Discussing Ingredient Science

Helping you understand the fine line between education and product marketing is one of the reasons I love writing Warning Letter Wednesday. We continue to see well intentioned companies perhaps unknowingly cross the line from “education” to “disease claims.” Here I explore how discussing science easily become disease claim marketing.

From warning letter. These lessons teach us what not to do.

• “In another recent study, correlations between CBD and blood pressure were examined. Two groups were evaluated, one being test subjects who were given CBD and the other being a control group with a placebo. All subjects were exposed to stressors that would induce a higher blood pressure. The study concluded that a dose of CBD was helpful to reducing blood pressure.”

• "CBD has been studied for its possible uses for children, and while the science is still preliminary, there are some promising opportunities. One of the best is the use of CBD for children with autism. One study of 188 children with autism, ages 5 to 18, found that some symptoms, such as seizures, restlessness and rage attacks, were lessened.”

How can you use science in marketing? Here’s what the FDA’s Small Entity Compliance Guide on Structure-Function Claims says. This basically means that some citations are permitted but ensuring the context does not imply your product treats or help diseases is essential to compliance. As with many things we “know it when we see it.” Examples of cross the compliance boundaries include social media posts which mention the ingredient and the disease name, social posts with where the meta description mentions the ingredient and disease, company or ingredient hashtags on carefully worded scientific literature posts. Also, science that is showcased on product or ingredient pages often may be considered non-compliant.

From FDA (Question and Answer). “Can I use citations of publications that relate to my product's intended use in labeling if the publication title or the journal name mentions a disease name?

Yes, but some limitations apply. If the citation implies treatment or prevention of a disease, it is a disease claim. Thus, if in the context of the labeling as a whole its presence implies treatment or prevention of disease (for example, by placement on the immediate product label or packaging, inappropriate prominence, or lack of relationship to the product's express claims), the citation is a disease claim.

If the citation is used in labeling, its context determines if it is a disease claim. A citation that is used in the bibliography section of labeling, is included in a balanced discussion of the scientific literature, is not excessively prominent relative to other citations, and provides legitimate support for a structure/function claim made for the product would not be a disease claim.”

DATE ORIGINALLY POSTED: 10/30/24

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.