FDA Guidelines

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).

About Pat Alves

Pat Alves is the Regional Coordinator for the Cancer Prevention Coalition, a not-for-profit organization dedicated to reducing escalating cancer rates through a comprehensive strategy of outreach, public education, advocacy and public policy initiatives. Pat is also a local director in the Chardon area, and works personally with the neighboring community chapters by speaking at all area meetings. Pat has been involved personally with cancer issues since 1997 when her father was diagnosed with terminal brain cancer (lymphoma) and given six months to live. Through her comprehensive study of alternative choices she was able to develop a plan that changed the outcome of her father's diagnosis. He was cancer free in four months. Since that time Pat has joined Cancer Prevention Coalition and has offered hope to any family or organization that is interested in hearing about prevention and alternative choices by speaking at meetings and through local radio broadcasts. Cancer topics are not her only subjects that she speaks about. She speaks on alternative health issues that currently have no cures, such as arthritis, osteoporosis, hormone replacement therapy and digestive disorders and helps people to understand their responsibility in making right choices about change and recovery. Pat also teaches clinics on Essential Oils, the aromatherapy and ancient approach of healing through oils and is an authorized representative of Neways International, the manufacturer of the purest essential oils in the world. Pat currently lives with her husband and daughter in Chardon, has two older children and is grandmother of two girls. She is currently studying in the area of BioScience Technology at Lakeland Community College. She is a member of the Lakeland Civic Band for 26 years, plays the flute, and is a professional seamstress with a home based sewing business.