The Peptide Fad: Caveat Emptor

I’m a bit slow when it comes to learning about popular culture and ‘wellness’ fads. But a drive-time piece from NPR this week about this peptide wellness fad captured my attention.

Does the science of peptides live up to the hype?

In the piece I learned FDA was having advisory committee hearings this week to recommend whether the FDA should legitimize the current ‘gray market’ for untested & unlicensed peptides by officially putting the drugs on the loophole list – called the Section 503A Bulks List.

Adding the untested drugs to that list makes it clear compounding pharmacies can legitimately supply them to med spas and other ‘wellness’ clinics. Right now, they’re doing it in a regulatory gray area.

A quick google search revealed that there are tons of these ‘wellness clinics’ all over Arizona making bold (and unsubstantiated) claims about how awesome and curative these peptides are.

I saw all kinds of claims that peptide injections and nasal sprays accelerate injury recovery, reduce inflammation, improve sleep, sharpen thinking and slow aging. Clinics across metro Phoenix and Tucson advertise products including BPC-157, TB-500, Semax and Epitalon. More on these later.

So…  I wanted to dig a little deeper and look at the actual evidence and also see how it is that these unapproved drugs are actually available even though they’re not assessed for safety and effectiveness nor licensed by the FDA.

What are Peptides?

You probably learned what peptides were in high school biology class. They’re short chains of amino acids that help regulate many biological functions. Insulin is a peptide, as are several proven and FDA-approved medications, including the new GLP-1 weight loss drugs (which are approved and licensed).

But those aren’t the peptides being promoted by the wellness med-spas and the like. The unlicensed drugs they’re claiming are so curative are called BPC-157, TB-500, KPV, MOTS-c, Semax and Epitalon.

They’re being marketed for broad ‘wellness’ purposes without the clinical evidence normally needed for a new drug.

Not surprisingly, Kennedy is an enthusiastic advocate of these untested and unlicensed peptide drugs & makes frequent public statements about how he wants to make them more available by clearly giving them an exemption in compounding pharmacies.

Demand is also being driven by a podcaster called Joe Rogan, who repeatedly praises BPC-157 and TB-500 for injury recovery, calling the combination the “Wolverine stack.”  Literally.

Med-spas and other wellness clinics use his name in their marketing. People hear that Rogan thinks they’re good, so they search for the product and arrive at a med spa to buy it.

FDA Advisory Committee Recommends Broadening Access Despite the Lack of Approval

This week (Thursday and Friday) an FDA advisory committee (which was recently stacked with new Kennedy appointees) recommended allowing the compounding of the peptides despite objections from the agency’s career scientific staff.

Advisers to the FDA will vote to ease regulation of popular peptides : NPR

The FDA advisory committee recommended that the untested peptides be officially placed on something called the Section 503A Bulks List, which makes it clear that state-licensed compounding pharmacies can make them available (with prescriptions) even though the products haven’t been FDA-approved.

I know that’s already happening – but right now it’s in a gray market. If FDA puts these them on the official Bulks List it’ll be clear they can fill the prescriptions even though the drugs aren’t tested or licensed.

What Does the Evidence Show?

Not much.

FDA staff reviewers (who supplied the evidence base with the advisory committee) found no human data for KPV, MOTS-c or TB-500 (Joe Rogan’s “Wolverine Stack”). In other words, they found no data at all to show that those peptides are either safe or effective.

They presented evidence that BPC-157 has a tiny (and inadequate) human evidence base that it may be effective (no safety data), despite widespread wellness industry claims that they heal muscles and tendons.

They also presented evidence to the advisory committee that Semax, Epitalon and emideltide had even limited animal testing which was poorly documented. No human data.

FDA’s career scientists recommended against allowing the compounding of all seven.

Naturally, a majority of the committee (recently overhauled with new members by Kennedy) disagreed with FDA professional staff and recommended 8-6 that all the peptides be given an exemption – to let compounding pharmacies fill prescriptions for them anyway.

If They’re Not Approved, How Come They’re Available?

A doctor or other clinician who can prescribe meds can conduct a consultation and send a patient-specific prescription to a compounding pharmacy, even if the drug isn’t licensed by the FDA. That’s the loophole.

