(March 5, 2008, Silver Spring, MD) — The American Herbal Products Association (AHPA) has submitted comments to the Food and Drug Administration (FDA) requesting the agency withdraw guidance it issued on the labeling of dietary supplements with respect to the reporting of adverse events.
FDA published two draft guidance documents on January 2, 2008 that were described as “intended to assist … industry” in complying with purported labeling requirements of the Dietary Supplement and Nonprescription Drug Consumer Protection Act.
AHPA asserts the draft documents are both unnecessary and contrary to the clear language of the statute. AHPA’s comments express particular concern with the agency’s recommendation that labels bear a “clear, prominent statement informing consumers that the domestic address or phone number is for reporting serious adverse events associated with use of this product.” This recommendation blatantly goes against the stated intent of Congress.
“Under this good law, FDA had no statutory requirement to issue this guidance,” said AHPA President Michael McGuffin. “Moreover, the Congress explicitly declared that no additional statements would be necessary on labels other than the address or phone number.”
AHPA’s comments, submitted on Monday March 3, can be found online:
The two FDA guidance documents are also online:
The American Herbal Products Association (www.ahpa.org) has served as the voice of the herbal products industry for over 25 years. Representing the finest growers, processors, manufacturers and marketers of herbal products worldwide, AHPA’s mission is to promote the responsible commerce of herbal products used to enhance health and quality of life.