FDA Herbal Regulations

Since ancient times, people have used plants to treat and alleviate symptoms of various diseases and ailments. There are people who swear by the healing powers of their herbal supplements. However, according to the Mayo Clinic, herbal remedies are not studied, scientifically tested or regulated in the same way that modern medications are today. Makers of herbal supplements do not have to get the approval of the Food and Drug Administration (FDA) in order to make their supplements available to the public.

Dietary Supplements

• The FDA has a special category for regulating herbal supplements. The category, known as dietary supplements, has its own set of rules. The Dietary Supplement Health and Education Act defines a dietary supplement as a product that is taken orally, in pill or liquid form, with the intention of supplementing the diet and that has a label stating as much on the front of its container.

  The FDA allows the manufacturers of dietary supplements to make certain claims about their products, provided they have research that supports these claims. Manufacturers may state that a herbal supplement helps to boost health, or that it can counteract a deficiency in certain nutrients; however, the package must state that none of their claims have actually been assessed by the FDA, and that the product is not intended to cure or treat a disease. Since it's essentially up to the manufacturer to ensure that their claims about their products aren't deceptive or untrue, and because they are not strictly regulated, there is still controversy regarding the use of herbal supplements.

Safety Measures

• The FDA keeps track of herbal supplements once they are made available to the public. The rules stipulate that producers of herbal supplements must ensure that their products meet certain standards, and that their ingredients are consistent and free of contaminants. In the event that an herbal or dietary supplement proves to be detrimental or hazardous, the FDA can have it taken off the shelves and may post warnings about the product.

Dangers

• While the rules that the FDA has in place for herbal supplements ensure that quality remains consistent, it does not promise their safety. Herbal supplements, like drugs, may affect people differently; in certain cases, their ingredients may interact with prescription medication that a patient is taking, leading to dangerous and potentially lethal side effects. The Mayo Clinic advises anyone who is considering taking a herbal supplement to consult a medical doctor before doing so. Women who are pregnant, planning to become pregnant or who are breast feeding should be especially cautious about taking herbal supplements. The plant's active ingredients could be harmful to an unborn child, or transmitted through breast milk in amounts that are dangerous to a newborn.