Compounded drugs aren’t FDA-approved and aren’t reviewed beforehand for safety, effectiveness or even manufacturing quality.

Compounding can be important when a patient needs an approved medication in a dosage that the manufacturer doesn’t provide. But in the case of peptides, wellness spas & woo-woo clinics drive a truck through that loophole.

The FDA’s advisory committee is nonbinding, so nothing immediately changes on the ground until (when) the FDA formally accepts the recommendations and updates its compounding policy, which is sure to happen given Kennedy’s zeal for the untested drugs.

When FDA adds the peptides to the bulk list, Arizona med spas, wellness stores etc. will have a much clearer legal supply route through compounding pharmacies and access (along with the unsubstantiated claims of safety and effectiveness) would likely expand.

BUT — but the decision still doesn’t establish that the peptide is safe, effective, or even clean.

Caveat Emptor, I guess.

Note: These peptide ‘treatments’ are almost entirely cash pay. Regular Medicare and most Medicare Advantage plans don’t cover bulk powders used as active ingredients in compounded drugs. Likewise, AHCCCS coverage is wired to evidence-based medicines, which these unapproved wellness peptides aren’t.

Private commercial insurance policies vary, so I can’t say that every plan excludes these peptides. But it’s safe to say that they’re unlikely to be covered.

So, for the most part, these drugs will be sold to people with enough disposable income to pay hundreds or thousands of dollars out of pocket. That means the people most likely to be ripped off (or potentially harmed) will tend to be higher-income people who can afford to experiment on themselves.

The Anatomy of a Foodborne Illness Investigation: The Cyclosporiasis Outbreak

Most foodborne illness clusters and outbreaks start with a sick person or people who go to their doctor to check out their symptoms. For example, someone with diarrhea, vomiting, cramps, fever or other G.I.  symptoms go to their doctor urgent care. The clinician examines the patient and might collect a stool sample, which they send to a lab.

If the lab finds a reportable foodborne germ in the specimen, the results are sent back to the doc but also (electronically) sent to the county/state health departments. An astute clinician might also alert call the county health department, especially if the illness is unusual or they’ve seen several patients w/ similar symptoms.

The next steps in finding whether the diagnosis is part of a cluster or outbreak happen at the county health department.

The County Investigation

A county health department epidemiologist then interviews the patient(s) – probably by phone. The epi asks the patient about symptoms, travel, restaurants, grocery purchases, social events and everything they might have eaten during the likely exposure period. Easier said than done.

Think about how difficult that is. What did you eat for lunch 11 days ago? Was there lettuce on your taco? Where did the restaurant buy it? Was the cilantro in the salsa fresh? Did you save the receipt? Where are all the other places you ate – including what you ate at home that you made yourself from groceries.

Investigators might also use restaurant records, shopper-card histories, receipts, food packaging and leftovers from the patient’s refrigerator.

If the evidence points toward a local restaurant, grocery store or food processor, environmental health sanitarians (also from the county) get involved. They can inspect the facility, interview employees, review food-handling and employee-illness records, collect samples and look for problems such as inadequate refrigeration, poor handwashing, cross-contamination or an ill food worker.

Sometimes they find a smoking gun. Often they don’t.

Connecting the Laboratory Results

Folks at the state and county health departments then look to see whether there are other reports of the same illness around the same time. If there is they’ll look at other county investigations to see whether there looks like there might be a common thread. One of the cluse they can use is to look at the genetics of the bacteria or parasite. The lab work is so good now they can often see whether it’s the same strain of the organism, which provides a good clue about whether the cases might be linked to the same food source.

Those results are uploaded into PulseNet, CDC’s national laboratory network.

When patients in several states have bacteria with nearly identical genetic fingerprints, investigators might figure out that illnesses which looked unrelated are actually part of the same outbreak – even among multiple states.

Cyclospora is among the more difficult outbreaks to identify. Routine stool tests don’t always include it. Detecting it in food is hard and investigators don’t yet have the same mature genetic-fingerprinting system used for many bacteria.

From One County to Several States

The state may set up a “case definition”—a standard set of laboratory, symptom and timing criteria used to decide which patients belong in the outbreak. They might alert clinicians and laboratories to watch for more cases (in AZ we call these HAN’s or Health Alert Network notices), review emergency-department records and ask neighboring states if they’re seeing anything similar.

