FDA Roadblocks Scientific Revolution in Food and Food Supplements

Everyone — except the FDA — seems to know that a scientific revolution is 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 can 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 high 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.

Unfortunately the American people do not hear about this research. Food producers would like to tell them about it. But FDA won’t let them.

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.

Like so much else that is happening at the FDA, this defies common sense. Cherries and blueberries are not “drugs.”

The FDA rejoinder is: take the food through the standard drug approval process anyway. But they know that the drug approval process commonly costs hundreds of millions of dollars and has cost nearly a billion in some instances. Nobody can afford to spend that kind of money on foods and supplements because they aren’t supposed to be patentable. The FDA knows this but just shrugs it off.

There have been a very few instances of 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? Not at all. This prescription fish oil costs as much as ten times what good quality non-prescription fish oil costs.

We live in America, don’t we? Why should companies even need government permission to cite the best science coming out of Harvard and the like? Doesn’t the first amendment mean anything? And since when did America get into the business of censoring science? How can we advance technologically if government bureaucrats decide what science gets cited?

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.

Not Just Food — Food Extracts and Supplements Too

A few critics will accept that there is a revolution taking place linking nutrition directly to health. But they think that we should just focus on food, not on food extracts and supplements. There are at least two problems with this. First, as we mentioned last week, studies show that the nutritional content of food has been declining for as long as the last 50 years (see especially the work of Dr David Thomas). The USDA has recently confirmed this analysis for more recent years. The problem seems to lie in depleted soil.

Second, nutrients sometimes have to be concentrated to have full therapeutic benefit. No one can get enough Vitamin D from food. We also get it from exposure to sunlight on our skin, but use of suntan lotion prevents it. Food supplements often make sense either for routine day to day use in lower potencies or as higher potency therapies devised and supervised by doctors.

The FDA’s own mission statement says that the Agency “is responsible for…helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.” Given this mission, it is perverse to allow pharmaceutical companies to spend so many billions on consumer advertising but not to allow food producers to tell the public about legitimate and revolutionary food research.

What Can You Do? 

Have you signed the Reform FDA petition? If not, please do so now.