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Is Your Cereal Giving You a Vitamin Overdose?

Mother Jones

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Those bran flakes with “original antioxidants” or “extra vitamin A”? You might be better off without the added nutrients. A report released on Tuesday by the Environmental Working Group (EWG) found that cereals and snack bars that have been fortified with extra vitamins and minerals to appear healthy may actually be harmful—particularly for kids.

The report, How Much is Too Much?, explains that there are some nutrients that most Americans don’t get enough of, like calcium, vitamin D, and vitamin E. But it turns out that kids are eating too much of other nutrients, and overconsuming certain vitamins and minerals for a long period of time can have negative health implications in the long run.

EWG focused on three nutrients that are regularly consumed in excess: vitamin A, zinc, and niacin. Only six percent of 2- to 8- year olds are deficient in vitamin A, and less than one percent are deficient in zinc and niacin. But, according to the report, an estimated 28 million children between the ages of two and eight are overexposed to these nutrients from food and supplements.

Studies have shown a host of illnesses associated with excessive intake of these nutrients. Here are the effects of overconsumption, according to the EWG:

Vitamin A: Liver damage, brittle nails, hair loss, skeletal abnormalities, osteoporosis and hip fracture (in older adults), and developmental abnormalities (of the fetus)
Zinc: Impaired copper absorption, anemia, changes in red and white blood cells, impaired immune function
Niacin: Skin reactions (flushing, rash), nausea, liver toxicity

Renée Sharp, the EWG’s director of toxics research, explained that the associated health risks are “more chronic than acute”: If a child eats too much of a given nutrient over a long period of time, he or she might experience the associated illnesses down the line. The tricky part is that it’s nearly impossible to link a specific case of an illness to overconsumption of fortified food, so there isn’t a hard and fast set of rules on what to eat and what to avoid. But, according to the report, several studies have shown that “cumulative exposures from fortified food and supplements could put children at risk for potential adverse effects.” Put more simply by Sharp: “if your kid is eating highly fortified cereal, and that kid is also eating snack bars and other fortified foods and you’re giving your kid a vitamin pill, that adds up. And there’s no reason to put your kid at that risk.”

Part of the reason for childrens’ overconsumption of certain nutrients is marketing: If products are marketed as healthy, people are more likely to buy them. According to NYU nutrition professor Marion Nestle, “Plenty of research demonstrates that nutrients sell food products. Any health or health-like claim on a food product—vitamins added, no trans fats, organic—makes people believe that the product has fewer calories and is a health food…Added vitamins are about marketing, not health.”

Adding to the confusion among shoppers is nutrition labels. Young kids have significantly lower recommended daily intakes of nutrients than adults, but nutrition labels, even on brands marketed towards kids, almost always show the recommended values for adults. Furthermore, the EWG contends that the intake recommendations, which were calculated by the FDA in 1968, are themselves out of date: “Those values were set at a time when people were worried about nutrient deficiencies,” explained Sharp. “Scientists just hadn’t done as much research on the potential pitfalls of over-consuming nutrients. Things have changed.”

Zinc perfectly exemplifies this double whammy. The FDA currently recommends that adults consume 15 milligrams of zinc per day, and that children less than five years old consume 8 milligrams per day. But food packaging, which shows recommended intake levels calculated in ’60s, still says that adults should consume 20 milligrams per day. “If you think about it, every single food sitting in the grocery store has a nutrition fact panel right now that is largely irrelevant for young children,” says Valerie Tarasuk, a University of Toronto nutritional scientist.

In the years since the FDA calculated its recommended Daily Values, the Institute of Medicine (IOM), a branch of the National Academy of Sciences, have developed “Tolerable Upper Intake Levels” for these three nutrients (referenced in the graph above). Often, they’re considerably lower than the FDA’s recommended daily allowances. An FDA proposal to revise nutrition labels is currently open for public comment. Though the FDA proposed similar changes in 2003, the Daily Values for nutrients have remained consistent since the 1960s. An FDA spokesperson declined to comment for this article.

In EWG’s review of fortified foods, the top source of excessive intake of the three studied nutrients was cereal. Cereals made up 43 percent of all sources of preformed vitamin A, 52 percent of added niacin, and 97 percent of added zinc.

