Tips For Understanding What A Claim Is
Arthritis claims attract scrutiny
Arthritis claims continue to be cited in warning letters. As many of you know, I love teaching about regulatory compliance to help you adjust your marketing and stay ahead of the regulatory curve.
We hear about not “making claims,” but it can be challenging to know what a claim is. Here are a few general rules for avoiding high-risk claims that can lead to a warning letter. What other tips can you share?
Anything ending in “itis,” such as “arthritis”. “Itis” means “inflammation of,” which helps me remember it should be avoided. Fun fact, “arthritis” is the most commonly referenced of all the words ending in “itis.”
Other than “antioxidant” and perhaps “anti-aging,” words with “anti” should be avoided. Immune-related words like “antiviral” or “antitumor” are higher risk than “anti-inflammatory.”
Words with an International Classification of Diseases (ICD) code.
The name of any illness or syndrome, such as Alzheimer’s or IBS. Some are obvious, but some of the syndromes, like Leaky Gut Syndrome, may not be as obvious. Here is a post about this. Searching past FDA warning letters can help you learn what they’ve previously cited. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters
“Better than drugs” statements attract FDA attention. Here’s a WLW post about this.
FDA sent out 12 arthritis-related warning letters last year, so please avoid making these types of claims. This includes:
Social share meta description
FDA has been quiet with supplement warning letters, and I am in New Zealand, so this is a shorter post than normal. I am writing this WLW for the beautiful Coromandel. Yes, I love compliance and writing this post (smiles)!
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.