Nutrishus Brands, Inc.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

The claims on your website establish that your products are 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)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease.

Passage 2

Accordingly, your RxSugar, RxSugar Organic Liquid Sugar, and RxSugar Organic Pancake Syrup fail to bear adequate directions for their intended uses and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)].

Passage 3

Your RxSugar and RxSugar Organic Liquid Sugar products are misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] in that the product labels fail to bear the common or usual name of the foods, which is allulose, as required by 21 CFR 101.3(b)(2).

Passage 4

Your RxSugar, RxSugar Organic Liquid Sugar, and RxSugar Organic Pancake Syrup products are misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. 343(r)(1)(A)] because their labeling bears nutrient content claims, but the products do not meet the requirements to bear the claim.

Passage 5

Further, your website labeling bears the claim “90% less Calories than Traditional Sugar” in the “Frequently Asked Questions” section. This is a comparative statement between the firm’s products and sugar. As such, it is a relative claim for calorie content that must comply with the requirements in 21 CFR 101.60(b)(4).

Passage 6

Your product RxSugar Organic Pancake Syrup is misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition information (e.g. Nutrition Facts label or NFL) does not comply with the requirements of 21 CFR 101.9, in that the serving size and nutrition information is not based on the correct Reference Amount Customarily Consumed (RACC).

Passage 7

The RxSugar Organic Liquid Sugar and RxSugar Organic Pancake Syrup products use a simplified Nutrition Facts label format that is not in accordance with 21 CFR 101.9(f)(4). Because the product label and website labeling bear nutrition claims, the statement “Not a significant source of ____” (with the blank filled in with the name(s) of any nutrient(s) identified in 21 CFR 101.9(f) that are present in insignificant amounts) must be included at the bottom of the Nutrition Facts label.