As more and more companies come under FDA and FTC scrutiny for their health and benefit claims, it is important to understand what it takes to prove a health or wellness claim.
The FDA recognizes four kinds of health claims, and requires commensurate proof as follows:
1) Unqualified claims —
These are claims that talk about the relationship between nutrients or foods, or possibly substances, and a disease or a health-related condition. They include statements such as 'vitamin C treats scurvy' or 'diets low in sodium may reduce the risk of high blood pressure, a disease associated with many factors.'
Such unqualified claims have highly repeatable cause-and-effect relations, are supported by substantial scientific evidence and rationale, and are broadly accepted by scientists almost as laws of science. For the FDA, there needs to be 'significant scientific agreement for any unqualified claim.
2) Structure-function claims —
These claims describe the role of a nutrient or substance in the normal structure or function of the human body, and there is no reference to any disease or abnormal state whatsoever. They include statements such as 'calcium builds strong bones,' or 'fibre maintains bowel regularity.' These claims talk about how the body operates and the role of substances therein.
Under DSHEA, these claims may not have been reviewed by the FDA, and they must be presented with the standard dietary-supplements disclaimer, which states that there has been no evaluation by the FDA and that the product involved should not be used 'to diagnose, treat, cure or prevent any disease.'
Many dietary-supplements or functional-foods products run afoul of the law here when they overstate structure-function claims, claiming more than the science proves or by implicating diseases or abnormal states.
3) Qualified claims —
Qualified claims may speak of the relationship between a nutrient or substance and a disease-related condition, but the statement must be clearly qualified and/or contain a disclaimer to keep from misleading consumers. An example of such a claim may be 'omega-3 fatty acids may reduce the risk of coronary health disease.' A disclaimer for a statement such as this may be, 'The FDA evaluated the data and determined, that, although there is scientific evidence supporting the claim(s), the evidence is not conclusive.'
In these claims the statement must accurately reflect the level of scientific knowledge available. If a party thinks the evidence is conclusive, it may file a petition for review with the FDA.
4) Dietary guidance statement —
These claims describe the general wellbeing to be derived from consuming a nutrient, food or substance, and like all allowable statements under regulatory authority, they must be truthful and not misleading. Examples may be, 'Calcium builds strong bones,' or 'fibre helps maintain bowel health.' These claims are based upon the idea that broadly accepted principles of nutrition helps maintain the health we normally enjoy.
All acceptable claims allowed under the law and regulatory authority must be based upon some level of scientific knowledge and proof. What the FDA wants — and what consumers and investors need — is significant scientific agreement, but it is willing to accept statements wherein the evidence is compelling or probable but not yet conclusive. Businesses undertake excessive risk, and may fail in their duty of care to their customers and investors, when they introduce products into the marketplace based on uncritical, limited, inconclusive or nonexistent scientific evidence.
No one study is ever enough to prove any health claim because it lacks any verification. Nor are a few or even a number of studies likely to rise to the level of probable or significant scientific agreement. Publicly responsible business is based upon science and the kinds of facts, truth and substantial verification that only arise with clear repeatability, peer corroboration, extensive published literature, statistically significant trials and cross-referencing secondary studies of the knowledge to be codified.
Before businesses rush to introduce products based upon the next 'hero ingredient' or newly discovered substance, their health claims and corporate responsibility should be carefully calibrated to reflect the kind of scientific verification and agreement that exists within the scientific community and is allowable under the law.
Lindsay Moore, PhD, is CEO of KLM, a management consultation firm in Boulder, Colorado, and co-author of Intellectual Capital in Enterprise Success: Strategy Revisited, published by Wiley. Respond: [email protected]