Background: Pai You Guo is a weight loss supplement manufactured in China and adulterated with the banned pharmaceutical products sibutramine and phenolphthalein.  The US Food and Drug Administration (FDA) announced a voluntary recall of Pai You Guo in 2009, yet clinicians have noted its continued use among Brazilian-born women in Massachusetts, USA.

Objective: To assess prevalence of Pai You Guo use, associated side effects, modes of acquisition, and impact of FDA regulatory action on these outcomes.

Design: Cross-sectional study using an anonymous questionnaire.

Participants: Women up to 60 years of age, born in Brazil who attended one primary care clinic or one of six churches in Massachusetts.

Main Measures: Prevalence of use, how users first heard about the product, location of purchase, associated side effects, patterns of use before and after the FDA recall.

Key Results: 23% (130/565) of respondents reported using Pai You Guo.  In multivariate analysis, obesity (adj OR 3.7, p-value less than 0.001) and lack of insurance (adj OR 2.6, p-value 0.005) were associated with use.  The majority of users (85%) reported at least one side effect.  Dry mouth (59%), anxiety (29%), and insomnia (26%) were most commonly reported adverse effects.  Nearly 30% of users (38/130) purchased Pai You Guo from local stores and 9% (11/130) purchased it over the Internet.  The majority of respondents (79/130; 61%) purchased Pai You Guo after the FDA recall.  No respondent was aware of the FDA recall.

Conclusions: Use of this pharmaceutically adulterated supplement is common among Brazilian-born women in Massachusetts.  The FDA alerts and recall did not appear to decrease its use.