As the FDA tightens its grip on peptides, a murky and inconsistent regulatory framework that’s not fit-for-purpose is putting patient access at risk. Action Alert!

THE TOPLINE

• Under current US law, most peptide bioregulators are neither lawful drugs, dietary supplements, or cosmetics; they are treated by the FDA as illegal drugs.
• FDA enforcement has focused increasingly on compounded peptides, using a spurious safety rationale that threatens patient access to therapies many rely on for healing or immune support.
• Despite public statements suggesting a more open, science-based approach under new HHS leadership, recent FDA actions show continued hostility toward compounding, supplements, and patient choice.

Peptide bioregulators are very short chains of amino acids—the same building blocks that make proteins—that are linked by peptide bonds that act as precision signals in the body. They help cells in specific tissues ‘know what to do and when to do it,’ supporting repair, regeneration, and healthy function in organs such as the brain, heart, immune system and endocrine glands. They’ve become one of the fastest‑growing categories in the wellness and longevity space. From BPC‑157 and epitalon to thymosin alpha‑1 (Ta1) and kisspeptin, these products show promise for a wide range of uses including tissue repair, immune modulation, and healthy aging.

Yet the marketplace for peptides can be difficult to navigate. Many that were available as injectables and delivered by integrative physicians are becoming harder to obtain through licensed compounding pharmacies, while remaining widely available online, often for oral delivery as supplements, sometimes with questionable quality and likely effectiveness. That trend isn’t a coincidence. It’s the result of a confused and increasingly aggressive FDA enforcement strategy inspired by growing interest in peptides by the biotech and pharmaceutical industries. It’s having the effect of shrinking safe, legitimate access and pushing patients toward a questionable grey market, some claiming to be for research use only (RUA) when being marketed directly to consumers. We think the FDA’s endgame—or at least that of its paymasters in Big Pharma—is to pave the way to turn these products into monopoly drugs.

HHS Secretary RFK Jr. has signaled a desire to reverse FDA suppression of peptides and to open markets to these and other experimental treatments. A tweet from RFK Jr. in 2024 stated: “FDA’s war on public health is about to end. This includes its aggressive suppression…peptides, stem cells, raw milk, hyperbaric therapies….” Even so, recent history has taught us not to take anything for granted. If we want access to healing peptides, we’re going to have to fight for it.

Where Peptides Fit Under the Law

Under US law, most peptide bioregulators are not lawful drugs or dietary supplements. If they have the effect of treating, curing, mitigating, or preventing disease, they fall under the definition of a drug under the Food, Drug and Cosmetic Act (FDCA). The Dietary Supplement Health and Education Act (DSHEA) limits supplements to recognized dietary ingredients with a history of food use—criteria peptides like BPC-157, epitalon, Ta1, and kisspeptin do not meet. This is why they are treated differently from collagen peptides, which are derived from food and long consumed as part of the diet (e.g., bovine (typically hide and/or bone), marine (fish skin/scales), chicken (sternum/cartilage, often for type II/UC-II), eggshell membrane, and porcine).

Repackaging peptides as creams, patches, or “cosmeceuticals” does not solve the problem. Cosmetics may alter appearance but cannot affect the body’s structure or function. Most peptides marketed for transdermal use are plainly intended to deliver systemic effects—modulating inflammation, immune signaling, tissue repair, or aging. That inferred intent places these products back into drug territory.

Most peptides also are not biologics. FDA rules classify biologics as proteins larger than 40 amino acids; commonly used peptide bioregulators fall below that threshold and are regulated as drugs, while larger compounds like human chorionic gonadotropin (HCG) are biologics and thus cannot be compounded by traditional pharmacies. Labels claiming “for research use only” or “not for human consumption” do not change this legal reality when products are clearly intended for human use.

In practical terms, from FDA’s current perspective, an injectable peptide (that has not been through a new drug application process) is an illegal drug if it is not specifically approved for compounding, oral peptides sold as dietary supplements are likely considered adulterated supplements, and transdermal ‘cosmeceutical’ peptides are also likely to be considered as unapproved drugs.

Why Are These Products Still Widely Available?

If these products occupy a grey area (at best) or are in fact illegal, why are they so easy to find online, including on major platforms like Amazon? We explained this dynamic in our coverage of homeopathy after the FDA declared that, technically speaking, all homeopathic products are illegal, yet consumers were still able to purchase a substantial diversity of homeopathic medicines. In the world of the FDA, a product being marketed illegally is a regulatory distinction and separate from the question of whether consumers can still purchase the product.

