Feature Article: July 2021 – Sign the New Petition to Save Peptides From the FDA

Sign the New Petition to Save Peptides From the FDA

 Edwin Lee, M.D., FACE

There is a new petition to save peptides from the FDA. The rate that the FDA is restricting compound pharmacies that make peptides is on the rise. If you want to save peptides then please sign the petition and pass it along to your friends and family.

 

We are asking our senators and congressmen to pass legislation allowing peptides to be compounded, specifically Thymosin Alpha 1, which has been used safely in over 30 countries for decades.

Background

Peptides, currently defined by the FDA as short chains of 40 or fewer amino acids, have been used for decades in the US and abroad. Peptides have been shown to be safe, effective and non-addictive with no major side effects. In particular, Thymosin Alpha 1, discovered in 1972, has been approved and used in the US on a limited basis and widely in over 30 countries to treat a variety of conditions, including viral, bacterial and fungal infections.

Current Situation

In March, 2020, the FDA placed new restrictions on compounding pharmacies regarding the production and sale of peptides. On February 24, 2021, the agency banned compounding pharmacies from producing Thymosin Alpha 1 and prohibited this peptide’s use to treat any condition, including Covid-19. With over 650,000 American lives lost in the current pandemic, an urgent need exists to fill in the gaps in immunity left by those unwilling or medically unable to get vaccinated against Covid-19. Fourteen published studies show that TA1 has benefits against Covid-19. Among these 14 studies, 3 demonstrate that TA1 improves survival in patients critically ill with Covid-19.

In addition, our basic human right to access alternative or integrative medical care using regenerative peptides is being stripped away by the FDA. The body can heal itself if it is given the correct path of wellness. If the FDA makes Thymosin Alpha 1 and other peptides unavailable from highly qualified medical professionals, many people who have failed conventional medicine will be injured or miss the opportunity to recover. Some might even lose their life unnecessarily.

Real Danger to the Public

Unsupervised individuals who order unregulated, impure substances online can waste resources and cause harm, even death. The FDA should focus its actions on peptides marketed in this environment but allow 503A and 503B compounding pharmacies to produce and sell peptides, especially Thymosin Alpha 1.

Petition

Therefore, we ask our senators and members of Congress to draft and pass legislation allowing 503A and 503B compounding pharmacies to produce peptides, especially Thymosin Alpha 1, based on their proven benefits in research and in years of clinical practice.

Please see our fundraising page for more information and to help us preserve the use of peptides.

Dr. Edwin Lee is co-founder of the Clinical Peptide Society.

 

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