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# Agebox Illegally Selling Unapproved iKids-Growth Drugs
- URL: https://www.fdaweb.com/agebox-illegally-selling-unapproved-ikids-growth-drugs/
- Published: 2026-01-07T12:00:00.000Z
- Updated: 2026-09-14T15:30:08.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160454

FDA says its review of the Web site and social media accounts maintained by Agebox, Inc., in Wilmington, DE, determined that it offered iKids-Growth products for sale in the U.S. A 12/19/2025 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/agebox-inc-718252-12192025?ref=fdaweb.com) says FDA obtained samples of the iKids-Growth products and determined that they are unapproved new drugs that also are misbranded.

“FDA confirmed through laboratory analysis that samples of both your iKids-Growth products contained the undeclared ingredient mesylate ibutamoren that is an active ingredient not approved by FDA and therefore its safety and efficacy have not been established,” the letter says. “Ibutamoren is a growth hormone secretagogue that stimulates the release of growth hormone. Use of ibutamoren may cause serious side effects, including increased appetite, water retention, fatigue, muscle pain, potential alterations in glucose metabolism and insulin sensitivity, and even may increase the potential for congestive heart failure in certain individuals.”

Although the Agebox products are marketed as dietary supplements, FDA says, the agency has concluded that ibutamoren is excluded from the legal dietary supplement definition.

In addition to being unapproved new drugs, the letter says, the iKids-Growth products are misbranded because their labels do not declare that they contain ibutamoren mesylate. “Parents may give these products to their children without knowing that they contain an ingredient that may cause serious harm or dangerous product interactions,” the Warning Letter says.

Agebox was told to respond with a list of specific steps it has taken to correct the violations and prevent their recurrence, with copies of related documentation and a schedule for completing the corrections.