FDA WARNING_LETTER - Nutrishus Brands, Inc. - July 28, 2021

The FDA issued a Warning Letter to RxSugar on July 28, 2021, following a May 2021 review of their website, therxsugar.com. The FDA determined that RxSugar, RxSugar Organic Liquid Sugar, and RxSugar Organic Pancake Syrup are unapproved new drugs and misbranded foods.

The products are deemed unapproved new drugs because website claims, such as "allulose may benefit people suffering from obesity, diabetes" and "may have antioxidant properties that reduce inflammation," establish their intent for use in disease treatment or prevention. These products are not generally recognized as safe and effective for these uses, making them "new drugs" requiring prior FDA approval. Additionally, they are misbranded as drugs under 21 U.S.C. 352(f)(1) because they lack adequate directions for use by a layperson, as the diseases they claim to treat are not amenable to self-diagnosis or treatment.

Even if not unapproved drugs, the products are misbranded foods. RxSugar and RxSugar Organic Liquid Sugar fail to bear the common or usual name "allulose" on their labels (21 CFR 101.3(b)(2)). All three products bear unauthorized nutrient content claims like "Healthiest" and "Healthy" but do not meet the requirements of 21 CFR 101.65(d)(2) for such claims, lacking sufficient amounts of required