Attorney General Phil Weiser tells businesses to stop illegally marketing COVID-19 tests that are not approved by the FDA

May 1, 2020 (DENVER, Colo.)—Attorney General Phil Weiser has sent cease and desist letters to three businesses that marketed tests for COVID-19 infection or immunity and overstated the reliability and accuracy of the tests.

According to the Food and Drug Administration, companies may distribute tests that are not FDA approved to identify antibodies to the virus that causes COVID-19. The FDA, however, has clearly stated that all unapproved antibody tests should be accompanied by appropriate disclosures, including that the tests should not be used as the sole basis to diagnose or exclude COVID-19 infection, and that positive results may be due to past or present infection with a different coronavirus strain. Additionally,  some antibody tests are unreliable and it is still unclear whether and to what extent COVID-19 antibodies provide immunity for those who have recovered from COVID-19.

“There are COVID-19 tests on the market and not all of them are FDA approved. 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. These misrepresentations can endanger individuals and public health as well as lead consumers to pay for non-existent benefits. To protect Coloradans, we directed these companies to stop their misleading marketing tactics.”

The companies that were served with a cease and desist letter include:

  • Zvia Weight Loss and MedSpa, a Lakewood-based weight loss clinic, for offering an at-home test for COVID-19 and falsely claiming that the test is FDA approved.
  • Functional Medicine Center of Fort Collins and Red Tail Wellness Centers in Boulder for misleadingly advertising blood tests that they claimed would reveal whether a person has recovered from COVID-19 and has antibodies that provide immunity to the virus. In an online ad, Functional Medicine Center falsely claimed that the antibody test is FDA approved.
  • Functional Medicine Center of Fort Collins and Red Tail Wellness Centers both overstated the reliability of the antibody test they sold, which is manufactured and distributed by Vibrant America. On Facebook posts and YouTube videos, the companies failed to adequately disclose that the antibody test, which has not been approved by the FDA, may not be reliable.

Weiser advises consumers to talk to their primary physicians about COVID-19 tests, and to visit the websites of the FDA (fda.gov) and the Centers for Disease Control and Prevention (cdc.gov).

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Contact: Lawrence Pacheco

Director of Communications

Mobile: (720) 245-4689

lawrence.pacheco@coag.gov