Comment from B.J. Ho
B.J. HoOpposeIndividual
Summary: The commenter opposes the proposed action, arguing that it unfairly targets peptides which they claim are safe, natural, and affordable medical treatments. They contend that the FDA lacks clinical evidence of harm for these substances and suggest the move is an attempt to remove products from the market for financial reasons rather than public safety.
The tremendous disservice you are doing in the name of protection and service is poorly decided and without merit or concern. There are numerous examples of "FDA approved drugs" that have life-threatening or dangerous side-effects (infections, cancer, dysrhythmias) that are even allowed to be directly marketed to patients. Conversely, peptides have been researched and in use for decades, without any demonstrated consequences.
Taking these specific amino-acid sequences, which are EXACT replicas of the constructs already in the body (not a synthetic, altered version available for patent and tremendous markup), and claiming you are helping the public by creating and then placing within a category without any clinical merit in order to invalidate their production and use, is removing an enormous piece in the arsenal against medical conditions for which there either isn't a solution, the solutions available have been exhausted, the solutions are too dangerous for the patient, or the solutions are unaffordable. The peptide is not new, and is not dangerous. You cannot provide any information to demonstrate its harm (thus the arbitrary label). You can only heavy-handedly remove products from the market that you cannot financially control or receive benefit, or plan to financially control and/or receive benefit.
The public deserves safe options. Doctors and providers would like to treat their patients with effective solutions. The safety of peptides is not in question. The validity and motives of removing these affordable medical treatments IS in question.