Does a statement that a Supplement can treat disease violate FDA Regulations?

[dab2d]

Hypo:

Say that one is claiming a supplement for the treatment of a condition or disease.

As examples and declarations, the inventor makes the claims that their supplement treats a disease, but they do not have any FDA approval to make such a claim.

Is such a claim in a Patent Setting, and what will become public documentation, a violation of FDA regulations.       

[Toot Aps Esroh]

To be clear - your hypothetical person is not advertising the product for sale stating that it treats or cures any disease, but is merely stating so in their patent documents?

I've seen many patents on supplements, most very poorly written, but most also claiming disease treatment and/or cure.  I don't think the FDA cares to police these sorts of documents that are not directly related to selling or promoting the procuct, but I am not positive.

Now, here's the next step question.  Your hypo person gets the patent and starts selling supplements, using the usual circumlocutory language in his advertising and packaging to avoid FDA wrath.  But he also says "Patented!  See US Patent 10,987,543 for details!"

Could the FDA then say he's making claims?  I'm not sure.  Maybe they would see this as similar to a pharma company rep passing out a "new study" showing a drug was efficacious for an non-cleared use, which I believe the FDA does see as a violation of drug promotion regulations.

[dab2d]

You bring up a lot of good points.

Another aspect would be, could illegal claims nullify a declaration if those claims were the basis for allowance.

Ex. Claim for treating a disease is rejected. Declaration has experts using the product and [[claiming]] asserting it treats the disease. The [[claim]] assertion for treating the disease is illegal because the product that was the basis of the declaration was not cleared by the FDA. Does this taint the declaration?

[mersenne]

could illegal claims nullify a declaration if those claims were the basis for allowance.

Are you mixing up patent "claims" and drug "claims"?  A patent claim is like:

I claim [the method of] administering snake oil to cure cancer.

If allowed, you can sue anybody else who administers snake oil (arguably) regardless of the person's intent in administering it.  I don't think there's any FDA problem there.  If the product works, you can certainly administer it to yourself (unless it's a scheduled drug, I guess, which you'd need a license of some sort to possess and/or use).  Hell, you can administer it to yourself whether or not it works.

A drug claim is like:

If I administer this snake oil to you, then it will cure your cancer.

The FDA requires you to pay a lot of money for the privilege of making that statement.

[Dazed-n-confused]

***
Another aspect would be, could illegal claims nullify a declaration if those claims were the basis for allowance.

Ex. Claim for treating a disease is rejected. Declaration has experts using the product and claiming it treats the disease. The claim for treating the disease is illegal because the product that was the basis of the declaration was not cleared by the FDA. Does this taint the declaration?

I am not an expert in this field, but I do not think that "illegal claims" (for example, an expert's statement in a patent application declaration attesting to the efficacy of the patent-application-claimed supplement, which is only "illegal" in the sense that the supplement itself may not be FDA approved) harm patentability.

As noted by brother mersenne, you should start helping us by being careful to parse what you mean when you use the word "claim", given it means one thing in the patent world and a wholly different thing in the medicament world.  And even in the patent world, if what you mean is "attestations in a declaration", you should not refer to that as a "claim", either.  Break things down for us, please.

[dab2d]

I fixed it.... Thanks for the suggestions.