Mandatory disclaimers on dietary supplements do not reliably communicate the intended issues.
Some efforts by the government to regulate the promotional statements of pharmaceutical manufacturers have recently been found unconstitutional under the First Amendment, which has been interpreted to protect commercial as well as personal speech. As an alternative means of protecting patients from unreliable marketing claims, courts have proposed that the Food and Drug Administration could add disclaimers to promotional messages that discuss off-label, or unapproved, uses. We conducted a systematic review of studies of the disclaimers currently required for dietary supplements, to assess how well disclaimers inform consumers' health choices. A few small studies reported a modest impact of disclaimers on consumers' attitudes about dietary supplements, but larger and more rigorous studies generally revealed that many consumers were unaware of a disclaimer or reported that it did not affect their perceptions of a product. The available evidence indicates that replacing government restrictions on pharmaceutical marketing with potentially ineffective disclaimers will be an inadequate way of informing patients about the efficacy and safety of drugs, and it risks returning the United States to a previous era when inappropriate marketing claims about prescription drugs proliferated and contributed to the inappropriate use of those products.
Aaron S. Kesselheim (akesselheim@partners.org) is an associate professor of medicine at Harvard Medical School, in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women's Hospital, in Boston, Massachusetts.
Aaron S
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John Connolly is a research assistant in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women's Hospital.
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James Rogers is a research assistant in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women's Hospital.
James
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Jerry Avorn is a professor of medicine at Harvard Medical School and chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women's Hospital.
Jerry
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D003142:Communication; D000529:Complementary Therapies / Q000941:ethics / Q000331:legislation & jurisprudence*; D019587:Dietary Supplements / Q000191:economics / Q000706:statistics & numerical data*; D004345:Drug Industry / Q000592:standards* / Q000639:trends; D005260:Female; D006801:Humans; D008297:Male; D008389:Marketing of Health Services; D010358:Patient Participation / Q000706:statistics & numerical data*; D011050:Policy Making; D016032:Randomized Controlled Trials as Topic; D015203:Reproducibility of Results; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*
Complementary and Alternative Medicine; Consumer Issues; Ethical Issues; Legal/Regulatory Issues; Public Health