A Utah-based marketer of herbal supplements and its two owners have agreed to settle a government lawsuit that alleged they made claims on their website that some of their products could treat or prevent diseases.
The U.S. Department of Justice (DOJ) complaint further alleged the products were misbranded drugs since their labeling did not include sufficient directions for use.
Under a consent decree of permanent injunction, Grandma’s Herbs Inc., Kevin Parr and Tracey Parr must stop manufacturing, processing, labeling, holding or distributing any drug—including any products they claim can cure or treat a disease—until they obey federal law, DOJ announced Wednesday in a news release.
If FDA determines the defendants have failed to comply with a provision of the court order or have violated the Federal Food, Drug & Cosmetic Act (FDCA) and its implementing regulations, the agency may notify them of their noncompliance and order them to take appropriate corrective action.
Such action may include, for example, a directive to stop manufacturing any drugs, recall such products, issue a safety alert and take any corrective actions that FDA considers necessary to comply with the court order, FDCA or its implementing regulations.
History of alleged violations
The defendants allegedly claimed, among other things, that some of their products possess antimicrobial and antiviral capabilities, prevent heart disease or treat urinary tract infections (UTIs), allergies, epilepsy and ulcers. The defendants made impermissible marketing claims for such herbs as devil’s claw (Harpagophytum procumbens), echinacea, goldenseal root (Hydrastis canadensis) and reishi mushroom (Ganoderma lingzhi), according to DOJ’s lawsuit.
The recently filed complaint seeking a permanent injunction didn’t come out of the blue: The defendants were repeatedly warned about the drug claims, according to DOJ.
In 2017, following a review of the company’s website, FDA warned the defendants in a letter that certain of their products were unapproved and/or misbranded drugs—and failure to correct the alleged violations could result in enforcement action. In the warning letter to Kevin Parr, the president and co-owner of Grandma’s Herbs, FDA provided several examples of website claims that purportedly showed the defendants’ products were intended for use as drugs.
“I am very excited with the results I have received from herbs,” one testimonial quoted by FDA stated. “I have been a Diabetic for 28 years and was diagnosed with Amyotrophic Lateral Sclerosis, ALS, or Lou Gehrigs Disease about a year and a half ago. Diabetic Neuropathy was very advanced in my feet….My brother, Bert S Leany, suggested that I use Cayenne (http://www.grandmasherbs.com/daily-herbal-vitamins-minerals/cayenne.html) to stop the bleeding in my eye when I was losing the sight in it due to complication of surgery following a detached retina...I have partially regained the feeling in my feet.”
The defendants failed to respond to FDA’s warning letter, according to DOJ’s lawsuit. The following year, during an inspection of defendants’ establishment, an FDA investigator mentioned to “Kevin Parr the continued presence of disease claims on the company’s website, grandmasherbs.com and in other labeling (e.g., leaflets that defendants distribute with their products), many of which were the same or similar to those cited in the warning letter,” DOJ proclaimed.
Although Kevin Parr suggested the claims would be corrected, and he subsequently responded to FDA in writing, his response failed to address the disease claims, the complaint alleged.
DOJ filed its lawsuit on Oct. 18, and the consent decree appears to have been signed by U.S. District Judge David Nuffer two days later.
Saint George-based Grandma’s Herbs has been in business since 1978, according to its website. The company did not immediately respond to an emailed request for comment.
“The FDA’s action is aimed at protecting consumers who unknowingly put their health at risk by using products with claims to cure, treat or prevent a serious illness,” Judy McMeekin, FDA’s associate commissioner for regulatory affairs, said in DOJ’s news release. “We urge consumers to seek proven treatments recommended by licensed health care professionals. We previously warned this manufacturer, but they continued to make claims that their products could treat or prevent serious diseases. We took action to protect consumers.”