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Urge the FDA to Reverse this Damaging Reclassification
As of September 2023, new guidance from the FDA moves 17 peptides , including BPC-157, epitalon, and thymosin alpha-1 (Ta1), to the Category 2 Bulk Drug Substance list.
This decision restricts compounding pharmacies from using several long-standing peptide formulations, effective immediately. As a result of this unexpected FDA decision:
- Potentially life-changing peptide therapies are now unavailable to patients, some of whom have few other alternatives.
- Providers are limited in the care options they can offer their patients.
- Important peptide research may come to a halt.
- Patients are denied their autonomy, or the right to choose the path to wellness that suits them best.
Together, we can challenge the FDA’s reclassification of peptides and protect patient health freedom.
The Promise of Peptide Therapy
Synthetic peptide drugs, strings of amino acids shown to mimic peptides present naturally in the human body, have been around since the development of insulin in 1921. Peptide therapy has been used since in limited ways, but an ever-growing body of research suggests that peptides are more potent agents of healing than originally thought.
Researchers, providers, and patients have found peptides to be potentially effective in the management of a wider array of conditions, including peptides for weight loss, anti-aging, chronic illness like Irritable Bowel Syndrome, and cancer.
Among the 17 recently reclassified peptides are:
- GHK-Copper, which studies show may have potent anti-aging affects.
- AOD-9604, which has displayed fat-burning properties in numerous studies.
- BPC-157, which has shown promise in addressing central nervous disorders, gastric ulcers, and Irritable Bowel Syndrome
- Thymosin alpha-1, or Ta1, a peptide that naturally occurs in the human thymus gland and an approved drug in 30 countries for the treatment of hepatitis B, hepatitis C, and the management of cancer-related symptoms.
Peptides could revolutionize the way we treat illness. They have the potential to target specific diseases, minimize side effects, and offer hope to millions of patients worldwide. But without the support and advocacy of people like you, their full potential will remain untapped.
What Category 2 Classification Means for Peptide Therapies
The FDA continuously evaluates substances nominated for inclusion in the Bulk Drugs List, a list of FDA-approved substances that can be legally compounded into medicine.
When a substance is nominated for inclusion in this list, there are three categories that a substance can be assigned to by the FDA:
- Category 1 substances that are deemed permissible by the FDA for compounding.
- Category 2 substances that cannot be compounded due to “safety risks.”
- Category 3 substances that need to be reevaluated by the FDA before being put into a category.
As of September 2023, 17 peptides have been put into Category 2. The FDA’s interim policy explains that these peptides can only continue to be compounded while the FDA reviews if these substances should be fully banned. If it comes to that, these peptides will become entirely unavailable to patients and providers.
Why Reclassify Peptides?
The FDA’s justification for this new guidance is that a significant number of peptides are “bulk drug substances that raise significant safety concerns,” due to a lack of safety data, the presence of impurities, and the potential risk of an adverse immune response that can impact drug safety and efficacy, called immunogenicity. For these reasons, they’ve decided the risks of peptides outweigh their benefits. This is blatantly misleading and a detestable overreach on the part of the FDA.
- Lack of data does not necessarily confirm the presence of risk. It implies that more money should be put into peptide research so we can fully understand their affects. Instead, this FDA ruling overreaches and limits research capabilities. In addition, there are reputable studies that present peptides, including peptides now on the Category 2 list, as “safe therapy options.”
- Accredited compounding pharmacies are required to follow good manufacturing and quality testing practices, as outlined by the Pharmacy Compounding Accreditation Board, when it comes to compounding any drug. When peptides are sourced from such reputable compounding pharmacies, the potential that a customer will receive an unsafe or impure product is significantly reduced. By banning compounding pharmacies from legally compounding these peptides, the FDA forces customers to turn to the black market, where peptide quality is poor and safety risks are high.
- Many FDA-approved drugs carry the potential risk of immunogenicity, including common treatments for cancer, psoriasis, rheumatoid arthritis (RA), and inflammatory bowel diseases like Crohn’s disease. Likewise, triggering an immune response may just imply that the peptide therapy is working.
Additionally, this reclassification, in our view, is a clear example of the FDA’s bias towards Big Pharma. Let’s not forget that in 2021 the FDA received $1.1 billion in funding from the pharmaceutical companies they regulate. With this reclassification, the FDA is ensuring patients and doctors cannot access these transformative peptide-based medications, unless they are approved as mass-market drugs. In effect, this FDA decision clears the way for Big Pharma to take over the peptide industry, which was worth 39.3 billion USD in 2022.
While the FDA hasn’t instigated a permanent ban of these peptides, this interim decision does not bode well for their continued availability. Your donation makes a significant impact. Each gift to the Peptide Legal Fund supports research, legal resources, and advocacy efforts aimed at urging the FDA to reevaluate the classification of these Category 2 peptides and protecting your medical freedom.
Banning Peptides Threatens Medical Progress and Health Freedoms
Reclassifying these peptides does more than prevent a peptide compounding pharmacy from creating custom-made drugs for patients with few other alternatives, it halts important research into peptides, with devastating effects on medical progress.
After all, several of these peptides have shown potential to actually extend lifespan. Research in animals and humans has shown that Ta1, a thymus peptide mentioned above, has immune-modulating effects, which can help people maintain and strengthen the ability to fight off disease. Likewise, epitalon may improve the immune system, activate antioxidant defenses, and have anticarcinogenic effects.
Additionally, with the FDA’s decision to reclassify these peptides as Category 2, providers will be left with fewer effective treatment options to offer their patients, forcing patients to resort to treatments that may not be the best fit for their needs. All of this constitutes a major affront to the patient’s right to choose their own medical treatments and access cutting edge therapies.
What’s worse, the ban on peptides is only one example of the continued threats to our medical freedom as Americans and our patient autonomy. Increasingly, the government dictates what treatments providers and patients can access, rather than allowing you to work with their healthcare provider to make informed decisions tailored to your specific needs.
The patient, not the government, should have the ultimate say in how they receive care. By donating to reverse this recategorization of peptides, you not only save lives, but also protect your right to access innovative medical therapies and choose the path to wellness that is best for you.