‘Legal Insight into Regulatory Issues Impacting Age Management Medicine.’
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Most lay people don’t know much about the FDA or CDC, pharmacies, and compounding pharmacies and how impactful their decisions are on your ultimate health. The topic of today is on the ever-shifting regulatory framework relative to physician’s use of peptides, hormones, and supplements, addressing in particular, peptides. Peptides, naturally occurring in our cells are defined as molecules containing 2 or more amino acids. Proteins are made of peptide chains.
This blog is something not many people in clinical practice write about but is a part of medicine that needs to be shared as it impacts our ability to advance good health.
‘Legal Insight into Regulatory Issues Impacting Age Management Medicine.’ was a lecture given at the Age Management Medicine Group spring conference by Paul D. Werner, Esq. and is paraphrased below.
FDA
FDA is a regulatory agency responsible for monitoring anything they choose if it is being used for medicinal purposes. Regulations are found in the Federal Food, Drug, and Cosmetic Act, FD&C.
Compounding Pharmacies
Compounding pharmacies allow for prescription and use of drugs exempted from FDA regulations concerning new drug approval, drug labeling, and drug manufacturing. This means compounded medications can get to the consumer much faster than traditional “new drugs” to the market. These pharmacies can combine 2 or more drugs together using a custom formulary, providing a unique delivery system. Compounded medications are prepared for individual patients, often with special needs.
Peptides
FDA defines peptides as having an amino acid chain made of 40 or less amino acids. peptidTherefore, as per FDA rules, peptides are regulated as drugs, not biologics because of the small number of amino acids.
Use of Peptides in Age Management Medicine
Prior to , the most commonly used peptides in Age Management Medicine were not explicitly addressed by the FDA in any capacity.
However, the peptides were submitted for bulk drug approval in the fall of . This is what got the ball rolling and changed the playing field.
When the FDA looked at the peptides submitted for bulk drug approval, many of those peptides were identified as Category 2 substances posing ‘significant safety risks’ as per the FDA. Meaning, there were not enough studies done as per the FDA to prove these peptides were safe. Note most peptides have few if any side effects. However, large studies proving this have not been done.
Beginning in October and culminating in February , the FDA made it very difficult and risky for compounding pharmacies to continue compounding peptides. This means penalties or restrictions are imposed on compounding pharmacies.
The New FDA Regulation does not Explicitly Prohibit Compounding Peptides.
However, the new FDA regulation also fails to explicitly approve the use of many of the most popular peptides in compounded products.
Since peptides are now unapproved by the FDA, compounding pharmacies face serious regulatory exposure if they continue to compound peptide products. The FDA has sent numerous warning letters to compounding pharmacies relative to the use of unapproved or inaccurately marketed peptide-based products. And to reiterate, the FDA has not banned peptides from use.
Why Now?
Doctors have been using peptides for years. However, the use of peptides for therapeutic purposes is an exploding field. In , peptides represented 5% of the pharmaceutical market equating to $42 billion globally and projected to double in the next 10 years. There are hundreds of peptides currently in clinical development undergoing preclinical studies. These peptides are now becoming the center of attention having been brought to the attention of the FDA.
What Peptides were impacted?
What Really Happened Here?
The answer to all these questions is “NO”.
What is the Aftermath?
Companies started popping up selling “research peptides” to get around FDA regulatory framework. Some of these research companies have already been shut down for telling customers how to use the peptides when they are not allowed to give out medical advice.
The difficult part for the consumer is there are no regulations on these research companies and unless you test every product by a 3rd party every time you get a product, you won’t know the quality of the product. This puts the consumer at risk for paying for poor products. Whereas, if compounding companies are making the product, they are regulated by the FDA, and are assured quality.
Summary
Recent changes in FDA regulatory framework:
This is not the end of the story. These regulations remain subject to further review and evaluation. Doctors need to speak up and be the loudest voice in the room.
Moving forward, RMC is positioning itself to be one of the centers to provide clinical data in a multi-center study to prove efficacy and safety of BPC-157. BPC-157 is a peptide well known for multiple uses such as brain injury, cardiac injury, gastrointestinal issues, and ligamentous injury.
It is RMC’s stance peptides are our medications of the future using natural products based on cellular science to prevent and treat diseases. We are very grateful to be able to herald peptide’s new place in medicine.
