You are currently browsing the category archive for the ‘FDA’ category.
The AP reported yesterday that melamine or the related chemical cyanuric acid were found in infant formula sold by the three largest U.S. producers—Abbott Laboratories, Nestle, and Mead Johnson. Melamine and cyanuric acid killed pets in the U.S. last year and children in China recently. The affected animals and children suffered from kidney stones and kidney failure.
According to the AP report, the FDA and other experts claim that the chemicals’ presence in U.S.-manufactured infant formula is not related to the Chinese incident, but is a consequence of normal manufacturing processes:
Melamine is used in some U.S. plastic food packaging and can rub off onto what we eat; it’s also contained in a cleaning solution used on some food processing equipment and can leach into the products being prepared.
The AP filed a Freedom of Information Act request to get data on two of the companies from the FDA. Those companies and their products [note: see update with correction below] are:
- Mead Johnson’s Enfamil LIPIL with Iron, which contained 0.14 parts per million (ppm) melamine.
- Nestle’s Good Start Supreme Infant Formula with Iron, which contained 0.247 ppm cyanuric acid.
A spokesman for the third company, Abbott Laboratories, said that the company’s own tests detected melamine in some of its products at levels “far below the health limits set by all countries in the world, including Taiwan, where the limit is 0.05 parts per million.” Abbott, the maker of Similac, did not say in which of its products the melamine was detected.
Last month, in updating its “Interim Safety and Risk Assessment of Melamine and its Analogues in Food for Humans,” the FDA said that it “cannot establish a level of melamine and its analogues in these products [infant formula] that does not raise public health concerns.” (In contrast, the FDA’s safe level for these chemicals in all other food products besides infant formula is 2.5 ppm.) In other words, back on October 3, the FDA said that any amount of melamine or its related chemicals in infant formula was a problem.
Today, however, the FDA contradicted itself. Agency spokeswoman Judy Leon said that the FDA allows anything below 250 parts per billion [0.25 ppm] of melamine in infant formula, and that “there’s no cause for concern or no risk from these levels.”
But considering that the incidence of kidney stones in U.S. children is skyrocketing and no one knows why, we here at What on Earth Are We Eating can’t help but be concerned.
Updated Thursday, 11/27/08: According to a new AP report, the spreadsheet with test results that the FDA provided on Tuesday contained an error. On Wednesday, FDA spokeswoman Judy Leon said that the FDA had incorrectly switched the names of the Mead Johnson and Nestle products on the spreadsheet. Thus Nestle’s Good Start had the melamine while Mead Johnson’s Enfamil had the cyanuric acid. The corrected data:
- 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.
Update II, Friday, 11/28/08: The FDA sets a new “safe” level for melamine and cyanuric acid in infant formula of 1 ppm. This contradicts both FDA spokeswoman Judy Leon’s statement the previous day that the safe level was 0.25 ppm and the FDA’s October 3 statement that there is no safe level of these substances in infant formula. Since the only thing that has changed since October 3 is that melamine and cyanuric acid were found in U.S. infant formula at levels below 1 ppm, it’s obvious that these new standards (both the 0.25 ppm level mentioned on November 27 and the 1 ppm level set on November 28) were not based on adequate science. (In fact, in the FDA’s updated risk analysis, the only study referenced is a 13-week rat study.)
This is the FDA’s explanation for how the formula became contaminated:
Melamine is not naturally occurring and is not approved to be directly added to food in the United States. However, melamine is approved for use as part of certain food contact substances. Low levels of melamine are present in the environment and trace amounts may occur in certain food commodities as a result of approved uses.
But there’s another possible source of the melamine contamination: the milk used in the infant formula may have come from cows that ate animal feed containing melamine. We have previously reported on the presence of melamine in U.S. animal feed, and it has also been found in Chinese animal feed.
