January 21, 2019
Supplement makers’ claims on labels and in advertising are subject to rules created by the Food and Drug Administration and the Federal Trade Commission. However, if those claims suggest the supplement can cure or ease the symptoms of a disease, the FDA must review them—and the science behind them—before the product goes to market.
To be safe, supplement makers should carefully evaluate their marketing and label content for compliance with federal standards.
A health claim is an implied or direct description of a substance's effect on a health condition. In this case, a supplement maker could say, "Our green yeast powder cures high blood pressure." This type of claim would require significant scientific agreement and must be authorized by FDA. A health claim can be a written statement, a third-party reference, a symbol or a vignette (21 CFR 101.14[a] and [c]). Generally, it is illegal to market a non-drug product as a cure for a specific disease or as a treatment for the symptoms of a disease. FDA requires all supplements making disease claims to complete premarket reviews and receive approval for all health claims as appropriate.
Structure/function claims describe the role of a supplement as it is intended to affect the function of the human body, such as, “Iron will give you energy and prevent anemia.” While health claims invoke scrutiny from FDA, structure/function claims are not required to be pre-approved by FDA. However, FTC requires an advertiser to show “competent and reliable scientific evidence.”
The FTC standard required for the substantiation of claims is “competent and reliable scientific evidence.” FTC case law defines “competent and reliable scientific evidence” as “tests, analyses, research, studies or other evidence based on the expertise of professionals in the relevant area, that has been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results.” Basically, FTC is using a flexible standard with no fixed formula.
FDA, similarly, has no set formula for the number or type of studies needed to substantiate an advertisement claim. FDA, instead, will consider what the accepted norms are in the relevant research fields and consult experts from various disciplines. More specifically, FDA will consider the meaning of the claim, the relationship of the evidence to the claim, the quality of the evidence and the totality of the evidence presented.
The meaning of the claim
It is possible that a supplement-maker's claim will be interpreted in multiple reasonable ways. In that case, the supplement-maker would need to substantiate all interpretations of the claims. Supplement-makers may use consumer testing to assess the general understanding of the consumer. While establishing consumer understanding is essential, supplement-makers must also substantiate the conclusions that form the basis of that customer understanding. Specifically, if a supplement-maker is saying its product will make a user's hair shiny, the maker must be able to show how the supplement makes users' hair shiny and how that process can be measured and repeated.
The relationship of the evidence to the claim
The supplement-maker may offer studies or other evidence to help substantiate the desired claim. FDA will look at the provided studies to see their relevance to the claim. The supplement-maker should ensure that the studies proffered as evidence identify the specific dietary supplement and serving size, the manner of administration, total length of time used and that the environmental conditions are like the labeling of the supplement in question. For example, a potassium-maker may want to use a high-quality study on bananas and the decreasing rate of muscle cramps for consumers. However, the use, manner and environmental conditions are not similar enough to use as evidence to substantiate the supplement-maker’s claim.
The quality of the evidence
The scientific quality of a supplement-maker's evidence offered to substantiate a claim is assessed on various factors including study population, population design and conduct, data collection, statistical analysis and outcome measures. FDA will place value on randomized, double-blind, placebo-controlled trials when possible and ethical. A failure to address bias, confounders and other limitations will detract from the value of the evidence.
FDA will look for evidence that would be sufficient to validate a claim by experts in the given field. To that end, evidence and information derived from human studies provide the most persuasive evidence for claims substantiation. Intervention studies conducted by an investigator control if the subject consumes the supplement or treatment to determine if it is effective. Observational studies where an investigator observes, but does not control, a treatment are also used. In an observational study, investigators find subjects and monitor those subjects either before or after a result occurs.
The totality of the evidence
In sum, FDA will look to all the evidence presented to substantiate a claim and judge whether the overall weight supports the supplement-maker’s conclusion. If the evidence conflicts with the cumulative existing evidence on the topic, the supplement-maker may find the evidence questioned by the regulatory authority.
Bridget Hill-Zayat, counsel, Hoban Law Group, is active in the Pennsylvania cannabis industry.
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