Are Peptides Legal? All About the FDA and Peptides in 2021




Peptides: An Introduction

Peptides are integral in our lives. Found in all living organisms, more than 7,000 peptides exist in the human body alone. As the building blocks of enzymes and hormones, peptides are responsible for several functions in the body including cardiovascular, cognitive, and immune functions. As we age, the natural production of these decline, resulting in hormonal imbalances. When this happens, conditions like depression, fatigue, weight gain, low sex drive and overall health decline can be experienced.

 

How do Peptides work?

Peptides carry out functions of hormones, directing the cells, molecules, and tissues in the body to complete specific functions. Commonly found in cosmetic products with anti-aging effects, peptides are used to address a variety of health issues. For patients with weight-related problems, peptide therapy works by eliminating stubborn fat without the need for surgery. Because of their microscopic size, peptides are easily absorbed by the body by travelling through the bloodstream and then through the skin and intestines. As such, peptides not only treat medical ailments but also become a preventive measure.

 

Benefits of Peptide Therapy

Peptides’ special properties and effects when utilized as a treatment or supplement dramatically improve the way our body works. Peptides address a number of health issues, providing an array of health benefits. In terms of neurological functions, peptides can intensify focus, memory, and creativity. They also can strengthen immunity by destroying microbes and protecting the body from viruses, bacteria, ultraviolet rays, pollution, and other toxins. 

In terms of skincare, peptides improve skin health and form, supplementing elasticity, firmness, and skin texture, while providing a wrinkle-free and hydrating effect. In the process, melanin is stimulated, breakouts disappear, and overall appearance is improved. Moreover, peptides can aid in losing weight. By increasing energy levels and stamina, sexual and athletic performance is increased and lean muscle mass is built. In addition, peptide therapy can repair damaged cells, reduce joint pain, and accelerate muscle recovery and repair.

Other benefits include anti-inflammatory effects, increased growth hormone production, improved sleep quality, increased blood flow, regulated blood pressure and amplified sex drive. When administered routinely, peptides can manage pain and improve overall health. As an effective alternative treatment for several health conditions, peptide therapy can be customized to address an individual’s specific needs or health objectives.

 

Brief Background on the FDA

The U.S. Food and Drug Administration (FDA) is a government body created under the Department of Health and Human Services. They are responsible for protecting the health, safety, and security of the public. By providing accurate and science-based information, the FDA regulates human and animal drugs, food, biological products, cosmetics, medical devices, supplements, tobacco, and consumer electronic products. Furthermore, the FDA has regulatory authority which qualifies the bureau to act when products do not meet federal quality standards. Additionally, the FDA inspects the results of laboratory research, verifies the safety and effectiveness of products, and provides approval if a product can be marketed or not. If suspected high-risk, the FDA issues recalls for such products. 

 

Compounded Drugs: A Patient-Specific Medication

Compounding is the practice of combining, mixing, or altering two or more ingredients to create a custom medication specific to a patient’s needs. Normally occurring in state-licensed pharmacies wherein a licensed pharmacist or physician is available, compounding can be done in an outsourced location that is supervised by a licensed pharmacist as well. When a certain FDA approved drug is not commercially available or is not medically suited for the patient’s treatment, some licensed medical practitioners may prescribe compounded drugs to the patient instead. An example of this is an elderly person or child who cannot swallow a capsule or tablet and would need their medicine in a liquid form, or someone who is allergic to an FDA approved medicine. In these circumstances, a compounded drug is the best solution for treatment. 

 

FDA Regulatory Standards for Compounded Drugs

Due to some compounding facilities claiming false and misleading statements about compounded drugs and engaging in actions that may put patients at risk or undermine the drug approval process, the FDA has created regulatory standards to ensure the safety, quality, and effectiveness of compounded drugs for human use. 

