Peptides at a Crossroads: What Wellness Providers Need to Know About HHS and FDA Actions

A news report in early October 2026 indicated that the U.S. Department of Health and Human Services (HHS) is preparing a temporary measure that would let certain compounding pharmacies dispense some previously restricted peptides while the U.S. Food and Drug Administration (FDA) develops formal regulations. The report, which relies on two unnamed sources, has led some media outlets to describe the FDA as "fast-tracking" peptides.

Most recently, on October 14, 2026, the HHS and FDA submitted an "Interim Access Policy for Compounding Using Certain Peptides" to the Office of Management and Budget (OMB) for regulatory review, but the policy has not yet been issued. Enforcement discretion generally refers to an agency's decision not to pursue specified enforcement actions under particular circumstances; it does not modify the underlying statutory framework or confer FDA approval on a compounded product. FDA also has not issued a proposed or final rule addressing access, and no executive order specifically addresses peptides. A look at the current landscape shows that FDA has taken several procedural steps toward expanding access, but absent the publishing of an interim policy, none yet authorizes the compounding of these peptides.

The Business Behind Peptides

Peptides are short chains of amino acids, the same building blocks that make up proteins. Because they are smaller and simpler than full proteins, peptides can act as targeted messengers in the body, binding to specific receptors and signaling cells to carry out functions such as repairing tissue, regulating metabolism, managing inflammation or releasing hormones. The body naturally produces many peptides, and scientists have developed synthetic versions designed to mimic or enhance those signals.

That targeted action is what makes peptides so appealing. Some, like the GLP-1 medications used for weight management, have become household names. Others have built devoted followings among consumers interested in recovery, longevity, skin health and performance. Medical spas, functional medicine practices, telehealth platforms and longevity clinics increasingly offer peptide therapies as part of their services, and consumer demand has grown rapidly through word of mouth, social media and high-profile endorsements.

For wellness providers, now is a pivotal moment. Federal policy on peptides is actively being reshaped, with senior HHS leadership publicly supporting broader access even as FDA steps up enforcement against sellers operating outside the licensed system. The decisions made over the next two years will determine which peptides can be offered, through which channels and on what terms. Businesses that understand the landscape and position themselves now will be best placed to serve patients and clients responsibly and take advantage of any lawful opening as it emerges.

How the Peptide Review Has Unfolded

Under Section 503A of the Federal Food, Drug, and Cosmetic Act, a licensed pharmacy may compound a drug from a bulk substance only if that substance is part of an FDA-approved drug, is covered by an official monograph (an established quality standard) or appears on the 503A Bulks List. In 2023, FDA placed more than a dozen peptides, including BPC-157, in Category 2 of its interim bulks policy – a designation for substances FDA believes raise significant safety risks. HHS Secretary Robert F. Kennedy Jr. has since publicly supported broader access, beginning with a February 27, 2026, announcement, and FDA has taken three significant steps in 2026:

• On April 15, 2026, FDA announced it would remove 12 peptides from Category 2 within seven days after their nominations were withdrawn. This lifted a safety designation but did not make any peptide eligible for compounding. At the same time, FDA published a Federal Register notice scheduling advisory committee review of the peptides.
• On June 29, 2026, FDA released staff briefing documents recommending against adding any of the seven peptides under review to the 503A Bulks List. Staff pointed to poorly characterized substances, limited or no human clinical data and safety concerns, including the risk of unwanted immune reactions. The same day, FDA announced a reconstituted Pharmacy Compounding Advisory Committee (PCAC), roughly half of whose members were reported to have ties to peptide businesses or clinics.
• On July 23 and 24, 2026, PCAC voted to recommend adding six peptides (BPC-157, KPV, TB-500, MOTS-c, Epitalon and Semax) to the 503A Bulks List and voted against a seventh, Emideltide (DSIP). Several votes were close: BPC-157, KPV and TB-500 each passed 8-6 with one abstention, and Emideltide failed 6-7 with one abstention.

