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  5. Nutrishus Brands, Inc. - 612938 - 07/28/2021
  1. Warning Letters

WARNING LETTER

Nutrishus Brands, Inc. MARCS-CMS 612938 —

Product:
Drugs
Food & Beverages
Recipient:
Recipient Name
Steven Hanley
Recipient Title
CEO
Nutrishus Brands, Inc.

3475 Oak Valley Rd NE, Unit 2150
Atlanta, GA 30326
United States

Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)

United States

July 28, 2021

WARNING LETTER
(CMS# 612938)

Dear Mr. Hanley:

This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address https://therxsugar.comin May, 2021, and has determined that you take orders there for your products RxSugar, RxSugar Organic Liquid Sugar, and RxSugar Organic Pancake Syrup. 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. In addition, your products RxSugar, RxSugar Organic Liquid Sugar, and RxSugar Organic Pancake Syrup are misbranded within section 403 of the Act.

As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.

Unapproved new drugs

Examples of website claims that provide evidence that your products are intended for use as drugs include:

All products:

“ . . . [the ingredient] allulose may benefit people suffering from obesity, diabetes . . . Additionally, it may haveantioxidant [sic] properties that reduce inflammation.”

“Allulose . . . has potential anti-obesity and antidiabetic properties. Allulose may also lower the risk of heartdisease [sic] . . . “

Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. 321(p)]. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.

A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.

Your products RxSugar, RxSugar Organic Liquid Sugar, and RxSugar Organic Pancake Syrup are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. 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)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. 331(a)].

Misbranded foods

Even if your RxSugar, RxSugar Organic Liquid Sugar, and RxSugar Organic Pancake Syrup were not unapproved new drugs, they would be misbranded foods, as follows:

1. 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). If “RxSugar” is being used as a fanciful name, it cannot be used in lieu of a common or usual name in accordance with 21 CFR 101.3(b).

2. 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. Your website therxsugar.com, from which your products are sold, bears claims for the products such as “Healthiest” and “Healthy.” However, these products do not meet the requirements for the implied nutrient content claim “healthy” as defined in 21 CFR 101.65(d)(2). This regulation requires, in part, that a product bearing the claim “healthy” must contain at least 10 percent of the Daily Value per RACC of one or more of vitamin A, vitamin C, calcium, iron, protein, or fiber.

In our Guidance, “Use of the Term “Healthy” in the Labeling of Human Food Products” at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-use-term-healthy-labeling-human-food-products, we stated that we intend to exercise enforcement discretion with respect to the current requirement that any food bearing the nutrient content claim “healthy” contain at least ten percent of the Daily Value (DV) per reference amount customarily consumed (RACC) of vitamin A, vitamin C, calcium, iron, protein, or fiber, if the food instead contains at least ten percent of the DV per RACC of potassium or vitamin D. However, based on the nutrition information listed on your website, none of these products contain any vitamin A, vitamin C, calcium, iron, protein, fiber, potassium or vitamin D.

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). Specifically, the quantitative information comparing the level of the nutrient per labeled serving size with that of the reference food that it replaces must be declared adjacent to the most prominent claim or to the nutrition label, except that if the nutrition label is on the information panel, the quantitative information may be located elsewhere on the information panel in accordance with §101.2 (21 CFR 101.60(b)(4)(ii)(B)).

3. 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). The appropriate category for this product is “Sugars and Sweets, Syrups,” which has a RACC of 30 mL for all syrups and a serving size of 2 tbsp (30 mL). However, the product’s Nutrition Facts label shown on your website’s product page lists a serving size of 1 Tbsp (15g).

The above violations are not intended to be an all-inclusive list of violations that exist in connection with the food you manufacture or have manufactured for you. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure your firm complies with all requirements of federal law and implementing regulations. You should take prompt action to address any violations. Failure to promptly address these violations may result in enforcement action by FDA without further notice, including seizure and/or injunction.

We have the following additional comment regarding this product’s Nutrition Facts label:

Additionally, we question whether the serving size for the RxSugar 1 Pound Canister is appropriate. The RACC for sugar is 8 g and the RACC for sugar substitute is “[a]n amount equivalent to one reference amount for sugar in sweetness.” As we stated in the Guidance for Industry: The Declaration of Allulose and Calories from Allulose on Nutrition and Supplement Facts Labels (https://www.fda.gov/regulatoryinformation/search-fda-guidance-documents/guidance-industry-declaration-allulose-and-calories-allulosenutrition-and-supplement-facts-labels), the available evidence submitted in comments on the guidance indicates that allulose is approximately 70 percent as sweet as sucrose. According to the ingredient statement, this product is 100% allulose, so the serving size would be more than 8 g to achieve the same sweetness as sugar. The product’s nutrition information lists a serving size of “1 Tsp. (4g)” and the “Frequently Asked Questions” section of the website stated that “1.25 cups of RxSugar = 1 cup of Refined Sugar.”

We recommend you review FDA’s guidance for declaration of calories from allulose, The Declaration of Allulose and Calories from Allulose on Nutrition and Supplement Facts Labels: Guidance for Industry, available at https://www.fda.gov/media/123342/download. The guidance recommends the use of a general factor of 0.4 calories per gram (kcal/g) for allulose when determining “Calories” on the Nutrition Facts label. For example, with the correct serving size of 2 Tbsp (30 g) for the syrup product, using 0.4 calories per gram, the calorie content would be 10 calories per serving. Therefore the “0 Calories” claim and 0 Calorie declaration in the NFL do not appear to be accurate for the syrup product. As mentioned above, we question whether the serving sizes for the other products addressed in this letter are correct. The 0 calorie claims should be reviewed once the serving sizes are confirmed to verify that the calorie claims are still truthful.

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.

You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should include the specific things you are doing to address these violations. You should include in your response documentation and information that would assist us in evaluating your corrections and plans to prevent recurrences. If you believe you have complied with the Act, include your reasoning and any supportive information for our consideration. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations.

Your written reply should be directed to Ms. Seri Essary, Compliance Officer, United States Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Drive, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835. If you have any questions, you may also contact Ms. Essary at CFSANResponse@fda.hhs.gov. Please include “CMS 612938” in the subject line of your email.

Sincerely,
/S/

Michael W. Roosevelt
Acting Director
Office of Compliance
Center for Food Safety and Applied Nutrition

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