The Federal Food, Drug, and Cosmetic Act (FDCA) Section 503A stipulates the conditions under which human drug products compounded by a licensed physician, or a licensed pharmacist in a Federal location, or a state-licensed pharmacy, are exempted from three FDCA sections: 1) compliance with current good manufacturing practice requirements (CGMP); 2) labeling with satisfactory directives for use; and 3) FDA endorsement before marketing. 

For a compounded drug product to qualify for the exemptions under section 503A, there are certain conditions that must be satisfied accordingly. Licensed pharmacists or physicians must compound products using bulk drug substances that: 1) comply with the standards of an applicable US Pharmacopeia (USP), an organization that sets public standards for quality, strength, and purity of medicines, or National Formulary (NF) drug substance monograph if a monograph exists, which is a written document that replicates the quality characteristics of medicines approved by the FDA, and the USP chapter on pharmacy compounding. Second, if a monograph does not exist for the bulk drug substances then the drug ingredients of these substances should be authorized by the Secretary; or lastly, if such a monograph is non-existent and the drug substance is not a component of a drug approved by the Secretary, appears on a list developed by the Secretary through regulations issued by the Secretary. The last two provisions also mean that the criteria for determining which bulk drug substances should appear on the bulks list must be included in the specifications laid out by the Secretary including historical usage and reports in the peer-reviewed medical literature.

Furthermore, a new section 503B was added by the Drug Quality Security Act or DQSA to the FDCA. This section established a new, voluntary category of compounders identified as outsourcing facilities. These outsourcing facilities are subject to Current Good Manufacturing Practice (CGMP) requirements, and they may distribute compounded drugs either as prerequisite to a patient-specific prescription or in response to an order from a health care provider. Compounded drug products developed by a licensed doctor or pharmacist in a state-licensed pharmacy, or in a federal site in accordance with the provisions of FDCA section 503A, are exempt from compliance with CGMP requirements. 

 

FDA Warning on Banned Compounded Drugs

Compounding pharmacies utilizing bulk drug substances of GHRP-6, AOD 9604, BPC 157, Ipamorelin, CJC 1295 and MK 677 are not eligible for the exemptions provided by FDCA Section 503A(a). Recently, the FDA has sent warning letters to a number of compounding pharmacies.  According to the letter, these peptides are “not the subject of an applicable USP or NF monograph, are not parts of an FDA-approved human drug, and do not show up on the 503A bulks list.” This means that bulk ingredients of peptides are not FDA approved for human use as medication and hence, are not legalized to be prescribed, compounded, or released within the US. 

Since these drugs do not meet the current FDA regulatory standards and have been the subject of regulatory actions by the FDA, these compounded drugs are not eligible for the exemptions in the FDA requirement approval of section 505 of the FDCA, the prerequisite under section 502 and the precondition of compliance with CGMP under section 501. 

In total, there have been two FDA warning letters issued to date. Non-FDA approved drugs may pose risks to humans when used and may contain ingredients that are unknown and harmful to one’s health.

 

List of Ineligible Compounded Drugs

Provided are the ineligible compounded drug products that are not included in the FDA’s approved drug list, are illegal to sell and use for humans, and do not qualify for exemptions under section 503A.

 

GHRP-6

GHRP-6 or growth releasing hormone peptide-6 is a synthetic peptide like GHRH working directly on pituitary somatotrophs, stimulating growth hormone secretion while promoting the viability of tissues in different organs. Staged for a number of experimental works, GHRP-6 is highly popular in the bodybuilding world and is promoted by several websites for slowing down the aging process. It has been suggested that GHRPs may stimulate multiple cells, may spur mixed signaling pathways and may have pharmacological potentialities. 

However, research gathered on GHRP-6 is still partial and unsubstantiated. Clinical studies and development were inconsistent. Currently, no approved therapeutic use of GHRPs exists in the US. Only anabolic and cytoprotective effects in animal models and anecdotal human use reports have been reported with this product. Thus, GHRP-6 should be used only for laboratory research and not as medicinal, agricultural, food additives or household chemical products. As such, GHRP-6 was not satisfactorily nominated for FDA .

