Lawsuit Investigation into Boric Acid Suppository Products

Attorneys working with ClassAction.org are looking into whether certain boric acid suppositories were illegally sold without approval from the U.S. Food and Drug Administration (FDA)—and whether class action lawsuits can be filed against the manufacturers.

They believe that these products, which are marketed as able to balance vaginal pH levels and treat and prevent infections, may qualify as drugs under federal law yet have not undergone the FDA’s strict testing and approval process to ensure that they are safe and effective for their intended use.

[UPDATE] As of April 11, 2024, the attorneys working with ClassAction.org only need to speak with those who purchased the pHresh products listed on this page.

[UPDATE] As of February 14, 2024, attorneys working with ClassAction.org are only investigating potential claims related to the Cora, Loyal Body and pHresh products listed above. 

Are Boric Acid Suppositories FDA Approved?

Boric acid suppositories are marketed as homeopathic products, which are not subject to the FDA’s stringent approval process for drugs. The purpose of the FDA’s approval process is to ensure that new drugs are effective and safe—meaning their benefits outweigh any known risks, such as side effects. New drugs, including both prescription and over-the-counter products, must be extensively tested prior to approval, and many of them require an FDA-approved label to ensure that users are provided with necessary directions for use and warnings about potential side effects and risks.

Under federal law, the definition of a “drug” requiring FDA approval includes products that are intended to diagnose, cure, mitigate, treat or prevent disease or affect the structure and function of the body. Depending on how they are marketed, boric acid suppositories could potentially fall under this definition.

In fact, in a warning letter sent to the maker of a certain boric acid suppository, the FDA noted that statements on the company’s website—including that the suppository could reduce vaginal irritation, discomfort and itch; “restore balance” to vaginal pH levels; and “may assist in treating” bacterial vaginosis and yeast infections—suggest that the product is a drug. The agency warned that the company was selling a product that is not generally recognized as safe and effective for its intended use and had not been approved by the FDA. The letter also stated that the suppository was misbranded because it did not have adequate directions for use.

Boric Acid Suppository Side Effects

FDA-approved labels for drugs often include information about risks and side effects, but these may not be listed on the packaging for unregulated homeopathic medicines like boric acid suppositories.

Because boric acid suppositories are not FDA approved and can come with certain risks and potentially harmful side effects, experts warn that patients should consult a healthcare professional before using them to treat vaginal health problems. Patients are also advised to call their doctor if their symptoms become worse or they experience a vaginal burning sensation or high fever after using a boric acid suppository.

How a Class Action Lawsuit Could Help

If filed and successful, a class action lawsuit could help consumers get back some of the money they spent on boric acid suppositories. It could also potentially order the manufacturer to stop selling an unapproved drug that has not received required testing for safety and efficacy.

Before commenting, please review our comment policy.