Posts tagged FDA
The Shutdown: Our Food Safety, Health and Welfare at Stake

AmericaHP While Congress battles it out over health care reform, the resulting government shutdown will have far-reaching impacts on food safety, environmental protections, food production and farming. It also has serious implications for the health and nutrition of many Americans. Depending on the duration of the shut down, it could be nothing less than catastrophic for a great number of people.

For those same Americans to whom the Republicans are so opposed to providing adequate health care, the shutdown will also affect their already limited ability to access healthy foods, further harming their health. This will be especially true for those most in need -- namely the nine million pregnant women and new mothers who rely on the Women, Infants, and Children program (WIC).

The U.S. Department of Agriculture (USDA) says that states will be able to fund WIC for a week and beyond that additional funds may be available through October, however, the USDA warns that state agencies "may still face funding shortfalls associated with FY 2014 obligations during the shutdown."

WIC is a critically important program that provides healthier food options for pregnant women and new mothers who are poor, have medical problems, or are considered to be at "nutrition risk." WIC also provides important health referrals to the nine million people who currently rely on the program. And when considering the negative long-term effects that poor nutrition has in utero and in young children, the true costs of cutting funding for WIC have not been accounted for.

Which brings us back to health care. Many politicians fail to see that the state of the economy depends in large part on the state of health among all Americans. American health is on a downward trend and by cutting crucial food funding for the poor, especially pregnant women and new mothers, we will only exacerbate this trend.

The shut down also means that the USDA's communications offices are now closed. So, if important information about food safety comes to light, we probably won't know.

USDA databases that provide import market information for farmers will also be closed. Modern Farmer reports that, "Markets rely on reports from the USDA to set the price of soy, wheat, corn, beef, etc. Without an October report traders would be adjusting prices in the dark and farmers would be selling without knowing the real value of their crops."

Small family farmers will also be affected since many are dependent on loans from the USDA and delays on loans will likely cost many their farms -- as many as 1,400 small farmers are likely to lose their farms as a result of the shutdown, according to Rural Foundation Advancement International.

Other agency shutdowns that will affect our food system include:

  • The Environmental Protection Agency (EPA), which is essentially completely shut down except for current work on Superfund sites. This means the EPA will stop monitoring air pollution and pesticide use.
  • The Food and Drug Administration (FDA), which will eliminate much of its food-safety checks, including "routine establishment inspections...monitoring of imports, notification programs (e.g., food contact substances, infant formula), and the majority of the laboratory research necessary to inform public health decision-making."
  • The National Institutes of Health (NIH), which has stopped taking new patients for clinical research and its hotline for medical questions is closed.
  • The Centers for Disease Control (CDC), which has stopped its flu program and says that it will have a "significantly reduced capacity to respond to outbreak investigations." The CDC has also stopped providing "support to state and local partners for infectious disease surveillance."

And while the USDA will continue to inspect meat, dairy, eggs and food imports with 87 percent of its employees still working, the agency has also said that if a violation is indeed found it may not have the resources to fully investigate. The USDA plan also warns that, "A lengthy hiatus would affect the safety of human life and have serious adverse effects on the industry, the consumer and the Agency."

The FDA, which is responsible for inspecting the majority of the food industry, will not be functioning in this capacity during the shutdown. Typically, the FDA inspects 80 food facilities a day and files reports on those in violation of health codes. This means an end to important investigations and reports, like the one that brought a peanut facility to a close last year after a salmonella outbreak.

It's beginning to look like what Republicans have wanted all along: To eliminate social programs to help the poor and scale back on regulations particularly when it comes to the environment and our food supply. But what kind of country would that look like? Currently four out of five Americans live in danger of falling into poverty and are struggling with joblessness.

These Americans are reliant on social programs like WIC or food stamps (which will continue to be funded at least through October) and without this help many will be forced to decide between medications, rent, or food.

Every American would be best served by understanding that the health of Americans comes first and defunding social programs, regulatory agencies, and independent research will only further undermine America's deteriorating health, which in the end, will cost us a lot more than a failing economy.