 

AOD 9604

AOD-9604 or Anti-Obesity Drug-9604 is derived from the fat-decreasing attribute of human growth hormone. Available in forms of injection and transdermal cream, its key role is to treat obesity by targeting the metabolic process resulting in accelerated weight loss. AOD-9604 directly enhances the breakdown of stored fats, prevents the synthesis of new fats, perks up anabolism and lessens the catabolic effects. Target areas include the abdomen, chin, flabby arms, buttocks, and around the knees. 

In addition, countless studies suggest that AOD-9604 is effective in muscle-building. However, AOD-9604 is not considered tolerable as an anti-obesity drug due to its side effects of diabetes as well as increasing mass in the muscles, organs, and bones.

 

BPC-157

BPC-157 or Body Protection Compound is a health supplement with multiple functions.. Existing studies on BPC-157 have been completed using animals that suggest this drug accelerates the rate of angiogenic repair which is the process responsible for wound healing through the production of new blood vessels, resulting in regenerative effects. Even though no existing studies have shown that BPC-157 is safe and effective for use by humans, a number of websites advertise this drug to address stomach ulcers, organ damage and improve performance when injected or taken orally. 

 

Currently, no global regulatory authority has approved the use of BPC-157 for human use due to its possible negative side effects. Extensive research and human studies are imperative in order to confirm the medical benefits of this drug. Existing claims are considered speculative for they are not supported by medical literature and institutions. In addition, the FDA has confirmed that there is no legal basis for BPC-157 to be sold by compounding pharmacies as a food, drug, or dietary supplement. BPC-157 should be used for research purposes only and should not be used in humans.

 

Ipamorelin

As a growth hormone secretagogue, Ipamorelin imitates the function of the natural hormone ghrelin in the body.  It stimulates and promotes the release of human growth hormone from the pituitary gland, restoring balance in the body. Ipamorelin also protects neurological function and increases fat loss, muscle mass, and bone density. Currently, Ipamorelin is not approved by the FDA due to safety concerns.  

 

CJC 1295

CJC 1295 plays the role of GHRH analog by stimulating growth hormone secretion. When combined with another GHRP, it may elevate vigor and athletic performance, reduce weight, support immune function, and address health deficiencies. Though popular and widely used in the bodybuilding industry, it is a prohibited drug in sports because of its performance-enhancing properties. Harmful side effects and adverse reactions have been reported by users of this drug. In actuality, this peptide has not been licensed by pharmaceutical companies or used by doctors because of insufficient testing. Further research and trials are imperative in order for this drug to be deemed safe for use and be approved by the FDA. 

 

MK-677

MK-677 or Ibutamoren is a novel bioactive agonist growth hormone secretagogue that works by attaching itself to ghrelin receptors and stimulating natural growth hormone release. As a result, benefits like intensified strength, accelerated healing, and improved cognitive function, metabolism, and libido are achieved. Though labeled as an anti-aging or performance-enhancing supplement, long term safety and benefits have not been established in the laboratory studies. As such, MK-677 has not been approved by the FDA for human consumption and can only be legally sold for research purposes. 

 

Overview of Legal and FDA Approved Peptides

Although certain peptides have been banned by the FDA, Sermorelin Acetate and PT-141 Bremelanotide have been accredited as safe and effective medications for a number of health conditions.

 

PT-141 Bremelanotide Acetate

Initially being studied for self-tanning purposes, PT-141 was mistakenly discovered as a sex drug due to its side effects. Since then, it has been well-known as an innovative aphrodisiac used for treating sexual disorders like erectile dysfunction in men as well as vaginal vasocongestion and hypoactive sexual desire disorder in premenopausal women.

