Learning Targets: definition of supplements, safety claims, disease statements

Today's #WarningLetterWednesday is cringeworthy but also contains learning lessons for product marketers and developers.

The product is a vape that contains caffeine, is labeled as a supplement, makes overt safety claims, and uses high risk marketing disease claims. There are a lot of learning lessons here.

Vapes by definition are very high risk. Adding caffeine into a smokable product with other herbal ingredients may seem like a good idea to an untrained development team, but it is actually exceptionally dangerous.

Supplements are defined as products taken by mouth that contain a "dietary ingredient" intended to supplement the diet. Smokable products by definition cannot be supplements because they are not ingested. As a side comment this is also why "sublingual" delivery is not suitable for supplements, as it's a drug delivery term.

I ask, what regulatory category does a vape with herbal ingredients belong to?

Making safety claims on any product must be substantiated. When statements like this are made it seems more like optimistic and potentially deceptive marketing than hard science:

(from warning letter) “Is it safe to inhale caffeine?.....Yes"

There are also high risk marketing disease claims mentioned in this warning letter. These include references to "inflammation" which I discussed in last week's Warning Letter Wednesday here.

Lots of claims here discuss ingredient benefits such as:

(from warning letter) "Vitamin B12 has even more science-based health benefits including:....Supporting bone health and preventing osteoporosis...Uplifting mood and symptoms of depression"

I review ingredient benefit claims in another Warning Letter Wednesday here.

Read 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.