James Henry states that under current regulation, it is illegal to publish statements on the health benefits of naturally occurring foods. Drug and pharmaceutical interests directly benefit by having an exclusive monopoly on claims for the treatment of disease in the sale of their products. This is the first in a series of three articles on this and related subjects.
Food and drug regulatory agencies in the United States and Europe act as competition police for the biggest pharmaceutical firms. The Food and Drug Administration (FDA) is no exception to this troubling tendency. The regulatory agency creates financial barriers that make entry impossible for all but the largest firms. Specifically, the FDA actively censors health information regarding the effects of nutrients on disease on behalf of competing pharmaceutical products. In Europe this role is performed by the European Food Safety Authority (EFSA).
The FDA has a mandate to regulate drugs and therefore any and all drug claims, which are defined as any substance that is promoted for the purpose of curing, treating, or mitigating a disease. A drug is not defined by its’ molecular composition, but rather whether it claims to be used to mitigate disease. This is purposeful. Under this arrangement, pharmaceutical companies have a complete monopoly on the ability to make any health claims and limit the information available to the consumer in the market.
Large drug firms are in the business of selling drugs and the only way to ensure maximum protection from competition to their products is to restrict speech regarding the treatment of disease to their products. Even if the statements about the beneficial compounds of foods are true, making these statements is illegal in the current regulatory environment. If the public were exposed to information on the benefits of eating different foods to alleviate disease, it would rely less on pharmaceutical products for the treatment of disease and illnesses, thereby reducing the market share of the drug industry in the health market.
Probably the greatest factor in this issue is that while vitamins and nutrients can have substantial health benefits, they cannot be patented. Therefore, the drug industry is solely interested in finding patentable synthetic compounds that can be put on the market, thus maintaining a monopoly for a given period of time. The large drug industry is pleased to have a drug approval system that takes three to ten years, requires hundreds of millions of dollars for approval, and an army of attorneys, since it is practically impossible for a food or supplement manufacturer to be able to successfully overcome that process. The Pharmaceutical Research and Manufacturers of America Publication estimated in December 2000 that the cost of introducing a new product to the market is over $500 million dollars. The current price tag of introducing a new drug exceeds $600 million dollars.
The insanity of this system is apparent through several simple examples. For instance, it is illegal to state that a bottled water product can be used to treat dehydration, or to state that a can of prune juice can treat constipation, even though these statements are undoubtedly true. The moment that the prune juice manufacturer places that statement on his product it becomes an illegal drug; his operation is shut down and serious criminal charges are likely to be levelled against him. One example is the vitamin B12, found in fish and fish oil supplements, which has been found to reduce the risk of coronary heart disease by 50%. However, this information is still not widely known, due to the FDA prohibiting companies selling omega-3 fatty acids from making any statements regarding the positive effects of their supplements, on their products from 1994 to 2000,. Instead of allowing health claims to be made along with disclaimers outlining the scientific studies strengthening the claims, the FDA simply prohibits any and all statements. This system effectively censors important health information that the public should find accessible and would undoubtedly benefit from.
The benefits of proper nutrition and its positive effects on illness and disease prevention have been widely discussed both by the public and the scientific community. We were all told in grade school; “You are what you eat.” Western medicine and researchers have discovered countless cures to disease originating from nutritional deficiency. Polish biochemist Kazimierz Funk cured beriberi by noticing the benefits of eating brown rice containing thiamine. Scottish physician James Lind discovered the cause of scurvy to be vitamin C deficiency. In the 20's a number of scientists established that vitamin D deficiency was the cause of rickets and in the 30's it was found by researchers that niacin deficiency is the cause of pellagra, to name but a few. Despite this obvious positive relationship between nutrition, diet, and health, the marketplace is barren of information due to government censorship on behalf of the drug industry. Next time you step into your local health-food store, try and find one product on the shelf that states anything regarding the purpose of the product. Not one bottle or food will make a single claim about their product, because doing so is illegal in the US.
The FDA enforces prior restraint on all firms in the market. Therefore all firms are restrained from making any claims until they are approved by the government. Even when ordered by federal courts to implement systems where claims would be allowed along with disclaimers concerning the level of scientific validity substantiating the claims, they have failed to act. Despite being sued and defeated five times in court about the suppression of health claims, and subsequently being ordered to stop, it has failed to change its’ ways. Unaccountable to the people, and unaccountable to various courts in the land, the FDA considers itself above the law and accountable to no one but the pharmaceutical industry.
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