Month: September 2024

Peptides are short chain amino acids (40 or less amino acids) that are fast becoming one of the underpinnings of the “wellness movement.”  When we’re young and healthy, our bodies make plenty of them.  When we’re older or stressed or sick, the story goes, their production falls off and our physical (and mental quality) of life is undermined.  Because they’re essentially the same chemicals made by our bodies, it makes sense that we ought to be able to augment their decline by injection or ingesting them, right?  Kinda of like bioidentical hormones.  Not so fast Charlie!

The biggest stumbling block re peptides is this:  the Food and Drug Administration (FDA) regulates them as drugs.  More specifically, the FDA has been clear that they can be compounded at compound pharmacies but not made by pharmaceutical companies, because they aren’t “approved” by the FDA.  Moreover, since they are essentially what’s found in nature, they are not subject to the usual intellectual property (IP) protections that allows a company that creates them to “own” them and monetize them in the same way that pharmaceutical companies can.  And unless and until Pharma changes the molecular structure of a peptide, no IP can be obtained and it cannot be FDA approved.

All that said, the FDA is clearly concerned about the growth of peptide use.  Which explains why in February, 2024 (updated in May), the FDA expanded the 503A Category 2 list (bulk drugs items raising “significant safety risks”) to include peptides like BPC-157, Kisspeptin, MOTs-C, ipamorelin, thymosin A and B and many other that were the cornerstone of the peptide wellness movement.  In many instances, the FDA commented about the peptides on the expanded Category 2 list that there was insufficient data to show efficacy or harm, so they’re “suspect.”  Even more “interesting” is the current Category 1 list (“under evaluation) that includes items like aloe vera, CoQ10, curcumin, glutathione, L-Theanine, NAD, pregnenolone, quercetin, resveratrol, tea tree oil and many others that clinicians and patients count on as part of their regular wellness regimen. 

The “why” of all this is confounding to clinicians in the wellness space and the patients who want the right to be proactive about their wellness.  One narrative is how it’s a Big Brother driven issue, that Big Money (i.e., Pharma) is behind it all and just wants to prevent people from driving their wellness regimen and instead turn each of us into drone like consumers of pharmaceutical products that have unwanted side effects.  I don’t know!  But I do know this:  if you don’t know how law is made and if you don’t have a “seat at the table,” your unique point of view will be completely missing from all the laws and regulatory activity downstreamed to us consumers.  Pharma knows the system and has a hand in designing it.  Those businesses understand how policy is created and enforced.  And they pay a ton of money each year to (1) validate their products, and (2) lobby both legislators and regulators to promote their products and invalidate products they didn’t create and which don’t meet the standards (they help design and implement). 

So then…where is all the research on peptides?  Why don’t compound pharmacies or providers that rely on peptides for wellness solutions spend millions of dollars a year on double blind studies to validate peptides?  Maybe…because there is no IP protection for such products.  And if there’s no IP protection, how can any company justify the investment?  They’ll never be repaid.  And if they did make the investment, all their competitors would reap the benefit, since there is no IP protection for wellness solutions found in nature.  Until stakeholders in the wellness industry either (1) invest in changing the regulatory/legislative game and (2) play a very active role in that process, they will just bugle victim and fairness stories.  They’ll sound like a bunch of sore losers.  There is no winning the game without playing it.

So where does that leave peptide providers and consumers right now?  Are they illegal?  Nope.  Can you go to jail if you prescribe or use them?  Nope.  That said, given the fact that the latest FDA directives are aimed at compound pharmacies, the pharmacy space is where we see the most scrambling and confusion.  Because if the FDA takes issue with them, their licensure is on the line.  The net effect for the moment is (i) fear among prescribing professionals and (ii) contraction of peptide availability.  That contraction in the compound pharmacy space has spurred new companies that label peptides “for research use only” or “not for human consumption.”  The trouble is that these new “research companies” are not subject to any quality related regulations.  

Consumers ought to be wary of these new (non pharmacy) companies.  The Alliance for Pharmacy Compounding (APC), for instance, advises that such peptides not be labeled as described above.  They advise that any such substances “must be manufactured by an FDA-registered facility.” For similar reasons, clinicians need to be selective about the companies they’re using to fulfill prescriptions for peptides during this dynamic time. 

All of that said, some peptides, like semaglutide and tirzepatide, are free flowing, which is confusing to consumers and clinicians.  The short reason is there’s an exception for compounding that applies to FDA approved drugs that are “currently in shortage.”                                      

The current state of the law and peptide industry is in flux.  That will mean some providers will contract and others will fill the void created by leaving the market.  It’s a short-lived situation that is expected to develop further during the next year or so.  But if the past is any predictor of the future, the future belongs only to those clinicians and providers (and consumers) that organize and interact with the FDA and legislators to demonstrate both safety and efficacy.