But not all cereals are fortified equally. The EWG’s analysis of the nutrition labels for 1,556 cereal brands found that 114 cereals were fortified with 30 percent or more of the FDA’s daily intake values (for adults) of Vitamin A, zinc, or niacin. The full list of those cereals is here, but here are a few brands you might recognize:

Cap’n Crunch’s Chocolatey Crunch
Food Lion Whole Grain 100 Cereal
General Mills Fiber One, Honey Clusters
General Mills Wheaties
General Mills Total Raisin Bran
Kashi U 7 Whole Grain Flakes & Granola with Black Currants & Walnuts
Kellogg’s Crispix Cereal
Kellogg’s Smart Start, Original Antioxidants
Kellogg’s Special K
Kroger Frosted Flakes of Corn
Malt-O-Meal Corn Bursts
Safeway Kitchens Bran Flakes
Stop & Shop/Giant Source 100 Crispy Whole Grain Wheat & Brown Rice Flakes
Trader Joe’s Bran Flakes

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Is Your Cereal Giving You a Vitamin Overdose?

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FDA tells livestock and dairy farmers: We’re cutting you off — no more beer!

FDA tells livestock and dairy farmers: We’re cutting you off — no more beer!

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The United States is about to have a slew of hungry and sober cows on our hands, which, for the record, is not a good combination for any mammal.

The FDA’s proposed Food Safety Modernization Act guidelines would prohibit breweries from sharing their fermented grains (yum!) with livestock farmers. Farmers have long been using this boozy mash as free feed for their cows, and this relationship has provided an efficient way for both the beer industry to repurpose its waste, and for cows, like so many humans, to possibly enjoy a little buzz with their carb intake.

From Politico:

“This is a practice that’s been going on for centuries without any incident or risk to human health,” said Chris Thorne, vice president of communications for the Beer Institute. Thorne said his association is “cautiously optimistic” that the FDA will address the issue and said several lawmakers have been receptive to its concerns.

Politico reports that 13 senators have moved to block this stipulation of the proposed regulations. Sen. Mark Udall (D-Colo.), for example, wrote an open letter to FDA Commissioner Margaret Hamburg to make his case for preserving the brewer-farmer relationship:

Regardless of the size of the brewer – whether the operation is small, medium or large the Colorado experience has been that this industry embraces community and prioritizes sustainable practices. Partnership between brewers and farmers is longstanding and it allows for an environmentally responsible way to dispense with an otherwise useless byproduct.

Udall also argues that decades worth of USDA data on spent brewers’ grains used as livestock feed includes no evidence of compromised food safety. On the citizen front, a petition to change the rules popped up on the White House website.

So what’s the effect on the farms? We learned about the situation of Krainick Dairy in Enumclaw, Wash., from Kendall Jones at Washington Beer Blog. For those curious as to how many pounds of spent grain one farm can use, Krainick Dairy collects between 3 and 4 million pounds of it from 11 breweries and four distilleries in the Puget Sound region, and uses it to feed 1,000 cows. This includes trub and yeast used in the fermentation process.

And how much spent grain would have to be thrown away if these regulations were instated? Seattle’s Georgetown Brewing Company told us that they can produce 200,000 pounds of it in one month, all in service of brewing 20,000 gallons of tasty beer. The Colorado-based Brewers Association issued a statement detailing the additional costs of waste management that breweries across the country would face if the proposed regulations go through:

The proposed FDA rules on animal feed could lead to significantly increased costs and disruption in the handling of spent grain. Brewers of all sizes must either adhere to new processes, testing requirements, recordkeeping and other regulatory requirements or send their spent grain to landfills, wasting a reliable food source for farm animals and triggering a significant economic and environmental cost.

We spoke with Mike Krainick, the owner of Krainick Dairy, about the proposed FDA legislation. He told us that the legislation has significant potential to harm his business.

“It could have a dramatic effect on our livelihood. We’ve spent a lot on trailers and infrastructure and support networks on our farm for all of this, and you don’t pay for that overnight — it’s an investment. I count on the breweries as much as they count on me.”

