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Dozens of over-the-counter health
supplements, including some potentially used by people living with HIV, viral
hepatitis and other chronic diseases, are illegally labeled and lack scientific
evidence for their marketed claims, according to a report released October 2 by
the Office of Inspector General (OIG) of the U.S. Department of Health and
Human Services.
The report stems from an analysis of
both the structure and function claims of 127 dietary supplements marketed for
weight loss or immune system support. OIG reviewed the claims to determine the
extent to which they complied with FDA regulations, along with substantiation
provided by manufacturers to describe the quantity and nature of the evidence.
Investigators also assessed the accuracy and completeness of notification
letters that manufacturers must submit to FDA for their structure/function
claims.
Overall, substantiation documents
for the supplements were inconsistent with FDA requirements for competent and
reliable scientific evidence. Additionally, the report notes, seven percent of
the supplements lacked the required disclaimer pertaining to unproven health
benefits and 20 percent included prohibited disease claims on their labels.
In light of these findings, OIG
recommends that the U.S. Food and Drug Administration (FDA) “seek explicit
statutory authority to review substantiation for structure/function claims to
determine whether they are truthful and not misleading.” The OIG investigators
also recommend “that FDA improve the notification system for these claims to
make it more organized, complete, and accurate,” adding that the agency should “expand
market surveillance to enforce the use of disclaimers for structure/function
claims and to detect disease claims.”
In commenting on the report, the FDA
did not explicitly concur with OIG’s first recommendation, but said it would
consider it. It did, however, concur with OIG’s second and third
recommendations.
To read the OIG report, visit: https://oig.hhs.gov/oei/reports/oei-01-11-00210.pdf
The Friends of AIDS Foundation is
dedicated to enhancing the quality of life for HIV positive individuals and
empowering people to make healthy choices to prevent the spread of the HIV
virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.
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