This week, the FDA halted the importation of all milk products from China until they are tested and proved free from melamine contamination. This action followed a string of recalls over the last couple of months:
- White Rabbit candy (September 26)
- Mr. Brown coffee mix (October 1)
- Blue Cat flavored beverages (October 3)
- YILI milk drinks (October 10)
- Koala’s March cookies (October 17)
- Fresh and Crispy Jacobina biscuits (October 29)
In 2007, melamine contamination of pet food ingredients imported from China was responsible for the deaths of cats and dogs throughout the U.S. The affected animals developed kidney stones and eventually kidney failure.
The problem resurfaced this year when thousands of Chinese babies became ill and at least four died after drinking infant formula made from milk adulterated with melamine. Just like the American pets, these children suffered from kidney stones and kidney failure.
According to news reports, many Chinese milk producers have been boosting their profits by diluting their milk with water and then adding melamine to give the illusion of a normal protein count. Recalls of products containing Chinese milk products have occurred worldwide, from Cadbury chocolate sold in Asia and Australia to chocolate coins in Canada. Two weeks ago, melamine was found in Chinese eggs and animal feed, raising the possibility that many more foods are contaminated.
The FDA claims that no illnesses linked to melamine in Chinese food products have been reported in the United States. But is it just a coincidence that doctors in the U.S. are seeing a steep rise in the incidence of kidney stones in children, some as young as 5 or 6?
“The older doctors would say in the ’70s and ’80s, they’d see a kid with a stone once every few months,” said Dr. Caleb P. Nelson, a urology instructor at Harvard Medical School who is co-director of the new kidney stone center at Children’s Hospital Boston. “Now we see kids once a week or less.”
According to that NY Times article, the increase has been attributed to high salt intake and not enough liquids. But have American kids really increased their salt consumption that dramatically in the last two or three decades? I remember loving Fritos way back in the ’60s. We here at What on Earth are We Eating are skeptical.
In early February of this year, the FDA began setting into motion a “field reorganization plan” that proposed to shut down five regional offices, four out of 20 district offices, and seven of the 13 labs it currently has in the U.S. This “reorganization”–which the FDA claimed was necessary in order to increase efficiency and save money on space–would have meant that 200 microbiologists, chemists, and engineers, all of them dedicated to ensuring the safety of America’s food supply, would lose their jobs.
But then in March, America’s pets began dying.
The ensuing uproar revealed the FDA’s woefully inadequate ability to protect us from an ever-increasing flood of toxic food imports, and eventually led to Congressional hearings. One of those hearings, held on July 17, was devoted to the FDA’s planned “reorganization.” You may not want to sit through the whole 5 hour and 40 minute hearing, so we did it for you. Here are a few highlights from the testimony:
1:03 – David Nelson, an investigator for the House Committee, reports that he visited the FDA’s San Francisco office and found that
“it is physically impossible for that office to perform more than a cursory review of most imports. The San Francisco office has four entry reviewers to oversee 4000 entry lines per day. A typical reviewer’s day involves examining 600 food entries, 300 medical device entries, 25 reagent entries, and 25 drug entries on a computer screen. That’s about one entry every 30 seconds. That’s the time they have to decide whether or not they even recommend sending an inspector out to physically look at the goods or to take a sample.”
1:49 – Mr. Nelson reports on a method that companies exporting fish to the U.S. use to evade import alerts. An exporter of large fish like tuna and swordfish will submit five consecutive tests, done by private, unaudited, uninspected, and uncertified labs, of samples taken from very young fish that haven’t yet accumulated dangerous levels of mercury and other heavy metals. Once those results have been submitted, FDA rules allow that exporter to be removed from the import alert, after which it is free to resume shipping its contaminated large fish.
1:51 – Investigator Kevin Barstow elaborates, “One FDA employee told me that with the private labs, the bottom line is money. I spoke with the owner of a private lab who says that he can point out numerous private labs that will guarantee you good test results.”
3:34 – Dr. Richard Jacobs, a chemist at the FDA’s slated-to-be-closed San Francisco lab, reports that his lab was instrumental in the analysis of melamine and its byproducts during the recent pet food scandal.
