Insiders react to FDA committee recommending legal access to six peptides

Last week’s decision by the FDA’s Pharmacy Compounding Advisory Committee to recommend six out of the seven peptides it was consideringbe available by prescription via compounding pharmacies got a very predictable reaction in the mainstream media. While both noted that the peptides are months or longer away from being dispensed legally, the New York Times warned of “The Coming Peptide Free-for-All,” and the Washington Post described regulators as “scrambling to protect consumers.”

Reaction closer to the actual practice of peptides was more enthusiastic, but also nuanced. We asked people in and adjacent to the therapeutic peptide industry about what the Committee’s actions might mean.

Let’s dive in.

“This meeting was really one of the first opportunities in which the FDA could directly engage with the public and industry participants as it relates to these peptides. I think FDA has a better understanding now as to the need. One theme that popped up throughout the two days was that the public had submitted hundreds of thousands of reports and studies and examples of these APIs being used in compounding, and FDA had only reviewed what they researched and identified. That frustrated a lot of the PCAC members because they reviewed all of the public information that was submitted to the docket, but FDA even admitted to not reviewing all of the data that was provided. Some of the committee members were disappointed because they couldn't have the level of dialog that they were hoping to achieve with FDA on this matter. So that's why a lot of this remains up in the air—because FDA was not really fully prepared for this discussion.” — Caitlin Koppenhaver, Chief Industry Advisor, American Peptide Association

“Being authorized to prescribe a peptide and being qualified to prescribe one are two different things, and nothing in the current system tells you which is which. A committee can decide whether a substance is safe. It can't decide whether the system around it is. That part is still ours to build. These decisions are being made in an environment where the evidence is fragmented and the systems for generating better evidence barely exist. That's the real problem, and it's the one PepMD was built to solve. The core issue has always been that when there's no legitimate pathway, patients turn to unregulated sources with no oversight at all. A regulated pathway, whatever form it takes, is categorically safer than a grey market. PepMD is the first organization we're aware of to bring all three functions together, clinician credentialing, pharmacy recognition, and research site authorization, under a single standard. Others do pieces of this. No one has unified them. You can't have a safe field without knowing who's qualified, where the product comes from, and whether it actually works. That's the infrastructure this field has been missing.” — Karthik Achari, clinician and founder of PepMD

Normally, the FDA would review the PCAC’s recommendations, and proceed with a formal rulemaking process to add them to the 503A Bulks List. However, given that the FDA has continually come out against peptides, it is unlikely that the FDA – through normal processes – would move to include them. However, it is possible that Secretary Kennedy could exercise his authority and move to include them based on public health interests.

With respect to peptide suppliers – especially the ones that are selling “research use only” products – these are the companies that stand to lose the most if they do not pivot their businesses, as we can expect greater enforcement against these “gray market” distributors once a lawful pathway exists for patients to obtain prescription-grade peptide medications.—Jesse Dresser, lawyer, Frier Levitt

If FDA were to agree with the PCAC, it would begin a rulemaking process that would likely take from 9-18 months. The status of the peptides in question would remain as not on the Bulk list, therefore not compoundable unless FDA announced enforcement discretion during this rulemaking period. We believe it is unlikely that FDA/CDER will go against its own scientists’ recommendations. But even if FDA decides that these peptides do not qualify for the Bulk List, Secretary Kennedy could invoke his Section 503A© public health authority to place the peptides on the Bulk List. This authority is arguably meant to remove unsafe substances, not fast-track new ones – a live possibility. Therefore, such a move could garner litigation.— Edgar Asebey, lawyer, Frier Leavitt,

"The news coverage keeps treating this as a decision to expand access, and that's the common misread. The committee made a recommendation, it didn't add anything to the bulks list, and a recommendation isn't an approval. What stands out to us is that every one of these peptides was nominated by parties who then withdrew their nominations, and the FDA chose to proceed anyway." — Omar Amer, founder, Validus Bio

The FDA does not have to make anyone wait two to four years. That multi-year rulemaking clock describes the formal, belt-and-suspenders path to permanent listing. It is not the only tool the agency has. The FDA can, and in my view should, short-cut the entire wait by simply adding the peptides that earned affirmative PCAC votes to the interim Category 1 bulk substances framework used for 503B outsourcing facilities, and by extending comparable enforcement discretion to 503A pharmacies while the formal rule works its way through the pipeline. This is not a novel maneuver. The agency has used interim enforcement categories precisely to bridge the gap between a substance that is plainly headed for the list and the slow grind of notice-and-comment rulemaking. A Category 1 designation tells the field, in effect, that the FDA does not intend to pursue enforcement against outsourcing facilities compounding the substance while it finishes the paperwork. Pairing that with 503A enforcement discretion would give patients access now, give pharmacies a defensible compliance posture now, and cost the agency nothing it has not already signaled it is willing to do.—Mark Boesen, Boesen & Snow Law

