In today’s video, we’ll talk about how FDA can classify your dietary supplement as a drug, subjecting you to enforcement that might require you to stop selling your product, and at a minimum will require significant rebranding.

Do you remember that song, 50 ways to leave your lover?  Hop on the bus, Gus … don’t mean to be coy, Roy.

Well, there are 10 ways FDA can say that your dietary supplement is really a drug.  In 21 CFR 101.93(g), FDA defines “disease” as, among other things, “damage to an organ, part, structure, or system of the body such that it does not function properly (e.g., cardiovascular disease), or a state of health leading to such dysfunctioning (e.g., hypertension).”

FDA then provide 10 different criteria for determining whether you have an allowable, structure/function claim as opposed an impermissible, disease claim.  The rules are quite detailed, and we could go through each one with examples.  But in this video, we’re going to follow the song and I’m going to see if I can summarize these 10 criteria with a rhyme because I want them to be memorable.

So, “make a new plan, Stan, just drop of the key, Lee, and set yourself free, let’s get through all ten, Jen”

Criterion 1. Don’t freeze, mention a disease.

Criterion 2. Hey Plimpton, don’t claim an effect on a symptom.

Criterion 3. Don’t be a physician, do not mention a condition.

Criterion 4. There’s no one else to blame, if you put a disease in the product name.

Criterion 5. If you claim your product can cure, you’ve got a drug, for sure.

Criterion 6. Don’t mention chronic or acute, and claim that for a drug your product can substitute.

Criterion 7. FDA will do more than shrug, if your product claims to augment an existing drug.

Criterion 8. In case your name is Hector, note that a dietary supplement cannot have a role in the body’s response to a disease or disease vector.

Criterion 9. Better to give charity than to claim to handle adverse events, associated with a therapy.

Criterion 10. FDA does what it pleases, when it comes to Criterion 10, which says “otherwise suggests an effect on diseases.”

If you remember nothing else, here are some key takeaways: first, there are ten criteria; second, the tenth criterion is a catch-all, very broad; and three, it’s good to have an FDA attorney review all your marketing to see whether you’ve inadvertently triggered any of the ten.

I’m Michael H. Cohen, founding attorney of the Cohen Healthcare Law Group. We help healthcare industry clients just like you navigate healthcare and FDA legal issues so they can launch, or continue to scale, their health and wellness product or service.

Thanks for watching. We look forward to speaking with you soon.