Let’s review: You have beer and cheese, two wonderful things without which life would be a much more depressing prospect. Their respective methods of production symbiotically support each other. That is a truly beautiful thing – almost as beautiful as beer cheese itself, which is the highest of high praise.

Eve Andrews is a Grist fellow and new Seattle transplant via the mean streets of Chicago, Poughkeepsie, and Pittsburgh, respectively and in order of meanness. Follow her on Twitter.Find this article interesting? Donate now to support our work.Read more: Business & Technology

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FDA tells livestock and dairy farmers: We’re cutting you off — no more beer!

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You Own Your DNA, But Who Gets to Interpret It?

Mother Jones

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Yesterday the FDA ordered 23andMe to immediately stop selling its DNA testing service until and unless it gets agency approval. This is the end game of a very long cycle: regulatory reviews of genetic testing have been going on, in one form or another, for more than 15 years, and along the way there have been repeated bipartisan calls for more rigorous rules to ensure that consumers get accurate and judicious information. In 2010, for example, the GAO conducted an undercover investigation of four genetic testing companies and concluded that “GAO’s fictitious consumers received test results that are misleading and of little or no practical use.”

Nonetheless, the FDA’s action yesterday produced a flurry of criticism, especially from the libertarian right. Alex Tabarrok is typical:

The FDA wants to judge not the analytic validity of the tests … but the clinical validity, whether particular identified alleles are causal for conditions or disease. The latter requirement is the death-knell for the products because of the expense and time it takes to prove specific genes are causal for diseases….Here is why I think the FDA’s actions are unconstitutional. Reading an individual’s code is safe and effective. Interpreting the code and communicating opinions about it may or may not be safe—just like all communication—but it falls squarely under the First Amendment.

I’m pretty sure this is nowhere near so cut and dried. The relevant distinction here is between medical information and medical advice: the former is protected speech while the latter isn’t. And while your genome may be medical information, interpreting your genome and explaining whether it puts you at risk for different diseases is very close to medical advice. And not just general medical advice, of the kind that Dr. Oz purveys on television. It’s specific, personal medical advice, of the kind that only licensed physicians are allowed to provide.

That’s the argument, anyway. If 23andMe is going to perform a lab test and then send you a personal letter suggesting that you, personally, are or aren’t at high risk for some disease, it’s acting an awful lot like a doctor. But for better or worse, only doctors are allowed to act like doctors, and the FDA thinks that complex and sometimes ambiguous test results should be communicated to patients by licensed MDs who know what they mean.

It turns out there’s more to this particular case, of course: the FDA’s letter makes it pretty clear that they’re fed up with 23andMe, which has apparently been almost arrogantly unresponsive to standard requests for documentation:

As part of our interactions with you, including more than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications, we provided you with specific feedback on study protocols and clinical and analytical validation requirements, discussed potential classifications and regulatory pathways (including reasonable submission timelines), provided statistical advice, and discussed potential risk mitigation strategies.

….However, even after these many interactions with 23andMe, we still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses….Months after you submitted your 510(k)s and more than 5 years after you began marketing, you still had not completed some of the studies and had not even started other studies….FDA has not received any communication from 23andMe since May. Instead, we have become aware that you have initiated new marketing campaigns, including television commercials that, together with an increasing list of indications, show that you plan to expand the PGS’s uses and consumer base without obtaining marketing authorization from FDA.

Ouch. By happenstance, this brought to mind a Felix Salmon post from yesterday. It was about GoldieBlox, another high-flying Silicon Valley startup that apparently believes federal laws apply only to ordinary mortals—not to rebelliously innovative and disruptive companies that are going to change the very way we interact with the world. Salmon describes the “Silicon Valley way” like this: “First you make your own rules — and then, if anybody tries to slap you down, you don’t apologize, you fight.”

This sure sounds an awful lot like 23andMe. I’m actually sort of agnostic about the issue of whether personal genome services should fall into the category of highly regulated diagnostic tests. The line between information and advice is genuinely gray here. But regardless of that, this isn’t something that suddenly popped up out of nowhere. It’s been on the FDA’s radar for a long time, and 23andMe was well aware of the FDA’s requirements. They sure look an awful lot like a Silicon Valley company that figured they could stall them forever and never pay a price.

