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For those who still believe that the herb and dietary supplement (DS) industry is “unregulated”, some highlights from recent congressional testimony by two senior Food and Drug Administration (FDA) and Federal Trade Commission (FTC) officials is illuminating.
On March 9, 2006 the House Committee on Government Reform held a hearing on “The Regulation of Dietary Supplements: A Review of Consumer Safeguards” Robert E. Brackett, PhD, Director of the Center for Food Safety and Applied Nutrition at the FDA provided an accounting of FDA activity in the area of enforcing federal regulations related to DS between October 2002 through February 2006. According to Dr. Brackett, FDA enforcement activity can be quantified as follows:
4000 foreign shipments of potentially unsafe or misbranded DS refused
588 domestic inspections of DS manufacturers
350+ “warning letters” and “cyber letters” to marketers of DS products
$13.4 million value of DS products seized
$3 million value of DS products destroyed voluntarily under FDA supervision due to
their having been promoted with unsubstantiated claims or that were
unapproved drugs or were deemed unsafe
5 permanent injunctions against companies distributing misbranded or
unapproved drugs as DS
The FTC actively monitors advertising and product claims made in magazines, newspapers, electronic media, as well as on the Internet. C. Lee Peeler, Deputy Director, Bureau of Consumer Protection at FTC provided a description of recent FTC enforcement activities in 2005, some of which can be quantified as follows:
14 complaints filed against companies marketing allegedly unsubstantiated or
false advertising claims for DS or other natural healthcare products,
including oral sprays, creams, and patches
40 companies against which FTC obtained court orders
44 individuals against whom FTC obtained court orders
$35.7 paid by these companies and individuals in consumer redress,
disgorgement, and civil penalties
90 warning letters to Internet operators selling HGH (human growth
hormone) enhancers, plus FTC monitoring of these operators to ensure
that the websites modified or discontinued marketing claims
--Mark Blumenthal
Sources:
Brackett RE. The Regulation of Dietary Supplements: A Review of Consumer Safeguards. Testimony before U.S. House Committee on Government Reform. March 9, 2006.
Peeler CL. Testimony before U.S. House Committee on Government Reform. March 9, 2006.
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