It is also impossible to bypass the U.S. Food and Drug Administration since it is the Federal agency responsible for “protecting consumers against unsafe and ineffective medicines and health products” as the Sourcebook further states. Its broad regulatory powers come from the Food, Drug, and Cosmetic Act (FDCA) which gives the FDA the power to oversee development and marketing of new drugs and medical devices, distribution of the nation’s food supply, and which supervises the promotion of these items for the safety of the consumer. In order to gain approval by the FDA of a new drug or alternative therapy, FDA regulations force sponsors to:
(1) spend millions of dollars on any new research to comply with the FDA’s regulations,
(2) must include over 100,000 pages of supporting documentation and,
(3) can take up to ten years and cost hundreds of millions of dollars to obtain approval (Cook 17-18).
And so it is obvious that only the major corporations can follow these guidelines to gain approval of any new drugs and then recoup the financial outlay when it receives a seventeen-year patent and brings financial success. A patented drug can cost as high as the market will bear. There is no place for alternative medicine to even begin to fit equally into these requirements, since nutritional therapies cannot be patented and the financial gain would not be as great as the drug-patented formulas and the returns it brings to its investors. The FDA and AMA have attempted to regulate vitamins and minerals and to classify them as drugs and have urged Congress to grant them that authority. To date, Congress has not found that necessary to implement (Cook 8-18).