Pomegranate Consulting, LLC started selling a “COVID Test Package” for the home in Spring 2020.
According to his advertisement,
“COVID-19 Home Tests. . . Whether you are currently sick and wondering, or have been sick but recovered, or suspected of exposure to someone who is sick, this FDA-registered test can put your mind at ease right away, from the comfort of your home . “
The only problem, according to the FDA, was that Denver-based Pomegranate Consulting was not truthful in its advertising. The home test kit maker, a Georgia-based company, had notified the FDA that it had developed and validated this test. When the agency felt the product should no longer be used, the manufacturer removed the kit from sales and distribution, according to the FDA website. That was in July; The FDA notified pomegranate shortly thereafter and again on September 15.
In an interview with Medical Daily, a Pomegranate executive, who asked for anonymity, said that when Pomegranate found out about the rapid COVID-19 test, he believed the test would benefit his clients at the naturopathic clinic.
However, shortly after the product was released, the company received a warning letter from the FDA explaining how the product was falsely advertised, not credible, and not FDA approved.
Pomegranate is just one of many companies that have been overseen by the FDA claiming that their products prevent or treat COVID-19 but do not meet FDA regulations.
Since the pandemic began in March, the agency has issued 120 warning letters related to COVID-19, an FDA spokesman told Medical Daily.
An FDA press release said the agency recently partnered with the Federal Trade Commission to issue warning letters to companies selling essential oils, teas, tinctures and more.
The FDA sends out warning letters when companies violate regulations, misrepresent the intent of their product, or spread misinformation related to health and safety. The warning letters are intended to help consumers identify false advertising.
According to the warning letter for this kit, the FDA wrote that the company was shipping test packs without regulatory approvals or approvals. The company was also accused of misbranding for failing to notify the FDA of its plans to sell the product. The FDA frowns at home COVID testing for a few reasons, least of all due to the test-taker’s ability to properly perform the test.
The pomegranate manager said that as soon as he received the letter from the FDA, the product was withdrawn from commercial distribution.
Warning letters state that companies must fix the problem and provide instructions and a time frame for resolving the issues. The FDA will then examine whether the corrections are appropriate, the FDA spokesman said.
As for consumers, in order to protect themselves from false advertising related to COVID-19, the FDA advises avoiding products that allegedly treat a variety of diseases that advertise personal testimonials to replace scientific evidence, or Quickly “announce fixes” for the global pandemic.
Lara Becker is an intern at Medical Daily and a senior at the College of New Jersey. She is studying journalism / professional writing and communication studies.