When the evidence suggests a multistate outbreak (as has been the case with the current Cyclosporiasis outbreak), CDC can start a national epidemiologic investigation.

Investigators create an epidemic curve showing when illnesses began and map where patients live. They give states a common questionnaire so everyone in all the states/counties ask the same detailed questions.

Following the Food Backward

Once they have an idea about what the source might be (from the food histories, lab results and sanitarian inspections) they can start traceback work. That’s what happened with the current Cyclo outbreak in several states.

Traceback starts with the places where patients ate or bought the suspected food. The federal/state team finds food invoices, shipping records, lot numbers, delivery dates and supplier information for the suspected products. They work backward from restaurants and stores to distributors, processors, packing facilities and farms.

Investigators might also collect leftover food and environmental samples. They may sample food-processing equipment, water sources, soil, irrigation systems or other parts of the growing and packing environment.

Note: At the national level FDA generally regulates produce and most other foods. USDA’s Food Safety and Inspection Service regulates meat, poultry and processed egg products. CDC manages the interstate epidemiological investigations.

Stopping a Multistate Outbreak

Investigators don’t always wait for perfect laboratory proof before acting, including during the current outbreak. When the combined epidemiologic and traceback evidence is clear and convincing, several interventions can happen even if they haven’t isolated the germ from the food – as has been the case so far with the multi-state Cyclosporiasis outbreak.

Distributors can (or be asked or compelled) to place suspected products on hold or recall them. A company can, and usually does, voluntarily recall food already in stores and warehouses. FDA can issue public warnings, increase inspections or screening at the border and work with retailers to find where the food was shipped.

If the source looks like it’s from a farm or processor they can examine irrigation water, sewage exposure, worker sanitation, harvesting equipment, wash water, sanitary packing practices etc.

After the product is removed, investigators keep watching the epidemic curve. Because of incubation periods and reporting delays, illnesses might continue to be reported for several weeks even after the contaminated food is gone.

The Current Cyclospora Investigation

That’s what we’re seeing in the current Cyclospora outbreak.

As of right now CDC/states/counties have found 1,644 laboratory-confirmed cases with exposure to iceberg lettuce in Taco Bell products mostly in Indiana, Kentucky, Michigan, Ohio and West Virginia. For example, Michigan epi’s found that of their 190 patients, 90%  ate at Taco Bell, eating food with iceberg lettuce.

The handful of cases in AZ over the last few weeks don’t appear to be part of the big national outbreak.

FDA traced the lettuce supplied to the Taco Bell locations to shredded iceberg lettuce from Taylor Farms de Mexico that was sourced from central Mexico.

Even though the parasite hasn’t been found in any lettuce so far, all the county health department and laboratory gumshoe work still leads back to the same lettuce producer: Taylor Farms’ source in Mexico.

Because the epi data were compelling, Taylor Farms recalled iceberg lettuce from that farm in Mexico.  Taco Bell has stopped using that lettuce. Mexican health and agricultural authorities also began inspections and traceback work.

There will still be lots more cases reported I the next couple weeks even though the source is likely gone – because the incubation period for the parasitic illness can be up to 10 days or 2 weeks.

Did Federal Staffing Cuts Cause the Outbreak?

Several journalists have asked me whether the federal staffing cuts caused this outbreak.

I can’t say that for sure, but it’s possible.

Why? Because DOGE and Kennedy’s firings at FDA and CDC in 2025 weakened parts of the food-safety system. FDA inspector firings, including all the probationary employees and other mass firings led to a lot fewer FDA inspectors posted in other countries and also to suspend laboratory quality-control work… including proficiency testing to detect Cyclospora in produce.

Those cuts didn’t necessarily cause this outbreak. But fewer inspectors, laboratory scientists, epidemiologists and support staff mean fewer opportunities to prevent contamination and detect illnesses earlier.

Summary

Foodborne illness investigations are slow, complicated and built on hundreds of small pieces of information collected by county/state/federal epidemiologists, doctors, labs, sanitarians and regulators.

The current Cyclospora outbreak highlights how those pieces can point to a likely source even when the organism hasn’t been isolated from the food itself. It also shows why a strong public health and food-safety workforce matters… from preventing contamination to finding illnesses and tracing the food backward.

