FDA warning letters

[pep_researcher]

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mile-high-compounds-llc-721600-03312026

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/guangzhou-huli-technology-co-ltd-dba-fantasy-face-722228-03312026

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pekcura-labs-721709-03312026

[WisGal64]

Hmmm a case of EL and Novo at it again but with the three letter agency to back them up?

I've been watching the eff dee aa site for awhile now since the whole fiasco with a certain pharmacy that telehealth companies use, received not one but 2 warning letters, March and Sept of last year. Interestingly enough, the Sept letter disappeared(but not before I grabbed a copy, which was heavily redacted). When I last checked, in January, there was still no follow up. Instead, I found this pharmacy was awarded a CSR with the dee ee aa?? ugh

Still no CoA for 5 vials I've been sitting on, the 2 CoAs I did receive(took them 2+ months to produce), appear to be transcribed by the Pharmacy not the Lab, RED flag to me.

While it's not surprising they are targeting the pep companies, I hope this doesn't go anywhere. Max seems like an upstanding guy, who takes testing seriously and engages with his customers publicly and privately.

[justalittleprick]

I read the letter for one of the vendors and it mentioned BAC water, which is disappointing and signals the direction they are going to go if/when they crack down.

"BAC Water
Your firm offers “BAC Water” for sale alongside peptide products, which are drugs intended for injection and require reconstitution, including the above-mentioned products. The sale of these products together demonstrates that you intend for your “BAC Water” to be used in combination for injection. Therefore, your “BAC Water” is a drug."

I've stocked up on a case of BAC and a couple years worth of Reta and a year of Tirz.

I can see the FDA throwing us a few bones, but coming down hard on the GLPs.

[Randy]

@justalittleprick I might have ordered another four cases of hospira.

[ResearchCat]

@justalittleprick I am not doubting what it said, but that seems a bit ridiculous since you need to reconstitute them with something regardless of what you are doing with them. It’s either sterile water or bac water.

I mean, I could be using CJC/Ipa on my mushroom to see if they grow faster. Though I think I would be using sterile water for that.

I guess bac water goes on the list after ammo for stuff you can never have too much of.

[pep_researcher]

@Randy I did order a few more single H BAC, but my usage is so tiny that I may not run out of them until their expiry next year.

Some researchers claim they use asceptic techniques and just use the same vial until it's fully empty, regardless of the 28 day rule or expiration.

What's the community sentiment? It feels okay to me given that most of the researchers are using it in a setup that's not poking vials aggressively like a clinical facility.

[Big McLargeHuge]

@justalittleprick said in FDA warning letters:

I read the letter for one of the vendors and it mentioned BAC water, which is disappointing and signals the direction they are going to go if/when they crack down.

This is largely how the FDA proves intent for human use. Vendors that sell anything that facilitates human use breaks the "for research use only" veil. The FDAs logic is that if you are selling peptides with everything you need to also inject those peptides, like BAC, syringes, and alcohol pads, you're not really selling them for research use and are fully aware your customers are injecting them.