FDA WARNING_LETTER - Great HealthWorks, Inc. - June 23, 2021

The FDA issued a Warning Letter to Great HealthWorks, Inc. following a May 2021 review of their website, which revealed that their products, ProbioticXL and OmegaXL, are marketed with claims that establish them as unapproved new drugs. Claims for ProbioticXL, such as combating bad bacteria, reducing abdominal pain, and alleviating inflammation, and for OmegaXL, including relieving joint pain due to inflammation, indicate their intended use in the cure, mitigation, treatment, or prevention of disease. These products are not generally recognized as safe and effective for such uses, classifying them as "new drugs" under 21 U.S.C. § 321(p), and their introduction into interstate commerce without FDA approval violates 21 U.S.C. §§ 331(d) and 355(a). Additionally, ProbioticXL is deemed a misbranded food under 21 U.S.C. 343(r)(1)(B) due to unauthorized health claims, specifically regarding the reduction of cardiovascular disease risk factors. Great HealthWorks is required to respond in writing within 15 working days, detailing corrective actions taken, plans to prevent recurrence, and supporting documentation. Failure to adequately address these violations may lead to legal action, including product seizure and injunction.