3:50 – A congressman asks seven members of a panel, five of whom are FDA employees working in facilities that are slated to be closed, to grade the FDA’s performance, on a scale of 1 to 10, in “protecting the American people and guaranteeing food safety.” The two non-FDA employees on the panel, one a scientist at Center for Science in the Public Interest, and the other a former FDA commissioner, give the FDA an abysmal score of “1”, while the FDA employees are not quite as harsh, rating their agency’s effectiveness from “2” to “5.” [Incidentally, the next day one of their bosses objected to their testimony in a department-wide email. Some of them took it as intimidation, and complained.]
Nine days after this hearing, the FDA temporarily suspended its field reorganization plan. The following day, July 27, the House of Representatives passed a version of the Farm Bill that includes a provision that would bar the use of funds for closing or consolidating FDA field laboratories, district offices or district office inspection or compliance functions. The Senate has yet to take up the Farm Bill, and President Bush has threatened to veto it, but for now, the Democratic Congress has saved the day.
We admit it. Neither one of us had ever heard the term “locavore” before we read Barbara Kingsolver’s new book a couple of months ago (Animal, Vegetable, Miracle— great for reading out loud, if you’re so inclined). But given Eric’s organic gardening ways and my preferences for fresh and unadulturated foods, it’s an approach to eating that appeals to us: cut down on the amount of fossil fuels being burned to transport foods across long distances; know where your food is coming from; support local farmers. We like it. Barbara, you’ve made converts of us!
Meanwhile, like everyone else, we’ve been tempted in our blog entries by the joys of alliteration (who can resist the Chinese Chickens?) as well as the colorful, gross-out images that have been coming to us in media accounts of food safety practices in China and elsewhere abroad. But recently we’ve noticed a rather disturbing trend. Some discussions of the seemingly benevolent choice to “eat locally” have crossed over into something a little darker: there’s a familiar note of protectionism and fear present–and a bit of racism, too. Like the familiar rants about “sending our jobs overseas,” and “saving our jobs for Americans,” these threads suggest some folks want to close the U.S. borders and hide from the world.
The Bush Administration announced on Wednesday that it’s establishing a government panel to recommend policy steps for protecting the safety of food shipped into the U.S., and to improve inspection of those imports. And last night, the House Agriculture Committee voted to require, as part of the U.S. Farm Bill, that country of origin labels be placed on meats starting next year.
Well, we’ve all heard the stereotype that making policy is like making sausage…you probably don’t want to know what’s in there! So, for those of you who like stickers and labels, you may well get them. But the Associated Press notes that some compromises have been made along the way in order to get those Band-aids–er–stickers. Namely, the Committee agreed, ” to soften penalties and burdensome record-keeping requirements that had concerned many food retailers and meatpackers who opposed the law.”
Silly us. Karen and I shared some grilled shrimp and a bowl of beef pho at a little Asian café in our neighborhood last Sunday, and afterwards we didn’t feel so good. Now we know why…
Today the FDA announced that it has found “recurrent contamination from carcinogens and antibiotics” in several kinds of “farm-raised seafood” imported from China, including shrimp, catfish, eel, and a couple of mystery fish known only as “basa” and “dace.” But the FDA is not recalling anything, and is only requiring that exporters provide information that demonstrates that the exporters have implemented steps to ensure that their products do not contain these substances. Great. The substances, by the way, are the antibiotics nitrofuran, malachite green, gentian violet, and fluoroquinolone. The first three are carcinogenic, and the last is banned (in the U.S., not China) because its overuse could lead to antibiotic resistance in bacteria.
The NY Times explains that this is a big deal, because the U.S. imports an ever-increasing amount—currently 81%—of its seafood, and 21% of that comes from China. The Times writer helpfully adds that in the last two months for which data is available, the FDA rejected 117 shipments of Chinese seafood for containing “filth,” salmonella, pesticides, or veterinary drugs.
