NSE Products, Inc. DBA Nu Skin Enterprises, Inc. MARCS-CMS 722667 — July 14, 2026

CLOSEOUT LETTER

• Delivery Method: Via Electronic Mail - Delivery and Read Receipt Requested
• Reference #: 3093 CMS 722667
• Product: Drugs

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• Recipient: Ryan Napierski; Chief Executive Officer; NSE Products, Inc. DBA Nu Skin Enterprises, Inc. ; 75 West Center Street; Provo, UT 84601; United States; rsnapier@nuskin.com

• Issuing Office: Center for Drug Evaluation and Research (CDER); United States

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To Ryan Napierski:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter # 3093 (722667). Based on our evaluation, it appears that your firm has addressed deficiencies identified in the warning letter by updating the drug listings for “AP-24 Fluoride,” NDC 62839-1151; “AP-24,” NDC 62839-1152; “AP-24 Whitening,” NDC 62839- 1155; and an additional 61 drug listings that were out of compliance. Future FDA regulatory activities will further assess the adequacy and sustainability of these corrections.

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.

Please note FDA posts close-out letters on www.fda.gov.

Sincerely,
/S/
Tina Smith, M.S.
Captain, U.S. Public Health Service
Director
Office of Unapproved Drugs and Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
U.S. Food and Drug Administration