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  5. IndulgeRx Brands, Inc - 703668 - 11/21/2025
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CLOSEOUT LETTER

IndulgeRx Brands, Inc MARCS-CMS 703668 —

Delivery Method:
Via Email with Confirmation of Delivery
Product:
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

jhastings@fightbackfoods.com
Issuing Office:
Human Foods Program

United States

Secondary Issuing Offices

United States

Dear Mr. Hastings:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS 703668, dated June 16, 2025. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

We note that with your submitted corrective actions, you included product labeling for review. Please note that our program experts do not provide product label approval. We offer the following comments for your consideration:

We recommend clarifying the saturated fat statement to provide greater transparency and help consumers understand that your product meets FDA healthy claim requirements while avoiding potential misinterpretation about the actual saturated fat content. The current labeling states "HEALTHY* NO MORE THAN 1g SAT FAT (Nuts are Exempt*)" while your product appears to contain more than 1g of saturated fat. You may want to consider alternative statements that emphasize that your product meets “Healthy” claim criteria for Saturated Fat or that clarify at the top of your labels that the product meets FDA “Healthy” claim requirements to establish clear context that references the healthy claim criteria.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.


Sincerely,
/S/
Branch Chief
Division of Critical Foods Labeling and Dietary Supplement Enforcement
Critical Foods and Labeling Enforcement Branch
Office of Compliance and Enforcement
Human Foods Program

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