Structure-Function vs Disease Claims

This is the single question that gets brands, distributors and retailers into trouble, and the line is narrower than most people selling the category realise. What follows is the short version of what module five of the course covers.

The line, in one sentence

You may describe how an ingredient affects the normal structure or function of the body. You may not say it treats, prevents, cures or diagnoses anything. The first is a structure-function claim. The second is a disease claim, and a disease claim turns a beverage into an unapproved drug in the FDA's eyes.

The same ingredient, three ways

Claim test Ashwagandha, as an example

OK "Supports a healthy stress response" Structure-function. Describes an effect on normal function, promises no medical outcome.

NO "Treats anxiety" Disease claim. Anxiety is a diagnosable condition, and treating it is what a drug does.

NO "Prevents the onset of Alzheimer's disease" Disease claim, and the clearest possible example of one.

Where the permission comes from

Structure-function claims are allowed on a dietary supplement without FDA pre-approval under DSHEA, the Dietary Supplement Health and Education Act of 1994. Two conditions come with that: the manufacturer notifies the FDA within thirty days, and the label carries the standard disclaimer that the FDA has not evaluated the statement. No pre-approval does not mean no rules.

Who carries the risk

Not only the brand. A claim repeated by a distributor rep in a buyer meeting, printed on a shelf talker, or said out loud by floor staff to a customer is still a claim. The retailer and the distributor are both in the chain. This is why "the brand told me it does that" is not a defence worth relying on.

Four habits that keep you inside the line

Lead with the outcome the label states, not one you infer. If the can says calm focus, say calm focus. Do not upgrade it.
Read by milligram dose, not by marketing. A named bioactive at a stated dose is a fact. A proprietary blend total is a red flag, because it hides the formulation.
Never name a condition. The moment a diagnosable illness enters the sentence, you have crossed over.
Answer a medical question with a referral. "I can tell you what is in it and at what dose" is always available to you, and it is always safe.

The same line applies to your marketing

An influencer post is advertising. The FTC requires a clear and conspicuous disclosure of any material connection to the brand, and the FDA claim rules do not relax because the words were said by somebody else on your behalf. A creator repeating a disease claim is your problem too.

This is a summary of what module five of Functional Beverage Certified teaches, written for trade professionals. It is education, not legal advice, and it is not a substitute for your own compliance review.