Remove “Buzzwords” To Reduce Regulatory Risk

“Buzzwords” or “trigger words” in marketing are one of the reasons companies receive warning letters. In today’s Warning Letter Wednesday, let’s explore some issues to avoid.

From warning letter. “[P]owerful antibacterial and antifungal properties.”

Asa Comments: Avoid words that contain “Anti.” There are a few exceptions, such as “antioxidant,” which is a nutrient content claim, and perhaps “anti-aging,”which is not typically considered a disease word.

From warning letter. “[U]sed for chest pain (angina), fluid retention” and “some blood pressure lowering activity”

Asa Comments: FDA takes heart disease-related claims very seriously, and they should also be avoided. This includes comparable biomarkers such as “lowers LDLs.” Also, “angina” is an example of a disease word in FDA’s Small Entity Compliance Guide on Structure/Function Claims. 

From warning letter. “Chaga is commonly used for the moderation of the signs of malignant and abnormal cell growth.”

Asa Comments: The word “malignant” in this context implies cancer treatment. This example shows that even if high-risk words like “cancer” are not used, FDA will cite implied claims, especially if the statements may lead to consumers foregoing serious treatment.

From warning letter. “[U]sed for fatigue, anxiety, depression, psychiatric disorders, Alzheimer’s disease.”

Asa Comments: This one is obvious. Do not imply that products can help with these diseases.

Read the letter here.