PeptideJournal
Regulatory & Legal12 min read

How the DSHEA Affects Peptide Supplements

The Dietary Supplement Health and Education Act of 1994 reshaped the American supplement industry overnight. It gave consumers direct access to vitamins, minerals, herbs, and amino acids without requiring FDA pre-approval.

The Dietary Supplement Health and Education Act of 1994 reshaped the American supplement industry overnight. It gave consumers direct access to vitamins, minerals, herbs, and amino acids without requiring FDA pre-approval. Thirty years later, that same law is at the center of a much messier question: where do peptides fit?

The short answer is that most of the peptides people actually care about — BPC-157, thymosin beta-4, ipamorelin, GHK-Cu taken orally — do not qualify as dietary supplements under DSHEA. The law was written for vitamins, minerals, and botanicals. Synthetic peptides with pharmacological activity fall outside that definition, no matter how they are marketed. Understanding why requires a closer look at what DSHEA actually says, what the FDA is doing about it, and what this means for anyone considering a peptide product sold as a "supplement."

Table of Contents

What DSHEA Actually Is (and Isn't)

DSHEA amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to carve out a distinct regulatory category for dietary supplements. Before 1994, the FDA had attempted to regulate high-dose vitamins and certain supplements as drugs. DSHEA pushed back by classifying supplements as a category of food — not drugs — and preventing the FDA from requiring pre-market approval.

Under this framework, manufacturers bear responsibility for ensuring their products are safe before marketing. The FDA's role shifts to post-market enforcement: it can act against unsafe or mislabeled products after they hit store shelves, but it cannot block them from reaching the market in the first place.

This structure made sense for products with long histories of safe use — vitamin C, fish oil, echinacea. It becomes far more complicated when applied to synthetic peptides engineered in laboratories to modify specific physiological pathways.

The Dietary Ingredient Definition Problem

DSHEA defines "dietary ingredient" as one of the following:

  • A vitamin or mineral
  • An herb or botanical
  • An amino acid
  • A dietary substance used to supplement the diet by increasing total dietary intake
  • A concentrate, metabolite, constituent, extract, or combination of any of the above

Peptides occupy an awkward space in this definition. Individual amino acids (like L-glutamine or L-arginine) clearly qualify. But a synthetic chain of 15 amino acids assembled in a specific sequence to produce a targeted pharmacological effect? That is a different proposition entirely.

BPC-157, for example, is a 15-amino-acid synthetic peptide derived from a fragment of a human gastric protein. It does not occur naturally in food. It was never part of the food supply. Nobody was consuming BPC-157 as part of their diet before a laboratory synthesized it. By DSHEA's own definitions, it is not a "dietary substance" and does not meet the criteria for a dietary ingredient.

The same logic applies to most research peptides sold online: thymosin beta-4, ipamorelin, CJC-1295, epitalon, and others. They are synthetic molecules with no history of use in the food supply. Calling them "amino acid supplements" stretches the definition past what the law actually supports.

New Dietary Ingredient Notifications: The Gateway Nobody Uses

DSHEA built in a mechanism for genuinely new ingredients. Any dietary ingredient not marketed in the United States before October 15, 1994, is classified as a "new dietary ingredient" (NDI). Before marketing an NDI, the manufacturer must submit a New Dietary Ingredient Notification (NDIN) to the FDA at least 75 days before the product goes on sale. The notification must include evidence that the ingredient is "reasonably expected to be safe."

Here is the problem: the FDA has received relatively few NDINs compared to the number of new supplements that have flooded the market. Between 1994 and 2012, despite thousands of new supplements being introduced, the FDA received adequate notifications for only about 170 new ingredients. The FDA has rejected roughly half of the NDINs it has received.

For peptides specifically, the situation is stark. Sellers of oral BPC-157, GHK-Cu capsules, and similar products have not filed NDINs. They have not submitted safety data. They have simply placed products on the market and called them supplements, bypassing the one regulatory pathway that might have given their products legal standing.

The FDA flagged this gap as a priority. In January 2026, the agency's Human Foods Program listed finalizing NDI guidance as a key objective, signaling that the loophole of skipping notification is likely to narrow.

Where Collagen Peptides Fit (And Why They Are Different)

Not all peptides face this regulatory ambiguity. Collagen peptides — the ones you find in tubs at grocery stores and health food shops — occupy a completely different legal position.

Collagen is derived from animal connective tissue and has been part of the human diet for thousands of years (think bone broth, gelatin desserts, and traditional stocks). Collagen peptides are hydrolyzed fragments of this naturally occurring protein. Because collagen was part of the food supply long before 1994, it is considered a "grandfathered" dietary ingredient under DSHEA. No NDIN is required.

This distinction matters: collagen peptides are legal dietary supplements. BPC-157 capsules are not. The difference is not about the word "peptide" — it is about origin, history of use, and whether the substance was part of the food supply before DSHEA was enacted.

Other peptide-adjacent ingredients that generally qualify as legitimate dietary supplements include creatine (a tripeptide precursor), individual amino acids like L-carnitine, and glutathione (a tripeptide found in food). The common thread is documented presence in the food supply and established safety profiles.

