# FDA WARNING_LETTER - Dr. Thomas Polucki Upper Cervical Chiropractic, Inc. - June 09, 2021

Source: https://www.keypedia.com/records/warning_letter/dr-thomas-polucki-upper-cervical-chiropractic-inc/f0fc9ba7-c95c-4d1a-ab10-1ee5614ab7b9

> FDA WARNING_LETTER for Dr. Thomas Polucki Upper Cervical Chiropractic, Inc. on June 09, 2021. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Dr. Thomas Polucki Upper Cervical Chiropractic, Inc.
- Inspection Date: 2021-06-09
- Product Type: Food
- Office Name: Center for Food Safety and Applied Nutrition
- Summary: On July 28, 2021, the FDA and FTC issued a Warning Letter to the company operating getbetterxshop.com and santaclaritachiropractor.com, following website reviews on June 2 and June 9, 2021. The letter addresses the sale of unapproved and misbranded products, Nitric Oxide Support and Melatonin, marketed with claims to mitigate, prevent, treat, diagnose, or cure COVID-19.

The FDA determined these products are unapproved new drugs under section 505(a) and misbranded drugs under section 502 of the FD&C Act, violating sections 301(a) and (d). Examples of violative claims include Nitric Oxide inhibiting coronavirus replication and Melatonin boosting immunity against COVID-19. The FTC also cited unsubstantiated claims on santaclaritachiropractor.com regarding chiropractic care and supplements providing an "immune boost" against COVID-19, violating the FTC Act.

The company must immediately cease selling unapproved COVID-19 products and making unsubstantiated claims. Within 48 hours, they must email COVID-19-Task-Force-CFSAN@fda.hhs.gov detailing corrective actions and documentation, and email rcleland@ftc.gov certifying cessation of unsubstantiated claims. Failure to comply may result in legal action, including seizure, injunction, civil penalties

## Related Officers

- [Program Division Director](https://www.keypedia.com/people/michael-w-roosevelt/136906d6-8e93-4080-acf9-5d48d4509a80)
- [Associate Director](https://www.keypedia.com/people/serena-viswanathan/7d1b292d-1f22-42ff-8452-0bc9673b8326)

Company: https://www.keypedia.com/companies/dr-thomas-polucki-upper-cervical-chiropractic-inc/786e07e8-31f2-43a7-9928-021cff0b0393

Office: https://www.keypedia.com/offices/center-for-food-safety-and-applied-nutrition/e04dc4e5-ee4f-4b0d-be8c-1139531ddab2