March 9, 2021

FDA warns Joseph Mercola on COVID-19 claims

FDA warns Joseph Mercola on COVID-19 claims


Those of you following the arena of unproven stem cells might recognize the name Dr. Joseph Mercola. He’s a promoter of alternative medicine. Over the years his name has also popped related to the marketing of unproven stem cell offerings in various ways.

Now the FDA has warned Joseph Mercola on what it says are unapproved and misbranded COVID-19 drug products.

FDA warns Joseph Mercola on COVID-19 claims
Joseph Mercola and promotion of unproven stem cells. Screenshot from Facebook.

Joseph Mercola and past promotion of unproven stem cells

FDA warns Joseph Mercola on COVID-19 claims
Joseph Mercola, D.O.

In the past Mercola has at times promoted what in my opinion are highly dubious claims about stem cell interventions. For instance, you can see a screenshot above from his Facebook page on a story he wrote about the supposed wonders of stem cells. I see it in part as promotion of U.S. Stem Cell (more below). Note the use of the word “can” in the title there. This suggests there is no doubt that these unproven stem cells are effective. The data don’t back that up.

Kristin Comella of U.S. Stem Cell also went on his show talking about her firm’s offerings.  To see the video you’ll have to register on Mercola’s site because it longer seems available on YouTube. Note that U.S. Stem Cell at present is under a permanent injunction from the FDA/DOJ while it appears the ruling in a federal discount court case against it.

Science Based Medicine has a whole library of posts related to Mercola if you want more background.

However, more recently, Mercola at least for a moment in time seemed to go the other direction on unproven stem cells. Mercola and his partner Erin Elizabeth made appearances in a striking stem cell expose movie, From Jail Cell to Stem Cell. They in a sense recounted how bad some of the stem cell clinics out there are and disavowed those.

Isn’t that a little late? Plus, if you feel that strongly, why is your promotional post about Comella and U.S. Stem Cell still up on your website?

The new FDA warning letter to Mercola

He seems more focused these days on COVID-19 than some of his past interests.

Getting back to the new action by the FDA against Mercola, the agency noted several products that Mercola has promoted to supposedly help COVID-19. From the FDA letter:

“The FDA has observed that your website offers “Liposomal Vitamin C,” “Liposomal Vitamin D3,” and “Quercetin and Pterostilbene Advanced” products for sale in the United States and that these products are intended to mitigate, prevent, treat, diagnose, or cure COVID-191 in people. Based on our review, these products are unapproved new drugs sold in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 2pt1 U.S.C. § 355(a). Furthermore, these products are misbranded drugs under section 502 of the FD&C Act, 21 U.S.C. § 352. The introduction or delivery for introduction of these products into interstate commerce is prohibited under sections 301(a) and (d) of the FD&C Act, 21 U.S.C. § 331(a) and (d).”

The agency notes these are unapproved drug products. They also assert that the products are misbranded and have been introduced into interstate commerce. These allegations taken together are a very big deal.  In my opinion, should Mercola continue to market these after this warning, the FDA could escalate things.

Mercola replies to FDA allegations

However, in a quote to Kristina Fiore of MedPage Today, Mercola’s team is not backing down:

In a statement to MedPage Today, Mercola’s media team said the physician has published papers on the link between vitamin D deficiency and severe COVID, and that he is “committed to providing truthful information and having a rigorous scientific debate.”

“We have fully addressed the warning letter and put FDA on notice that it cannot stop speech it does not like,” the statement said.

It’s unclear what will happen next here.

More broadly, the FDA and FTC have both stepped up actions on questionable COVID-19 claims.

In the stem cell clinic and unproven regenerative therapy arena alone, the FDA has issued many cautionary letters related to COVID-19.

References

  1. FDA statement on injunction against US Stem Cell
  2. FDA Warns Mercola for Selling Bogus COVID Treatments, MedPage Today, Kristina Fiore, March 5, 2021.
  3. Variety of Science-Based Medicine posts related to Mercola and his partner, Science Based Medicine.
  4. Patient lawsuits, federal investigations and a ‘virtual’ PhD: Inside a would-be stem cell empire, Michael Hiltzik, LA Times.



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