The Drug Preclusion Clause

DSHEA includes a provision that further complicates things for peptides. Under the FD&C Act, the dietary supplement definition excludes any ingredient that:

  1. Has been approved as a new drug
  2. Has been licensed as a biologic
  3. Has been authorized for investigation under an Investigational New Drug (IND) application

...unless that ingredient was previously marketed as a dietary supplement or as a food before the drug approval or IND authorization.

This "drug preclusion clause" means that if a peptide enters clinical trials under an IND before anyone markets it as a supplement, it can never be sold as a dietary supplement — even if it would otherwise qualify. Several peptides currently being investigated in FDA-regulated clinical trials could fall into this category, permanently barring their supplement status.

Structure/Function Claims vs. Drug Claims

Even for ingredients that legitimately qualify under DSHEA, the law draws a hard line between what you can and cannot say about them.

Permitted structure/function claims describe the role of a nutrient or dietary ingredient in maintaining the body's normal structure or function. Examples: "supports joint health," "promotes digestive comfort," "helps maintain healthy skin."

Prohibited drug claims state or imply that a product can diagnose, treat, cure, or prevent disease. Examples: "heals leaky gut," "reverses tendon damage," "treats growth hormone deficiency."

DSHEA requires that any structure/function claim carry a disclaimer: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease."

Many peptide products sold online ignore this distinction entirely. Marketing materials for oral BPC-157 routinely reference "healing," "repair," and specific medical conditions. Under the FD&C Act, these claims classify the product as a drug, regardless of what the label says. When a product is marketed with claims to treat, mitigate, or cure conditions, it is legally classified as a drug — and without FDA approval, it is an unapproved drug.

FDA Enforcement: What Is Actually Happening

The FDA has taken concrete action against peptide products that cross regulatory boundaries. Enforcement has accelerated since 2023, and the pace picked up through 2024 and 2025.

Warning letters to peptide vendors. The FDA issued a warning letter to Pinnacle Professional Research (operating as Pinnacle Peptides) in December 2025 for marketing products as selective androgen receptor modulators and unapproved new drugs. Similar letters have gone to dozens of online vendors selling peptides with therapeutic claims.

Category 2 bulk drug substance designations. The FDA placed popular peptides including BPC-157, thymosin beta-4, and AOD-9604 on its Category 2 list, designating them as substances that "raise significant safety risks." This classification bars their use in compounding under Section 503A of the FD&C Act.

GLP-1 compounder crackdowns. In September 2025, the FDA sent warning letters to more than 50 compounders and manufacturers of GLP-1 receptor agonists like semaglutide, targeting false claims that compounded products were "generic versions" of approved drugs. For more details, see our full analysis of the FDA's compounding crackdown.

Import alerts. The FDA maintains import alert lists that allow customs officers to detain shipments of unapproved peptide products entering the United States without inspection.

The "Research Use Only" Loophole That Isn't

Many online peptide vendors sell their products with labels stating "for research use only" or "not for human consumption." This labeling strategy is an attempt to sidestep FDA jurisdiction by positioning the product as a laboratory reagent rather than a supplement or drug.

The FDA has made clear that these disclaimers do not provide legal protection when the actual intent is human use. The agency looks at the totality of evidence: marketing materials, dosing instructions, inclusion of bacteriostatic water or syringes, customer reviews describing personal use, and website copy referencing human health benefits. When these factors suggest a product is intended for human consumption, the "research only" label is treated as what the FDA has called a "ruse to avoid FDA scrutiny."

Several enforcement actions have targeted vendors selling peptides alongside reconstitution kits and injection supplies. The pairing of a "research chemical" with tools clearly designed for self-administration undermines any claim that the product is not intended for human use.

State-Level Enforcement Is Ramping Up

Federal enforcement is only part of the picture. State attorneys general and state medical boards have begun independent enforcement actions against peptide sellers and prescribers.

In 2024 and 2025, several states moved to suspend medical licenses and pharmacy permits — not because patients were harmed, but simply because research-labeled peptide vials were found in clinical settings. State regulators are using consumer protection statutes, unfair trade practice laws, and public health authority to target distribution channels that fall outside federal drug law.

This creates a multi-layered enforcement environment. Even if the FDA has not acted against a particular vendor, state regulators may. The regulatory risk for peptide sellers and the consumers who buy from them extends well beyond federal agencies.

For a broader look at peptide legality by state and a global overview, see our dedicated regulatory guides.

Consumer Implications: What This Means for You

If you are considering purchasing a peptide product marketed as a dietary supplement, here is what the regulatory reality means in practice:

Most peptide "supplements" are legally questionable. Any synthetic peptide sold as a dietary supplement without an NDIN filing is, by the FDA's reading of the law, an adulterated supplement. Products making therapeutic claims are classified as unapproved drugs.

Collagen peptides and amino acids are the exception. These have legitimate status under DSHEA. When you buy collagen powder or L-glutamine capsules from a reputable retailer, you are purchasing a legal dietary supplement.

