Biscuit, Ol’ Roy Peanut Butter Biscuit and Pet Life Large Biscuit.

Conrad Pitts, a lawyer for Sunshine Mills, said 80 percent of the tainted biscuits were sold by Wal-Mart, under the Ol’ Roy brand. Mr. Pitts said that the company had produced about 24 truckloads of biscuits with the contaminated gluten, and that the majority of the product was large biscuits. He said wheat gluten accounted for less than 1 percent of the total weight of the biscuits.

Until last week, when moist cat treats, dog jerky and a type of dry cat food were added to the recall, it had been limited to wet pet food sold under a variety of brand names.

Menu Foods, which last month recalled more than 90 brands of its “cuts and gravy” pet food, said yesterday that it had extended the period of time covered by its recall to include food made after Nov. 8, 2006. The company, based in Ontario, initially recalled only food made from Dec. 3, 2006, to March 6, 2007.

The ongoing and growing list of recalls means that you almost have to check back hourly or daily to see whether the recalls have affecting the pet food you may have bought. The FDA has compiled the list and provides additional information.

UPDATE:
The Chinese companies implicated in the tainted pet food are hemming and hawing over their role.

The Chinese agency that monitors food exports says China has never exported wheat or wheat gluten to the U.S.

The accused company, Xuzhou Anying Biologic Technology Development, at first said the U.S. was its main overseas customer for wheat gluten. But then the company said it had never shipped gluten directly to the U.S.

A company official was later quoted as saying it sold the suspect gluten to another Chinese food processor, and that company "probably" shipped it to the States.

This is the latest in a series of food scares in China in recent years.

Considering that the Chinese government has been notorious in its coverup of environmental disasters and poisonings, I would be reluctant to trust the Chinese government when it issues definitive statements denying a role in the pet food poisonings.