The FDA did a superb job in their analysis of the nominated peptides, concluding that none should be approved. That most were approved speaks volumes but has little near-term impact. As FDA intimated, the supply chain for these substances must mature before they can become approvable for use. This can happen only if serious experts make this a priority. Having an approved formulary of qualified substances physicians can prescribe to patients for lawful compounding by state-licensed compounding pharmacies is a “middle lane” approach some have suggested. If there is an appetite for that approach, several considerations must be included. A formulary populated by objective subject matter experts could qualify a specific compound for inclusion on the formulary, determining the compound, controls and characterization needed to assure freedom from dangerous adulterants, stability. Vigorous enforcement by FDA of gray market players selling direct to consumers and/or via e-distributors (e.g., Amazon) would also be required. Without enforcement of existing laws, little would change in our current environment, and public health would continue to be compromised by criminal fraudsters. State AGs, FTC, and FDA might be wise to develop a joint enforcement campaign.—Michael D Levin, founder, Health Business Strategies

“Running a clinic directory, what I see is that demand for these peptides never waited for regulators. Rather, it's been sitting with unregulated grey market online vendors for years. The committee's vote, if the FDA follows it, moves that demand somewhere accountable, somewhere safe. Whether that’s a prescriber, a licensed pharmacy or a paper trail. That's the real significance. But it's a recommendation, not an approval, and the panel went against FDA's own scientists and clinics that are celebrating a green light are reading more than was written.” — Gabriel Brocklesby, Peptide Clinic Finder

“It is good to know that the committee took a look at each peptide separately instead of considering them as one category. Peptides are not all the same and can differ from each other in their safety and efficacy. All except for one of the seven peptides seem to be a good decision to approve based on the available evidence.” — Stephen Cosentino, DO, Medical Director, Empire Medical Training

“The committee’s recommendation to add six of seven peptides to the 503A Bulks List is striking because the votes were narrow and repeatedly departed from FDA scientists’ advice. BPC-157, KPV and TB-500 passed 8–6; MOTS-c 7–5; Semax 8–5; and epitalon 7–4, while emideltide was rejected 7–6. FDA reviewers had recommended against all seven, citing major gaps in human efficacy, dosing and safety evidence. Regulated compounding may be safer than grey-market sourcing, but it must not become a shortcut around clinical development. These products remain unapproved, and access should require quality controls, informed consent, pharmacovigilance and further rigorous trials in patients.” —Egle Pavyde, Pharmacist/Researcher

“The PCAC’s votes recognize what many patients and clinicians have been saying for years: there is a responsible path forward. While this is only one step in the FDA's process, it's an encouraging signal that science, patient access, and public safety can coexist. The real opportunity now is to keep these therapies within state-licensed compounding pharmacies, where patient-specific prescriptions, quality standards, and professional oversight exist. Pushing demand into the illicit market has never protected patients. Thoughtful regulation, not prohibition, is how we best safeguard both innovation and public health.” — Joey Stiver, CEO, Amble Health

“The Kennedy-appointed PCAC members voted to add unapproved peptides to the 503A Bulk list, emphasizing patient access to higher-quality compounded products. Opposing members cited poor peptide quality characterization and insufficient safety and efficacy data. The FDA must now decide whether to follow the PCAC recommendation, a move that would conflict with its own criteria permitting unapproved drugs only when no approved alternative exists and a serious medical condition warrants it. That bar is hard to clear here, as FDA-approved drugs with proven efficacy already exist for the conditions these peptides claim to treat.” — Oliver Caitlin, Banned Substances Control Group

Peptides in supplements and peptides in syringes find parallel lines wellness market

When Neal Foster joined Nuritas 10 years ago to help the company sell the plant peptides its AI engine discovered, he spent a lot of time explaining to potential customers what peptides are and how they can promote health as ingredients in dietary supplements.

“What peptides are” has disappeared from those conversations.

“My phone is ringing more every day,” Foster says. “I think there isn't a company in this space that isn't receptive and interested now to peptide-based ingredients.” After so many years educating on the basics of peptides, his job now is to navigate the enthusiasm. “It’s really, ‘What else do you have? What's next? When is it coming? When can I buy it? When can I get that information?’”

The peptide wave that’s cresting in clinics and podcasts and sketchy internet shopping sites is also washing over the dietary supplement industry. Primed by the science-forward marketing of Nuritas and a decade-plus of collagen peptides in pills and powders, the supplement industry is racing to hijack the buzz of pharmaceutical peptides that are injected and layer it over dietary supplements that are ingested.

That buzzy rush is sweeping the industry with few in-the-pill products yet on the market, but supplement product development consultant Doug Lynch says the industry is both excited and ideally positioned. “A brand-new category has now opened in the dietary supplement realm, and that does not happen very often,” Lynch notes, going on to explain that artificial intelligence is going to get products to market faster than pharmaceutical companies can dream of doing. “I'm seeing companies that are able to have three new products discovered and on the market within three to five years.”

