Best Practices For Using Clinical Study Citations

Using clinical study citations can be a crucial part of product marketing. If the study citations are from well-powered studies using competent and reliable scientific evidence, they can bolster the brand's scientifically supported position, which is important to many customers. I have heard this also helps boost Google's SEO rankings. There is, however, a fine line between compliantly using clinical study stations and making high-risk disease claims.

When can clinical study citations be used? FDA addresses this question in the Small Entity Compliance Guide On Structure-Function Claims.

• From FDA. "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 suggests 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."

Asa comments. Adding citations at the bottom of a scientific blog is not likely to attract a warning letter, but the keywords do attract attention. For example, words like Alzheimer's will be picked up by web crawlers and invite attention. This means if you are using clinical citations in product marketing, ensure these are not construed as marketing by showcasing them. Also, double-checking the rest of your web and social marketing is crucial, as extra attention will be paid to ALL marketing.

Elaborating on the studies does cross the line into marketing, as we see with this recent warning letter. 

• From warning letter. "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."

FDA has also cited companies for posting about clinical studies on social media. This includes sharing clinical studies that have ingredient and disease containing meta descriptions such as "X ingredient studied for depression.

The moral here is when including citations in your marketing materials, ensure they are appropriately placed—ideally within a bibliography or as part of a balanced discussion of scientific literature. They should not be excessively prominent or showcased.

The Small Entity Compliance Guide is also an excellent resource for helping us understand the nuances of dietary supplement marketing such as this.

• From FDA, "Examples of acceptable structure/function claims are "mild memory loss associated with aging," "noncystic acne," or "mild mood changes, cramps, and edema associated with the menstrual cycle."

• From FDA, "Examples of disease claims are "Alzheimer's disease or senile dementias in the elderly," "cystic acne," or "severe depression associated with the menstrual cycle."

DATE ORIGINALLY POSTED: 9/18/24

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.