Recalls & Warnings
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Posted November 10, 2020
FDA Warns Immusist for Drug Claims
On October 16, 2020, the FDA issued a warning letter to Immusist, LLC following a review of the company's website, which found statements made about the company's products IMMUSIST Original and IMMUSIST Natural to be drug claims.
These products were promoted with statements such as "IMMUSIST... was formulated by blending certain surfactants with characteristics such as Antivirals, Antifungals... and Antibacterials that can... reduce inflammation..." and "I found Immusist; it calmed the acid and took my heartburn away without the bad side effects."
In addition, IMMUSIST Original and IMMUSIST Natural were found to be misbranded because they do not contain adequate directions for safe use, as required by federal regulations.
The Immusist website also contains personal testimonials recommending or describing the use of Immusist products for the cure, mitigation, treatment, or prevention of diseases, including heartburn, cancer, diabetes, foot problems, lupus, migraines, mouth problems, multiple sclerosis, psoriasis, and rheumatoid arthritis.
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