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Why the FDA cannot be trusted

By Paul Chek and James Phelps

         This is an intriguing objection, because in the latter part of 2004, we learned that a number of extremely harmful drugs had made it past the FDA screening process and into our medicine cabinets. Among its various claims on its Web page, the FDA states: The public trusts FDA to ensure that: 1. Foods are safe, wholesome and truthfully labeled.

            Now, you might say that even if the FDA doesn’t do a particularly good job with drugs (such as Vioxx and Celebrex), that

doesn’t mean it can’t meet its obligations in making certain that harmless ingredients don’t get into your food.

Question: Should the public trust the FDA to ensure that foods are safe, wholesome and truthfully labeled?

         Americans consume around 26 million hotdogs per year in baseball parks during a single season. On average, Americans consume 60 hotdogs per person in a given year. If the hotdog is so widely consumed and such a part of our identity, the FDA had better have approved of it and all its ingredients. It has, of course, and that seems to carry weight. Enough so, in fact, that

even NASA has approved the hotdog as a regular item on Apollo moon flights, Skylab missions and space shuttle flights.

           Before we start switching to a diet of Tang and franks, let’s look at a key ingredient in most hotdogs: sodium nitrite. Sodium nitrite has been used for over 100 years as an additive to many cured meats: hotdogs, bacon, ham, bologna, pepperoni and some smoke-cured fish. It has two roles. The first is to prevent the growth of bacteria that causes botulism – a sometimes

fatal condition. The second is to enhance the color and flavor of meat. That all sounds nice.

         But the downside is that nitrite combines with secondary amines found in your stomach and other foods to form highly carcinogenic (cancer-causing) substances called nitrosamines. A number of studies have provided evidence that nitrite is

harmful, yet the FDA has not banned the substance, nor has it even recommended that companies making use of nitrite label their products with a warning.

        So why is sodium nitrite still used as a preservative? According to “A Consumer’s Dictionary of Food Additives,” … a Committee on Nitrite and Alternative Curing Agents in Food, formed by the National Research Council in the United States, concluded that there was no single agent or process that could replace nitrite completely: “Several chemical and physical treatments appear to be comparable in inhibiting outgrowth of Clostridium botulinum spores in types of meat products, but

none confers the color and flavor that consumers come to expect in nitrite cured meats.”

        In other words, this committee seemed to think that given a choice, consumers would rather sacrifice health for taste and color. Is it true there are no alternatives? Visit your local whole foods grocer to see that there are numerous meat products

without nitrites and nitrates, and these meats look and taste delicious. In fact, ascorbic acid (vitamin C) can be used as a preservative without the harmful side effects of nitrite.

But we’re not rats!

Now, many experiments – that show that additives like nitrite are carcinogenic – rely on nonhuman subjects (none of us humans seem to want to volunteer for the job). This fact sometimes gets used against the studies. After all, even if the nitrosamines produced by hotdogs and that ham roast you had for dinner last night cause cancer in rats, rats aren’t humans. What do studies about rats tell us about humans?

         There’s two answers here. If you don’t trust scientific studies using animals to tell us when something is bad, you shouldn’t trust those studies to tell us when something is good, either. Unfortunately, that would mean the folks who want to defend the FDA and food companies against these studies shouldn’t trust most commercial products out there, as animal testing has been used to verify the safety of a great deal of their components!

         But there’s a deeper reason to accept the results of animal testing if done correctly: Evolutionary biology tells us that all organisms are related by descent from a common ancestor. (Even if you don’t believe in evolution, rats and humans – on the molecular level – are pretty similar as far as the four basic components of the DNA molecule!)

         For our purpose, what this means is that we’re likely to share a good deal of similarities in physiology and body chemistry with other animal species. Enough so that studies on nonhuman animals can be revealing about how our own bodies will react to

things like food additives. If we didn’t share these commonalities, life would be a lot rougher for us.

         For instance, we give antivenins to people bitten or stung by poisonous animals to prevent the toxins from running their course. But we make these antivenins by injecting slowly-increasing doses of the poison into horses and sheep. This triggers the immune response of the animal and it builds up antibodies to the poison. The antibodies are then concentrated into an

antivenin. So in essence, when you’re given an antivenin, you’re given horse or sheep antibodies!

       The success of antivenin relies on the fact that horses and humans have sufficiently similar body chemistries. So scientists who use rats in their studies are acting on these similarities to develop their experiments. When a well-constructed experiment shows that a substance causes cancer in rats, it’s a smart idea to pay attention!

