September 8, 2023 – Culturelle Supplements Lawsuit Filed in California
The maker of Culturelle Probiotics Ultimate Balance for Antibiotics supplements has been hit with a proposed class action lawsuit in California.
The case, filed on September 7, 2023, alleges I-Health has violated federal regulations by marketing the supplements as able to treat or prevent infections caused by antibiotics without FDA approval to do so. According to the suit, these “deceptive” claims could mislead consumers into believing they can use the products to treat diseases without the supervision of a medical professional.
Read ClassAction.org’s write-up of the lawsuit here.
At A Glance
This Alert Affects:
California residents who purchased the Culturelle Probiotics Ultimate Balance for Antibiotics supplement.
What’s Going On?
Attorneys working with ClassAction.org are looking into whether the maker of the Culturelle Probiotics supplement made false claims about the product’s benefits or otherwise violated federal labeling laws. If so, it’s possible that a class action lawsuit could be filed on behalf of people who bought the probiotics supplement.
How Could a Lawsuit Help?
A class action lawsuit could help buyers get back some of the money they spent on the Culturelle Probiotics product and potentially force the manufacturer to change how the supplement is advertised.
Attorneys working with ClassAction.org are looking into whether the maker of Culturelle Probiotics Ultimate Balance for Antibiotics has made false or misleading claims about the supplement’s benefits.
It’s believed that statements on the product’s label and in advertisements – including that it can “rebuild bacterial balance lost to antibiotic use” – may have violated federal labeling guidelines and potentially misled consumers.
A class action is now being considered to help customers get some of their money back, but the attorneys first need to speak with more people who bought the Culturelle product.
Does Culturelle Make Unapproved Drug Claims?
Although all new drugs require approval from the U.S. Food and Drug Administration before they can be sold in the U.S., dietary supplements like Culturelle generally do not need FDA approval before they can be sold.
However, if a supplement makes certain claims about its ability to treat, prevent, cure or alleviate the symptoms of a disease, it falls under the Federal Food, Drug, and Cosmetic Act’s definition of a drug and must undergo the FDA’s testing and review process to ensure the product is safe and effective for its intended use.
It’s being investigated whether certain claims made by the maker of the Culturelle Probiotics Ultimate Balance for Antibiotics supplement – namely, that it can “rebuild bacterial balance lost to antibiotic use” and is “specifically formulated to rebuild bacterial balance during and after antibiotic use” – indicate that the product can be used to treat, prevent or cure disease.
Significantly, a footnote on the Culturelle website indicates that these statements and other health-related claims “have not been evaluated by the Food and Drug Administration.”
Some customers have complained in online reviews that the Culturelle Probiotics Ultimate Balance for Antibiotics product did not meet their expectations. Others called into question whether the supplement could live up to its advertised claims. A sample of these complaints can be seen below [sic throughout]:
…This is pretty disappointing. Culturelle touts the benefits of taking probiotics after a round of antibiotics (“Culturelle Ultimate Balance restores good bacteria lost to antibiotic use”), but most of the studies done on exactly that subject found no benefit. Further, according to the authors of The Good Gut, strains like Lactobacillus rhamnosus are transients that pass through your gut rather than making it their home. So the claim that Culturelle helps restore good bacteria lost to antibiotics is a stretch at best…” — 06/22/19 review, Amazon.com
Useless! Does not prevent yeast infection when taking an antibiotic!” — 10/09/19 review, Amazon.com
Haven’t noticed a difference” — 01/14/23 review, Amazon.com
[D]oes not help with diarrhea caused by antibiotics” — 07/12/19 review, Amazon.com
I still burped and my tummy still bloats after meals....” — 07/24/21 review, iHerb.com
I didn’t feel a lot of difference with me and it didn’t help me with constipation…” — 05/05/22 review, iHerb.com
How Could a Class Action Lawsuit Help?
If the Culturelle Probiotics product is being illegally advertised and labeled, a class action lawsuit could help buyers get back some of the money they spent on the supplement. It could also potentially force the company to change how it advertises the product.