We’ll never know whether the DOGE/Kennedy firings led to this outbreak, but weakening the system at the federal level makes outbreaks like this harder to prevent.

Saving Lives Through Heat Relief: Arizona’s Novel Approach

Extreme heat is the deadliest weather threat in the Southwest — but Arizona is proving those deaths are preventable. Join the Arizona Public Health Association and the Health Insights Hub by Hess III Consulting for this free webinar, featuring Maricopa County and Pima County Departments of Public Health, for a closer look at their novel, coordinated approaches to heat relief.

Discover how Maricopa and Pima Counties are tackling extreme heat with coordinated networks of hydration stations, cooling centers, respite sites, and outreach programs.

View the 60-minute webinar

Learn about data-driven interventions, transportation solutions, partnerships with Red Cross and utility companies, and the impact of substance use and chronic disease on heat-related deaths. Get actionable tips for community preparedness, access to toolkits, and insights into the challenges posed by funding cuts to critical services like 211.

This webinar is ideal for health professionals, community organizations, and anyone seeking practical strategies to protect vulnerable populations during Arizona’s record-breaking heat seasons. This session shows public health leaders, health and human services organizations, and community partners how cross-sector coordination saves lives — and how to adapt these strategies in your own community.

Trump Administration Takes Shots at Olmstead… but Institutionalization Unlikely to Return

Last summer, the president issued an executive order called “Ending Crime and Disorder on America’s Streets.”  The order argued that homelessness, serious mental illness and substance use should be addressed via more “long-term institutional settings.”

Ending Crime and Disorder on America’s Streets – The White House

The EO mainly focused on people with serious mental illness, but it could potentially have broader consequences for people with all kinds of disabilities, (including intellectual and developmental disabilities).

The EO directed the Justice Department to seek the reversal of court decisions and consent agreements that stand in the way of increasing institutionalization of people with disabilities.

Of course, the Justice Department lawyers dutifully followed through and last month issued a memo about the Rehabilitation Act, the ADA and the Olmstead decision.

The densely worded 38-page complicated memo argues that no federal law (the Rehabilitation Act of 1974 nor the ADA) requires states to provide services in the most integrated setting appropriate.

The memo claims that Olmstead only established that unjustified institutionalization can be discrimination (not that states must build their care systems around community placement).

Before you freak out, remember that the memo was written by lawyers in this administration’s DOJ, so any Justice Department lawyer that wants to keep their job would have to validate the president’s position pressing for more institutionalization.

The memo was just that – a Justice Dept lawyer writing something that the White House dictated. It’s not a court ruling – not even close.

But – it’s still meaningful, because for the next 2.5 years Kennedy and other federal agency directors can use the memo to justify and craft harmful actions or look the other way when it comes to civil-rights and civil liberties or even actively pursue more institutional models of care.

Note: The memo isn’t a Supreme Court ruling and it doesn’t repeal the ADA, the Rehabilitation Act or the Medicaid statutes. The memo never even mentions Medicaid, CMS and doesn’t even use the words Home and Community-Based Services. It also doesn’t overturn Olmstead.

Arizona’s Model

On the local stage, AZ is far down the road toward community-based care. Our current Olmstead Plan continues to emphasize HCBS (home and community-based services), supportive housing, integrated care and services that help people remain in their communities. ADES/DDD serves more than 60,000 people, and only about 9% of ALTCS members are placed in institutional settings.

Based on my conversations with Arizona agency leaders last week, the Justice Department memo is being treated as something to watch, but not as something that changes how Arizona currently serves (or plans to serve) people with developmental disabilities or serious mental illness.

But – a future AZ administration could want to expand institutional care… but I really don’t think it would take off because institutional care is WAY more expensive that community-based care.

The bottom line is that the DOJ memo (which has freaked a lot of people out) is really just the opinion of a Trump Administration DOJ lawyer who was instructed to write a memo that the president likes.

Any attempt to dismantle the integration mandate will almost certainly face years of litigation – time that this administration doesn’t have left (only 916 days… but who’s counting).

How Care for People w/ Disabilities Transitioned from Institutions to Communities

During the 18th 19th and most of the 20th century in the standard of care for helping persons with serious mental illness or intellectual and developmental disabilities in the US (to the extent there was any help at all), was institutionalization.

