Anyone who purchased certain boric acid suppository products within the past four years.
What’s Going On?
Attorneys working with ClassAction.org believe some boric acid suppositories may have been illegally sold without being approved by the FDA. They’re now looking into whether class action lawsuits can be filed on behalf of people who purchased these products.
How Could a Lawsuit Help?
Class action lawsuits could help consumers get back some of the money they spent on these suppositories and potentially force the manufacturers to ensure that their products receive required testing and approval.
What You Can Do
If you bought a boric acid suppository from one of the brands listed below, fill out the form on this page to help the investigation.
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.
As part of their investigation, the attorneys want to speak with people who purchased the following boric acid suppository products:
AZO Boric Acid Suppositories
Love Wellness – The Killer Boric Acid Suppositories
The Honey Pot Company – Boric Acid & Herbs Suppositories and Applicator
Cora – The Balancing Boric Acid Suppository
NewLife – Boric Acid Vaginal Suppositories
NutraBlast – Boric Life Boric Acid Suppositories
BoriCap Pharmaceutical-Grade Boric Acid Suppositories by Heale
Pelvana – Boric Acid 600mg Vaginal Suppositories
Intimate Rose – Boric Balance Suppositories
pHresh – Boric Acid Vaginal Suppositories
Loyal Body – Boric Life Boric Acid Suppositories
[UPDATE] As of February 14, 2024, attorneys working with ClassAction.org are only investigating potential claims related to the Cora and Loyal Body products listed above.
If you bought one of these products within the past four years, fill out the form on this page to share your story. You may be able to help get a class action lawsuit started.
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.
What You Can Do
If you bought either the Cora or Loyal Body products listed above within the past four years, fill out the form on this page to help the investigation.
After you get in touch, an attorney or legal representative may reach out to you directly to explain more about what’s involved with filing a class action lawsuit. It costs nothing to fill out the form or speak with someone about your options, and you’re not obligated to take legal action if you don’t want to.