FDA WARNING_LETTER - jlm nutritionals, inc. - May 26, 2021

The FDA issued a Warning Letter to Super Naturals Health on May 26, 2021, following a review of their websites (supernaturalshealth.com, ibsformula.com), Amazon pages, and Facebook pages in May 2021. The FDA determined that the company's products—Super Naturals brand IBSolution, Premium Probiotic, Sleep Solution, Joint Solution, and Ultra Omega Fish Oil—are unapproved and misbranded new drugs.

The FDA cited numerous claims on the company's online platforms that establish the products' intended use for the cure, mitigation, treatment, or prevention of diseases, thus classifying them as drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B)]. Examples of such claims include "Designed to relieve Irritable Bowel Syndrome (IBS) symptoms," "Probiotics are proven to reduce the severity of diarrhea," "Helps improve insomnia," "All-natural joint pain relief with anti-inflammatory ingredients," and "Omega-3 Fatty Acids are proven to improve heart health." Testimonials also supported these drug claims.

Since these products are not generally recognized as safe and effective for their intended uses, they are considered "new drugs" under section 201(p) of the Act [21 U.S.