People were often separated from their families & communities and sent to state-operated facilities (like the Arizona State Hospital) for most of their lives. Those institutions often had limited healthcare and few opportunities to have meaningful days etc.

Families were commonly told that institutional placement was the only realistic option. Some did stay with their families, but there was little to no support services or even educational opportunities for most of those decades.

Conditions in many facilities were often bad, with overcrowding, neglect, sometimes even abuse and little personal choice. By 1967, nearly half of the people living in institutions for people with intellectual and developmental disabilities were kids. Super sad.

For people with serious mental illness, care was centered in state psychiatric hospitals, like the Arizona State Hospital.

Deinstitutionalization of persons with a mental illness began slowly in the 1950s and 1960s, driven by better and new medications, changing treatment philosophies and by court decisions that compelled the development of community mental-health programs.

Over those decades (1950s and 1960s) many states closed mental hospitals but at the same time didn’t build the community supports like residential living arrangements, outpatient treatment, crisis services and intensive case management.

A major deinstitutional turning point came with the Rehabilitation Act of 1973. That federal law recognized the institutional model as a violation of civil rights and liberties issue. After that law came into effect, Medicaid agencies couldn’t use federal funds if they excluded or segregated people because of their disabilities.

The 1974 Rehabilitation Act didn’t pay for community services, but it set the stage for Medicaid to start using a community-based care model… what we now call Home and Community-Based Services.

Beginning in 1983, states could use Medicaid money for those kinds of community supports (e.g. providing services in family homes, apartments, supported-living arrangements and small group homes rather than institutions).

Note: Arizona was the last state to implement Medicaid (in 1982). All other states implemented Medicaid in the late 1960s.

The Watershed Moment

The 1999 Supreme Court decision in Olmstead v. L.C. is what really changed the landscape. The court held that unjustified institutional segregation constitutes discrimination under the Americans with Disabilities Act. That gave the 1974 Rehabilitation Act more teeth.

Olmstead didn’t compel (or pay for) community-based care, but it gave people with disabilities (both mental and developmental) a way to compel states to change their Medicaid treatment and care model to a more therapeutic and community-based model.

Arizona was the last state to join Medicaid, launching AHCCCS in 1982 several years after the Rehabilitation Act and just as Medicaid HCBS waivers were becoming available (but many years before the Olmstead decision).

AHCCCS 101 (Part 1 of 4): AHCCCS’ Origin Story – Why Arizona Built Medicaid Different

Arizona built much of its Medicaid system during an era when community living was already mostly established. Arizona still had institutions (ICFMR’s – I won’t define the acronym because it’s disgusting) and the AZ State Hospital.

But, because we weren’t financially and operationally tied to a Medicaid-funded institutional structure like most other states were, Arizona’s transition from institutional care to residential/community care wasn’t as rocky as it was in other states.

Arizona’s mental health system was also shaped by the Arnold v. Sarn lawsuit (filed in 1981) which found that the state had failed to provide the comprehensive community mental-health system required by Arizona law.

Arizona’s late arrival to Medicaid was usually considered a disadvantage, and our late adoption of Medicaid came with tragic human costs… but it also allowed AZ to avoid the hassles that came with fighting care systems to shift from institutional to community care.

The move from institutions to community-based care didn’t happen fast, and it wasn’t easy. It took decades of advocacy, lawsuits, changes in federal law and new Medicaid policies to establish the idea that people with disabilities should be able to live, work and receive services in their own communities.

Arizona benefited from building much of its Medicaid system after that approach had already begun to take hold. Community-based care still depends on adequate funding, a stable workforce, available housing and continued enforcement of the civil-rights protections that helped make the change possible.

In my next piece we’ll explore how the Trump Administration is moving the turn the clock back on community supports toward institutionalization.

AHCCCS Proposal Expands Access to a Full Year of Birth Control AZPHA Submitted Comments Supporting the Move

Last week AHCCCS proposed a change to their pharmacy policy to make it easier for Medicaid members to get an extended supply of contraceptives.

The proposed change (to AMPM Policy 310-V) allows AHCCCS members to get a 12-month supply of oral contraceptive products at one time. Non-oral contraceptive products could continue to be dispensed in supplies up to 90 days.