 

FDA: Working Hard to Protect Industry
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The U.S. Food & Drug Administration (FDA) made two moves in recent days that seemingly address consumer concerns on some hot button issues. First, it banned the use of bisphenol A (BPA) based epoxy resins in coatings for baby formula packaging. Second, it proposed a limit on how much arsenic is allowed in apple juice. Looking more closely at these decisions, however, it seems that FDA is really more interested in appeasing industry, than doing its duty to protect the public.

So what action is the FDA really taking? Due to intense consumer demand, manufacturers of infant formula packaging have already stopped using BPA. And, based on the new standard for arsenic levels, 95 percent of companies that make apple juice are already in compliance.

The FDA’s BPA ban is actually an abandonment petition coming from industry stating that it is now illegal to use BPA for those specific products—but it does not say anything about the safety of BPA.

“It is a ban but it’s a ban that was initiated by the industry,” Dr. Michael Hansen, a senior scientist at Consumer’s Union, said in a recent telephone interview. “They have not taken action on the safety of BPA even though they have been pressured to. But when industry comes in and says, ‘This is no longer being sold,’ that’s an easy out for them because if industry didn’t agree and FDA tried to ban it or take action, maybe the industry would go after them.”

The FDA made a similar move last year when it banned BPA from baby bottles and sippy cups when nearly all U.S. manufacturers had already stopped using BPA for those products. The move was mainly said to be about “boosting consumer’s confidence.”

Both the FDA and the American Chemistry Council, an industry trade group, have said that the BPA ban is in response to marketplace demands, not due to safety concerns regarding the ubiquitous substance.

And there are an abundance of safety concerns regarding BPA as well as increased public awareness about the potential dangers of BPA. The American Chemistry Council has repeatedly dismissed the hundreds of peer-reviewed studies that link BPA to a wide range of health concerns including various types of cancer, impaired immune function, early onset of puberty, obesity, diabetes, and hyperactivity.

In addition, a recent study published this June in the journal Environmental Health Perspectives changes our understanding of how BPA is absorbed by the body. Researchers found that BPA is absorbed under the tongue and goes directly to the bloodstream, resulting in a much higher exposure to the chemical.

Of further concern is the fact that without clear government regulations, manufacturers can replace BPA with other chemicals that may be just as harmful. (I wrote about this in a previous article for Civil Eats).

“Anything that substitutes for BPA should have to go through a screen for hormonal activity,” Hansen said. “There is a report that looks at 16 different replacements for BPA and I would suspect all of these have the same hormonal activity.”

Hansen was more optimistic about the FDA’s new federal limits on arsenic in apple juice. The new regulation says that apple juice containing more than 10 parts per billion could be removed from the market and companies could face legal action. But the FDA stressed that most companies on the market are already below that threshold.

Much of the concern around apple juice stems from a Consumer Reports finding published last year in which researchers tested 28 different apple juices bought from stores in Connecticut, New Jersey and New York. Five samples of apple juice tested and four of grape juice had total arsenic levels exceeding the 10 parts per billion federal limit for bottled and drinking water, according to the report.

Consumer Reports also found high levels of lead in apple juice and grape juice as a result of insecticide use. The report also brought to light the fact that for the past decade, most concentrate has come from China (PDF) and concerns have been raised about the possible continuing use of arsenical pesticides there.

Hansen said the new limit is important because, for the first time, it puts a federal limit on the amount of arsenic in a juice product. But the limits don’t address the arsenic found in grape juice, nor the levels of lead in any juice products. “Yes, that is problematic,” Hansen said. “It’s good that they’ve done it for apple juice but they should be doing it in other juices as well. We found [arsenic] in grape juice and FDA’s own data has found it can show up in pear juice as well.”

While inorganic and organic arsenic are both found in these juices, it was originally thought that inorganic arsenic was of greatest concern, since it is a known carcinogen. According to the FDA, inorganic arsenic has also been associated with skin lesions, developmental effects, cardiovascular disease, neurotoxicity and diabetes.

