Researchers find safety disclaimers do not register with consumers

Researchers at Brigham and Women's Hospital, a teaching hospital affiliated with Harvard Medical School, took a look at weight-loss supplement disclaimers—“This statement has not been evaluated by the Food and Drug Administration”—and did not like what they saw.


The three researchers pooled a number of consumer perception studies and found that the statement did not have an impact on how consumers perceived a supplement's safety profile, compared to control-group users, and that many consumers dismissed disclaimers as “a mandatory statement of liability protection,” according to a study published in the March issue of Health Affairs. They did find, however, that an FDA approval increased a consumer's perception of safety.


Although weight-loss supplements are not prescription drugs, the researchers said the results should be worrisome because a 2012 court decision suggested that an alternative to regulating marketing would be to allow drug manufacturers to counterbalance off-label information they provide to physicians and patients with a disclaimer like those seen on weight-loss supplements.


The researchers wrote that this language would 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 inappropriate use of those products.”


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