Do the new regulations apply to individual herbalists?
In short, the answer to this question is largely to be seen. The FDA has clearly stated that individual herbalists are not excluded from this new regulation. However, FDA has indicated that it will use its “enforcement discretion in deciding whether to apply the requirements of this final rule to certain health care practitioners, such as herbalists, acupuncturists, naturopaths, and other related health care providers.” [Federal Register: June 25, 2007 (Volume 72, Number 121) p. 34793] Although our analysis of this new rule is preliminary and ongoing, we believe—based upon statements made by the FDA in its final rule—that individual herbalists will generally not be subject to enforcement if they: • Are appropriately trained to prescribe herbs; • Provide individualized, appropriate herbal formulations based upon a one-on-one personal consultation; and • Avoid the use of dietary supplements or dietary ingredients—including herbs—that pose a known or suspected safety concern. If you meet
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