Peptides and peptide therapy is a popular health and wellness trend. People are either taking peptides or trying to figure out if they should. Even if you think you’ve never heard of peptides, chances are you have. Some very well-known treatments and medications are actually peptides—you just wouldn’t know it because “peptide” isn’t in their name.
For example, we’re sure you’ve heard of semaglutide. You know, the extremely popular medication for weight loss and diabetes management? Well, semaglutide is actually a synthetic version of a naturally occurring peptide in the body. What about collagen? While collagen itself isn’t a peptide (it’s a protein), when sold as a supplement, it is often in peptide form.
Semaglutide and collagen are just two examples of peptides. There are hundreds of peptides, both synthetic and naturally occurring, that target specific functions in the body. From regulating metabolism to improving skin elasticity and reducing the effects of aging, enhancing muscle recovery, and more, peptides play an important role in many essential bodily functions.
Peptides are no doubt having a moment right now. But with all the buzz comes confusion. Most people have no idea what peptides are, why they’re being used, or which ones they should consider.
With long numerical names, like BPC-157 and CJC-, peptides sound scientific and impressive. But since your body actually makes a lot of different peptides, is it really necessary to add more through peptide therapy? Or are peptides just another passing trend?
We are going to cut through the confusion and explain what peptides are, which ones your body makes and must get from an outside source, how they work in the body, and why countless people are turning to peptide therapy for anything from anti-aging and weight management to improving muscle mass and athletic performance, sexual health, and more!
Peptides are naturally occurring molecules made from short chains of amino acids critical for many different biological processes in the body. Your body makes some peptides, while others must come from outside sources.
Peptides consist of two to 50 amino acids linked together. Unlike proteins, which are larger and more complex, the small size of peptides makes them easier for your body to use for very specific roles, like repairing tissue, hormone regulation, and cellular repair.
There are two types of peptides:
Because peptides are involved in so many processes within the body, whatever concern you have, there’s probably a peptide that can potentially help.
Peptides work as signaling molecules that bind to specific receptors on cells, triggering cascades of biochemical processes. These processes influence a wide range of functions, like metabolism, cell growth, and tissue repair.
Sometimes, your body can’t produce enough of certain peptides on its own, or it might need a little extra help to optimize certain functions. Additionally, there are many peptides that your body needs but cannot make on its own. You must get these peptides from outside sources, such as peptide therapy.
Peptide therapy is a treatment that uses specific peptides to address or optimize various functions in the body. Synthetic or naturally occurring peptides are introduced into your body to fill gaps, providing your body with peptides that your body is lacking or could use a little boost.
The peptides used in peptide therapy depend on your health goals or the specific functions you want to target. For example, there are peptides that help with fat loss and metabolism, others that promote muscle growth and boost athletic performance, and some that promote healing and recovery.
Some people are also using peptides for hormone balance (either in conjunction with hormone replacement therapy or as a stand-alone treatment), and there are even peptides that are so effective at targeting aging-related issues like skin elasticity and collagen production that they are being deemed the fountain of youth!
Just as there are many different types of peptides, there are also different delivery methods. How your peptides are administered depends on the peptide and its intended use. We will discuss delivery methods used in peptide therapy in more detail later. But typically, injections are the preferred delivery method because they allow the peptides to be absorbed directly into the bloodstream, ensuring maximum effectiveness.
Currently, there are at least 100 different types of peptides used in peptide therapy, with more being researched and developed. However, some peptides are more widely used and researched than others.
Some peptides, like semaglutide, are FDA-approved for specific uses, such as managing type 2 diabetes or supporting weight loss. However, many others are considered experimental or are prescribed off-label, meaning their use for certain conditions has not yet been approved by the FDA.
Each peptide has unique properties, and the right choice depends on your health goals and needs. A qualified peptide therapy provider can guide you in selecting the peptides that best suit your individual needs and help create a personalized plan.
Here is a list of the most popular peptides used in peptide therapy and some of the specific benefits they offer:
Sometimes called the “healing peptide,” BPC-157 is best known for its ability to repair tissues, reduce inflammation, and accelerate recovery from injuries.
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This is a popular growth hormone-releasing peptide that has been shown to increase growth hormone production, which supports muscle growth, fat loss, and overall metabolism.
A clinical trial published in Clinical Endocrinology found that CJC- stimulated a sustained release of growth hormone in participants, resulting in enhanced IGF-1 levels over an extended period.
