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FDA Backs 6 of 7 Peptides: What It Means for Black Patients

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peptides

If you’ve spent time scrolling through the internet or social media lately, then you are probably familiar with the sudden popularity of peptides. Fitness influencers, celebrities, and even Health and Human Services Secretary Robert F. Kennedy Jr. have all discussed their supposed benefits.

Peptides have been promoted for their ability to support everything from wound healing and metabolism to digestion, sleep, and healthy aging.

However, until recently, many of the peptides circulating on social media could only be legally manufactured and sold for research purposes. As a result, people already using them were often turning to online retailers operating in a “gray market.

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To address this, the Food and Drug Administration (FDA) recently held a meeting to discuss whether seven popular peptides should be allowed for broader use. The consensus? The FDA ultimately recommended that six peptides be added to the compounding eligibility list, meaning they may soon become easier to access through regulated sources.

For Black patients, who may already face barriers to accessing quality healthcare and may encounter health information through social media and other online communities, understanding what peptides are—and what is actually known about them—is especially important.

RELATED: Peptides? Here’s What You Need to Know

What Are Peptides?

Peptide describes a broad class of molecules rather than a single medication. Some peptides are FDA-approved prescription drugs with well-established clinical uses, while others are investigational or have little supporting evidence. That’s why it’s important to evaluate each peptide individually rather than assuming findings about one peptide apply to all others.

As a class, peptides are short chains of amino acids that play a role in many biological processes throughout the body, including hormone activity, immune defense, and metabolism.

“I think they’re generating so much attention right now because certain peptide medications have been studied and approved for specific medical conditions, while others are being promoted online despite limited clinical evidence or regulatory oversight,” Jean Cunningham, PharmD, BCPS, Senior Director of Medical Affairs at Empower Pharmacy, tells BlackDoctor.

While peptides are often accompanied by big claims, the evidence varies depending on the specific peptide and how it is being used. Some peptide medications have strong clinical evidence and FDA approval for specific conditions. In contrast, many peptides promoted online have little or no high-quality clinical evidence supporting the claims being made about them.

This distinction is particularly important when considering health information shared online. Black communities have historically experienced disparities in access to healthcare, clinical research, and trustworthy health information. At the same time, social media has become an increasingly important source of health information for many people. That can make it even more important to look beyond testimonials and influencer recommendations and understand what the research actually says.

Cunningham advises being cautious of broad marketing claims and discussing any proposed peptide therapy with a licensed healthcare provider before starting treatment.

FDA-Approved vs. Compounded vs. Gray Market Peptides

Cunningham highlights three key differences between FDA-approved, compounded, and gray market peptides:

  • FDA-approved peptides have been reviewed by the FDA for safety and effectiveness and are manufactured under FDA requirements designed to ensure consistent quality.
  • Compounded peptides are prepared by licensed pharmacies using ingredients from FDA-registered suppliers pursuant to a patient-specific prescription from a licensed healthcare provider. They are intended to meet an individual patient’s medical needs when an FDA-approved product is not appropriate or cannot meet those needs.
  • Gray market peptides are sold as “research chemicals” or through unregulated online vendors and are often labeled “not for human consumption” or “for research use only.” These products are not approved medications and may not meet standards for identity, potency, sterility, or purity.

For Black patients, this distinction matters. It can be tempting to purchase a peptide directly from an online seller, particularly when a product is heavily promoted by someone who looks like you, shares your health concerns, or says they experienced positive results. But a relatable testimonial is not the same thing as clinical evidence.

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RELATED: The Truth About Collagen Peptides: Do They Really Work for Black Skin?

What to Ask Before Taking a Peptide

Before using any peptide promoted online or by an influencer, Cunningham recommends discussing the following questions with a licensed healthcare provider:

  • Is this peptide appropriate for my specific health needs?
  • Does it come from a licensed, reputable source?
  • What evidence supports its use?
  • What are the potential risks and side effects?
  • How will I be monitored while taking it?
  • Is this medication FDA-approved? If it’s compounded, why is a compounded medication appropriate for me?

Black patients should also feel comfortable asking their healthcare providers questions about how much evidence exists for a particular peptide in people with similar health conditions, medications, or risk factors.

You don’t have to accept a treatment simply because it is trending online, and you shouldn’t feel pressured to start something because friends, family members, or influencers say it worked for them.

Peptides should only be used under the guidance of a qualified healthcare provider.

Be Careful When Buying Peptides Online

You should also use caution when buying peptides. Peptides purchased online or from sources that aren’t regulated can pose several risks, including uncertainty about what you are actually receiving.