The committee's recommendations are advisory only. Before any of the six peptides may be lawfully compounded, FDA must decide whether to accept them and, if it does, publish a proposed rule, consider public comments and issue a final rule. No law sets a deadline for that process, and history suggests it will take time: FDA's 2016 proposed rule on 10 bulk substances was not finalized until 2019. A second PCAC meeting is expected before the end of February 2027 to consider the remaining five peptides removed from Category 2 (GHK-Cu, LL-37, Dihexa, Melanotan II and PEG-MGF). FDA has not yet set a date.

The Reported Stopgap and Its Limits

The interim policy has not yet been published, and details on the policy remain to be seen. The most likely approach of the policy is interim enforcement discretion, such as moving the peptides into Category 1 of FDA's interim bulks policy. FDA would then signal that it does not plan to take action against 503A pharmacies compounding certain peptides for individual patients, subject to conditions.

Enforcement discretion would open a prescription-only channel through licensed pharmacies, but it would not change the underlying law. Covered peptides would remain unapproved drugs. The policy would not extend to products sold as research chemicals or dietary supplements, would not bind state boards of pharmacy and medicine, and could be narrowed or withdrawn at any time without a formal public comment process. FDA could also limit the policy to certain routes of administration (for example, injectable versus oral), since some committee members tied their support to specific routes. Any such policy would also run counter to the recommendations of FDA's own scientific reviewers. Pharmaceutical trade groups have already argued, in comments to the PCAC, that FDA cannot lawfully authorize compounding through an interim policy while rulemaking is pending – a preview of a possible legal challenge if FDA adopts a stopgap.

Enforcement Continues to Intensify

Headlines about potential access have overshadowed a parallel rise in enforcement activity, which has a more direct effect on wellness companies in the near term.

• On August 24, 2026, FDA issued five warning letters to online peptide vendors. The letters concluded that "research use only" labels did not outweigh evidence that the products were intended for human use, pointing to bacteriostatic water sold for mixing the products and dosing calculators offered alongside them.
• On September 18, 2026, FDA issued a warning letter stating that a compounder's GLP-1 products with added B12 or niacinamide were essentially copies of approved drugs. The letter also questioned prescriptions generated through preselected options on third-party telehealth platforms, a practice common in direct-to-consumer wellness models.
• In August and September 2026, FDA and the Centers for Disease Control and Prevention reported more than two dozen illnesses, including hospitalizations, in at least four states linked to compounded glutathione injections. The injections were made with dietary supplement-grade ingredients contaminated with endotoxins (bacterial toxins). These cases are a reminder that quality failures within the licensed compounding channel also draw federal attention.

Private enforcement is growing as well. In August 2026, the developer of retatrutide, an investigational drug, filed six lawsuits against sellers of the drug and reported more than 200 referrals to FDA, the U.S. Department of Justice, state attorneys general and licensing boards. These developments are likely to influence the conditions FDA attaches to any interim access.

Timing and Political Considerations

A clear federal path out of the gray market is unlikely before 2027 and may not be finalized until 2028. One plausible sequence: FDA holds the second PCAC meeting in early 2027, then issues a proposed rule covering both groups of peptides, followed by a final rule in late 2027 or 2028.

That timeline overlaps with the 2028 presidential election, which adds uncertainty to each option. Interim enforcement discretion could be put in place quickly but reversed just as quickly by a future administration. A final rule would be more durable, but one issued late in 2028 could be overturned by a new Congress and administration under the Congressional Review Act. A rule that departs from FDA staff's scientific findings and relies on a committee whose makeup drew conflict-of-interest scrutiny could also face a court challenge under the Administrative Procedure Act. Because peptide access has become closely tied to Secretary Kennedy's Make America Healthy Again agenda, the status of these substances after January 2029 will likely depend on the outcome of the 2028 election.

