MORE FDA LETTERS BUT GOOD NEWS

[Stevepep]

So the take away is letters are only going to companies that give guidance on usage in humans, sell Bac water, and/or use the copyrighted names of certain peptides. So the takeaway is they aren't being aggressive at all but pacifying pharma. Now, if we get new leadership that is in pharma's pocket, things could change like we saw when things got banned.

https://krysia0430.substack.com/p/five-warning-letters-and-a-problem?utm_source=post-email-title&publication_id=7774139&post_id=213779466&utm_campaign=email-post-title&isFreemail=true&r=8xcjom&triedRedirect=true&utm_medium=email

This is kind of funny
https://krysia0430.substack.com/p/how-to-operate-an-ruo-website-all?utm_source=post-email-title&publication_id=7774139&post_id=213850256&utm_campaign=email-post-title&isFreemail=true&r=8xcjom&triedRedirect=true&utm_medium=email

[ResearchCat]

And this is where the whole ‘research rat’ thing came from.

[Stevepep]

@ResearchCat Ha ha, I doubt the FDA is looking at you and your Rat. They probably have some idea you don't have a lab with a bunch of rats, hamsters, or whatever. This is about how the companies present themselves from a legality standpoint.

Bottom line: those who have Jeff Cohen on retainer. He is a Florida healthcare attorney aren't getting letters. He knows the law inside and out and has taken on the FDA before. Former in-house counsel for the FMA.

[ursus]

They’re absolutely going to target retailers on the GLPs. All of those have patents and they want karma bucks rolling in.

A company like kimera cut off all glps this year and put their catalog on login to keep going.

[Stevepep]

@ursus I have actually had this conversation with Jeff Cohen at a conference, and many have patents on the use of the products for specific conditions and for PHARMACEUTICAL USE only. The formulations themselves mostly don't have patents (some do before someone searches AI but the vast majority are incomplete for a reason) because you have to disclose them, so they patent them for specific ailments, conditions, or comorbidities. It's why Coke never patented Coca-Cola because they didn't want to release the recipe. Bottom line, they patent therapeutic uses of the drug itself and continue to add on to those. They copyright the names, which Lilly is going after right now.

Not to drone on, but we are already seeing the labs allow for calling something the retailers names as the test result instead of the copyrighted name. There is a lawyer behind that as well. Pharma is careful about lawsuits because if they lose, they are screwed. So they may start lawsuits, but the vast majority settle in an undisclosed settlement.