The FDA is moving to ban compounded peptides like thymosin alpha 1—safe, natural compounds with powerful healing potential—based on speculative risks rather than solid science. Action Alert!
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THE TOPLINE
- The Makary-led FDA is continuing its work to eliminate access to compounded natural peptides, including Thymosin alpha 1, despite strong evidence of their safety and effectiveness in treating immune-related conditions, infections, and cancer.
- Research shows injectable Thymosin alpha 1 is well-tolerated, virtually free of side effects, and widely used internationally to help combat a range of serious illnesses.
- The FDA’s actions appear motivated not by genuine safety concerns but by an effort to consolidate control over these therapies within the pharmaceutical industry.
We’ve been reporting on the FDA’s assault on compounded natural peptides for some time now. In a series of actions over the last couple of years, the agency has made it clear that it intends to ban these incredible healing compounds. In many cases this means complete loss of access, as there are not off-the-shelf, commercial versions of these peptides available. We cannot let this happen. Research has suggested that long-term treatment with peptides can increase lifespan by as much as 40 percent and slow down age-related changes. That’s just a taste of what the science is beginning to tell us of the incredible healing potential of these compounds, yet the FDA is trying to ban them on the most spurious grounds.
Case Study: Thymosin alpha 1
Thymosin alpha 1 (Ta1) is among the peptides on the FDA’s chopping block. It is a naturally occurring 28-amino-acid peptide physiologically present in the thymus. It plays a critical role in modulating, enhancing, and restoring immune function. Ta1 increases the number of important immune cells (CD4) and improves the balance between different immune cells. It helps the thymus produce more new immune cells, allowing the body to better fight infections. It improves immune system communication, allowing the body to better recognize and respond to threats.
This is one powerful peptide! It’s no wonder, then, that research is showing that Ta1 can help with a variety of diseases. Ta1 has been used extensively in a wide array of applications:
- It’s been approved for the treatment of Hepatitis B and C in over 35 countries and as an immune enhancer for several diseases.
- Ta1 has demonstrated an ability to help HIV patients modulate immune function.
- Large scale trials have found that Ta1 is a promising therapy for sepsis, with one trial demonstrating a 9 percent reduction in mortality compared to the control group.
- Ta1 is used in infections like (bacterial) pseudomonas, including those following bone marrow transplant.
- It can help protect against mold toxicity and fungal infections.
- Other evidence has found that Ta1 reduced mortality from severe COVID-19 infection.
- Ta1 has been useful in the treatment of various cancers, improving outcomes and exhibiting anti-tumor activity.
If you felt inclined to read the abundance of research articles that celebrate the promise of Ta1, you would start to notice a pattern: almost all of them report that Ta1 is incredibly safe. One researcher concludes that “The safety profile of Ta1 is excellent and it is virtually devoid of toxicity.” This is echoed by other authors, emphasizing Ta1’s “absolute safety” and “high tolerability” while being “without side effects at all used doses.”
So, to sum up, Ta1 is showing incredible efficacy in modulating and improving immune function, helping with a variety of illnesses, all while being incredibly safe. So, what’s the issue?
Enter the FDA
Despite strong clinical evidence supporting Ta1, the FDA continues to cite safety concerns as justification for banning its compounding. In our view, these concerns are largely unfounded and likely driven by the fact Ta1 cannot be patented because nature got there first. The FDA points to a lack of safety data, the potential presence of impurities, or a theoretical risk of “immunogenicity.” But a lack of data does not imply harm; impurities can be addressed through proper manufacturing protocols; and immunogenicity—by definition—means that a substance activates or supports the immune system, a quality that can be beneficial, not dangerous.
At the December 2024 meeting of the Pharmacy Compounding Advisory Committee (PCAC) that we attended online, where Ta1 was evaluated, PCAC members questioned FDA officials about the specific risks of immunogenicity. Beyond citing anaphylaxis, the FDA offered no concrete examples of harm. Instead, their argument rested on speculation—that impurities in peptides might somehow alter protein function and cause deficiency syndromes.
Notably, the FDA has failed to explain why, if impurities are the issue, it won’t issue guidance to help compounders perform quality control testing on bulk ingredients. This omission suggests the agency’s concern isn’t really about safety or purity—it’s about eliminating access to compounded medications based on hypothetical risks rather than evidence.
We believe the FDA’s ultimate goal is to reserve peptides and other bioidentical medicines for exclusive use by pharmaceutical companies, shutting down competition from compounders. This mirrors the agency’s broader hostility toward natural medicines, from bioidentical hormones to homeopathy and dietary supplements.
Relatedly, as part of our broader mission to defend medical freedom and promote integrative health, ANH-USA is at work behind the scenes on the Future Medicines Project—a strategic campaign aimed at dismantling the FDA’s unjustified barriers to clinical research on promising natural and innovative therapies like Ta1. Through this initiative, ANH will be working to expose how the FDA routinely delays or blocks clinical trials based on flimsy or implausible safety objections, especially when those trials involve non-patentable, naturally derived substances. Our goal is to streamline the path from discovery to availability for life-saving treatments—ensuring that safe, affordable, and effective medicines are no longer kept from patients due to regulatory overreach or industry bias.
The FDA’s campaign against compounded peptides like Ta1 is a direct threat to medical freedom and patient access to safe, effective therapies. By targeting these naturally occurring compounds on such flimsy grounds, the agency is endangering innovation and limiting the treatment options available to patients battling chronic illness, immune dysfunction, infection, and more. The science on peptides like Ta1 is clear: they are not only safe but hold extraordinary potential for improving and saving lives. We must resist the FDA’s efforts to put these compounds out of reach and demand a regulatory framework that prioritizes evidence, transparency, and the rights of patients to choose personalized, integrative care.
Action Alert!