China may be concerned about the international reputation of its food and drug exports, but it’s certainly not worried about its reputation for ruthlessness. Two weeks ago, Zheng Xiaoyu, the man who had headed China’s FDA from its founding nine years ago until he was fired in 2005, was put on trial for dereliction of duty, accepting bribes from drug companies in exchange for production licenses, and for leading a “dissolute life.”
It wasn’t a long trial. Today, Zheng was sentenced to death.
Those communists don’t fool around.
It probably won’t be up for much longer, but for now you can read a statement by Zheng on the China-FDA website:
The State Food and Drug Administration of P. R. China, a government department directly under the central government, is in charge of comprehensive supervision on the safety management of food, health food and cosmetics and is the competent authority of drug regulation. As the commissioner, I will always work to make the food and drug administration of China towards law-based supervision, science & equity, honesty and upright & high efficiency, standardized behavior, to gradually establish a legal system in line with a socialist market economy and international practice and to work hard to fulfill the lofty and sacred duties.
Thousands of people in China are sickened or killed every year by phony or counterfeit drugs and tainted food, according to the NY Times’ David Barboza, but only today did the government announce that it is preparing to release its first regulation on nationwide food recalls. Zheng apparently had been fulfilling the lofty and sacred duties a little too gradually.
Update: Zheng was executed on July 10.
Last Monday, we pointed out that the Bush administration’s anti-regulatory policies, as implemented by its former “regulations czar” John D. Graham, have contributed to the rapidly escalating problem of unregulated food imports. In yesterday’s NY Times, Paul Krugman took us back a little further, placing the blame squarely on the shoulders of Milton Friedman—the Nobel Prize winning American economist who spent most of his career (1946-1977) at the University of Chicago.
Friedman, a believer in laissez-faire capitalism, saw economic freedom as a necessary precursor to political freedom. In his mind, the benefits of the free market always outweigh those of government intervention. His ideas helped shape the economic policies of modern conservatives from Nixon to Reagan and Thatcher, and on down the line to our current President. In his column yesterday, Krugman draws this link:
Friedman called for the abolition of both the food and the drug sides of the F.D.A. What would protect the public from dangerous or ineffective drugs? “It’s in the self-interest of pharmaceutical companies not to have these bad things,” he insisted in a 1999 interview. He would presumably have applied the same logic to food safety (as he did to airline safety): regardless of circumstances, you can always trust the private sector to police itself.
Obviously, Friedman was a smart guy. We haven’t read his books, and hell, maybe we should add them to the list of items to bring to the beach this summer! (Or maybe not.) But we must admit—we’re baffled. How could a man who was 26 years old when the 1938 Food, Drug, and Cosmetic Act was passed conclude that the free market cleans up its own messes?
Rick Weiss at the Washington Post had a great article yesterday on how the FDA has been overwhelmed by the flood of toxic food, drugs, and cosmetics coming into the U.S. from China. An excerpt:
Dried apples preserved with a cancer-causing chemical. Frozen catfish laden with banned antibiotics. Scallops and sardines coated with putrefying bacteria. Mushrooms laced with illegal pesticides. These were among the 107 food imports from China that the Food and Drug Administration detained at U.S. ports just last month, agency documents reveal, along with more than 1,000 shipments of tainted Chinese dietary supplements, toxic Chinese cosmetics and counterfeit Chinese medicines…
And they only inspect 1% of imported food shipments!
Maybe you’re a lover of barbecue. Maybe you’ve been wanting to fire up that charcoal pit, but you’ve been thinking to yourself, “Damn. That melamine-tainted pork! Is it safe?? Should I resign myself to eating marinated tofu this summer?” Well, you can rest easy!! The FDA announced yesterday that it is safe to eat pork from hogs who’ve been chowing down on melamine-adulterated pet food scraps. In fact, you can eat 799 POUNDS of that pork!! But—watch out for the 800th pound…they’re not making any promises for your safety on that one. As is the case so frequently when it comes to eating the things we love, moderation is key…
What on Earth Are We Eating? 