Source – 

You Own Your DNA, But Who Gets to Interpret It?

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FDA Reviewing Evidence That Morning-After Pill Doesn’t Work in Women Weighing Over 176 Pounds

Mother Jones

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Monday morning, Mother Jones reported that the European manufacturer of an emergency contraceptive pill identical to Plan B, also known as the morning-after pill, will warn women that the drug is completely ineffective in women weighing more than 176 pounds, and begins to lose effectiveness in women weighing more than 165 pounds. HRA Pharma, which makes the European drug, Norlevo, asked European regulators for permission to change the drug’s labeling after reviewing its own clinical data and scientific research from 2011 which showed emergency contraceptives are prone to fail in women with higher body mass indexes.

Now the Food and Drug Administration has responded to this story, telling Mother Jones that FDA officials are weighing whether pharmaceutical companies that sell similar emergency contraceptive pills in the US must change their labeling. Many popular morning-after pills sold in the US—including one-pill emergency contraceptives Plan B One-Step, Next Choice One Dose, and My Way, as well as a number of generic two-pill emergency contraceptives—are chemically identical to Norlevo, which also uses the chemical compound levonorgestrel to prevent pregnancy after sex.

“The FDA is currently reviewing the available and related scientific information on this issue, including the publication upon which the Norlevo labeling change was based,” FDA spokeswoman Erica Jefferson writes in an email. “The agency will then determine what, if any, labeling changes to approved emergency contraceptives are warranted.”

Jefferson declined to say when the FDA began its review. If FDA officials feel they have sufficient data to justify a change to product information, the FDA can order companies to update their labels. Jefferson adds that US drug companies have a legal obligation to alert the FDA if new information makes their existing labeling inaccurate.

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FDA Reviewing Evidence That Morning-After Pill Doesn’t Work in Women Weighing Over 176 Pounds

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Were Your Dental Crowns, Retainers, and Dentures Made in Someone’s Dirty Cellar?

Mother Jones

Earlier this month, the ABC News affiliate in Columbus, Ohio, aired a strange story: Police in Springfield had received a call-in report that a man was standing on a street corner and “shooting a gun off all day.” After a five-hour standoff, they arrested the man and searched his house. They found guns, knives, swords, and in the basement, hot plates, pots and pans, and boxes of teeth. Perplexed, they investigated further and discovered that the man’s brother had been running a dental lab out of the home for about a year, supplying devices such as dentures to local dentists’ offices. The photos of the basement lab are sickening: paint peeling off the walls, dust everywhere, lots of clutter. Not exactly the kind of pristine environment you’d imagine for the manufacture of something that goes in your mouth.

Amazingly, the scuzzy basement lab was completely legal. In fact, I, Kiera Butler, could go home tonight and start making dentures in my basement and selling them to dentists. Ohio is one of many states where dental labs and their employees—who produce crowns, night guards, dentures, and your kids’ braces and retainers—don’t have to be trained, licensed, or certified in any way. Heck, they don’t even have to register with the state health department. While Ohio at least asks dental labs to disclose to clients what their products are made of and where they come from, most states have no such requirement. (You can check out the rules for individual states here.)

Is your dentist even aware of this? Perhaps not. In a 2008 survey by the American Dental Association, fewer than half of dentists knew whether their state regulates these labs, and 86 percent couldn’t say whether the federal government does. As it turns out, the manufacturers of many common dental devices are actually exempt from federal rules that medical-device makers have to follow. The FDA “handles questions associated with these dental-device exemptions on a case-by-case basis,” explains David Gartner, who heads the regulatory policy division of the agency’s Center for Devices and Radiological Health.

The National Association of Dental Labs (NADL) estimates that Americans spend around $7 billion on dental devices annually, and that there are some 10,000 dental labs in the United States. But the FDA has inspected only 146 of them during the last decade. Because most don’t have to register, state and federal authorities have no real record of their existence.

