Blood Sugar, Arthritis & Immunity Claims Lead to Warning Letter

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 to the product ingredient page where the company states that ingredients like hordenine are components of bitter orange extract.

From warning letter. “Bitter orange extract contains neuroactive agents, synephrine, hordenine, and octopamine.”

This is detailed diligence by FDA, showing that small copywriter comments can lead to increased scrutiny. FDA goes on to mention the previous hordenine and octopamine warning letters. I write about this here.  I suggest scanning websites to see if keywords such as hordenine and octopamine show up. I offer this service and can do this at no charge if you mention “Warning Letter Wednesday.”

Many of the claims cited in this warning letter involve the company discussing ingredient benefits. I wrote about this on a #WarningLetterWednesday just a few weeks ago.

Blood sugar claims enforcement continues to be top of mind for FDA, and there are several citations in the warning letter. I review 56 diabetes-related warning letters here.

Old social media posts are also mentioned in this letter. This includes a post from early in the pandemic with the high-risk word “coronavirus.” I would guess the company had long forgotten about this post. Here is a WLW write-up and video about this.

Words ending in “itis” (meaning “inflammation of”) are disease claims, and the most commonly cited “itis” in warning letters is arthritis. This letter references five occurrences of this word, demonstrating that words like arthritis do not belong in supplement marketing.

Read the full warning letter here. 

Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading.