Claims & Labeling
The sequence most brands follow is backwards. Marketing writes the proposition, the formula is built to support it, and regulatory is asked late whether the claim is permissible. By then the artwork brief exists and the answer is expensive.
The workable order is the reverse. Establish what the evidence actually supports, at the dose your product contains, in the population you are selling to. Then determine what claim language each target market permits for that evidence. Then build the positioning inside those constraints.
This feels restrictive and produces better marketing, because a claim you can defend is a claim you can put weight behind. A claim you are quietly hoping nobody examines constrains everything downstream, including how confidently you can sell.
Claim rules differ so fundamentally between markets that the same sentence can be pre-approved in one, self-substantiated in another, prohibited in a third and require its own application in the fourth.
In Canada, claims come from Health Canada monographs in prescribed wording. Your approved claim set is issued with the licence and published in a public database. A claim outside the monographs pushes the product into Class III with a full efficacy dossier.
In the United States, structure function claims are self-substantiated. You may claim a product supports a function of the body provided you hold competent and reliable scientific evidence, notify the FDA within thirty days of first use, and carry the required disclaimer. Nobody reviews it in advance.
In the European Union, only claims appearing in the EU Register may be used, in wording carrying the same meaning as the authorised entry and subject to its conditions of use. A claim absent from the register cannot be used regardless of the evidence behind it, until an application is made and granted.
In Australia, listed medicines may only carry indications from the Permissible Indications Determination, used in the exact published wording. Paraphrasing is non-compliance.
This is the single most common substantive failure, and it is rarely deliberate.
A study demonstrates an effect at 600 mg. The formula contains 200 mg because that is what fits the capsule, the cost target or the flavour system. The claim carries forward from the study. The evidence no longer supports it.
Regulators check this. Health Canada checks it during review. EFSA checks it in an Article 13.5 assessment. The FTC checks it when someone complains. The fix is not to find a more favourable study, it is to either raise the dose or change the claim.
Most brands treat the label as the compliance surface and the website as marketing. Regulators do not make that distinction.
In the United States the FTC regulates advertising to a stricter substantiation standard than the FDA applies to labels, and applies it to your website, your email, your social media, your affiliate partners and your influencers. An influencer who describes your product as treating a condition has created a drug claim on your behalf.
The practical requirement is that claim review covers every channel, and that anyone speaking on your behalf has a written brief on what may and may not be said. An affiliate programme without claim guidelines is an unmanaged liability.
Across every market, the boundary that matters most is between supporting a normal function and treating, preventing or curing a condition. Cross it and the product becomes a drug requiring approval it does not have.
The line is not always obvious. Supporting healthy joint function is a structure function claim. Relieving arthritis pain is a disease claim. Supporting cardiovascular health is generally acceptable. Lowering cholesterol is, in most markets, a disease risk reduction claim requiring its own pathway.
Implication counts as much as statement. Imagery, product naming, customer testimonials and the conditions listed on a website can together create a disease claim that no single sentence makes explicitly. Regulators read the page, not the sentence.
A claim substantiation dossier should exist before the claim is published, not after someone asks.
It contains the claim as it will appear, the evidence supporting it, an assessment of that evidence for quality and relevance, the reasoning connecting the dose studied to the dose in the product, and an acknowledgement of contrary evidence and why it does not change the conclusion.
Assembled in advance it takes days. Assembled under a regulatory deadline or an FTC inquiry it takes weeks, costs considerably more, and is visibly retrospective.