Natural Health Regulations Review

Executive summary

Regulation of healthcare in America continues to be a divisive topic. The regulatory process is convoluted, impacting healthcare payers, providers, and consumers. Polar views on market dynamics and the right to healthcare assist to the quagmire. Healthcare regulations thus far have been made in piecemeal fashion. As the issues of cost, quality, and access to care augment with the aging of the U.S. citizenry, Federal change may be in store. While it is incorrect and unsafe to assume that all natural remedies are inherently beneficial and innocuous, some herbs have been proven to possess qualities that do promote health or treat illness when used properly. Similarly, while many believe that synthetic drug manufacturers strive to marginalize the use of herbal supplements (and therefore are suspicious of government-funded studies that seem to discredit alternative medicine), it is important to note that those supplements are largely deregulated and some suppliers will use this uncertainty to their own advantage.

Table of Content

EXECUTIVE SUMMARY1

BACKGROUND4

DOMESTIC REGULATION OF HERBAL MEDICINE4

INTEGRATING HERBAL AND CONVENTIONAL MEDICINE7

DISCUSSION OF FINDINGS8

ECHINACEA8

GINSENG9

GINKGO BILOBA9

GARLIC10

ST. JOHN'S WORT10

CONCLUSION11

RECOMMENDATIONS11

WORKS CITED12

Background

In the United States, the use of natural remedies is on the upswing (nearly one in five people reported having used at least one such product in 2002) after a significant decline following the spread of synthetic pharmaceuticals, which provided larger effects and profits.(Busse, 37) This resurgence may be attributed to a variety of factors, such as a desire among some people to seek out unconventional and “natural” paths, the inability of conventional medicine to cure chronic conditions (such as arthritis, depression, and memory loss), a loss of faith in the pharmaceutical companies and/or the government, and misleading advertising on the part of some herbal supplement providers.(Newall,321)

Domestic Regulation of Herbal Medicine

The increased public interest in natural healthcare that began in the 1960s prompted Congress to establish the National Institutes of Health Office of Alternative Medicine in 1992, which became the National Center for Complementary and Alternative Medicine (NCCAM) six years later. Thirty years after the Kefauver-Harris Drug Amendment of 1962 relegated herbal remedies to the laxly monitored classification of food supplements, the Food and Drug Administration (FDA) tried to develop a more stringent set of regulations but was opposed, resulting in the 1994 passage of the Dietary Supplement Health and Education Act (DSHEA) which failed to require supplement manufacturers to prove that a product was either safe or efficacious prior to release. Due to the FDA's lack of premarket involvement, supplements must state on the label “This statement has not been evaluated by the FDA. (Busse, 37) This product is not intended to diagnose, treat, cure, or prevent any disease” although the labels may still claim that the herbs “improve memory” or “support digestive health”.

Statistical Data

National surveys show that 81 percent of Americans believe a supplement should not be sold without proven safety, but 70 percent believe the FDA currently tests and regulates all herbal products on the market. As recently as November 9, 2004, the FDA announced major initiatives to improve the transparency ...