Abstract
To the Editor: Dietary supplement labels can include claims regarding the effect of the product on the structure or function of the body (i.e., structure/function claims), but cannot be labeled for the treatment or prevention of disease. Labels must also carry a disclaimer that states that the Food and Drug Administration (FDA) has not evaluated the claim and that the product is not intended to diagnose, treat, cure, or prevent disease. 1 Because of potential adverse consequences of self-diagnosis and treatment with dietary supplements, it is important from a public health standpoint to know whether patients understand, based on the labeled information, the conditions for which these products are indicated and are aware that these products are not intended to treat or prevent disease. An unfunded pilot study was undertaken to determine whether patients understand the meaning of the “suggested use” listed on selected herbal product labels and the “disclaimer.”
Five pharmacies in West Virginia participated. After obtaining consent from the pharmacists in charge and the approval of the institutional review board (IRB), each site received 20 copies each of surveys for ginkgo biloba leaf standardized extract (Pharmavite), St. John's wort (Movana), Panax ginseng (Ginsana), horse chestnut (Venastat), and echinacea (Nature's Resource). Pharmacy patrons were directed to the survey by use of IRB-approved signage. (The IRB prohibited pharmacists from verbally directing patrons toward the survey or suggesting that they participate.) Each subject completed 1 survey.
On each survey, the patron was asked to (1) read a suggested use statement and disclaimer taken directly from a product label and “list the problems or conditions you think this product would help” and (2) write in his/her own words the meaning of the disclaimer. To illustrate, 1 response to the latter question was, “The FDA hasn't approved this product.” Subjects were told the statements were taken from product labels, but to minimize bias from subjects' prior product knowledge, the name of the herb or product was not listed. If, on the label, the product name was included in the suggested use statement, it was replaced by the words “this product” on the survey. Subjects were also asked their highest level of education attained.
Twenty-five surveys were returned. Based on their responses, 64% of the subjects appeared to understand the product's intended use, and 56% appeared to understand the disclaimer's meaning; however, only 28% of the subjects who appeared to understand the product's intended use also correctly interpreted the meaning of the disclaimer. Eighteen of the 23 subjects who provided educational background data had attended college. Although the survey did not ask whether the subjects had ever used a dietary supplement, the percentage of survey responders who had education beyond high school was similar to that found in studies of dietary supplement users.2,3 In contrast to a previous study, 3 survey response was relatively low (5%). This may reflect the passive manner in which the survey was distributed. More studies are needed to ensure that supplement labels clearly convey the intended use of the product.