This makes CJC- a favorite for those looking for anti-aging perks and fitness-focused individuals hoping to improve muscle tone.
Often paired with CJC-, Ipamorelin is a potent growth hormone stimulator. It is often used to enhance recovery, improve sleep, and combat signs of aging.
If you want to lose body fat and improve your metabolism, 5-Amino-1MQ will likely be suggested as part of your peptide treatment. This peptide works by inhibiting an enzyme linked to fat cell metabolism, potentially promoting fat loss and supporting better metabolic health.
Do you feel sluggish or like you just seem to recover from your workouts? Sermorelin is a versatile peptide for anyone looking to feel more rejuvenated. Sermorelin is well known for its ability to boost energy and improve muscle recovery. It is also used to rejuvenate the skin and support anti-aging.
Dubbed the “libido peptide,” PT-141 is for anyone struggling with low libido and sexual function. PT-141 success stories report overall enhanced sexual wellness, including a higher sex drive, improved arousal, and greater satisfaction during intimacy.
This copper peptide is a game-changer for skin health due to its potential role in collagen synthesis and wound healing. A study in The Journal of Investigative Dermatology demonstrated that GHK-Cu significantly improved skin elasticity, reduced wrinkles, and accelerated the healing process by boosting collagen production.
You’ve probably always heard you can’t “target” fat. Well, users of Tesamorelin might disagree with that statement. This peptide is gaining popularity for enhancing general weight loss efforts, specifically for its ability to specifically target abdominal fat. It is also effective in addressing HIV-associated lipodystrophy.
Last but certainly not least is semaglutide—the peptide you’ve probably heard about a million times but didn’t realize was a peptide. Semaglutide was originally developed to treat type 2 diabetes, but in recent years, it has become a breakthrough in weight management after scientists discovered its ability to control appetite, regulate blood sugar levels, and promote sustainable weight loss.
Peptide therapy is popular for a reason—it’s tailored to meet your body’s specific needs and can deliver targeted benefits.
Different peptides play distinct roles, meaning the outcomes you experience depend entirely on the peptides used in your treatment plan. But here’s a look at just a few of the benefits peptide therapy may offer:
Certain peptides, such as CJC- and Ipamorelin, can support muscle development, improve strength, and boost endurance. These peptides stimulate growth hormone release, which is crucial for muscle repair and growth.
But these peptides go beyond gains—they also help with post-workout recovery by promoting tissue repair and reducing inflammation, allowing you to recover faster and perform better in your next workout.
Some peptides, like semaglutide and 5-Amino-1MQ, work to regulate appetite, enhance fat metabolism, and support balanced blood sugar levels. These peptides can be powerful tools for losing weight or maintaining a healthy metabolism.
Peptides like CJC- and Ipamorelin are said to stimulate growth hormone production, which can help restore hormonal balance. When your hormones are balanced, this can result in better sleep, increased energy, a higher libido, and a sense of overall enhanced vitality.
Peptides such as GHK-Cu are widely used for skin health. They support collagen production, improve elasticity, and reduce fine lines, making your skin look and feel more youthful and rejuvenated.
Peptides like BPC-157 can help strengthen your immune system by enhancing your body’s natural defenses. This can help you stay healthier and more resilient, especially during times of stress or recovery.
Peptides like PT-141 have become a game-changer for sexual health. Users report improvements in low libido and sexual dysfunction, resulting in improved sexual wellness and overall sexual satisfaction.
If you are experiencing pain from an injury or even just over-training, peptides such as BPC-157 can help. These peptides assist with tissue repair and inflammation reduction, both of which are crucial for speeding up recovery and relieving discomfort.
Certain peptides may help optimize brain health, support brain function, and enhance focus, memory, and mental clarity by promoting neuroplasticity—the brain’s ability to form new neural connections.
These peptides also support the brain’s natural repair processes and protect against cognitive decline by boosting cellular regeneration, reducing inflammation, and potentially offering neuroprotective effects that safeguard brain cells from damage.
Peptides like CJC- and others may assist in regulating blood pressure by supporting the health of your blood vessels and improving circulation. Certain peptides are also said to help relax blood vessel walls, enhancing vasodilation, which can lower blood pressure.
Peptides like GHK-Cu can help stimulate hair follicles and promote new hair growth by encouraging key growth factors and improving scalp health. They can also support the hair growth cycle by increasing blood flow to the scalp and strengthening hair follicles.
