FDA warning letter · #716695
Try Nova: What the FDA Letter Means for What You Pay
Operating
marketing / labeling
September 2025
Not logged
Primary source
Read the original letter on fda.gov →
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/try-nova-716695-09092025
What FDA cited
Quoted verbatim from the letter dated
Read the full letter →This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://trynovamd.com in August 2025 and has observed that your website offers various compounded drug products, including semaglutide.
- 1
“The following claim concerning compounded semaglutide products appears on your website:”
- 2
“• “Same active ingredient as Wegovy & Ozempic.””
- 3
“Compounded drug products are not FDA-approved. Your claim implies that your products are the same as an FDA-approved product when they are not. As a result, this claim is 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)].”
- 4
“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 claim identified in this letter puts you on notice of our concerns but does not represent an exhaustive list of misbranding violations.”
Process
How a warning letter proceeds
- 1
Letter issued
September 2025
- 2
15-working-day response window
FDA gives the company 15 working days to respond in writing.
- 3
Close-out, if issued
FDA may post one once it is satisfied the cited issues have been corrected.
Is Try Nova still operating?
trynovamd.com returned a live client-rendered storefront on 2026-08-09 trading as "Nova MD". The served HTML is a shell, so the check was made against the site's own JavaScript bundle rather than the raw page — it carries the product catalogue, an intake flow and pricing including a $105/month plan with quarterly billing. That is a check of whether the site is up and trading; it is not a check of anything the letter alleges.
What this means for what you pay
Nothing unusual happened here, and that is the reason to read it. Fifty-eight of these went out on one day in September 2025, and this is what the ordinary one looks like once you strip away the letters with invented approvals, mislabelled vials and four-molecule catalogues: a single sentence, seven words long, sitting under a product on a working checkout. "Same active ingredient as Wegovy & Ozempic." It is true about the molecule and it is the reason the page exists — the sentence is doing the entire job of explaining what you are buying, by pointing at two drugs that went through a review this one did not. That is the whole of FDA's objection, and it is worth holding onto precisely because the sentence sounds so reasonable. The practical version, for someone comparing a compounded price against a brand price: the gap is not a discount on the same thing. It is the price of the review, the approved formulation, the named manufacturer and the labelling that comes with them. This letter makes no finding about safety, quality or what was in the vial, and FDA has not closed it out.
Has Try Nova responded?
As of , FDA’s public tracking for this letter does not show a logged company response. Companies are not required to make a response public, and FDA does not always update this field promptly — this is not evidence Try Nova failed to respond.
Sources
Other letters in this index
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Editorial disclaimer: An FDA warning letter is a public regulatory communication stating the agency's view. It is not a recall, a fine, a criminal charge, an injunction, or a finding that a company has broken the law.