Gluten Free Remedies LLC

WARNING LETTER Gluten Free Remedies LLC MARCS-CMS 687832 — April 15, 2025 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Email Product: Dietary Supplements Recipient: Recipient Name Alex Shikhman Recipient Title CEO/Founder Gluten Free Remedies LLC 4125 Sorrento Valley Boulevard Ste A San Diego , CA 92121 United States info@glutenfreeremedies.com Issuing Office: Human Foods Program United States WARNING LETTER April 15, 2025 CMS #687832 Dear Mr. Shikhman, This letter concerns your product Sulbutiamine Plus Brain Support, which is labeled as a dietary supplement. As explained further below, introducing or delivering this product for introduction into interstate commerce violates the Federal Food, Drug, and Cosmetic Act (the Act) because this product is a misbranded dietary supplement. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov. The label of your product Sulbutiamine Plus Brain Support declares sulbutiamine as a dietary ingredient; however, sulbutiamine is not a dietary ingredient. Under section 201(ff)(1) of the Act [21 U.S.C. § 321(ff)(1)], a dietary ingredient is a vitamin; a mineral; an herb or other botanical; an amino acid; a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of any dietary ingredient from the preceding categories. Sulbutiamine does not qualify as a dietary ingredient under section 201(ff)(1) of the Act because it is not a vitamin; a mineral; an herb or other botanical; an amino acid; a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of any dietary ingredient from the preceding categories. Declaring sulbutiamine on your product label as a dietary ingredient causes your product to be misbranded under section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the labeling is false or misleading in any particular. 1 The introduction or delivery for introduction into interstate commerce of any food that is misbranded is a prohibited act under section 301(a) of the Act [21 U.S.C. § 331(a)]. This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. 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 that your firm complies with all requirements of federal law, including FDA regulations. This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction. Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. Your written reply should be directed via email to Quyen Tien, Compliance Officer, at HFP-OCE-DietarySupplements@fda.hhs.gov. Please reference CMS #687832 on any submissions and within the subject line of any emails to us. If you have any questions, you may also email at HFP-OCE-DietarySupplements@fda.hhs.gov. Sincerely, /S/ Laura Akowuah, JD, MPH Acting Director, Office of Enforcement Office of Compliance and Enforcement Human Foods Program Food and Drug Administration _____________________ 1 This warning letter does not address whether sulbutiamine can be lawfully marketed in dietary supplements as a non-dietary ingredient. For non-dietary ingredients used in dietary supplements, the substance must be used in accordance with a food additive regulation or be generally recognized as safe (GRAS) for its intended use or qualify for another exception from the food additive definition (see section 201(s) of the Act [21 U.S.C. § 321(s)]). Content current as of: 05/20/2025 Regulated Product(s) Dietary Supplements