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FDA Warning Letter Explorer
FDA warning letter · Drugs

NSE Products, Inc. DBA Nu Skin Enterprises, Inc.

Issued · Posted by FDA

FDA published a close-out letter on Jul 21, 2026. The passages below are from the original warning letter.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

The drug listings stated above reference a manufacturing establishment, **(b)(4)**, that has confirmed that it has not been involved in the manufacturing of these drugs for more than five years, yet they continue to be cited in your listings with no end marketing date.

Passage 2

Additionally, your firm has 61 drug listings that have not been updated or certified as required and therefore have been inactivated by FDA.

Citations in the original letter

As cited in this historical letter, not a statement of current regulatory requirements.

  • 21 CFR 207.57(b)
  • 21 CFR 207.57(b)(1)(iv)
  • 21 CFR 207.49(a)(12)
  • 21 CFR 207.57(b)(2)
  • 21 CFR 207.33(c)
  • 21 CFR 207