Herbs are regulated
A Response and Clarification to the article “Counter Your Cold” By Sarah L. Stewart.
I was pleased to see Counter Your Cold in the Feb. 23 edition of the Mountain Weekly. As the current owner of Wise Woman Herbals, which represented the majority of botanical medicines pictured in the story, and a former Vail practitioner and 20-year resident, I feel obligated to respond and offer clarification on an incorrect and misleading statement made in the article.
The article stated herbal supplements are not regulated by the FDA, which implies there are no laws governing supplements and that their use is not based in science. However, in addition to state laws and regulations, herbal supplements are in fact regulated by two federal agencies. The Food and Drug Administration (FDA) oversees manufacturing and labeling compliance and the Federal Trade Commission (FTC) regulates advertising and marketing of herbal and dietary supplements. These agencies have joint jurisdiction over supplements, and each has the power to enforce compliance.
The Dietary Supplement Health and Education Act (DSHEA) of 1994 requires the manufacturer to ensure a dietary supplement is safe prior to bringing it to the marketplace. Under DSHEA, manufacturers must assure that the product label information and claims are truthful, accurate and not misleading.
The FDA’s Current Good Manufacturing Practices (cGMP) establish a set of stringent guidelines based on pharmaceutical industry standards, requiring manufacturers to maintain sanitary conditions and properly identify products that are free of adulteration and contamination and are fit for human consumption. Maintaining cGMP status requires an on-site quality control team and undergoing regular in-depth facility-wide inspections by independent auditors.
The FDA classifies herbal supplements as foods and does recognize their value as supplements to the diet in supporting the normal structure and function of organs, glands and body systems, as well as overall good health. In accordance with Congressional Findings (Section 2 of DSHEA): “…the importance of nutrition and the benefits of dietary supplements to health promotion and disease prevention have been documented increasingly in scientific studies.”
Offering additional substantiation for their efficacy, the therapeutic applications of herbs have remained consistent for thousands of years, often referred to as “traditional use” evidence. Further, active plant constituents form the basis for many of their pharmaceutical counterparts. When properly used and if taken according to label directions, herbal preparations are generally free of harmful side effects and are not toxic unless otherwise indicated.
Herbal supplements are natural substances that tend to work in harmony with the normal healthy function of our systems. They can aid in maintaining a healthy lifestyle and offer a gentle way to support normal health and promote longevity.
Ken Koenig, D.C., President
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