(March 6, 2008, Silver Spring, MD) — The Small Business Association’s (SBA) Office of Advocacy has written the Food and Drug Administration (FDA) to express concerns over the agency’s draft guidance document addressing purported labeling requirements under the Dietary Supplement and Nonprescription Drug Consumer Protection Act.
SBA’s letter to FDA Commissioner Andrew C. von Eschenbach singles out the American Herbal Products Association (AHPA) as a motivating force behind its decision to write the agency, as well as inquiries from small dietary supplement manufacturers and industry representatives.
Of particular concern to the SBA office is the re-labeling costs small dietary supplement companies would incur in order to meet FDA’s “recommendation” that a label bear a prominent statement notifying consumers the address or phone number is provided for the reporting of serious adverse events associated with use of the product.
In the letter, the advocacy branch of SBA suggests the agency “reconsider” the recommendation due to its potential to “greatly increase” costs to industry.
“AHPA appreciates the SBA advocacy office’s firm action on this matter, and is pleased to see the SBA actively protecting small dietary supplement companies,” said AHPA President Michael McGuffin.
The letter from the SBA Office of Advocacy to the FDA is available online: http://www.ahpa.org/Portals/0/pdfs/08_0228_SBA_Letter_to_FDA_re_SAER_Guidance.pdf
AHPA’s comments to FDA are available online: http://www.ahpa.org/portals/0/pdfs/08_0303_AHPAComments_FDA_SAER_Label_Guidance_Final.pdf
FDA’s draft guidance document is also online: http://www.cfsan.fda.gov/~dms/dsaergu2.html
The American Herbal Products Association (AHPA) is the only national trade association devoted to herbal issues. Representing the core of the botanical trade—comprised of the finest growers, processors, manufacturers and marketers of herbal products—our mission is to promote the responsible commerce of herbal products. AHPA committees generate self-regulations to ensure the highest level of quality with respect to the way herbal products are manufactured, labeled, and sold. Website: www.ahpa.org.