The Food and Drug Administration issued a warning letter to a Newhall-based chiropractor regarding unapproved and misbranded drugs being listed on his website as ways to “mitigate, prevent, treat, diagnose, or cure COVID-19 in people.”
In the letter sent last month by the FDA, Dr. Thomas Polucki, of Dr. Thomas Polucki Cervical Chiropractic Inc., was issued a warning for his website offering nitric oxide support and melatonin products and “misleadingly” representing them as safe and/or effective for the treatment or prevention of COVID-19, according to the FDA letter.
While the products remained listed on the website as of Tuesday, their pages on Polucki’s website no longer mention the coronavirus or COVID-19.
Polucki could not be reached for comment as of the publication of this article.
Polucki would have had 48 hours to respond in an email to the FDA’s COVID-19 Task Force telling them the exact steps he had taken to right the misleading information given on his website surrounding these products, according to the letter sent by the FDA.
“You should take immediate action to address the violations cited in this letter,” it reads. “This letter is not meant to be an all-inclusive list of violations that exist in connection with your products or operations.”
The letter goes on to make a cease-and-desist demand to Polucki because federal law states that if you wish to advertise a product, you must provide scientific evidence and/or competent studies supporting your statements.
For COVID-19, no such study is currently known to exist for the products identified above. Thus, any coronavirus-related prevention or treatment claims regarding such products are not supported by competent and reliable scientific evidence, according to the FDA.
The letter concludes by saying that the website santaclaritachiropractor.com, a site also run by Polucki, uses anecdotal evidence to support his products as opposed to peer-reviewed scientific evidence.
One blog post, which appears to be no longer listed on the site, discussed a client becoming “COVID proof” on a cruise ship that she and her husband were on in February 2020.
While the husband tested positive, the client, “Jeri,” noted she was never sick from the virus or tested positive for the antibodies. While no peer-reviewed studies have yet been released making someone COVID-19-proof — even with the vaccinations — Polucki offered a solution to the question.
“So what is so different about Jeri? .. [I]f you act more like her you, too, could have the same immune boost that kept her COVID proof. And that immune boost is not as hard as you might think…. So what’s Jeri’s secret? Even though Jeri promotes her relationship with upper cervical chiropractic care… And the immune-boosting supplements she takes… None of that ever made any news story,” said the FDA letter’s transcription of content from Polucki’s website.
The claims resulted in the FDA demanding their removal from the chiropractor’s website within 48 hours due to them being “unsubstantiated claims” or face a $43,792 civil penalty per violation.
