Alexander Gaffney

Well, it's #healthpolicyvalentines day, which means it's time to repost THE GREATEST FDA WARNING LETTER EVER. Ahem:

Roses are red,
Violets are blue,
Your product is made with "Love," yes, a ton,
But that's a labeling violation under 21 CFR 101.4(a)(1)

fda.gov/ICECI/Enforcem…

politico.com/news/2026/11/0…

This is going to have reverberations throughout government.

For any of my subscribers on here, today's FDA Today newsletter edition is an absurdly good read.
- Full details on election impact on FDA and its oversight committees
- Scoopy details from yesterday's AAM meeting, including an incredible admission from FDA's biosimilars leader
- FDA's top legal official, Sean Keveney, is set to resign
- Details on a new law affecting FDA
- FDA's new regulatory science priorities, including AI and longevity research
- One of the most laugh-out-loud FDA Untitled Letters i've ever read
- FDA needs to pay, indirectly, an anti-vax law firm about $615,000

If you aren't yet signed up to receive the abbreviated free version, do so here: agencyiq.com/subscribe-fda-…

This is a really fun (and informative) watch, hosted by some of POLITICO's sharpest political minds and best interviewers.

"FDA staffers ultimately provided technical assistance in drafting the HHS plan, including guardrails intended to improve safety, such as requiring pharmacies to use peptide ingredients from FDA-registered factories."

New details on why HHS, and not FDA, published this 👇