Organic arsenic was once thought to pass through the body more quickly and not cause harm. However, the FDA now states that organic arsenic may cause harm as well. “Some organic forms can be even more toxic than the inorganic,” Hansen explained.

The arsenic found in apple juice is largely the result of years of arsenical insecticides being applied to apple orchards, Hansen said.  He added that the science on arsenic is evolving so that scientists now believe it is far more toxic than was previously thought.

Consumers Union, the advocacy arm of Consumer Reports, wanted a limit as low as three parts per billion, but the FDA is putting that limit at 10 parts per billion, a threshold that the vast majority of manufacturers already meet.

According to an Associated Press article, “All of the experts—including the government and the consumer advocates—agree that drinking small amounts of apple juice isn’t harmful. The concern involves the effects of drinking large amounts of juice over long periods of time.” But for the public, that language is vague—especially for an overburdened consumer scanning labels and reading ingredients for products on grocery store shelves.

Furthermore, a new study found that the combined effect of estrogen and arsenic significantly increases the risk of prostate cancer. BPA is one of the many endocrine disrupting chemicals in our food supply that has an estrogen-like effect in the body. Therefore, it is possible, that within that plastic bottle of apple juice is a potent concoction of chemicals that may lead to prostate and other forms of cancer.

Ultimately, the public is left with many questions regarding the safety of foods, beverages, and packaging—all of which the FDA is supposed to screen. According to the FDA’s Web site, its designated role is “protecting the public health by assuring the safety, effectiveness, quality…of most of our nation’s food supply…”

What will it take for the FDA to do its job and protect the American people? So far it seems that public and consumer pressure haven’t been enough. The FDA has yet to respond to the two million comments on the petition to stop the approval of genetically engineered salmon or the one million comments on labeling genetically modified foods.

As is the case with the latest BPA ban and proposed limits to arsenic in apple juice, the public is left with no clear answers and no real assurance that the agency has its best interest in mind.

Photo: baby drinking formula, by Shutterstock

This article also appeared on Civil Eats

BPA Free Baby Bottles Now Law, But We’re Not in the Clear

Recently, the U.S. Food and Drug Administration (FDA) announced a ban on the use of bisphenol A, or BPA, in baby bottles and children’s cups. BPA is an estrogen-mimicking chemical that has been used in hard plastics, the linings of cans, food packaging, and dental fillings, among other places, for years. We’ve reported about the dangers of BPA on Civil Eats here, here, and here. This move essentially made official a practice that many manufacturers of baby bottles and cups already follow in response to growing pressure from consumers.

Questions of safety remain when it comes to the use of any plastic products that come in contact with our foods. The FDA ban is raising concern and creating headlines about what manufacturers will substitute in place of the BPA. A 2011 study published in Environmental Health Perspectives found that all plastics contain estrogenic activity (EA) and in some cases, those labeled “BPA free” leached more chemicals with EA than did BPA-containing products. The study’s authors write, “Almost all commercially available plastic products we sampled—independent of the type of resin, product, or retail source—leached chemicals having reliably detectable EA, including those advertised as BPA free.”

EA interferes with our endocrine system, a complex signaling network that is made up of glands (the thyroid) as well as glandular tissue and cells within organs (testes, ovaries, pancreas, etc). Our endocrine systems use hormones that send signals to our various organs and tissues that work over minutes, hours, weeks, and years. The processes these hormones regulate include metabolism, growth and development, and sexual reproduction. As hormones travel in the blood to reach each body part, the specific molecular shape of each hormone fits like a key-in-a-lock into receptors on target tissues. Endocrine disrupting chemicals may interfere with, block, or mimic the action of our hormones. As a result, EA and endocrine disruptors have been linked in hundreds of studies to brain development problems, breast and prostate cancer, birth defects, learning and behavioral problems in children, early onset of puberty, and obesity.

