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Posted July 10, 2021

FDA Warns Seller of Omega XL

On June 31, 2021 the FDA issued a warning letter to Great Healthworks, Inc. following a review of the company's website, which found statements made about Omega XL and ProbioticXL supplements to be drug claims.

OmegaXL was promoted with statements such as "[S]hown to help relieve joint pain due to inflammation" and "OmegaXL is widely recognized as a leader in natural relief from pain due to inflammation." It has also been promoted as a "highly concentrated Omega-3 'Super Oil' supplement," although past ConsumerLab tests of the product found surprisingly little omega-3 fatty acids (EPA and DHA).

See ConsumerLab's answer to the question: What is Omega XL and does it work? and the section about OmegaXL in CL's Fish Oil and Omega-3 Supplements Review for more information about this product.

ProbioticXL was promoted with statements such as "Combats bad bacteria" and "Reduces harmful bacteria with its prebiotic — ClearPhage." In addition, the FDA warned that the product is a misbranded food because its labeling bears unauthorized health claims such as "Reduce cardiovascular disease risk factors together with Lactobacillus Rhamnosus and Lactobacillus Acidophilus."

See ConsumerLab's Probiotic Supplements Review for tests of related products.

The FDA advised Great Healthworks to notify the agency in writing within 15 working days of receipt of the warning letter letter the specific steps it has taken to address these violations.

For more information, use the link below.

WARNING LETTER : Great Healthworks, Inc.

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