The current policy limits all contraceptive products to a maximum 90-day supply. The revised policy is available here.

We submitted comments supporting the proposed policy change.

Providing a longer supply of oral contraceptives can help patients use their medication more consistently and minimizes gaps from delayed refills. Consistent access to contraception supports reproductive autonomy, healthier birth spacing, and improved maternal and infant health outcomes.

The change also improves efficiency by reducing unnecessary pharmacy visits and provider appointments that occur only to obtain routine refills.

AzPHA submitted this letter of support for the policy change. Our comments also recommended that AHCCCS clearly define the term “non-oral contraceptive products”, so health plans, clinicians and members understand which products qualify for the 90-day supply.

The public comment period remains open until July 26, 2026, at 5 p.m. AzPHA members can submit their own comments here.

 

Surprise

AZ’s First Rural Health Transformation Grants Target Overdose Prevention, Telehealth & Data Management

After months of planning (and missed timelines) Arizona finally released the first of the competitive grant opportunities under the Rural Health Transformation Program.

AHCCCS posted the Opioid Antagonist Distribution Initiative Request for Grant Applications last week. Applications are due August 7, 2026. Here’s the full grant announcement and application informationThe other two grants focus on Medical Diagnostic Equipment and EHR upgrades and Telehealth Digital Transformation   

State Turns in Revised Rural Health Transformation Grant Proposal

The Rural Health Transformation Program was created by Congress as political cover for what they did to rural health in H.R. 1… made decisions that will dramatically hurt access to care and health system solvency in rural places.

These solicitations are coming from AHCCCS. The lion’s share of the funds will be coming from the Governor’s Office of Economic Opportunity, which has provided very little publicly accessible information about its part of the program.

AZ Submits Rural Health Transformation Grant Application to Feds

Several much larger grant opportunities are supposed to follow over the next few weeks. This first procurement is a welcome start… but it’s only the beginning.

Arizona Grant Opportunities (Compiled by the Vitalyst Health Foundation)

NEW Due July 9th: Cigna Military Mental Health Grant

NEW Due July 10th:Pathways Impact Fund

Due July 10th: FY26 Transit-Oriented Development (TDO) Planning Pilot 

NEW Due July 14th: USDOJ Housing Assistance for DV Victims

Due July 14th: The Indigenous Tomorrows Fund

Due July 15th: Spark Good Local Grants

NEW Due July 17: City of Phx Fast-Track Initiative Sponsorship Opportunities

Due July 29th: W.T. Grant Foundation Rsch on Reducing Inequality Grants

NEW Due July 31: Overwatch Alliance Grants

NEW Due July 31st:Lululemon Community Wellbeing Grants

Due August 29th: National Science Foundation Grants for Undergraduates

Due September 1st: The Bolger Foundation Grants (Favors Capital Grants)

Due September 1st: Nationwide Foundation Grants

Due September 15th:Journey for Good Foundation Grants

Due October 11th: Whole Foods Market Store Giving

Due October 31st:Dudley T. Dougherty Foundation Grants

Due October 31st: TJX Grant

NEW Ongoing:Susan & Michael Dell Foundation Grants

Ongoing: SC Johnson Grants and Product Donations

Ongoing: Affirm Cares Grants

Ongoing: The Impact Fund Legal Case Grants

Ongoing Until September: GM Corporate Giving Grants

Ongoing: Novartis Educational Grants

Ongoing: QuikTrip Community Grants

Ongoing: U-Haul Community Donations

Ongoing: Cogir Foundation (Youth, Seniors)

Ongoing: BNSF Railway Foundation

Ongoing: PNC Foundation (Education, Economic Development)

Ongoing: Brutten Family Fdn Grant (Environment, Education, Mental Health)

Ongoing: Community Possible grant program (Work, Home, Play)

Ongoing: Native Youth Media Project

Ongoing: Arizona Housing Fund 

Ongoing: Arizona Together for Impact Fund

Additional Resources

AZ Impact for Good Membership: Membership Scholarship Application

Research: Lab For Economic Opportunities (LEO)

Securing Funding (Rural & Tribal): Arizona Economic Resource Center

Board Matching Tool: AZ Leaders on Board

Toolkit: Advocating for Federal Spending: A Practical Guide for Nonprofits