There is already no shortage of enthusiasm about new access to BPC-157, Epitalon, KPV, MOTS-c, Semax, and TB-500. But bringing them out of what is often called the regulatory Wild West and under an FDA enforcement framework brings something else with it: regulatory scrutiny of how they are being marketed. As we discussed in our August and October articles, once FDA begins drawing regulatory lines around a developing market, companies need to think beyond whether the product itself can be offered and consider the regulatory implications of how the entire business operates.[1]
First, get the peptides themselves right. The new federal enforcement discretion policy is detailed and conditional. But once the operational pieces are in place, look outward. Does the marketing accurately reflect what the product is, what the evidence supports, and the regulatory framework under which it is being compounded? That is an obvious next place for regulatory scrutiny.
Keep in mind that these peptides occupy an unusual regulatory position as well, creating an equally unusual marketing task in explaining what the products are and what they may offer without implying a status or foundation they do not have. As the market develops around the peptides, public-facing claims can quickly get ahead of them. And those claims are among the easiest things for regulators to see. FDA does not need to inspect a facility or request internal records to review a website, social media post, paid advertisement, or patient-facing claim.
Recent enforcement involving compounded GLP-1 drugs is instructive, with one caveat: those products had FDA-approved drugs as comparators, and there are no FDA-approved versions of the six peptides covered by the new policy. But FDA’s warning letters demonstrate its willingness to scrutinize public-facing promotion of compounded drugs and whether marketing accurately reflects the product, its evidence, and its regulatory status.[2]
What to Look For
- Regulatory status. Does the marketing accurately describe the peptide’s regulatory posture, or does it imply FDA approval, review, or endorsement that does not exist?
- Evidence. Do the studies and publications cited actually support the claims being made? Be careful not to present evidence in a way that suggests the particular compounded product was clinically studied, or that the evidence establishes more than it does.
- Claim strength. Look closely at words such as “proven,” “clinically tested,” “safe,” and “effective,” as well as treatment, healing, recovery, performance, and anti-aging claims. The strength of the claim needs to match the strength and relevance of the support behind it.
- Source and identity. Does the marketing accurately identify who compounds the product and the regulatory status of the pharmacy or facility? FDA has objected to references to “FDA-approved” or “FDA-licensed” compounding pharmacies and to marketing that obscures the identity of the actual compounder.
- Every channel. Review websites, social media, paid advertising, influencer content, patient communications, and sales materials together. A carefully qualified product page will not cure more aggressive claims elsewhere.
Regulators may not be the only audience. Plaintiffs’ bar often follows enforcement. A recently filed complaint involving Empower Clinic Services LLC, for example, alleges among other things that references to studies of authorized GLP-1 drugs misleadingly suggested that compounded products themselves had been clinically tested and proven effective.[3] The facts are different, but the broader warning holds: claims that outrun their support create exposure beyond FDA.
The immediate task is getting the six peptides into the new enforcement discretion framework. The next is making sure the story being told about them matches what they are, what the evidence supports, and the regulatory framework under which they are reaching patients.
Get the peptides right. Then make sure the marketing tells the right story about them.
How We Can Help
Vedder’s FDA Regulatory Strategy & Compliance team advises compounders, telehealth platforms, prescribers, clinics, suppliers, investors, and other market participants on peptide regulatory strategy, compliance, marketing and claims review, and evolving FDA enforcement priorities.
[1] Melissa Gilmore, “After the Peptide Vote: Why FDA’s PCAC Recommendations Could Mark an Inflection Point for Peptide Compounding,” Vedder (Aug. 6, 2026); Melissa Gilmore, “HHS Opens an Interim Pathway for Peptide Compounding,” Vedder (Oct. 28, 2026).
[2] U.S. Food & Drug Administration, “FDA Warns 30 Telehealth Companies Against Illegal Marketing of Compounded GLP-1s” (Mar. 3, 2026); see also “FDA to Telehealth Companies: What to Know When Promoting Compounded Drugs.”
[3] Forcier et al. v. Empower Clinic Services LLC et al., No. 3:26-cv-14183 (D.N.J. filed Oct. 30, 2026).