Manufacturers are now flaunting their “BPA free” versions of products as though they are safe and free of toxins—but it turns out BPA is possibly just the tip of the iceberg. Bisphenol S, or BPS, is another chemical that manufacturers are using to replace BPA and it may be just as harmful. In a study this year in Environmental Science and Technology, researchers wrote, “As the evidence of the toxic effects of bisphenol A (BPA) grows, its application in commercial products is gradually being replaced with other related compounds, such as bisphenol S (BPS). Nevertheless, very little is known about the occurrence of BPS in the environment.”

In this study, the authors found BPS present in 16 types of paper products, including thermal receipts, paper currencies, flyers, magazines, newspapers, food contact papers, airplane luggage tags, printing paper, paper towels, and toilet paper. The thermal receipt paper samples contained concentrations of BPS that were similar to the concentrations of BPA reported earlier and raised alarm for some scientists. BPS was also detected in 87 percent of currency bill samples. The authors write that several other related compounds are also used to replace BPA: bisphenol B, bisphenol F, and bisphenol AF. BPA and BPS are found in high concentrations in canned foods, BPF has been found in surface water, sewage sludge, and sediments, and BPB was found in human serum in Italy. “Limited studies have shown that BPS, BPB, and BPF possess acute toxicity, genotoxicity, and estrogenic activity, similar to BPA,” the authors write, adding that, “The environmental biodegradation rates of BPS and BPB were similar to or less than those of BPA. Although considerable controversy still surrounds the safety of BPA, the potential for human exposure to alternatives to BPA cannot be ignored.” The researchers also note that people may be absorbing BPS in much larger doses—19 times more than the BPA they absorbed when it was more widely used.

Bruce Blumberg, professor of developmental and cell biology and pharmaceutical sciences at the University of California, Irvine, wrote in an e-mail, “There are emerging data to show that BPS is an estrogen but relatively less on the other chemicals. Therefore, it is hard to say with certainty at the moment whether the BPA replacements lack estrogenic activity. BPA free means simply that—that the product is stated to be BPA free.”

I asked Diana Zuckerman, president of the National Research Center for Women and Families if she was concerned about the substitutes being used in place of BPA. “We are very concerned that BPA could be replaced with products that are just as risky, or even more risky. The federal government is not doing what is needed to protect the American public, either in their regulation of BPA or any of these potential substitutes.”

But the FDA continues to insist that BPA is still safe. In a recent New York Times article, Michael Taylor, deputy commissioner for foods said that the agency, “has been looking hard at BPA for a long time, and based on all the evidence, we continue to support its safe use.”

Zuckerman added that part of the problem lies in the heavy influence that industry has on members of Congress and the FDA. “Whenever the FDA does something to improve patient safeguards, Members of Congress get lobbied by the industry involved and some of those Members pressure [the] FDA to back off,” she wrote in an e-mail. “This has happened for years but the last few years have been even worse than usual.”

At Mother Jones, Tom Philpott points out that the heavily monied interests behind BPA are none other than the chemical giants Dow and Bayer who produce the bulk of BPA. Frederick S. vom Saal, curators’ professor at the University of Missouri-Columbia and BPA researcher told me that BPA represents a $10 billion a year industry. It’s important to note that the recent FDA ban comes at the behest of the American Chemistry Council, an industry trade group that denies any negative health effects from BPA. Why would they have done this? “[The American Chemistry Council’s] petition to the FDA puts it plainly: ‘All Major Product Manufacturers Have Abandoned the Use of Polycarbonate’ (BPA). In other words: Go ahead and ban it—it’s already been phased out and a ban gives the appearance of strict oversight,” Philpott writes.

By creating the ban, the FDA at least acknowledges that babies and children should lessen their exposure to BPA. But what about the rest of the population? “BPA remains in millions of food and beverage containers that affect the BPA levels of pregnant women, children of all ages, and all adults,” Zuckerman wrote to me in an e-mail. “The impact on the developing fetus and young children, and on breast cancer patients undergoing chemotherapy, are of particular concern to our Center. One study indicates that BPA may interfere with the effectiveness of chemo for breast cancer patients.”

