There have been four kratom warning letters this year compared to just one last year, a 400% increase. This shows there has never been a riskier time than now to ...

Warning Letter Wednesday focuses on label violations that helped lead to a warning letter. These are basic but important reminders. This company was inspected by FDA when they collected product ...

This is yet another example of a well-intentioned herbalist-owned, very small company being cited for disease claims. I write about how no company is “too small to be off FDA ...

The warning letter has a unique “we offer the following comment” section. FDA references bitter orange extract (Citrus aurantium) as an ingredient in the Supplement Fact Panel. It then refers ...

Anxiety claims enforcement continues to be top of mind for the FDA. In this Warning Letter Wednesday I compare 2022 anxiety claims enforcement with the same time last year. I ...

Small herb company cited for elderberry-oriented disease claims. This is a good reminder there is no such thing as “too small to be on the FDA’s radar.” Claims in the ...

YouTube video claims lead to a warning letter. The claims cited in this letter are not from people talking but from image text on the screen. This is the first ...

I reviewed all diabetes and blood sugar related FDA warning letters since the beginning of last year and found some interesting results. These findings provide a snapshot of where the ...

This company received a warning letter for claims made in a product name. The product “Covid-19 Immune Support” is a bold Covid prevention and treatment claim. This is a basic ...

FDA inspected a facility, then six months later they reviewed the company website. This is a continuing trend and a reminder to screen for disease words online, especially after a ...

This year there have been 26 CBD-related warning letters. This is up from just seven in all of 2021. That is over a 300% increase, and we are only in ...

I’m sometimes asked if supplements can make disease claims with competent and reliable scientific evidence. Unfortunately not; even if a Randomized Controlled Clinical Study (RCT) was conducted on a supplement, ...