Congress is unlikely to pass legislation in the near term. Sen. Tommy Tuberville (R-Ala.) and Rep. Diana Harshbarger (R-Tenn.) have urged Secretary Kennedy to ease restrictions, while consumer and public health groups have criticized the PCAC process.

Congress is more likely to weigh in through oversight hearings in the new Congress beginning in January 2027 and through the fiscal year 2027 Agriculture-FDA funding bill, which could include instructions to FDA. The U.S. House of Representatives passed its bill in June 2026, the U.S. Senate has not acted, and FDA is funded under a temporary spending measure through December 11, 2026.

Practical Guidance: How Wellness Companies Can Move Forward with Confidence

The path to broader peptide access is taking shape, and wellness companies that prepare now will be well positioned to grow with it. The most realistic near-term opportunity is a targeted, conditional opening through licensed pharmacies rather than broad federal legalization. The following steps can help companies build a compliant, sustainable peptide offering:

• Communicate Accurately and Build Trust. Describe peptide offerings in terms of their actual regulatory status. Avoid calling any peptide under review FDA-approved, "cleared" or "fast-tracked," since none of those labels applies today and such claims can attract attention from FDA and the Federal Trade Commission. Review websites, social media, influencer content and patient materials so that benefit claims are supported and balanced, and consider having marketing review before launch. Clear, accurate messaging protects the business and builds lasting client trust.
• Review Your Sales Channels. Companies that currently sell peptides as research-use-only products or dietary supplements should take stock of those offerings now. FDA looks at a company's website and product lineup as a whole to judge whether products are intended for human use, so items such as reconstitution supplies, dosing tools or usage instructions can shape how a product is viewed. Because no interim policy under discussion would cover these channels, now is a good time to consider transitioning toward a licensed, prescription-based model.
• Partner with the Right Pharmacies and Prescribers. Companies that want to participate in a regulated market should plan to work through state-licensed 503A pharmacies, with prescriptions written for individual patients. Review pharmacy partners’ licenses, quality controls, and the source and grade of their ingredients, especially given recent illnesses linked to contaminated compounded products. In light of FDA's September 2026 warning letter, telehealth companies should also review their workflows so that prescribers make independent, individualized decisions rather than relying on templated or pre-selected options.
• Get Ahead of Likely Conditions. Any interim access will likely come with conditions similar to those the compounding industry has proposed, such as patient disclosures, adverse event reporting and outcomes data collection. Companies can prepare now by developing informed consent materials, setting up a process to track and report side effects and organizing patient outcome data. Building these systems early can make it easier to move quickly if access opens.
• Map State Requirements. State pharmacy and medical practice rules will continue to govern day-to-day operations regardless of FDA's approach. Before entering or expanding in a market, confirm each state's rules on prescriber licensure, telehealth, delegation to non-physician staff and corporate ownership of medical practices.
• Stay Informed and Flexible. Policy may shift quickly, including after the 2028 election. Build business plans that can adapt if access expands, narrows or changes conditions, and monitor FDA announcements, the upcoming PCAC meeting and any rulemaking so you can respond promptly.

For wellness companies, telehealth platforms, compounders and investors, the clearest near-term signal to watch is whether FDA moves any of the six recommended peptides into Category 1 and on what conditions. Those conditions will show how the agency plans to balance expanded access with its enforcement priorities.

Holland & Knight will continue to track regulatory, congressional and legal developments on peptides. For questions or help with compliance planning, risk assessment or opportunities to engage with the administration, please contact the authors.

Information contained in this alert is for the general education and knowledge of our readers. It is not designed to be, and should not be used as, the sole source of information when analyzing and resolving a legal problem, and it should not be substituted for legal advice, which relies on a specific factual analysis. Moreover, the laws of each jurisdiction are different and are constantly changing. This information is not intended to create, and receipt of it does not constitute, an attorney-client relationship. If you have specific questions regarding a particular fact situation, we urge you to consult the authors of this publication, your Holland & Knight representative or other competent legal counsel.