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FDA Roadblocks Revolution in Nutrition

by Hunter Lewis, President, ANH-USA

There is a real scientific revolution taking place at the intersection of food, food extracts, and food supplements. Solid, peer reviewed scientific research is pouring forth from reputable research institutions, especially research universities such as Harvard, Stanford, and the like.

This research suggests that changes in diet could reduce both heart disease and cancer by as much as 90%. (For example, see Archives of Internal Medicine, Oct 22, 2007; 167(19): 2122-7.) Alzheimers too by a significant but still to be determined percentage (Neurology, 2007:69:1921-30).

This is not just a question of eating more fruits and vegetables, although that alone might increase lifespan by an estimated average of 14 years. It is also about specific nutrients. In many cases, there is strong scientific evidence that a specific nutrient may be used to prevent, moderate, reverse, or in therapeutic doses cure disease.

Scientific Research Censored by FDA

Unfortunately the American people do not hear about this research. Food producers would like to tell them about it. But FDA rules prevent it.

The FDA has imposed its “Extended Label” rule on food producers and dietary supplements manufacturers. This rule does not allow the circulation of truthful scientific information about food and nutrient health benefits.

Take cherries. Research from Harvard published in the Annals of Internal Medicine suggested that cherries could reduce heart attack risk (Ann Inter Med, 1996, Sept 1: 125 (5): 384-9). A large number of other studies published in prestigious journals have indicated that cherries could do that and also reduce pain and cancer. But the FDA says that cherry producers, sellers, and food manufacturers may not talk about this research.

In February 2008, the FDA even obtained a court order to silence 29 cherry orchards. The FDA held that any discussion of the health benefits of cherries automatically turned cherries into “unapproved” drugs. Moreover, the Agency says that any “claim” made for an “unapproved drug” is by definition false and legally actionable, even if the claim originates at the Harvard Medical School.

By the way, many people think of “health food” as less “tasty”. But nobody dislikes cherries. And blueberries have a large amount of research supporting them as a “superfood” too.

The FDA presumably wants to protect the American public from “snake oil.” But the best scientific research on critical health issues is not “snake oil.” In general, there are a number of problems with the FDA’s over-restrictive approach.

1) It defies common sense to call cherries or blueberries “drugs.”

The FDA rejoinder is: take the food through the standard drug approval process anyway. Why not? For one thing, approval of a drug commonly costs hundreds of millions of dollars and has cost nearly a billion in some instances. No company can afford to spend even much smaller sums on a food or food supplement because neither can be patented. Even if cherries and blueberries and their juices are deemed to be “drugs,” it is completely unrealistic to treat them exactly like patented drugs. The FDA knows this but just shrugs it off.

There have been very few instances of any foods actually being taken through the drug approval process. One recent exception is fish oil. For years, the FDA refused to accept any health claims for fish oil despite mounting research about its widespread health benefits for heart, cancer, depression, pain, and other conditions. Then a drug company decided to pay for the approval process. Its fish oil was approved, which means that Medicare and insurance companies will now pay for this particular brand of approved prescription fish oil. Happy ending to the story? Well, no. This prescription fish oil costs as much as ten times what good quality non-prescription fish oil costs.

What does a drug company usually do when a natural substance is proven to be of medical value? The usual approach is to “twist the molecules” of the natural substance until a “new” and patentable substance results. The trouble with this approach is that the “new” drug may or may not be as effective as the natural substance, but precisely because it is new to the human body, may be much more toxic and dangerous. Whether it is much more dangerous may also take years to find out. Even if the new drug really is safe and effective, it will cost vastly more than the original natural substance.

Melatonin provides a recent example of how this works. Melatonin is a natural substance. Our bodies produce it every day. It has been found to cure ‘jet lag”. So did drug companies take melatonin through the FDA approval process. No. Instead they created a new and thus patentable substance named Tasimelteon. This new drug binds to the same receptors in the brain that melatonin binds to, will do the same job with unknown toxicity. Unlike melatonin, Tasimelteon will be FDA approved, thus potentially prescribable under Medicare. Unlike melatonin, it will also cost an arm and a leg to buy it.

2) Logic and cost are key considerations. But there are equally important reasons to feel that the current FDA stance needs revision.

In particular, communicating accurately about legitimate, peer-reviewed scientific research should be protected under the first amendment.

3) Even if it weren’t stretching the Constitution beyond recognition and violating our most basic American values, censorship of science also thwarts technological advance.

Technological advance means using science and telling people about it, not hiding it in little read journals.

4) Specific nutrients.

The taking of specific nutrients in foods or supplements (or the withholding of the same, for example by denying iron to cancer cells—see August 2007 Journal of Integrative and Comparative Biology) is not only a very promising approach to preventing, moderating, or even curing disease. It is also a much cheaper approach than drugs or surgery. At a time when spiraling healthcare costs are threatening jobs and our economy, we should be embracing new science to help reduce healthcare costs.