The rush of enthusiasm, as supplement industry veterans like Lynch and Foster know too well, will not come without irresponsible companies flaming out with bad products and questionable marketing. Among the challenges in the blur between the peptides in dietary supplements and the peptides that a doctor might be able to prescribe is that dietary supplements are not drugs and thus cannot make drug claims.

Conversely, the synthetic peptides that are defined as drugs can’t be used in supplements. Supplements, legally, are foods. BPC-157 and TB-500 are not foods. They can’t show up in a gummy on the supplement shelf. “Just calling it a supplement, doesn’t make it legal,” explains lawyer Ashish Talati, who works with both supplement companies looking at peptides derived from nutritional ingredients and compound pharmacists eyeing entry into dispensing synthetic peptides.

On the supplement side, he observes, people are trumpeting “peptide” on label as though they have a specific signaling peptide when peptides are inherent components of the product, says Talati. Hydrolyzed protein powders, for instance, are peptides. “They say, ‘Oh! We have a peptide,’ implying it's just one peptide, when it's a complex. But people are buying it left and right.”

Throwing the pharmaceutical peptides into supplements is also happening, Talati claims. It’s clearly illegal, and a risky business move. Supplements, legally, are foods. BPC-157 and TB-500 are not foods, and they’re not yet legal, pending action by the FDA following the Pharmacy Compounding Advisory Council. A supplement label is no protection. “Just calling it a supplement, doesn’t make it legal.”

The peptides Nuritas sells are single cell-signaling peptides, very different from the peptide complexes in the hydrolyzed proteins Talati describes. Two of them, PeptiStrong for muscle health and PeptiSleep for sleep health, are supplements. The brands Foster is working with, he says, are creating products based on what peptides can do, rather than seeing a market need and then searching for ingredients that can provide benefits for that need. “I've never seen a class of ingredients start to shape and almost dictate the product architecture of those types of businesses,” Foster says.

Both Foster and Lynch agree that supplement peptides and pharmaceutical peptides will each likely drive interest in the other. Peptides and supplements already share space in practitioner-designed stacks, with more supplement brands likely to make pitches as “nutritional support” for people taking pharmaceutical peptides, something Talati explains is legal as long as the supplement is not claiming to treat a side effect that could be considered a disease state.

But supplement industry advisor Noah Voreades advises supplement companies to keep a close eye on who is seeking the pharmaceutical peptides and whether those consumers might see the injectable drugs as replacing their supplement regimen. The price of the pharmaceutical peptides could determine who is buying them, Voreades says, and the people who can afford the price might be the people who are now spending the most on supplements. “Will the premium buyer start to shift more and more of their spend towards peptides versus their supplement stack for things that they're optimizing for through the peptide? It's quite possible. I think the question is whether they still truly see them as complementary?”

How specific pharmaceutical peptides line up with specific supplement categories will also be interesting, Voreades notes. “I think if BPC 157 really takes off and supports gut lining, and that’s seen in general markers of gut health, it will be interesting to see how it affects the general digestive health product market, including supplements,” Voreades says.

Whatever happens with pharmaceutical peptides, the opportunity for supplements is undeniable, says Lynch. Despite years of GLP1s normalizing self-injection, there are still plenty of people who don’t want to jab themselves, he explains, and pharmaceutical companies are not likely to pour money into developing oral delivery for ingredients with little or no IP protection. Side effects are another challenge, Lynch claims, and gentler supplement-form peptides might come with fewer or no side effects at all. Even if the benefits take longer to appear, the possibility that more people will adhere to their peptide supplement regimen than will last on an injection protocol is very real, he says.

Lynch says he also believes that supplement companies have the technology to get the peptides into the gut and allow them to produce the desired effect, pointing to microencapsulation and enteric coating techniques. The benefits need to be clinically proven, he points out, but he is confident that peptides are powerful enough to deliver on the promise. Putting “peptide” on the label is not enough. “I think that will sell the product once, but if it doesn't work, people will not continue to buy these things.”

Foster says Nuritas is already expecting that—“Peptides won't be the first category that that happens in”—but he insists that bioactive peptides like his company will win the day, and find a place in practitioners’ medicine bags, possibly accompanying pharmaceutical peptides and possibly all on their own. Nuritas is already selling their ingredients into practitioner-channel supplement brands.

Foster points to telehealth outfits that might offer GLP1 drugs, but also offer sexual health drugs, and hair loss treatments. Supplements, he says, are “a natural progression,” and supplements containing bioactive peptides from Nuritas will beat pharmaceutical peptides to the legal-and-legitimate shelf by months at the very least, possibly months. That means a lot for a publicly traded telehealth company like HIMS.

“We've got an affluent customer base who wants results and is willing to pay for those results. It stands to reason that they want to use the best tools to achieve that. Yes, they want to use the drugs, because those work, but they also want to use the best supplements with the best clinical evidence as well,” Fosters says. “We're not trying to be direct replacements, albeit some may see it as that way, but we work well alongside those things.”