"Research only" labels do not protect buyers. If you are purchasing a peptide and reconstituting it for self-administration, the regulatory framework does not recognize a distinction between buying a "research chemical" and buying a drug.

Quality is not guaranteed. Because these products exist outside the regulated supplement framework, they are not subject to Good Manufacturing Practice (GMP) requirements that apply to legitimate supplements. Independent testing has revealed significant purity and content variability among peptide products. Learn more about how to verify peptide purity and how to read a certificate of analysis.

Work with a physician. For peptides that are FDA-approved — such as semaglutide and tirzepatide — the safest and legal path is through a licensed prescriber. Our guide on how to choose a peptide therapy clinic can help you find a qualified provider.

FAQ

Can peptides be legally sold as dietary supplements in the U.S.?

It depends on the peptide. Collagen peptides, individual amino acids, and certain food-derived peptides like glutathione can be legally sold as dietary supplements because they were part of the food supply before DSHEA was enacted in 1994. Synthetic peptides like BPC-157, thymosin beta-4, and ipamorelin do not qualify as dietary ingredients under DSHEA and cannot be legally sold as supplements.

What is a New Dietary Ingredient Notification (NDIN)?

An NDIN is a notification that manufacturers must submit to the FDA at least 75 days before marketing any dietary ingredient not sold in the U.S. before October 15, 1994. The notification must include evidence that the ingredient is reasonably expected to be safe. Most peptide vendors have not filed NDINs for their products.

Does the "research use only" label make peptide purchases legal?

No. The FDA evaluates the actual intended use of a product, not just its label. If marketing materials, dosing guides, or product pairings (like including syringes) suggest human use, the "research only" disclaimer is considered legally meaningless. The FDA has described such labels as a tactic to avoid regulatory scrutiny.

Why are collagen peptides treated differently from other peptides?

Collagen is derived from animal connective tissue and has been consumed as food for centuries (bone broth, gelatin). Because it was part of the food supply before 1994, it is a grandfathered dietary ingredient under DSHEA. Synthetic peptides like BPC-157 were created in laboratories and have no history as food, so they do not receive the same legal treatment.

What happens if the FDA takes action against a peptide supplement?

The FDA can issue warning letters, seize products, seek injunctions against manufacturers, and place products on import alert lists. State attorneys general can pursue additional enforcement under consumer protection laws. Consumers who have purchased affected products have no legal recourse to recover their money from the FDA — enforcement is directed at sellers, not buyers.

Is DSHEA likely to be updated to address peptides?

There have been legislative proposals to modernize DSHEA, including Senator Dick Durbin's bills to improve supplement safety and transparency. The FDA's Human Foods Program listed NDI guidance finalization as a 2026 priority. However, major changes to DSHEA would require Congressional action, which has historically been slow due to industry lobbying. Any updates would likely tighten NDI requirements rather than expand supplement definitions to include synthetic peptides.

The Bottom Line

DSHEA created a workable framework for vitamins, minerals, herbs, and food-derived supplements. It was not designed for synthetic peptides with targeted pharmacological activity, and three decades later, the regulatory gap is widening.

The law's definitions exclude most synthetic peptides from supplement status. The NDIN process that might provide a pathway has been largely ignored by peptide vendors. The FDA is enforcing these boundaries with increasing frequency, and state regulators are joining in.

For consumers, the practical takeaway is straightforward: collagen peptides and amino acid supplements are legitimate products under DSHEA. Synthetic bioactive peptides sold online as "supplements" or "research chemicals" are not. If you are interested in therapeutic peptides, the safest and most legally sound path runs through a licensed healthcare provider and, where available, FDA-approved products.

References

  1. Dietary Supplement Health and Education Act of 1994, Public Law 103-417, 108 Stat. 4325. FDA - Dietary Supplements
  2. FDA. "Questions and Answers on Dietary Supplements." FDA Q&A
  3. Council for Responsible Nutrition. "Dietary Supplement Health & Education Act (DSHEA)." CRN - DSHEA
  4. Holt Law. "The Unregulated World of Peptides: A Legal Minefield for Providers." Holt Law
  5. Holt Law. "Deep Dive: Regulatory Status of Popular Compounded Peptides." Holt Law
  6. FDA. Warning Letter to Pinnacle Professional Research dba Pinnacle Peptides, 719337, December 12, 2025. FDA Warning Letter
  7. Wilson Sonsini. "FDA Sends Warning Letters to More Than 50 GLP-1 Compounders and Manufacturers." Wilson Sonsini
  8. Cohen PA. "DSHEA 1994 – Celebrating 30 Years of Dietary Supplement Regulation in the United States." Journal of Dietary Supplements (2024). Taylor & Francis
  9. Cohen PA. "Too Little, Too Late: Ineffective Regulation of Dietary Supplements in the United States." American Journal of Public Health (2015). PMC
  10. FDA. "FDA's Updates on Dietary Supplement Regulation in 2025." Global Regulatory Partners