WARNING LETTER
Roen Health, Inc. dba RoenRx
MARCS-CMS 728293 —
June 08, 2026
Delivery Method:
VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTED
Product:
Drugs
Recipient:
Recipient Name
Kyle Robertson
Recipient Title
Founder & Chief Executive Officer
Roen Health, Inc. dba RoenRx
30 Irving Pl
New York
,
NY
10003
United States
support@roenrx.com
Issuing Office:
Center for Drug Evaluation and Research (CDER)
United States
June 8, 2026
WARNING LETTER
Reference number: MARCS-CMS 728293
To Mr. Robertson:
This warning letter advises you of significant violations identified during a U.S. Food and Drug Administration (FDA) review of your website. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. The violations cited in this letter are not intended to be an all-inclusive list of violations that may exist in connection with your products. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
FDA Review
Violations were identified and documented during a review of RoenRx’s website, https://roenrx.com, FDA Establishment Identifier (FEI) 3044022969, in March 2026. FDA observed that your website offers compounded drug products, including semaglutide products.
1
As described below, your website’s false or misleading claims concerning compounded semaglutide products under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 352(a) and 352(bb)], result in products being 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)]. This review was conducted under FDA’s public health responsibilities to protect the public from unsafe, ineffective, and poor quality drug products.
Violations of the Federal Food, Drug, and Cosmetic Act
The following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations.
Your representations regarding compounded semaglutide products are false or misleading. Under section 502(a) of the FD&C Act [21 U.S.C. § 352(a)], a drug product is misbranded if its labeling is false or misleading in any particular. Furthermore, under section 502(bb) of the FD&C Act [21 U.S.C. § 352(bb)], a compounded drug product is misbranded if its advertising or promotion is false or misleading in any particular.
More specifically,
1. The compounded semaglutide products displayed on your website identify “RoenRx” on the pictured label, suggesting RoenRx is the compounder of those drugs when in fact it is not.
2
2. The following claims concerning compounded semaglutide products appear on your website:
“Semaglutide is the active ingredient in FDA-approved medications like Wegovy and Ozempic….”
“RoenRx also offers semaglutide, the active ingredient in Wegovy® and Ozempic®….”
“Get affordable semaglutide (main ingredient in Ozempic® & Wegovy®) at an affordable price.”
Compounded drug products are not FDA-approved. Your claims represent that the compounded drug products you offer have been FDA-approved or otherwise evaluated for safety and effectiveness when they have not.
Accordingly, these representations cause your compounded drug products to be misbranded under sections 502(a) and 502(bb) of the FD&C Act [21 U.S.C. §§ 352(a) and (bb)]. 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)]. The violations described in this letter put you on notice of our concerns but may not represent an exhaustive list of violations. Please be advised, the receipt in interstate commerce of misbranded drug products, and the delivery or proffered delivery thereof, is also a violation of section 301(c) of the FD&C Act [21 U.S.C. § 331(c)].
You are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur. It is your responsibility to ensure that your operations comply with all requirements of federal law, including FDA regulations. For example, compounded drug products must meet the conditions in sections 503A or 503B of the FD&C Act [21 U.S.C. §§ 353a or 353b] in order to be exempt from certain requirements under the FD&C Act, including the new drug approval requirements.
Conclusion
As previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.
Send your written response to the Office of Compounding Quality and Compliance (OCQC) within the Center for Drug Evaluation and Research (CDER)’s Office of Compliance at compoundinginspections@fda.hhs.gov within fifteen (15) business days of receipt of this letter. Identify your written response with reference number MARCS-CMS 728293 and Response to Warning Letter in the subject line of the email. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Such steps may include the following:
1. Identifying the entities that produce the compounded drug products offered on your website;
2. Providing a representative sample of labeling for such drug products; and
3. Addressing other website claims that contain false or misleading representations about your compounded drug products or demonstrating that such claims have been modified or removed in light of FD&C Act §§ 502(a) and 502(bb) [21 U.S.C. §§ 352(a) and 352(bb)].
This letter notifies you of our concerns and provides you an opportunity to address them. If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration. If you cannot completely address this matter within fifteen (15) business days, state the reason for the delay and the time within which you will do so.
If you are not located in the U.S., please note that drug products that appear to be misbranded may be detained or refused admission. We may advise the appropriate regulatory officials in the country from which you operate that your drug products referenced above appear to be misbranded drug products that cannot be legally sold to consumers in the U.S.
Please note FDA posts warning letters on www.FDA.gov.
Sincerely,
/S/
Matthew J. Lash, JD
Acting Director
Office of Compounding Quality and Compliance
Office of Compliance
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
______________________
1
The semaglutide products offered on your website are drugs within the meaning of section 201(g) of the FD&C Act [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases and/or because they are intended to affect the structure or any function of the body. Further, they are “new drugs” within the meaning of section 201(p) of the FD&C Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for their labeled uses.
2
See 21 C.F.R. § 201.1(h)(2) (“The appearance on a drug product label of a person’s name without qualification is a representation that the named person is the sole manufacturer of the product. That representation is false and misleading, and the drug product is misbranded under section 502(a) of the act, if the person is not the manufacturer of the product in accordance with this section.”); see also FD&C Act § 503(b) [21 U.S.C. § 353(b)], FD&C Act § 503B(a)(10)(A)(ii) [21 U.S.C. § 353b(a)(10)(A)(ii)]. We note that 21 C.F.R. § 201.1(a) does not apply to drug products dispensed in accordance with section 503(b)(1) of the FD&C Act [21 U.S.C. § 353(b)(1)]. However, see 45 Fed. Reg. 25760, 25765 (Apr. 15, 1980) (“…if the label of a prescription drug product dispensed by a pharmacist does contain a representation as to the manufacturer, packer, or distributor, it must comply with all the provisions of § 201.1….”). In addition, the labels of your drug products as depicted on the website do not indicate that they are dispensed under section 503(b)(1) of the FD&C Act [21 U.S.C. § 353(b)(1)], nor do they appear to comply with the requirements of section 503(b)(2) [21 U.S.C. § 353(b)(2)].
Content current as of:
06/16/2026
Regulated Product(s)
Drugs