The FDA should concede that if BPA is a risk for babies and children, it is most likely a risk to all of us. And what about the various substitutes that will be used for BPA and the numerous other toxins lurking in the plastics and other containers that package our foods and drinks? “FDA’s decision is a step in the right direction, but it is a baby step,” Zuckerman said. “They have done the minimum.” Blumberg added that the answers to all of these questions are complex. “We do not know nearly as much as we need to know,” he said. “I think that it is prudent to reduce our consumption of packaged foods of all sorts for a variety of reasons, including reducing exposure to contaminants from the containers.”

Our Deadly, Daily Chemical Cocktail

Chemicals and additives found in the food supply and other consumer products are making headlines regularly as more and more groups  raise concern over the safety of these substances. In a statement released yesterday, the American Academy of Pediatrics (AAP) asked for reform to the Toxic Substances Control Act of 1976. The group is particularly concerned about the effects these substances have on children and babies. Last month, the U.S. Food & Drug Administration (FDA) held hearings on the safety of food dyes but failed to make a definitive ruling—the most recent study on Bisphenol-A (BPA) added to growing doubts about its safety but the FDA’s stance remains ambiguous. Meanwhile, in 2010, the Government Accountability Office (GAO) reported that the FDA is not ensuring the safety of many chemicals.

Yet while the FDA drags its heels and hedges on the safety of these substances, Americans are exposed to untested combinations of food additives, dyes, preservatives, and chemicals on a daily basis. Indeed, for the vast majority of Americans consuming industrial foods, a veritable chemical cocktail enters their bodies every day and according to the GAO report, “FDA is not systematically ensuring the continued safety of current GRAS substances.”

The term GRAS refers to “generally regarded as safe,” the moniker the FDA uses to regulate food additives, dyes, and preservatives. The trouble is this system is not effective. Dr. Michael Hansen, a senior scientist at Consumers Union, said in an interview that many additives in our food supply are never even tested. That’s because the GRAS designation is a voluntary process—instead of being required to register food additives, companies can notify the FDA about their product, but only if they so choose. Hansen added that even for those additives considered GRAS, he didn’t have much faith in the designation.

So just how many of these largely untested and unregulated chemicals is the average American consuming every day? As of yet, no study has determined this number nor has looked at what the effects of the various combinations might be. But according to the Body Burden Web site, there are 80,000 chemicals in commerce and the site says that, “No one is ever exposed to a single chemical, but to a chemical soup, the ingredients of which may interact to cause unpredictable health effects.”

There are only a few studies that evaluate the combined effects of food additives. One 2006 study published in Toxicology Science concludes that the combination of several common additives appears to have a neurotoxic effect: “Although the use of single food additives at their regulated concentrations is believed to be relatively safe in terms of neuronal development, their combined effects remain unclear.” Of the four additives looked at, only one is now banned in the U.S., while the rest remain in the foods on our grocery store shelves. In a 2000 study, researchers looked at the combination of four major food additives or a mixture of six typical artificial food colors and found indications of toxicity in both.

And perhaps the most alarming study dates back to 1976 from the Journal of Food Science. In this study, young rats were fed a low-fiber diet along with sodium cyclamate, FD&C Red No. 2 and polyoxyethylene (20) sorbitan monostearate individually and in combination. While the study found that any one of the three food additives given individually had little negative effect, the combination of all three additives resulted in weight loss and the death of all test animals within fourteen days. Sodium cyclamate is an artificial sweetener now banned in the U.S., but FD&C Red No. 2, a food dye, and polyoxyethylene (20) sorbitan monostearate, an emulsifier, are still in regular use in the food supply, according to the FDA’s Web site.

