FDA Warning Letter · #716506
Healthy Male — FDA Warning Letter (September 9, 2025)
Primary Source
View the original FDA letter on fda.gov →
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/healthy-male-716506-09092025
Summary
- Company
- Healthy Male
- Letter number
- #716506
- Issue date
- September 9, 2025
- Subject
- Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)
What FDA cited
This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://healthymale.com in August 2025 and has observed that your website offers various compounded drug products, including tirzepatide.1 As described below, your claims concerning compounded tirzepatide products are false or misleading under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C.
How this letter sits against the other 185
Our reading, from the 186 letters on this register — not part of the FDA’s document.
The FDA issued 97 of the 186 letters on this register on the same day, September 9, 2025, the largest single action in our records. This company was part of a sweep rather than singled out — which does not make the letter less serious, but it does mean the agency was acting against a practice across the market, not against one seller's conduct alone.
This is not the only letter to this operator. We hold 2 for the same company, from September 9, 2025 to September 9, 2025. A repeat letter is a materially stronger signal than a first one: it means the agency wrote once and then wrote again. Read them together rather than one at a time.
A warning letter is the agency putting a company on notice, not a court finding and not a ban. What it is worth to you is in what it alleges, so read the original on fda.gov rather than the fact that one exists.
Other letters to this operator
From the letter
Read full letter on FDA.gov →Word for word, from the letter of September 9, 2025
This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://healthymale.com in August 2025 and has observed that your website offers various compounded drug products, including tirzepatide.1 As described below, your claims concerning compounded tirzepatide products are false or misleading under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. §§ 352(a) and 352(bb)], resulting in products being introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FDCA [21 U.S.C. § 331(a)].
Under section 502(a) of the FDCA [21 U.S.C. § 352(a)] a drug is misbranded if its labeling is false or misleading in any particular. Furthermore, under section 502(bb) of the FDCA [21 U.S.C. § 352(bb)], a compounded drug is misbranded if its advertising or promotion is false or misleading in any particular.
• “Clinically shown to support 15-22% average body weight reduction.”• “Clinically proven medications and compounds for sustainable weight management”• “Clinically proven to deliver sustainable results….”
Compounded drug products are not FDA-approved. Your claims imply that your products are the same as an FDA-approved product when they are not. As a result, these claims are false or misleading and your products are therefore misbranded under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and (bb)].
The introduction or delivery for introduction into interstate commerce of these misbranded products is a prohibited act under section 301(a) of the FDCA [21 U.S.C. § 331(a)]. The claims identified in this letter put you on notice of our concerns but do not represent an exhaustive list of misbranding violations.2
For the reasons discussed above, your compounded tirzepatide products are misbranded drugs under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and 352(bb)], introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FDCA [21 U.S.C. § 331(a)]. Please be advised, the receipt in interstate commerce of misbranded drugs, and the delivery or proffered delivery thereof, is also a violation of section 301(c) of the FDCA [21 U.S.C. § 331(c)].
As previously stated, 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 operations comply with all requirements of federal law, including FDA regulations.
You should take immediate action to address any violations (including, for example, ceasing and desisting from using the language cited above that misbrands the product). Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
Quoted word for word from the U.S. Food and Drug Administration. We assert nothing beyond what the agency published, and the full letter is at https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/healthy-male-716506-09092025
What FDA warning letters mean
It is the agency writing to a company to say it believes something that company is doing breaks the Federal Food, Drug, and Cosmetic Act — usually a claim on a website, a labeling choice, or how a drug is being made. The company has about fifteen working days to write back.
Read carefully what it is not. It is not a recall, not a criminal charge, and not a court deciding anyone broke the law. It is the regulator opening a file. Companies frequently answer a letter, fix what was cited, and carry on trading, and when FDA accepts that it can issue a close-out letter. We do not track close-outs, so the presence of a letter on this page tells you what FDA said on one date — not where the matter stands today. Ask the company; they will usually tell you, and how they answer is informative in itself.
Across this market the same three citations recur: claiming a compounded product is equivalent to an approved one, labeling that misleads, and compounding from bulk substances FDA has not cleared under sections 503A and 503B. If you are reading a letter here, it is probably one of those.
Where to get GLP-1 online, safely: sellers our editors have checked
These are telehealth sellers our editors have checked. For each one we hold a price, the form the drug comes in, and the states it reaches.
No insurance needed · vetted by our editors
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Direct Meds
Compounded semaglutide at $249/month
Pricing Compare
Get started →Found
Tirzepatide at $169/month, 37% under the register median
Pricing Compare
Get started →Breeze Meds
Knowing which pharmacy fills the vial — it names Belmar Pharmacy
Pricing Compare
Get started →Other warning letters in our database
- Maximus — June 8, 2026
- altRx — June 8, 2026
- Mint Med — June 8, 2026
- Ezra — June 8, 2026
- DrMedHealth — June 8, 2026
Editorial Disclaimer
This is a public communication from a regulator, and by itself it settles nothing about whether the company broke any law. Corrective action is a common response, and a fair number of letters end in a close-out. Read the whole thing on fda.gov through the link above rather than taking our excerpt as the full picture.
Glossary
The words sellers use, defined. Tap any term.
- Compounded GLP-1 · Pharmacy and drug forms
- 503A pharmacy · Pharmacy and drug forms
- 503B outsourcing facility · Pharmacy and drug forms
- PCAB accreditation · Pharmacy and drug forms
- FDA Warning Letter · Insurance and regulatory
- Off-label use · Insurance and regulatory
- FDA Drug Shortage List · Insurance and regulatory