IndulgeRx Brands, Inc

WARNING LETTER IndulgeRx Brands, Inc MARCS-CMS 703668 — June 16, 2025 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Overnight Delivery Product: Drugs Food & Beverages Recipient: Recipient Name Mr. John Hastings Recipient Title Founder and CEO IndulgeRx Brands, Inc 1273 S 1800 W, Unit 13 Woods Cross , UT 84087-2551 United States Issuing Office: Human Foods Program United States June 16, 2025 WARNING LETTER RE: 703668 Dear Mr. Hastings: This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at https://www.fightbackfoods.com in April 2025 and determined that you take orders there for your FightBack Foods Bravezil Butter, FightBack Foods Inspiration Butter, and FightBack Foods Wellnut Butter. 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. As explained further below, introducing or delivering these products for introduction into interstate commerce violates the Act. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov. Examples of some of the claims that provide evidence that your products are intended for use as drugs include: On your website for FightBack Foods Inspiration Butter https://www.fightbackfoods.com/product-page/inspiration-butter: “[R]ecent studies have highlighted the potential of Brazil nuts, almonds, and cashews (ingredients in your Inspiration Butter) in fighting against cancer, thanks to their antioxidant properties and beneficial nutrients.” (From an image of your product label) “OUR MISSION: We craft calorie-dense and nutrient-intense foods for people fighting cancer . . .. Organic INSPIRATION BUTTER supports our mission of bringing naturally nutritious foods to market which ‘Fuel the Fight’.” (From the image of your product label) “THE POWER OF NUTRIENTS: Our uniquely tasty multi-nut butter blend contains Omega 3-6-9 fats with powerful antioxidant polyphenols, which studies have shown may . . . assist in the fight against certain diseases*.” On your website for FightBack Foods Bravezil Butter, https://www.fightbackfoods.com/product-page/bravezil-butter, an image of your product label includes the following statements: “OUR MISSION: We craft calorie-dense and nutrient-intense foods for people fighting cancer . . .. Organic BRAVEZIL BUTTER supports our mission of bringing naturally nutritious foods to market which ‘Fuel the Fight’.” “THE POWER OF NUTRIENTS: Brazil nuts (an ingredient in your Bravezil Butter) contain Omega 3-6-9 fats with powerful antioxidant polyphenols and high natural selenium, which studies have shown may . . . assist in the fight against certain diseases*.” On your website for FightBack Foods Wellnut Butter, https://www.fightbackfoods.com/product-page/wellnut-butter, an image of your product label includes the following statements: “OUR MISSION: We craft calorie-dense and nutrient-intense foods for people fighting cancer . . .. Organic WELLNUT BUTTER supports our mission of bringing naturally nutritious foods to market which ‘Fuel the Fight’.”” “THE POWER OF NUTRIENTS: Walnuts (an ingredient in your Wellnut Butter) contain Omega 3-6-9 fats with powerful antioxidant polyphenols, which studies have shown may . . . assist in the fight against certain diseases*.” Your FightBack Foods Bravezil Butter, FightBack Foods Inspiration Butter, and FightBack Foods Wellnut Butter are not generally recognized as safe and effective for the above referenced uses and, therefore, these 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 C.F.R. § 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 FightBack Foods Bravezil Butter, FightBack Foods Inspiration Butter, and FightBack Foods Wellnut Butter 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 product safely for its intended purposes. Accordingly, your FightBack Foods Bravezil Butter, FightBack Foods Inspiration Butter, and FightBack Foods Wellnut Butter fail to bear adequate directions for their intended use 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 this misbranded drug violates 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 response should be sent electronically to: HFP-OCE-CriticalFoods@fda.hhs.gov, copying Simone E. Hollis, Compliance Officer, at Simone.Hollis@fda.hhs.gov. Refer to Unique Identification Number, CMS 703668, when replying. If you have questions regarding this letter, please contact Simone E. Hollis, Compliance Officer at simone.hollis@fda.hhs.gov. Sincerely, /S/ Maria S. Knirk, JD, MBA Acting Director, Office of Enforcement Office of Compliance and Enforcement Human Foods Program Content current as of: 07/22/2025 Regulated Product(s) Drugs Food & Beverages