Just because certain products may be marketed illegally doesn’t mean the FDA will take enforcement action. Note, though, that the agency has sent warning letters to peptide sellers. What this schism between legal interpretation by FDA and its sporadic enforcement does, however, is create a chilling effect on the whole natural peptides sector. As a business proprietor, would you want to invest heavily into a sector that the national regulator—in this case FDA—had clearly indicated was illegal?

Allowing the continued sale of adulterated or misbranded products could be intentional. Recall that, after DSHEA became law in 1994, then-FDA Commissioner David Kessler reportedly directed the agency not to enforce it. Former FDA officials later admitted this was a deliberate strategy to allow abuses in the supplement market to escalate, with the aim of undermining the law itself.

A similar dynamic may now be playing out with peptides. By largely tolerating poorly regulated online sales, the FDA is effectively setting the stage for bad outcomes that can then be cited as justification for further crackdowns. Secretary Kennedy? Please tell us we are wrong in drawing such a conclusion!

The Escalating Threat to Compounded Peptides

All of this underscores the importance of maintaining access to compounded peptides, delivered often as injectables via integrated physicians and nurse practitioners, which face a dire threat.

ANH has previously warned about the FDA’s increasing hostility toward compounded peptides. FDA guidance has prohibited compounder from producing a wide range of peptides, including BPC‑157, epitalon, Ta1, and kisspeptin‑10.

The FDA justifies these actions by citing alleged safety concerns, such as lack of data, potential impurities, or theoretical immunogenicity. These arguments are deeply flawed, as we’ve explained elsewhere.

Although the FDA has not imposed a permanent ban, it is using this interim policy to squeeze these peptides out of compounding. Every signal from the agency suggests that this interim ban will eventually become permanent.

Why is the FDA Doing This?

The FDA says peptides pose “potential significant safety risks.” But does the agency really believe that peptides are dangerous? Consider this statement from the FDA’s own review of Ta1: “In most clinical studies, Ta1 has not been associated with significant adverse events attributable to Ta1 when administered in doses in the range of 1-16mg via the subcutaneous route of administration for up to 12 months.”

The fact is that peptide bioregulators have a strong safety profile. If the issue isn’t safety, then what is it?

We believe the FDA’s broader objective is to reserve these and other valuable natural peptides for pharmaceutical development—while eliminating competition from compounding pharmacies.

A synthetic version of Ta1 is already approved in more than 30 countries for chronic hepatitis B and C and has orphan drug designation for cancer, with dozens of clinical trials exploring its broader therapeutic potential. BPC-157 has shown promise across a wide range of conditions, including central nervous system disorders. Epitalon, also referred to as Epithalamin, is an extract of the pineal gland. Animal and human research has shown that it can extend life and decrease mortality by, among other things, improving the immune system, stimulating antioxidant defenses, and producing anticarcinogenic effects.

What the FDA wants is for peptides to become patented, monopoly drugs. Big Pharma makes a mint selling them, and the FDA collects its user fees. It’s a win-win, except if you’re a health consumer.

Looking Ahead

Consumer access to peptides remains tenuous. In a May 2025 podcast appearance, Kennedy said in relation to peptides, “Our position is that FDA has a job, which is to do the science on these kinds of issues and then tell the public what they’ve learned from the science.” Individuals should be able to make informed decisions on whether or not to take experimental treatments.

While those are good signs, recent developments make us skeptical of a change of course. Under Kennedy’s leadership, the FDA has rejected opportunities offered by ANH to allow more supplement health claims and to ensure a legal pathway for homeopathic medicines to be marketed.

What is clear is that the current approach has sent consumers to a grey market, which is neither tenable, not in their best interest. ANH will continue to monitor developments closely and advocate for a science‑based framework that protects both safety and access.

Please take a minute or two to circulate this article widely to your networks and send the Action Alert below to your representative.

Action Alert!

The post Peptides: Why FDA’s Stance is Putting Patients at Risk first appeared on Alliance for Natural Health USA - Protecting Natural Health.

The FDA’s new, more open tone on compounded bioidentical hormones is a promising shift—but without sustained public pressure, meaningful change is far from guaranteed. Action Alert!

