WARNING LETTER
Agebox Inc.
MARCS-CMS 718252 —
December 19, 2025
Delivery Method:
Via Email
Product:
Drugs
Recipient:
Recipient Name
Wang Zheng
Agebox Inc.
108 W 13th St
Wilmington
,
DE
19801-1145
United States
info@agebox.com
cw3@agebox.com
serv@agebox-ops.com
Issuing Office:
Center for Drug Evaluation and Research (CDER)
United States
WARNING LETTER
December 19, 2025
RE: 718252
Wang Zheng:
This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://agebox.com/ and your social media accounts, including Facebook at www.facebook.com/Agebox.Official, in September 2025. The FDA has observed that your website offered “iKids-Growth IGF-1 Support Day Formula” and “iKids-Growth IGF-1 Support Night Formula” (hereinafter iKids-Growth products) for sale in the United States. Additionally, FDA has obtained samples of your iKids-Growth products. As described below, these products are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d). Furthermore, your iKids-Growth products are misbranded drugs under section 502 of the FD&C Act, 21 U.S.C. 352, and introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
FDA confirmed through laboratory analysis that samples of both your iKids-Growth products contain the undeclared ingredient ibutamoren mesylate. Ibutamoren (also known as MK-677) is an active ingredient not approved by FDA, and therefore its safety and efficacy have not been established. 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. Long-term effects of ibutamoren use are unknown and may pose additional health risks. This ingredient may also interact with medications and products a consumer may be taking in potentially harmful ways.
Your iKids-Growth products are marketed as dietary supplements, according to information found on the labels and/or labeling of the products. However, FDA has concluded that ibutamoren is excluded from the dietary supplement definition under section 201(ff)(3)(B)(ii) of the FD&C Act, 21 U.S.C. 321(ff)(3)(B)(ii). Under that provision, if an article has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are outside the definition of a dietary supplement, unless the substance was marketed as a dietary supplement or as a conventional food before such authorization. Based on available evidence, ibutamoren has been authorized for investigation as a new drug, substantial clinical investigations of ibutamoren as a new drug have been instituted, and the existence of such investigations has been made public,
1
and ibutamoren was not marketed as a dietary supplement or as a conventional food prior to such authorization. Therefore, FDA has determined that ibutamoren is excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(ii) of the FD&C Act, 21 U.S.C. 321(ff)(3)(B)(ii).
Unapproved New Drugs
Your iKids-Growth products are drugs as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body. Examples observed on your website and social media that provide evidence of the intended use of these products as drugs include, but may not be limited to, the following:
On your webpage https://agebox.com/:
“iKids-Growth doesn't add hormones or just nutrients—it works within this natural pathway to amplify your child’s own growth signals”
“Daytime
Supports bone and muscle function associated with IGF-1 activity”
“Nighttime
Supports liver function involved in GH and IGF-1 pathways”
On your webpage https://agebox.com/pages/help-faq?_pos=1&_psq=faq&_ss=e&_v=1.0:
“Will iKids-Growth help my kid grow taller?
Yes. iKids-Growth is designed to amplify the body’s own growth signals within the GH-IGF-1 axis, which plays a key role in healthy height development.”
How does iKids-Growth work?
It works within the GH-IGF-1 axis by directly amplifying the body’s own growth signals:
o Helps the liver respond better to growth hormone, increasing IGF-1 production
o Helps bones and muscles respond better to IGF-1, promoting healty height gain
By gently enhancing both ends of this key growth pathway, iKids-Growth helps unlock children’s natural growth potential – through a science-backed, hormone-free solution.”
On your webpage https://agebox.com/pages/join-investment?_pos=1&_psq=joint+inves&_ss=e&_v=1.0:
“The formula of iKids-Growth is scientifically validated to effectively increase IGF-1 levels in children, promoting healthy bone growth.”
“iKids-Growth by Agebox is specially formulated to support children’s height development by increasing GH sensitivity in liver cells to boost IGF-1 production. It also enhances IGF-1 utilization, promoting bone cell proliferation and differentiation for optimal growth and development.”
On a September 4, 2024, post on your Facebook social media website https://www.facebook.com/photo?fbid=122152760630252675&set=a.122146580282252675:
“iKids-Growth is a specialized dietary supplement that enhances insulin-like growth factor 1 (IGF-1) levels.”
“IGF-1 has a direct and powerful role in promoting height increase.”
“This process effectively regulates and increases height growth.”
“Let's unlock the potential of our kids’ growth with the power of the GH–IGF-1 Axis!”
On a September 25, 2024, post on your Facebook social media website https://www.facebook.com/photo?fbid=122157196292252675&set=a.122146580282252675:
“Unlock Your Child's Growth Potential with Agebox iKids-Growth!”
“iKids-Growth is specially formulated to enhance IGF-1 levels, promoting healthy bone development and height increase.”
“Boosts Growth Hormones: Stimulates natural growth processes.”
“[S]tart your journey towards a healthier, taller future with Agebox!”
Your iKids-Growth products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective (GRASE) for use under the above-described conditions prescribed, recommended, or suggested in their labeling. With certain exceptions not applicable here, a new drug may not be legally introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products. Accordingly, these products are unapproved new drugs. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).
Misbranded Drugs
Your iKids-Growth products are misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a). Under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), a drug is misbranded if its labeling is false or misleading in any particular. Section 201(n) of the FD&C Act, 21 U.S.C. 321(n), provides that, in determining whether an article’s labeling or advertising “is misleading there shall be taken into account . . . not only representations made or suggested . . . but also the extent to which the labeling or advertising fails to reveal facts material in light of such representations.”
The labeling for your iKids-Growth products do not declare that they contain ibutamoren mesylate. As previously mentioned, 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 failure to disclose ibutamoren mesylate in product labeling renders your iKids-Growth products misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a).
The introduction or delivery for introduction into interstate commerce of these misbranded drug products is a prohibited act under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
Conclusion
The violations cited in this letter are 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 lead to regulatory or legal action including, without limitation, seizure and injunction.
Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct 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 believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov. Please include your firm name and the unique identifier “718252” in the subject line of the email.
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
Food and Drug Administration
____________________
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See, e.g., Copinschi G, et al. Effects of a 7-day treatment with a novel, orally active, growth hormone (GH) secretagogue, MK-677, on 24-hour GH profiles, insulin-like growth factor I, and adrenocortical function in normal young men. J Clin Endocrinol Metab. 1996 Aug;81(8):2776-82. doi: 10.1210/jcem.81.8.8768828. PMID: 8768828 and Codner E, et al. Effects of oral administration of ibutamoren mesylate, a nonpeptide growth hormone secretagogue, on the growth hormone-insulin-like growth factor I axis in growth hormone-deficient children. Clin Pharmacol Ther. 2001 Jul;70(1):91-8. doi: 10.1067/mcp.2001.116514. PMID: 11452249.
Content current as of:
12/30/2025
Regulated Product(s)
Drugs