FDA Regulations - Legal Information

Why do FDA regulations prohibit labels from saying so? The answer is the pharmaceutical companies are very powerful and good old bureaucracy.

Echinacia boosts the immune system, Garlic reduces cholesterol, Ginger prevents motion sickness; Ginko stimulates the brain.  Then why do FDA regulations prohibit labels from saying so?  The answer is the pharmaceutical companies are very powerful and good old bureaucracy. 

In reality the regulations governing herbs probably do more harm than good. One must wonder the logic in this madness. Garlic has been proven to reduce cholesterol. It costs pennies a day, is easily available, and yet very few people know its value. Doctors constantly prescribing drugs to reduce cholesterol but how often will you hear a doctor say take garlic? Not only are cholesterol drugs far more expensive, they also are not natural to the body.

Common sense says that if you can cure something naturally you are far better of then if you take a prescription, although the pharmaceutical companies would like us to believe otherwise.  Why is the awareness about Garlic’s value so secretive?  Because the moment a company touts its medicinal value it is no longer considered a food, it is now considered a drug..  Since the FDA has not approved this “new drug claim” the product is in violation of FDA regulation. 

That is until over 5000  babies were born with serious arm and leg deformities caused by Thalidomide, an over-the-counter sedative sold throughout the world.  In 1962 Congress directed the FDA to pass safety and effectiveness testing for all new drugs.  Unfortunately, the regulations were so restrictive that they threatened herbs and over-the-counter drugs. 

To address the problem, the FDA set up panels to determine the safety of drugs already on the shelf for sale.  During this era most of the herbal sources were small mom and pop operations who could not afford the horendous cost of having their herbal remedies approved.  Thus to this day, herbs are not approved for therapeutic use, nor are they recognized as having any
 medicinal value.

Germany has a much different drug approval system, one that is far more friendly to herbal medicines.  Although Germany requires pre-approval testing for all new synthetic drugs it does hold herbs to such high standards. 

In 1978 the Germany Agency equivalent to our FDA began to study the volumes of scientific literature available on herbs..  Over the last 20 years the agency has published over 280 papers that appear to be the best information available on herbs today.  Today over 70% of German Physicians prescribe herbal medicine on a regular basis. 

The World Health Organization estimates that over 89% of the world’s population use herbal medicine,  and more than one third of North Americans use non-mainstream approaches to health care.  This would indicate that now is the time to rethink the FDA rules and regulations covering herbal medicine.