BPA, another regularly used chemical, has raised a number of concerns. The most recent study found that when participants switched to a diet with minimal amounts of canned foods or plastic food packaging, urinary levels of BPA decreased by more than 60 percent after just three days. According to the Centers for Disease Control (CDC), nearly all Americans have detectable levels of BPA in their bodies, which has been linked to breast and prostate cancer, infertility, early puberty in girls, obesity, and ADHD. This study indicates how quickly the body will excrete BPA if given the opportunity, but here’s the key: The body must be given the opportunity to do so. Many Americans don’t take three-day fresh food breaks from a diet based largely on packaged and processed foods. What’s more, BPA is just one of the chemical compounds with potentially harmful effects entering into our systems.

Based on the anecdotal information I see in my client’s food journals, people eating processed and packaged foods are taking in exorbitant amounts of artificial ingredients and additives. Typically, a client will say something like, “I eat a bowl of cereal with low-fat milk, have yogurt for a snack, and a Subway sandwich for lunch.” While this sounds relatively harmless, here’s what it might actually look like based on some popular “health food” items:

  • One serving of Kellogg’s Fiber Plus Antioxidants Berry Yogurt Crunch contains more than 13 different additives, preservatives, and food dyes, including Red 40 and Blue 1, which are known to cause allergic reactions in some people and mutations leading to cancer in lab animals. It also contains BHT, monoglycerides, and cellulose gum. In addition, conventional milk often contains residues of artificial bovine growth hormones, known endocrine disruptors as well as antibiotics used in industrial milk production.
  • Dannon Light & Fit Peach yogurt contains more than 11 different additives including Red 40, aspartame, potassium sorbate, sucralose, and acesulfame potassium.
  • A Subway sandwich of turkey and cheese on nine-grain bread with fat-free honey mustard, peppers, and pickles contains more than 40 different additives, preservatives, and dyes. The pickles and peppers have yellow 5 and polysorbate 80, the bread has ten different additives including dough conditioners, DATEM, and sodium stearoyl lactylate, and the turkey contains ten additives as well.

The person in this example has consumed more than 60 food additives eating breakfast, a small snack, and lunch alone, to say nothing of dinner, dessert, further snacking and drinks. Consumers Union’s Dr. Hansen told me, “I wouldn’t be surprised if it were up to 100 additives or more that people are taking in on a daily basis.”

And it’s not just food. A number of additional toxins also enter our systems from other industrial sources and often come in the form of phthalate plasticizers and parabens—both of which are used in personal care products, some medications, and even foods and food preservation. Most Americans use some form of shampoo, soap, lotion, and antiperspirant every day, and these toxins, applied to the skin, are absorbed dermally.

According to a 2010 study, like BPA, parabens and phthalates can clear our bodies relatively quickly but only if we aren’t exposed to them on a regular basis. The study states, “For serious health problems to arise, exposure to these rapidly-clearing compounds must occur on a daily basis.” Phthalates are associated with infertility, obesity, asthma, and allergies, as well as breast cancer; parabens are a cause for concern regarding breast cancer.

So what if it’s not the dyes alone, the preservatives alone, or the BPA alone, but some haphazard combination thereof that has yet to be studied or evaluated properly? Jason August, with the FDA’s Office of Food Additive Safety, admitted as much in his defense of food dyes in relation to ADHD recently when he said, “There were other factors in most of these studies that could have been the reason or could have gone hand in hand with the dyes to create these problems in these particular children, including preservatives.”

This is precisely why the FDA needs to be more rigorous with its testing of individual additives and start evaluating the combined effects or “other factors” that August so blithely refers to here.

Chemicals used in all of these industrial products are big business—food corporations own some of the largest personal care companies and they’re profiting on multiple fronts with cheap, industrial ingredients. For example, Nestlé owns 30 percent of the world’s largest cosmetic and beauty company L’Oreal—tightly regulating these substances and evaluating potential harm would be a financial hardship for these corporations.

But the real hardship is placed on the American people who trust that the foods they eat are properly regulated by the government and safe for themselves and their families. How long will the FDA continue to put the health of the American people at risk with its antiquated policy? Let’s hope with pressure from groups like the AAP, changing consumer demand, and continued headlines, the FDA will finally do its job.