IBS & Cholesterol Claims Cited in Warning Letter
Scan marketing for “mid-risk” heart health claims
This letter primarily cites digestive ailment claims such as Irritable Bowel Syndrome (IBS) and heart health claims such as “lowers cholesterol.” While these types of statements should be avoided, they are not usually enough to tip the scale into a warning letter.
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Here are some key learning opportunities.
🔹Statements related to cholesterol and blood pressure should be avoided. In the past, statements like “lowering cholesterol and blood pressure” were not enough to attract a warning letter unless higher-risk disease words were present, but this seems to be changing. I write about last year’s crackdown on companies making biomarker claims here. I expect this trend to continue, so the learning target here is re-review all marketing and remove statements like these.
• Lowers blood pressure
• Lower A1C and LDLs
• Lower arterial plaque
• Lower blood sugar
• Lower bad fats
🔹We have always known that Irritable Bowel Syndrome (IBS) is considered a claim, but it’s not commonly cited unless words like Crohn’s Disease are also used. I also suggest using caution when talking about bloating, constipation, and abdominal pain, as they may be symptoms of serious diseases. If accurate a potential risk mitigating factor is talking about occasional abdominal discomfort and attributing bloating to occasional overeating. These strategies help separate normal life events from those related to disease.
🔹The company receiving this warning letter appears to be very small, which again shows that us no one is too small to be off FDA’s radar.
🔹This company also makes statements in testimonials that have been highlighted on the website. When a company engages or calls outs a product review, this then becomes an endorsed testimonial, which is marketing. I write about the endorsement of social media claims here.
Read the 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.