Domestic dental labs get a good portion of their materials (about 38 percent, the NADL estimates) from thousands of overseas labs, which are supposed to register with the FDA. But the agency has inspected only 113 of those labs in the last decade—even after lead was found in some imported Chinese crowns in 2008.

So are these unregulated devices creating problems for patients? Hard to say, says Eric Thorn, the NADL’s chief staff executive. “In the vast majority of these occurrences the patient would report it to their dentist and their dentist would address the issue,” he says. Dentists are not requires to file official reports of most problems with appliances.

The ABC reporters asked the Springfield man whether he had any training as a dental lab technician, and it turned out he did: He got certified in prison—which actually makes him more qualified than the law requires.

Both NADL and the American Dental Association are urging states to require dental labs to register. That way, at least authorities will be able to track them. “It’s really important that these devices get made in clean, hygienic labs, and that states require those labs to be registered,” says Bennett Napier, NADL’s executive director. “Otherwise, patients have no way of knowing their devices are made under acceptable conditions.”

Here are a few more pictures that the Springfield, Ohio, police took of the basement dental lab:

Police Department of Springfield, Ohio

Police Department of Springfield, Ohio

Police Department of Springfield, Ohio

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Were Your Dental Crowns, Retainers, and Dentures Made in Someone’s Dirty Cellar?

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New food safety rules are not making us feel all that nauseated

New food safety rules are not making us feel all that nauseated

A bout of food poisoning is a memorable and vomitous experience. According to the Centers for Disease Control and Prevention, about 48 million Americans each year are sickened by bad food and 3,000 of them die. In the case of food-borne illness outbreaks, like the one we saw this fall in peanuts, it can take weeks and even months to track down the culprit. We’d love for causes to be clear, but of course it’s not that easy.

NIAID

Please stay out of my peanut butter, salmonella.

The Columbia Journalism Review has a long feature on why it’s so hard for scientists and reporters to identify the sources of food-borne illnessess.

The epidemiology of foodborne disease is complicated; there are numerous barriers to definitively linking sick people in multiple states to the same pathogen and a common food product. One of the biggest hurdles is that foodborne illnesses are severely underreported. For every case of Salmonella that is reported, the CDC estimates that some 29 are not. …

Detecting and solving foodborne-illness outbreaks relies heavily on the capacity and expertise of state and local health departments, which have been hit hard by budget cuts and are often tracking multiple outbreaks or small clusters of disease at once. …

Even when dealing with confirmed illnesses, it’s difficult to definitively link them to a food product. Health officials use food-history questionnaires to help identify foods that sick people have in common, but it’s not easy to recall what you had for lunch three days ago, down to the ingredient. Cracking the cases can take some time.

It’s not just our bad food memories at play here, of course — industrial farming practices have done wonders to mix our spinach with our pig feces.

But now the Food and Drug Administration is proposing big, new food-safety rules, especially in some key farming states where our food has gotten pretty gross in recent years. The Los Angeles Times reports that the new rules are aimed at transforming the FDA “into an agency that prevents contamination, not one that merely investigates outbreaks”:

The rules, drafted with an eye toward strict standards in California and some other states, enable the implementation of the landmark Food Safety Modernization Act that President Obama signed two years ago in response to a string of deadly outbreaks of illness from contaminated spinach, eggs, peanut butter and imported produce.

The first proposed rule would require domestic and overseas producers of food sold in the U.S. to craft a plan to prevent and deal with contamination of their products. The plans would be open to federal audits. The second rule would address contamination of fruit and vegetables during harvesting. …

The third rule, which has yet to be issued, would establish how food importers would verify that the products they bring in meet U.S. standards. …

The FDA said developing the complex new rules took time as it consulted “consumers, government, industry, researchers and many others,” and “studied, among many other sources, the California leafy greens marketing agreement.” Additional rules will “follow soon,” the agency said.

USA Today reports that “[f]ood safety advocates and the food industry, who have been waiting for the rules with mounting frustration, are thrilled.”

But the frustrated waiting isn’t over yet: There will be a four-month period for public comment before the rules are finalized, and then at least 26 months before farms have to comply. That sounds like a glass of ginger ale for a food industry sick with E. coli.

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New food safety rules are not making us feel all that nauseated

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