THE TOPLINE

• FDA Commissioner Marty Makary signaled a potential break from the agency’s long-standing, biased hostility toward compounded bioidentical hormone therapy, offering a rare opportunity to push for evidence-based policy.
• Despite this encouraging tone, the FDA could still move to ban key compounded hormones like estriol based on a flawed, industry-influenced NASEM report that misrepresents the science and patient experience.
• Protecting access to cBHRT will require continued advocacy to ensure the FDA rejects the NASEM recommendations and preserves individualized, patient-centered hormone care.

In a surprising turn, FDA Commissioner Marty Makary made a comment recently that may signal a long-overdue shift in the agency’s position on compounded bioidentical hormone therapy (cBHT). During a press conference about removing black-box warnings from hormone products, Makary struck an encouraging tone when asked about compounded hormone therapy, suggesting that under his leadership, the FDA may take a more evidence-based, patient-centered view—unlike the government’s previous position that cBHRT is a “public health concern.”

If Makary’s remarks reflect a shift not just at the head of the agency, but also inside the agency, it could mark a significant victory for patients and practitioners. But we must remain vigilant and continue to make our voices heard. Particularly given that cBHT will be seen by Big Pharma manufacturers of synthetic HRT as direct competition.

How We Got Here

Estriol and other bioidentical hormones have been nominated to the FDA’s Demonstrably Difficult to Compound List (under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act); items that appear on the list when it is final will no longer be able to be made at compounding pharmacies. ANH-USA and other stakeholders pushed back forcefully against the nomination of estriol and other compounded hormones, so the FDA convened a NASEM committee to study cBHRT and aid in the agency’s final determination.

It is our view that the FDA wanted to ban hormones but knew they couldn’t do it quietly due to the large consumer response, so they commissioned NASEM to study the matter and give them cover to ban these hormones.

Unsurprisingly, the resulting report was hostile toward these therapies, claiming that their “widespread use poses a public health concern” due to “a lack of high-quality evidence.”

This conclusion ignores scientific literature showing that bioidentical hormones—when prescribed and compounded appropriately—can offer lower risks of breast cancer and cardiovascular disease and better symptom relief than synthetic or animal-derived hormones. It also ignores decades of clinical experience of tens of thousands of American women.

NASEM, it must be recognized, is not the objective, neutral body it purports to be. For example, conspicuously missing from the committee was anyone with an expertise on how compounded bioidentical hormones are used to treat patients. Further, a review of NASEM’s financials shows that they accept millions in donations from Big Pharma—that is, the very players that stand to gain from the elimination of cBHRT, which competes with pharmaceutical menopause products. 

It’s also clear that the FDA was heavily involved in the development NASEM’s final report, all but guaranteeing that it reached the “proper” conclusions. The most glaring example of this is the FDA’s insistence that Jane Axelrad, former associate director for policy at the FDA’s Center for Drug Evaluation and Research and the agency’s lead on compounding issues, help develop the NASEM committee’s final report. In her work overseeing the compounding industry, Ms. Axelrad on numerous occasions stated publicly her opposition to compounded medicines.

The point is, this was not an unbiased analysis of the facts. From the beginning, it was a carefully managed process to arrive at the desired conclusion: a ban on cBHRT.

What’s at Stake

To be clear, the FDA has not yet moved forward with a ban, which would require a formal rulemaking. We emphasize yet.

But when the FDA finalizes this ban, countless patients will lose access to the personalized hormone therapies that have improved their quality of life—sometimes after years of trial and error with commercial products that didn’t work or caused side effects.

By eliminating competition from compounded products, the FDA effectively hands the market over to a few large pharmaceutical manufacturers. Women lose, patients lose, and innovation loses.

A Chance to Change Course

Commissioner Makary’s recent comments give us a rare opening. They suggest that he recognizes the need to take a fresh look at compounded hormones based on real-world evidence and patient outcomes—not bureaucratic bias or industry pressure.

For years, ANH-USA has submitted data, practitioner testimony, and patient experiences to the FDA showing that compounded bioidentical hormones are safe, effective, and essential for individualized care. Makary’s remarks could mean that work is finally being heard.

But make no mistake: until we see concrete policy changes—such as the FDA rejecting NASEM’s conclusions and ensuring estriol remains available—this fight isn’t over.

Tell the FDA and Congress: stop the attack on compounded bioidentical hormones, listen to patients—not industry—and preserve access to individualized, evidence-based care.

Action Alert!

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Despite large pay outs to victims, Pfizer keeps selling the hormone replacement drug and the government keeps trying to make sure there’s no competition from the natural alternative!

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