If we don’t stand up and defend access to these “miracle molecules,” the FDA will almost certainly ban these extraordinary and versatile products that can regenerate tissues, enhance immune function, reduce inflammation, improve brain function, promote muscle repair, modulate hormone production, and slow the aging process. Action Alert!
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THE TOPLINE
- The FDA is considering a ban on several compounded peptides like AOD-9604, CJC-1295, and thymosin alpha-1, despite evidence of their safety and potential benefits for anti-aging, immunity, and healing.
- A ban would remove access to some of these biological age-reversing peptides, many of which are made available through compounding pharmacies.
- It seems clear that the FDA is clearing the path for Big Pharma control—we need to create a public outcry to protect access.
Peptide bioregulators are on the cutting edge of anti-aging. Animal research has shown that the administration of certain peptides can extend lifespan by up to 40 percent. Increasing longevity is just the beginning. Different peptides have exhibited neuroprotective, immune-modulating, anti-cancer, and incredible injury-healing effects—many of them without any safety concerns whatsoever. Sounds good, right? Not if the FDA has anything to say about it!
It seems clear that the FDA is moving in to ban several compounded peptides. Once it bans them in compounding, it’s just a matter of time before it turns its attention to supplements and functional foods that contain these peptide bioregulators.
In December of this year, the FDA’s Pharmacy Compounding Advisory Committee (PCAC) will meet to discuss whether to allow the compounding of AOD-9604, CJC-1295, and thymosin alpha-1, as well as several substances related to these compounds. Given the abysmal track record of both the FDA and PCAC in allowing natural substances to be used in compounding pharmacies, we need a powerful demonstration of grassroots support to protect our access to these peptides.
Peptides in FDA’s crosshairs
The announcement of this meeting follows a 2023 action from the FDA that put all of the above-mentioned peptides, plus more, on a list of compounds that the agency believes have safety concerns (you can read our previous coverage for more details). We believe the science is clear that these peptides are safe and the FDA’s reasoning is deeply suspect.
To be clear: the December PCAC meeting will result in a recommendation to the FDA, but the FDA is not tied to that recommendation. The FDA then goes through the formal rulemaking process in either adding or rejecting these substances, and the public has an opportunity to weigh in. Because the FDA has stated its belief that there are safety issues with these peptides, it would be a shock if they actually get added to the Bulk Drug Substances List—whatever PCAC recommends.
Spotlight on Thymosin alpha-1
A ban on this peptide, discovered as far back as 1961, would be a disaster. It may be one of the best weapons we could have in treating early-stage cancers, especially when combined with other therapies. Thymosin alpha-1, or Ta1, is a naturally-occurring peptide produced by the thymus. It’s a delicate peptide that needs to be kept cool and delivered by injection so it can’t be used as a supplement. The synthetic version of Ta1 is approved as an injectable drug in over 30 countries, though not in the US, to treat chronic hepatitis B and C as well as having an orphan drug indication for cancer treatment. Ta1 has, in fact, far-ranging applications that have yet to be tapped—no wonder there have been dozens of clinical trials looking at Ta1 for the treatment of a variety of diseases. As we age, our thymus gland gets progressively less capable of producing all-important T cells. Not only that, it enhances the maturation of another key type of immune cell that fights infection, natural killer (NK) cells. Declining thymus function is known to be an important reason for the growing prevalence of cancer—has the FDA got a right to stop people from taking a therapy that saves lives?
FDA’s War on Compounding
This a new step in the FDA’s war on pharmacy compounding, a war that we’ve been drawing public attention to for years. These are specialist pharmacies that create customized medicines for patients with special needs, such as an alternative dosage forms, delivery mechanisms, or preparations that aren’t commercially available. They have, for example, been vital in the supply of bioidentical hormones for women looking for natural alternatives to synthetic hormone replacement therapy.
According to the law, to be eligible to be made at a compounding pharmacy, a medicine must either: 1) be a component of an FDA-approved drug, 2) have a USP monograph, or 3) appear on a list (referred to as the Bulk Drug List) developed through regulation by the FDA.
The agency elicited nominations to the Bulk Drug Substances List and has, for years, been reviewing these nominations to determine which will be added to the List and which will be banned. As the peptides in question do not satisfy conditions 1 or 2 above, they were nominated for inclusion on the Bulk Drugs List.
Call to action
We believe the agency’s overarching goal is to secure these and other useful, natural and bioidentical peptides for exclusive use by the pharmaceutical industry and shut down competition from compounders. As we’ve seen many times, the FDA is antagonistic towards almost any natural medicine that has powerful healing properties but has not gone through the agency’s expensive and burdensome drug approval process. That’s why compounded medicines like bioidentical hormones are a target; that’s why homeopathy is in the FDA’s crosshairs, as are many safe and beneficial dietary supplements.
The science behind peptides is too promising for the FDA to turn these miracle molecules into monopoly drugs. Join us in sending a strong message to Congress and the FDA to protect our access to these medicines!
Action Alert! Write to Congress and the FDA, telling them to retain consumer access to natural peptide medicines! Please send your message immediately.