Researchers are also exploring peptides’ role in gut health. One peptide in particular, BPC-157, is gaining attention for its potential in promoting intestinal repair and healing.
Studies suggest that BPC-157 may help reduce inflammation in the gut, speed up the healing of intestinal wounds, and improve overall gut integrity. This peptide has shown promise in animal models for helping to repair damage caused by conditions like leaky gut and inflammatory bowel disease (IBD).
As more research emerges, peptides like BPC-157 could become a key player in addressing gastrointestinal health concerns.
Peptides can be administered in several ways. The delivery method is chosen based on your treatment goals and the peptide’s unique properties.
Each delivery method offers unique advantages and is selected based on the peptide’s properties and your therapeutic needs. Your provider will help you decide which method best aligns with your treatment goals and lifestyle.
Subcutaneous injections are the most common and effective method for peptide therapy. Injecting the peptide ensures maximum absorption into your system without being broken down by the digestive process.
Subcutaneous injections are frequently used for peptides targeting systemic benefits like muscle recovery, metabolism, or overall healing.
Taking peptides orally is convenient and can be effective for some peptides. However, not all peptides can survive the digestive process. An expert in peptide therapy can tell you which peptides can be taken orally and which ones require a different delivery method to be effective.
Some peptides are available as nasal sprays, which are easy to use and can deliver the peptide directly to the bloodstream via the nasal membranes.
Creams containing peptides are most commonly used in skincare. Peptides like GHK-Cu are formulated into creams for targeted skin benefits, such as improving elasticity, reducing wrinkles, or supporting wound healing.
The specifics of what happens during peptide therapy can vary depending on the peptides used and delivery method, but here’s a general idea of what you can expect:
Before anything else, you need to determine if peptides are right for you. This requires an in-depth consultation to assess your medical history, overall health, lifestyle, health issues you are facing or want to prevent, and your desired outcomes.
Your provider will then recommend peptides based on your evaluation, symptoms, goals, and sometimes bloodwork results.
After determining the right peptides for you, your provider will create a tailored plan that includes dosage, frequency, and the best delivery method. Delivery methods can include injections, oral tablets, topical creams, or nasal sprays, with injections often being the most effective for targeted results.
Some patients want to come into the office and have a nurse give them their injections, while others are comfortable doing it themselves at home.
Peptide therapy isn’t static—it evolves as your body responds. For most peptides, therapy involves gradual dose adjustments, or titration, to optimize results while minimizing side effects.
Regular check-ins with your provider will track your progress and allow for dosage or delivery method adjustments to maximize effectiveness.
Peptide therapy offers many potential benefits and most peptides are well-tolerated. However, there are some risks and side effects that can occur, especially with improper use or administration.
To minimize these risks, it’s essential to follow the dosage instructions carefully as prescribed by a qualified healthcare provider. In the next section, we’ll guide you on how to find a qualified peptide therapy provider to ensure your treatment is safe and effective.
If you do experience any side effects, it’s important to contact your healthcare provider right away to discuss the symptoms and adjust your treatment plan as needed.
The most common side effects include redness, swelling, or irritation at the injection site. These reactions are typically mild and temporary.
In some cases, your body may recognize synthetic peptides as foreign, potentially triggering an immune response. This could lead to symptoms such as fatigue, mild fever, or more pronounced inflammation.
Overusing growth hormone-releasing peptides (like CJC-) can lead to excessive growth hormone levels, which may result in side effects such as joint pain, water retention, or even metabolic disturbances. Long-term overuse could increase the risk of more serious conditions like insulin resistance.
While some peptides, like collagen and many of the peptides found in topical skincare products, are generally safe to use without medical supervision, most peptides should be dosed and administered with the guidance of a qualified peptide therapy provider.
There are numerous benefits of using a qualified peptide therapy provider over self-dosing and administration.
Whether you’re looking to boost recovery, improve energy, or support anti-aging efforts, working with a medical professional ensures your therapy is safe, effective, and properly dosed to your unique health needs and goals.
At Relive Health, our goal is to help you extend your health span from the inside out. This might mean peptide therapy, but other treatments, like hormone therapy, might be better suited for your needs. We also offer other holistic therapies, such as IV Vitamin Therapy and Ozone Therapy, to complement your journey to optimal health.
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