Assignment: The Ethnic Healers
The FDA is responsible for ensuring the safety of all foods, drugs, and medical devices marketed and distributed in the United States. How the FDA views a particular remedy, and therefore the amount of regulation applicable to it, depends on how that remedy is classified.
Pharmaceutical products are subject to stringent regulation and testing both before and after approval by the FDA for placement on the market. These drugs are researched for mass production and distribution. No traditional ethnic remedy has ever been taken through the rigorous process for FDA approval.
Because traditional folk remedies contain ingredients such as vitamins, minerals, herbs, or other botanicals and substances such as enzymes and glandular and organ tissues, they are more likely to be viewed as dietary supplements and subject to less stringent regulation. The Dietary Supplement Health and Education Act of 1994 (DSHEA) established the FDA’s current authority to regulate dietary supplements. A dietary supplement is a product taken by mouth that contains a “ dietary ingredient” intended to supplement the diet. Those ingredients often are the very things that were previously noted as the components of ethnic remedies.
According to the DSHEA, a producer is responsible for determining that the dietary supplements it manufactures or distributes are safe and that any representations or claims made about them are substantiated by adequate evidence to show that they are not false or misleading. Dietary supplements do not need approval from the FDA before they are marketed (Center for Food Safety and Applied Nutrition, 2001). After a dietary supplement is on the market, the FDA has the responsibility of monitoring its safety and, if found to be unsafe, to take action to remove it from the market. Further, a product may not be sold as a dietary supplement and promoted as a treatment, prevention, or cure for a specific disease or condition. Such an action would be considered the distribution of an illegal drug (Center for Food Safety and Applied Nutrition, 2001). Although most ethnic healers would not consider their practices to include marketing a dietary supplement, nonetheless a traditional healer who provides any type of remedy is technically subject to these regulations and could be held responsible for their violation.
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