Unpublished HHS Report Questions Oversight of Supplements

WASHINGTON--In an unpublished report, obtained by NBC News, Michael Mangano, inspector general of the Department of Health and Human Services (HHS), apparently wrote that not only is the government clueless about the vast amount of unreported adverse events suffered from dietary supplements, but that more measures need to be taken by the government to more efficiently regulate these products. According to MSNBC.com, the report stated that the Food and Drug Administration (FDA), an arm of HHS, is unable to effectively protect consumers due to the agency's underfunding and lack of manpower to research dietary supplements.

The report also noted that in one recent year, FDA received 470 adverse event reports (AERs), although the U.S. poison control clinics had reported treating 13,000 AERs. With figures such as these cited, the HHS report concluded that the entire "oversight system" needed to be overhauled. On the manufacturing front, the author(s) of the report recommended that supplement manufacturers need to be required to report all side effects to FDA, should register their products with a detailed list of ingredients to the agency and need to standardize ingredients as a precaution against contamination.

An FDA spokesperson said that she did not know who wrote the report but that it will be officially published in the near future. Industry associations contacted by Insider said they would not comment until the report was published and they had reviewed its contents. To read the NBC News article, visit www.msnbc.com./news/557618.asp?cp1=1.