Lawsuit: Culturelle Ultimate Balance for Antibiotics Mislabeled

Dietary supplement manufacturer I-Health, Inc., the maker of Culturelle Ultimate Balance for Antibiotics probiotics, mislabeled and misrepresented the products because it makes claims not approved by the FDA, alleges a Milberg class action lawsuit.

The lawsuit seeks damages for class members who purchased certain types of Culturelle probiotic supplements. If you bought these products, you may be automatically eligible to join the lawsuit and receive compensation.

Antibiotics, Probiotics, and Gut Health

The human body is host to trillions of microbes. Most of these reside in the gut. They play a fundamental role in human health, including how we digest food and immune system response.

Antibiotics kill both harmful and beneficial bacteria in the gut.

Antibiotics have been shown to kill healthy gut bacteria during use, which can have a negative impact on overall health. The author of one study notes that, “Many antibiotics inhibit the growth of various pathogenic bacteria. This broad activity spectrum is useful when treating infections, but it increases the risk that the microbes in our gut are targeted as well.”

It is on the basis of such research that health experts recommend taking measures to protect “good” bacteria in the gut during antibiotic use. One method is to eat foods rich in probiotics, such as yogurt, sauerkraut, and kimchi. Another option is to purchase probiotic supplements.

Product Makes Unverified Disease Claims

Culturelle Ultimate Balance for Antibiotics, formulated for adults and kids, is designed to “rebuild bacterial balance lost to antibiotic use,” the manufacturer states on its website. The products, sold in all 50 states, retail for between $19.99 and $32.99 on the Culturelle website, retailer websites like Amazon.com, and brick-and-mortar stores like Walmart.

The adult formulation is sold is capsules while the formulation for kids ages 3-12 comes in a chewable. Adults get 20 billion live cultures of the probiotic Lactobacillus rhamnosus GG per capsule. A kids’ chewable delivers 10 billion Lactobacillus rhamnosus GG cultures.

“When you take Culturelle® with the #1 clinically studied probiotic, Lactobacillus rhamnosus GG, you help restore your natural balance of bacteria to keep your digestive system running smoothly and support your overall health,” the manufacturer says.

These statements, however, have not been evaluated by the Food and Drug Administration, the manufacturer admits. And according to Milberg’s class action lawsuit, the manufacturer makes illegal implied disease claims that violate FDA regulations.

Defendant represents on its packaging that the Products ‘Rebuild Bacterial Balance Lost to Antibiotic Use,’ explicitly or implicitly claiming the Products are intended to be used as a drug to treat diseases like infections caused by antibiotics.

Disease claims require FDA approval and can only be made for products that that are approved drug products. In their complaint, Milberg attorneys note that other companies have been sent FDA warning letters for making similar illegal implied disease claims.

For example, in 2021, the FDA told probiotic maker Great Healthworks, Inc., that its product claims (e.g., “combats bad bacteria,” “targets harmful bacteria,” and “reduces potentially harmful bacteria”) establish the products as drugs under federal law, and that they are unapproved and misbranded.

Lead Plaintiffs and Proposed Classes

The plaintiffs purchased Defendant’s products and paid a premium for them due to the claims and promises made by Defendant, according to Milberg’s lawsuit. They assert that they would not have bought them if not for Defendant’s “materially misleading misrepresentations” on product labels and online descriptions.

Plaintiffs filed their claim in U.S. District Court for the Eastern District of California and seek to establish two consumer classes:

• A National Class consisting of all persons in the United States who, within the applicable limitations period, purchased the products for personal use and not for resale.
• A California Subclass composed of all persons in the State of California who purchased the products for personal use and not for resale within the appliable statute of limitations.

If successful, the lawsuit could recover damages sustained by class members due to Defendant’s allegedly illegal sales and false and misleading marketing. It could also result in an injunction that halts the sale of the products as currently marketed.

Plaintiffs and class members are represented by Milberg’s Nick Suciu III and J. Hunter Bryson. Mr. Suciu’s practice is focused on the dietary and sports supplement space and he has achieved several multi-million-dollar settlements against national brands. Mr. Bryson has secured settlements for thousands of individuals and recovered over $168 million for his clients.

Since 1965, Milberg has filed thousands of class action lawsuits, recovered billions of dollars for our clients, set groundbreaking legal precedents, and prompted meaningful changes in how big companies do business.