Dr. Jeff Marrongelle, a Doctor of Chiropractic and an certified clinicial nutritionist and a researcher on the effects of electromagnetic fields on human physiology, opened the day with a discussion of the history of the creation and radical expansion of the powers of the Food and Drug Administration (FDA), and how that regulatory entity has been impacting our health care choices for over 70 years.

The FDA was created as an entity to prevent interstate commerce of adulterated foods and drugs in 1930.  The advent of the Roosevelt administration and their radical expansion of federal power with numerous acts such as the National Industrial Recovery Act and the Judicial Reorganization Act of 1937 broke down the wall of separation of powers and gave sweeping legislative and judicial authority to executive branch regulatory agencies, including the FDA.

A crisis is usually used to consolidate power, and the FDA’s expansion of control over the American populace was generated the same way.  The 1938 Food, Drug and Cosmetic Act, which created safety standard testing, was passed as a result of a problem with a sulfa drug creation problem that resulted in 107 deaths among children.  This act also set the standard that if a drug is proven safe at standard doses, then it was approved.  This approval usually took about 60 days.  The act also swept in those preparations that were already considered “safe”, including homeopathy, grandfathering them, but also including them under the statutory definition of a “drug”.

Over time, the control over “drugs’ was expanded with the Kefauver-Harris Act of 1962, which expanded the required testing beyond showing “safety” to including “efficacy” as the standard for approval.  This increased the time to get a new drug approved from 60 days to 6 months or more, and drove the cost up to over $138 million for the industry (which today is in the range of $1.6 billion dollars).   It also limited competition in the industry significantly, which also drove up the final costs of these drugs.

Today, the FDA is by and large a self-contained regulatory giant.  It creates its own rules, regulations and edits with little to no legislative oversight or control.  One study recognized that 25 cents of every dollar spent in the United States is on products over which the FDA has regulatory control over, and the FDA continues to try to expand its power by attempting to regulate vitamins and minerals as “drugs”.  They have complete control over all medical and food advertising (remember the recent edict that Cheerios had to be regulated because of making “health claims”), even to the point of being able to disallow claims that are already proven and truthful.

The most concerning issue with the unfettered power of this regulatory agency is that their governing philosophy is not “should we approve this” but “how can we get this approved”, which has led the FDA bureaucracy and directorate to approve drugs for consumer use even over the objections of their own scientists and safety officers, leading to numerous adverse health effects and deaths among the populace at large (remember the Vioxx debacle?)

The FDA’s hubris is exampled by the 1990 Nutrition Labeling and Education Act, which Congress passed that allowed food and supplement claims to be made as to their effects on disease without having the approval of FDA as a “drug”.  Between 1990-1999, the FDA routinely ignored this statute and pursued regulatory action against many making such claims.  The worst instance of this was the 1991-1993 debacle over the FDA’s refusal to allow information to be published on the beneficial effects of folic acid consumption by pregnant women on preventing Neural Tube birth defects.  Over 2500 cases of this defect could have been prevented in babies if not for the FDA’s insistence on keeping this information from the general public “for their own good”.

Marrongelle summed up his presentation by noting that there are created “artificial crises” to expand the powers of these regulatory agencies, and gave some data.  The total number of deaths from both avian and swine flus from 2003-present is 431 people, according to the World Health Organization.  Conversely, the number of deaths in the same period from iatrogenic causes is 786,936, according to the Journal of the American Medical Association.  This data is indicative of the idea that the cure may actually be worse than the disease, and the FDA may be causing more harm to the public than preventing such harms.