It’s also in my water?!

Nitrite is a primary ingredient in fertilizer, and much of this fertilizer enters our drinking water as runoff, so you may be consuming nitrite through your water. So even if you eat artificially preserved meats only once a week, you can still be getting greater amounts of nitrite and nitrosamines than you think.

        Another reason to take the carcinogenic label seriously, even if you “hardly” eat these foods, is that when scientists test to see whether an ingredient is carcinogenic, they generally err on the side of safety. They label any substance as carcinogenic that produces cancer in test subjects with significantly greater frequency than test subjects not exposed to the substance, regardless of the amount required to induce cancer.

        The point is to establish some sense of when any person would run a high risk of developing cancer. That does not tell us about how you would react to the ingredient; different people have different biochemistries. So while scientists establish the high hazard-end of the scale, your body chemistry may make you more prone to getting cancer in the presence of the substance.

For that reason, we think it’s best to play it safe and avoid carcinogens whenever possible.

        Processing companies using these preservatives generally don’t dispute the use of rats, but they have raised other questions over the studies linking nitrite and cancer. Despite these disputes, the FDA and USDA recognize that there is enough of a worry to require that meats using nitrite as a curative must also be treated with vitamin E and C, which retard the change from nitrite to nitrosamine.

          With the knowledge of alternatives to nitrate, and the vitamin E and C requirement, it’s hard not to take the FDA’s failure to act, as a concession to big corporations. Moreover, the FDA has begun to rely more than ever on the very corporations it’s supposed to be watching over to shoulder the burden of testing their own products.

        Here’s just one example. In the late 1990s the FDA made a key change to substances labeled as GRAS – Generally Regarded as Safe and do not require premarket clearance by the FDA. Before the change, GRAS status required either a demonstrated history of safe use in foods prior to 1958, or recognition as safe by qualified scientists.

        In the second case, the evidence provided by these scientists was reviewed by FDA experts as part of a petition for GRAS status. This petition requirement was removed in the late 1990s. Rather, all one had to do was notify the FDA of GRAS status. According to “A Consumer’s Dictionary of Food Additives,” … “[M]anufacturers could simply notify the FDA of their additives’ GRAS status and provide some evidence to support it.”

        This is an important shift! There’s a world of difference between petitioning the FDA for GRAS status and informing or notifying it of GRAS status. If the whole point of the FDA was to serve as an advocate for the health and wellbeing of the populace by monitoring food companies and their products, it hardly achieves this purpose by letting these very companies monitor themselves! Even prior to the lower standard, carcinogenic substances, e.g., cyclamates, had been found on the GRAS

list and had to be removed.

          The current GRAS substances can have a whole host of side effects such as gastrointestinal inflammation. We find it hard to see how the public is served by weakening standards that have already let us down in these ways. Beyond the GRAS list, there are other warning signs that the FDA is shortchanging us.

        We’ve been discussing meat so far, but a January 2004 article in USA Today revealed some frightening statistics about fruit and vegetables. According to the article, “the Produce Marketing Association reports that imports of fresh produce increased from 13.8 billion pounds in 1993 to 20.2 billion pounds in 2000. Of that amount, the association says, the Food and Drug Administration inspects 2% to 3%.”

           That’s a mighty big margin for error, and if it were the case that other countries exporting their food to us followed strict health standards, we might be all right. But that isn’t the case. Major chemical corporations like Monsanto commonly sell particular pesticides, fungicides and chemicals that are banned in the U.S. to countries like Mexico that have no such ban. Unfortunately, Mexico turns around and exports those chemical-laden fruits and vegetables right back to us!

           Essentially, the FDA is allowing you to eat banned chemicals as long as they aren’t sprayed on your food here! The FDA seems to spring into action once there is significant evidence of a problem (i.e., strokes caused by Vioxx, and the case of cyclamates). As the authors of the USA Today article put it, the FDA “presumes that all is well until something goes wrong.”

            This means poor health and possibly death for any number of Americans before something is done. The FDA just doesn’t have a terribly rigorous or thorough system for catching many of the harmful materials in our food and drugs, and often it has no system at all – it leaves the job to the companies it is supposed to be monitoring. It seems to us that there’s such a thing as a healthy bit of skepticism, and if you take to heart what we’ve said here, when it comes to the FDA and your food, your health requires that skepticism.

          The best and safest way to exercise that skepticism is to support your local organic farmers and organic meat producers. You’ll be sustaining yourself with nutritious, clean food, supporting those who farm ethically, and just as importantly, caring for Mother Earth.

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