Approved by the FDA, PT-141 is a peptide hormone treatment that works through the brain by inducing dopamine hormones that are responsible for the enrichment of sex life, urge, function, and performance. When PT-141 activates the limbic system and blood flow to the penis, vagina, and clitoris is increased, the body becomes more aroused. As this sex drug works through the nervous system, it is safer and healthier to use compared to other treatments like viagra or Cialis. PT-141 restores intimacy in a healthy way, without raising blood pressure or creating other health risks.

 

Benefits of PT-141

As a sex life enhancer, PT-141 provides an array of benefits including a sizable upsurge in sexual pleasure, performance, and frequency. As it works, mood and natural energy levels are elevated and stress is reduced, letting you achieve orgasm and sexual enjoyment more easily.

PT-141 strengthens the pelvic floor muscles and promotes bladder control in women. In men, it treats erectile dysfunction, impotence, and premature ejaculation. In the process of achieving frequent and intense erections, risks of heart attack and stroke are reduced. Added benefits include weight loss, relief from lethargy, and a strengthened immune system. Consequently, self-confidence and self-esteem are elevated, and overall mental and physical well-being are massively improved. 

 

Sermorelin Acetate: A Superior Peptide

In our younger years, there is an abundance of growth hormone-releasing hormone (GHRH) in our body. As we grow older, our GHRH levels decline, resulting in a dramatic decrease in human growth hormone (HGH) production. When this happens, our body undergoes deficiencies leading to fatigue, weight gain, poor cognitive function, and other related aging symptoms. Our body then fails to function properly resulting in regressed stamina and overall health.

As a groundbreaking medication, Sermorelin Acetate is the first-choice of treatment for HGH deficiency in both children and adults. Approved by the FDA for more than 20 years, Sermorelin stimulates the pituitary gland to naturally produce and restore HGH in the body. Based on widespread recognition, it is the safest and most effective HGH supplement in the market. It is the healthiest option for achieving your health goals since Sermorelin provides HGH regeneration without the high cost and unwanted side effects of similar drugs that are not approved. 

 

How does Sermorelin Acetate work?

GHRH sends signals to the pituitary gland which then triggers the natural release of HGH into the body.  However, there are cases wherein GHRH is not being released enough, due to issues in the pituitary gland. When this occurs, the aging process accelerates. This is where Sermorelin treatment comes in. As a biologically modified version of GHRH, Sermorelin imitates the function and effects of the hypothalamic peptide. It works by traveling through the bloodstream instead of the pituitary gland, attaches to GHRH receptors, and stimulates the somatotroph cells to produce HGH naturally. As a result, Sermorelin achieves similar effects of HGH, and several health issues due to HGH deficiency are stopped and treated.

 

Benefits of Sermorelin Acetate

Sermorelin addresses several health problems in the body and provides a comprehensive list of positive effects such as heightened energy levels, deeper sleep quality, improved metabolism, better sex drive, reversed aging process, enhanced appearance, and improved health. As a powerful anti-aging drug, it slows down and reverses the effects of aging by improving skin quality, tone and elasticity, and increasing collagen density. For cognitive function, Sermorelin improves focus, mental clarity, and memory.

By increasing one’s strength and endurance, Sermorelin enhances sexual and physical performance without getting tired easily. In the process, fat is reduced and lean muscle mass is built. Muscle repair and recovery are hastened along with relief from joint and muscle pain. Likewise, Sermorelin repairs nerve tissues, speeds up healing, increases calcium retention, strengthens bone and mineral density, and regulates cellular processes.

Recommended for pre-diabetic patients, Sermorelin reduces the risk of developing metabolic diseases by reducing liver uptake of glucose. In the same manner, it is used to address conditions, in particular, weight loss induced by HIV and increasing insulin-like IGF-1.  It does not negatively impact glucose, insulin, or thyroid levels, and also will not affect luteinizing or follicle-stimulating hormones. It contributes to fuel homeostasis, increasing protein synthesis, maintenance, and function of pancreatic islets, and promotes liver glycogenesis. As a result, Sermorelin enhances the body and promotes well-being and overall quality of life.