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Member Advisory
American Botanical Council Sends TIME a Letter to the Editor on “Cleveland Clinic's New Medicine”
ABC's letter attempts to correct erroneous statement that "FDA doesn't regulate herbs and supplements..."
(AUSTIN, Texas, May 2, 2014) On Friday, April 25, 2014, American Botanical Council (ABC) Founder and Executive Director Mark Blumenthal submitted a letter to the editor of TIME in response to an article entitled "Cleveland Clinic's New Medicine" written by Alexandra Sifferlin. The article, originally published April 17, 2014, gives a firsthand account of Sifferlin's visit to the new herbal therapy ward at the prestigious Cleveland Clinic in Cleveland, Ohhio, where high-quality Traditional Chinese Medicinal herbs are being employed.
Blumenthal's letter has yet to be published by TIME and the article itself has yet to reflect any requested changes. The full text of the letter is as follows:
April 25, 2014 Letter to the Editor TIME Sifferlin A. “Cleveland Clinic’s New Medicine”. TIME. April 17, 2014. Dear Sir or Madam: It is heartening to see TIME cover the compelling development of the use of Traditional Chinese Herbal Medicine at the prestigious Cleveland Clinic. However, the interesting and otherwise factual article contains a statement that is erroneous and highly misleading.
The author writes, “The FDA doesn’t regulate herbs and supplements, so finding pharmacies that can both supply them and still meet hospital safety standards was a top priority.”
With all due respect to the author, the statement that “FDA doesn’t regulate herbs and supplements” is totally false.
The area of regulation of herbs and other dietary supplements has been curiously misunderstood in the American media, and elsewhere, for the past several decades. The relatively simple fact is that the US Food and Drug Administration has the authority to regulate all aspects related to the manufacture and marketing of herbal dietary supplements.
Recent years have witnessed increased and highly assertive enforcement by FDA of the herb and dietary supplement industry, particularly in the area of manufacturing by FDA’s enforcement of its Good Manufacturing Practices (GMPs). FDA has inspected hundreds of manufacturing facilities, cited numerous companies for major and minor infractions related to manufacturing, appropriate product ingredient identification, unsubstantiated and/or illegal product claims, and much more. In some cases product recalls have been ordered and FDA has levied fines or other penalties against offending companies.
In 2012 the American Botanical Council published an extensive review article on the regulation of herbs and other dietary supplements. [1] This seminal article was written by a former professor of pharmacy and an experienced food and drug law attorney with extensive experience with herbal dietary supplements; it was peer-reviewed by experienced food and drug law attorneys and other experts on the regulation of dietary supplements.
As the TIME article noted, in its diligence process, the Cleveland Clinic was able to locate a reliable manufacturer of high quality Chinese herbal products to dispense to its patients. Hopefully, more mainstream medical facilities will follow suit and provide this type of integrative healthcare that millions of American consumers clearly want.
Sincerely,
Mark Blumenthal Founder & Executive Director American Botanical Council Editor-in-Chief, HerbalGram & HerbClip www.herbalgram.org
Reference
1. Soller RW, Bayne HJ, Shaheen C. The Regulated Dietary Supplement Industry: Myths of an Unregulated Industry Dispelled. HerbalGram 2012;93:42-57. Available at: http://cms.herbalgram.org/herbalgram/issue93/FEAT_myth.html.
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