Among the many urgent priorities it faces during the pandemic, the FDA is devoting substantial resources to monitoring fraudulent COVID-19 products, issuing two dozen warning letters in May — including, for the first time, one to a company selling a fake vaccine.
To date, the agency has posted 64 COVID-19-related warning letters. It issued most of the warnings in April and May and expects to maintain that level of surveillance.
The agency will “continue to actively monitor” companies engaging in COVID-19-related fraud, an FDA spokesperson said, acknowledging that the already stretched thin FDA is devoting significant resources to combating an unprecedented surge in fraudulent COVID products.
The FDA warned North Coast Biologics for marketing its “nCoV19 spike protein vaccine” on its website and on social media. The Seattle, Wash., company and its owner used Facebook to advertise the product and to falsely represent it as safe and effective, the agency said.
“I have boosted myself five times with my vaccine and I have a screaming antibody titer to the spike protein,” Johnny Stine, founder of North Coast Biologics, said on Facebook.
Stine also posted about his immune response to the vaccine on his Facebook page. “I have ~50 different target-specific IgG’s to COVID19 vaccine that I made. This is not even after one boost — just one dose of vaccine,” he said.
The company’s Facebook page has since been taken down and its website no longer lists the product.
In April, the agency warned a self-described church for selling an unapproved new drug, Miracle Mineral Solution (MMS), as a COVID-19 treatment. When combined with an accompanying activator, the product has a chlorine dioxide content on par with industrial bleach, the FDA warned. The Genesis 2 Church is still offering the product on its website, in return for a donation, despite a federal judge entering a temporary junction against the firm.
Read the North Coast Biologics warning letter here: www.fdanews.com/06-01-20-NorthCoastBiologicsWL.pdf.
Read the Genesis 2 Church warning letter here: www.fdanews.com/06-01-20-Genesis2ChurchWL.pdf. — James Miessler