Align®

September 2017: Plaintiffs moved for preliminary approval of a proposed settlement agreement. According to its terms, class members who purchased Align products from March 2009 to October 2009 (i.e., the period when the “clinically proven” claims were made) may receive a $15.88 refund for up to two purchases and class members who purchased products from November 2009 to June 2016 may receive a $17.50 refund for one purchase of Align. Each class member may receive a maximum cash refund of $49.26 for three purchases of Align. In addition, the company agreed not to make the “clinically proven” claims without new clinical data to support the claims. The company also agreed to contribute $5 million worth of intellectual property, know-how, research and education grants, and product donations to institutions and programs working to improve digestive health.

2010: A false advertising class-action lawsuit was filed against Procter & Gamble. The complaint, which was originally filed in 2010 and amended in 2017, alleges that the company misleadingly markets Align® (an over-the-counter product with Bifantis®, a patented probiotic) as providing digestive health benefits – including building and maintaining a healthy digestive system, restoring natural digestive balance, and protecting against occasional digestive upsets – without adequate support to make such claims. (Rikos et al v. The Procter & Gamble Company, Case No. 11-cv-226, S. D. OH.)

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