A proposed class action alleges I-Health, Inc. has deceptively touted its Culturelle Probiotics Ultimate Balance for Antibiotics supplements as able to treat or prevent infections caused by antibiotics.
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The 21-page lawsuit alleges I-Health’s claim that the Culturelle supplements “rebuild bacterial balance lost to antibiotic use” amounts to an “illegal implied disease claim” given that the products have not been approved by the U.S. Food and Drug Administration (FDA) to provide these purported benefits. As a result, the complaint argues, the Culturelle supplements at issue are misbranded and, therefore, “illegal to sell and worthless.”
The filing stresses that a company must obtain approval from the FDA in order to make “disease claims” about a dietary supplement. Pursuant to FDA regulations, a “disease claim” is essentially any label statement that explicitly or implicitly implies that the product can be used as a drug to “treat, cure, mitigate, or prevent a disease.”
The complaint contends that the company’s misleading advertising of the Culturelle supplements—sold in capsule form for adults and as chewables for children—is “reasonably likely to deceive the public” and could lead to “substantial societal harm.”
“These claims mislead consumers into believing they can use the Products to self-diagnose and treat without the supervision of a licensed practitioner,” the filing alleges.
The plaintiffs, two California residents, say they paid a premium price for the Culturelle supplements based on I-Health’s claims that the product could mitigate and prevent diseases. Per the case, the plaintiffs would not have purchased the supplements had they known the FDA has not approved them as effective for their intended use.
The lawsuit looks to represent anyone in the United States who, during the applicable statute of limitations period, purchased Culturelle Probiotics Ultimate Balance for Antibiotics supplements for personal use and not for resale.
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