Navigating the Risks of Therapy-Adjacent Health Claims
Use FDA's helpful resource (Criterion 7)
Navigating allowable and off-limits claims can be confusing. Fortunately, the FDA offers a helpful resource, The “Small Entity Compliance Guide on Structure/Function Claims” which includes a Q&A format outlining 10 key criteria to help distinguish between disease claims and structure-function claims.
In today’s Warning Letter Wednesday, I am exploring Criterion #7, “Claims to augment a therapy or drug intended to diagnose, mitigate, treat, cure, or prevent a disease.” This criterion shows the FDA’s thinking on why statements like “useful on your chemotherapy journey” or “take with antibiotics” are disease claims.
From FDA Guide. “A claim that a dietary supplement will augment a particular therapy or drug action that is intended to diagnose, mitigate, treat, cure, or prevent disease is a disease claim.”
Asa Comments: The best example of what not to do is from this 2021 warning letter where the company stated “ Vitamin C May Combat Cancer & Ease Cancer Treatment.” This is an issue because it claims to support or ease an oncology treatment and the vitamin C is positioned as an adjunct to drug therapy.
From FDA Guide. “A dietary supplement may state that it is useful in providing nutritional support, as long as that claim doesn’t imply disease.”
Asa Comments: This is an interesting one as there is a fine line between making statements like “Omega 3’s are helpful at supporting mood” and making a “People with depression are often low in Omega 3’s, which is why we made this fish oil product” which would be crossing the compliance line.
From FDA Guide. In general, mentioning the name of a specific therapy, drug, or drug action will associate the claim with the intended use of the therapy, drug, or drug action and be a disease claim.
Asa Comments: Another 2021 warning letter shows us that FDA will flag supplements claiming to reduce the side effects of drugs. This is an area of the regulation that can be improved in my opinion as it’s well known that prescription drugs have side effects such as hurting the microbiome that can be lessened by taking probiotics. Addressing drug induced nutrient deficiencies is vital to health such as with statins which are known to deplete CoQ10 which is crucial to heart health. While a statement like “Replenishes CoQ10 lost when you’re on a statin” may attract regulatory scrutiny, sticking with “Take CoQ10 as part of your heart wellness protocol” are lower risk, if substantiated.
From warning letter. “Helps to reduce the risk of antibiotic-associated diarrhea…”
When supplements are marketed to be taken with drugs this can also lead to litigation as we saw with the Culterelle case. This involves a probiotic product being labeled to be taken with antibiotics.
Read FDA’s Small Entity Compliance Guide on Structure Function Claims. This is a great resource!
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