“Some products sold through unregulated sources have also been found to contain completely different substances than listed on the label, incorrect dosages, contaminants, or inconsistent quality, which can create serious safety risks and may make treatment ineffective. Patients should obtain medications through a licensed healthcare provider and reputable pharmacy,” Cunningham explains.

This is especially important when a product is being marketed as a quick fix for concerns that disproportionately affect or are particularly important to Black communities, such as weight management, diabetes, cardiovascular health, or hair and skin concerns. A product being marketed toward a specific community does not mean it has been adequately studied for that population—or that its claims are supported by evidence.

You also shouldn’t assume that peptides available through compounding pharmacies are automatically safe or proven to work.

Although medications prepared in compounding pharmacies use active pharmaceutical ingredients from FDA-registered suppliers and may undergo testing for purity and sterility, compounded medications are not evaluated by the FDA for safety or efficacy and are not FDA-approved. They are compounded for a specific patient based on a prescription from a licensed healthcare provider and under the supervision of a licensed pharmacist.

“As with any medication, the potential benefits and risks should be evaluated by a licensed healthcare provider based on a patient’s individual circumstances,” Cunningham notes.

What Does a Compounding Pharmacy Do?

A licensed compounding pharmacy, such as Empower Pharmacy, creates customized medications tailored to a specific patient’s needs. This may include adjusting the strength, dosage form, or ingredients when a licensed healthcare provider determines that commercially available drugs aren’t appropriate.

“Most prescriptions filled at retail pharmacies are commercially manufactured medications. In contrast, compounded medications are custom prepared by a pharmacy according to a licensed healthcare provider’s patient-specific prescription,” Cunningham shares.

Compounded peptides may not be appropriate for everyone. As with any new therapeutic regimen, pregnant or breastfeeding women, people with certain chronic medical conditions, and individuals taking medications that could interact with peptide therapies should discuss their medical history with a licensed healthcare provider before starting treatment.

“A qualified healthcare provider can determine whether a particular therapy is appropriate based on an individual’s health status and treatment goals,” Cunningham adds.

Potential side effects vary depending on the specific peptide, its route of administration, and its quality. The prescribing healthcare provider can discuss the potential side effects associated with a particular peptide, so you know what symptoms to watch for when starting a new therapy. You should contact your healthcare provider if symptoms persist or worsen and seek immediate medical attention for severe symptoms.

Don’t Believe Every Peptide Claim You See Online

With so much information—and misinformation—circulating online, it can be hard to know what to trust or believe. Be cautious of claims that sound too good to be true, especially when they are based on testimonials or influencer endorsements rather than clinical evidence.

“Patients should rely on trusted medical professionals and reputable, evidence-based sources rather than social media or online hype. Discuss peptides with a qualified healthcare provider who can determine whether they’re appropriate and ensure they’re obtained from a reputable source,” Cunningham says.

If you feel uncomfortable asking questions or don’t feel your concerns are being heard, consider seeking a second opinion from another qualified healthcare professional. Your healthcare decisions should be based on your individual health needs—not social media trends.

Which Peptides May Be Added to the Compounding List?

The six peptides that were recommended to be added to the compounding eligibility list—and the uses they are most commonly promoted or studied for—include:

  • BPC-157: Gut health and connective tissue repair
  • KPV: Anti-inflammatory effects and gut health
  • TB-500: Tissue repair and wound healing
  • MOTS-c: Glucose metabolism and muscle health
  • Semax: Cognitive function
  • Epitalon: Sleep

Emideltide, which has been investigated for insomnia and pain relief, was the seventh peptide discussed during the meeting. However, it was the only one that was not recommended for addition to the compounding eligibility list.

It’s important to remember that being recommended for addition to a compounding eligibility list does not mean a peptide has been FDA-approved or proven safe and effective for the conditions it is promoted for.

What’s Next?

The FDA will review the Pharmacy Compounding Advisory Committee’s recent recommendations regarding the six peptides before deciding whether to take regulatory action.

In the meantime, Black patients—and all patients—should continue working with their healthcare providers to determine which treatments are appropriate for them and avoid making treatment decisions based solely on the committee’s recommendations or what they see online.

The bottom line: Peptides may have potential, but not every peptide—or every claim made about one—has been proven safe or effective. Before starting a peptide therapy, talk with a qualified healthcare provider who can help you understand the evidence, potential risks, and whether the treatment is appropriate for you.

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