New Study Finds Diet Supplement Still in Use Despite FDA Recall

By Mike Rozembajgier

The Boston Globe recently reported recently that a Chinese diet supplement continues to be sold in American stores despite product recalls and warnings issued by the Food Drug Administration (FDA).

The weight loss supplement Pai You Guo, which is sold as both over-the-counter diet pills and as tea, was banned in 2009 because it contained two pharmaceutical substances that are prohibited by US regulators. But the Globe reports that the product is not only readily available throughout Greater Boston, but is especially popular among local Brazilian women. The Globe report raises important concerns and serves as a reminder of the need for effective communication when managing product recalls.

The article follows a recent study in the Journal of General Internal Medicine that sought to explore why Pai You Guo continues to be popular despite FDA alerts about its harmful side effects, which can include heart attacks and strokes. After consulting with clinicians who had observed the use of the supplement, researchers focused their study on Brazilian women between the ages of twelve and sixty currently residing in Massachusetts – the group among whom the supplement seemed to be the most popular.

Of the women sampled, twenty-three percent had used Pai You Guo, with a majority using it since the FDA issued its recall in November 2009.  The vast majority of users (85 percent) reported some side effects, including dry mouth, anxiety and insomnia.  Most troubling, however, is that “no respondent was aware of the FDA recall” and the “FDA alerts and recall did not appear to decrease its use.”

While nearly 30 percent of Pai You Guo users had heard of potential harmful effects, most received warnings from their friends or family. Med channels (including television radio and the internet) served were far less relevant sources of information.  All but seven of the Brazilian women who participated in the study completed the survey questionnaire in Portuguese.

The lack of awareness among survey participants, along with the apparent language barrier suggests a need for a re-evaluation of the methods used to communicate with the public about product recalls.

In addition to sending alerts in the most relevant languages for each consumer base, one way the FDA might seek to mitigate these risks is to ensure that product recalls are better communicated with retailers.  As the Boston Globe reported, supplements such as Pai You Guo are frequently made overseas and then sold by smaller distributors.  It is important that the FDA is aware of the size and type of retailers that are selling recalled products in order to conduct an effective communication campaign. The FDA should also follow up with retailers to make sure they are communicating with their customers.

One particular segment of the population—in this case Brazilian women—cannot be left in the dark about product recalls.  The FDA needs to improve its communication procedures in order to better alert the public.

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