Great Healthworks, Inc.

Warning LetterClosed

Mr. Ken Meares Chief Executive Officer Great Healthworks, Inc. 4150 SW 28th Way Fort Lauderdale , FL 33312-5201 United StatesFEI 3009677375Issued Jun 23, 2021Office of Human and Animal Food Operations, Division IV East

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3009677375.

Violations0

Issue DateJun 23, 2021

Product TypeDrugs

StatusClosed

Closeout LetterFeb 2, 2022

Letter Details

Firm: Great Healthworks, Inc.
Location: Mr. Ken Meares Chief Executive Officer Great Healthworks, Inc. 4150 SW 28th Way Fort Lauderdale , FL 33312-5201 United States
FEI Number: 3009677375
Country: United States
Issue Date: June 23, 2021
Issuing Office: Office of Human and Animal Food Operations, Division IV East
Product Type: Drugs
Status: Closed
Closeout Letter: February 02, 2022

Summary

Great Healthworks, Inc. was cited for marketing ProbioticXL and OmegaXL as unapproved new drugs based on disease claims made on their website, including statements that the products "reduce harmful bacteria," "inhibit yeast growth," "reduce abdominal pain," and "reduce the risk factors of cardiovascular disease." These claims established the products as drugs under the Federal Food, Drug, and Cosmetic Act rather than dietary supplements or foods, since they were intended for the cure, mitigation, treatment, or prevention of disease. The company was also cited for misbranding because even if ProbioticXL were not an unapproved new drug, it would violate labeling requirements as a misbranded food. The FDA inspection of the company's website in May 2021 identified multiple therapeutic claims across product pages that constituted violations of federal law.

Great Healthworks, Inc. FDA Warning Letter, June 23, 2021