Legal Insight Into Peptide Regulation

April 29, 2024

‘Legal Insight into Regulatory Issues Impacting Age Management Medicine.’

Most lay people don’t know much about the FDA or CDC, pharmacies, and compounding  pharmacies and how impactful their decisions are on your ultimate health. The topic of today is  on the ever-shifting regulatory framework relative to physician’s use of peptides, hormones, and  supplements, addressing in particular, peptides. Peptides, naturally occurring in our cells are  defined as molecules containing 2 or more amino acids. Proteins are made of peptide chains.

This blog is something not many people in clinical practice write about but is a part of medicine  that needs to be shared as it impacts our ability to advance good health.

‘Legal Insight into Regulatory Issues Impacting Age Management Medicine.’ was a lecture given at the Age Management Medicine Group spring conference by Paul D. Werner, Esq. and is  paraphrased below.

FDA  

FDA is a regulatory agency responsible for monitoring anything they choose if it is being used  for medicinal purposes. Regulations are found in the Federal Food, Drug, and Cosmetic Act,  FD&C.

Compounding Pharmacies 

Compounding pharmacies allow for prescription and use of drugs exempted from FDA  regulations concerning new drug approval, drug labeling, and drug manufacturing. This means  compounded medications can get to the consumer much faster than traditional “new drugs” to  the market. These pharmacies can combine 2 or more drugs together using a custom formulary,  providing a unique delivery system. Compounded medications are prepared for individual patients, often with special needs.

Peptides 

FDA defines peptides as having an amino acid chain made of 40 or less amino acids. peptidTherefore, as per FDA rules, peptides are regulated as drugs, not biologics because of  the small number of amino acids.

  • Per FD&C, sections 503A and B outlines conditions which “drugs” like peptides can be  compounded.
    • Peptides can be compounded at compound pharmacies, found in supplements, or  other products.
    • Peptides are not made by pharmaceutical companies because the FDA hasn’t  approved them.
    • Because of the peptide’s chemical composition, most peptides cannot be taken in  pill form and have to be injected
  • To be legally included in a compounded product, an ingredient must:
    • Already be a component of an FDA approved drug
    • Have a USP-NF monograph
    • Or appear in Category 1 of 503A bulk substances noted for use in compounding.

Use of Peptides in Age Management Medicine 

Prior to 2024, the most commonly used peptides in Age Management Medicine were not  explicitly addressed by the FDA in any capacity.

However, the peptides were submitted for bulk drug approval in the fall of 2023. This is what  got the ball rolling and changed the playing field.

When the FDA looked at the peptides submitted for bulk drug approval, many of those peptides  were identified as Category 2 substances posing ‘significant safety risks’ as per the FDA.  Meaning, there were not enough studies done as per the FDA to prove these peptides were safe.  Note most peptides have few if any side effects. However, large studies proving this have not  been done.

Beginning in October 2023 and culminating in February 2024, the FDA made it very difficult  and risky for compounding pharmacies to continue compounding peptides. This means penalties  or restrictions are imposed on compounding pharmacies.

The New FDA Regulation does not Explicitly Prohibit Compounding Peptides.

However, the new FDA regulation also fails to explicitly approve the use of many of the most  popular peptides in compounded products.

Since peptides are now unapproved by the FDA, compounding pharmacies face serious  regulatory exposure if they continue to compound peptide products. The FDA has sent  numerous warning letters to compounding pharmacies relative to the use of unapproved or  inaccurately marketed peptide-based products. And to reiterate, the FDA has not banned  peptides from use. 

Why Now? 

Doctors have been using peptides for years. However, the use of peptides for therapeutic  purposes is an exploding field. In 2022, peptides represented 5% of the pharmaceutical market  equating to $42 billion globally and projected to double in the next 10 years. There are  hundreds of peptides currently in clinical development undergoing preclinical studies. These  peptides are now becoming the center of attention having been brought to the attention of the  FDA.

What Peptides were impacted? 

  • AOD 9604
  • BPC-157
  • Cathelicidin
  • LL-37
  • CJC-1295
  • Dihexa Acetate
  • Emideltide (DSIP)
  • Epitalon
  • GHK-Cu (for injectable routes of administration)
  • Ibutamoren Mesylate
  • Ipamorelin Acetate
  • Kisspeptin-10
  • KPV
  • Melanotan II
  • Mechano Growth Factor,
  • Pegylated (PEG-MGF)
  • MOTs-C
  • Selank Acetate (TP-7)
  • Semax (heptapeptide)
  • Thymosin Alpha-1 (Ta1)
  • Thymosin Beta-4, Fragment

What Really Happened Here? 

  • Did the FDA really “ban” anything?
  • Did the FDA prohibit the use of peptides?
  • Did the law change?
  • Are practitioners prohibited from prescribing peptide-based medications, supplements, or  hormones?

The answer to all these questions is “NO”.

What is the Aftermath? 

Companies started popping up selling “research peptides” to get around FDA regulatory  framework. Some of these research companies have already been shut down for telling  customers how to use the peptides when they are not allowed to give out medical advice.

The difficult part for the consumer is there are no regulations on these research companies and  unless you test every product by a 3rd party every time you get a product, you won’t know the  quality of the product. This puts the consumer at risk for paying for poor products. Whereas, if  compounding companies are making the product, they are regulated by the FDA, and are assured  quality.

Summary 

Recent changes in FDA regulatory framework:

  • did NOT ban the use of peptide based drugs or supplements.
  • did NOT make use of peptides illegal.
  • DID impose significant restrictions on the ability of compounding pharmacies to produce  compounded peptide-based products.
  • DID make it much harder for physicians to prescribe, and patients to obtain, safe peptide based products

This is not the end of the story. These regulations remain subject to further review and  evaluation. Doctors need to speak up and be the loudest voice in the room.

Moving forward, RMC is positioning itself to be one of the centers to provide clinical data in a  multi-center study to prove efficacy and safety of BPC-157. BPC-157 is a peptide well known  for multiple uses such as brain injury, cardiac injury, gastrointestinal issues, and ligamentous  injury.

It is RMC’s stance peptides are our medications of the future using natural products based on  cellular science to prevent and treat diseases. We are very grateful to be able to herald peptide’s new place in medicine.

References:
Federal Drugs and Cosmetics Act (FD&C Act), 21 USC 9
Posted in Peptide Regulation