Attorney General Phil Weiser’s office has sent cease-and-desist letters to three businesses that he alleges were marketing COVID-19 tests using misleading or unproven claims.
“Unfortunately, some Colorado companies have falsely claimed that tests they administer are FDA approved, and other companies are overstating the reliability and benefits of the unapproved tests they offer,” Weiser said. “It is a violation of the Colorado Consumer Protection Act to falsely claim these tests are FDA approved or to withhold details about the known limitations of the tests.”
The U.S. Food and Drug Administration has given limited permission, known as emergency use authorization, for tests used to identify COVID-19 antibodies to determine if someone was exposed to the coronavirus. In the early infection period, people still build up antibodies in their blood, which may go undetected in a test. Therefore, the agency advises against using such tests as the “sole basis” for determining exposure, and it is unaware of any antibody tests that can diagnose COVID-19.
In a letter to Zvia Weight Loss & Medspa LLC in Lakewood dated April 23, assistant attorney general Jonathan A. Helfgott accused the company of “knowingly or recklessly making a false representation” about FDA approval, characteristics or benefits of its home testing kits. Zvia’s website advertises that the product “allows you to avoid overcrowded clinics, hospitals, long waits and risks of exposure.”
The home test kits cost $149 and Zvia acknowledges that the FDA has not reviewed them. The company repeats the FDA’s finding that the antibody test alone should not determine whether a person was infected, and that negative test results “do not rule out” an infection. It also discloses that the test is awaiting an emergency use authorization.
A similar advisement to Functional Medical Center of Fort Collins included the claims of misleading marketing tactics, but also a charge of “making false or misleading statements concerning the cost to Functional Medical Center of any antibody test, Functional Medical Center’s overhead, and/or the profit or loss realized by Functional Medical Center for administering any such test.” As of Friday, there appeared to be no mention of a test on the center’s website.
"My marketing team made an error on the verbiage they used and it was removed," said Ben Galyardt, the center's CEO and founder. "We have decided to only offer antibody testing to our current patients as we are able to go back to our regular practice and continue helping people as we always have."
The third and final letter went out to Red Tail Wellness Centers LLC of Boulder. "The type of test you receive is extremely important and you should be highly suspicious of any online offers," the company wrote on its website. The $240 "Coronavirus Care package" is an antibody test that the center advertises as "especially important" for those with underlying health conditions or who are pregnant.
In all three communications, Helfgott pointed out that violations of the Colorado Consumer Protection Act carry a fine of up to $20,000 per instance, or up to $50,000 if a victim is 60 years or older.
Thomas P. Higgins, the CEO of Zvia, responded that he, along with everyone, is still trying to gain an understanding of the disease and how to respond to it.
“I cannot stress enough that we are just trying to help during these times,” he said. Higgins said that Zvia, normally a medical weight-loss and spa company, wanted to assist with COVID-19 response and identified a testing shortage as the biggest problem. The company primarily tested medical workers early in the pandemic and recently received money through the federal Paycheck Protection Program to retain two of its employees.
“We would never jeopardize our reputation," Higgins said. “We are a small company and outsource the management of our webpage. The issue the attorney general had was with the language associated with the tests we were using.”
He added that the website misidentified the test as having FDA authorization, when in reality it was the lab equipment that did.