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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.