Natural Products Insider

JAN-FEB 2019

INSIDER is the leading information source for marketers, manufacturers and formulators of dietary supplements, healthy foods and cosmeceuticals. Since 1997, INSIDER has been serving the needs of the global nutrition industry.

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Page 22 of 40

18 INSIDER January/February 2019 FDA and FTC are the two major U.S. federal agencies that regulate health claims made by the supplement industry. Supplement makers may make claims on labels and in advertising, making each regulatory body's evaluation relevant. To be safe, supplement makers should carefully evaluate their marketing and label content for compliance with federal standards. Claim Types A "health claim" is an implied or direct description of a substance's effect on a health condition. In this case, a supplement maker might say, "Our green yeast powder cures high blood pressure." This type of claim would require signifi cant scientifi c 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][1] and [c]). Generally, it is illegal to market a nondrug product as a cure for a specifi c 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. For example, "Iron will give you energy and prevent anemia." While health claims invoke scrutiny from FDA, structure/function claims are not required to be preapproved by FDA. However, FTC requires an advertiser to substantiate the claim with scientifi c evidence. Substantiation Standards The FTC standard required for the substantiation of claims is, "competent and reliable scientifi c evidence." FTC case law defi nes "competent and reliable scientifi c 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 qualifi ed to do so, using proce- dures generally accepted in the profession to yield accurate and reliable results." Basically, FTC is using a fl exible standard with no fi xed 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 fi elds and consult experts from various disciplines. More specifi cally, FDA will consider: The meaning of the claim The relationship of the evidence to the claim The quality of the evidence 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. Specifi cally, 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 specifi c dietary supplement and serving size, the manner of administration, total length of time used, and that the environ- mental conditions are like the labeling of the supplement in question. For example, the manufacturer of a potassium-rich product 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 su pplement maker's claim. The Quality of the Evidence The scientifi c quality of a supplement maker's evidence offered to substantiate a claim is assessed on various factors including: 1 study population, 2 population design and conduct, 3 data collection, 4 statistical analysis and 5 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 suffi cient to validate a claim by experts in the given fi eld. 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 fi nd 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 confl icts with the cumulative existing evidence on the topic, the supplement maker may fi nd the evidence questioned by the regulatory authority. Bridget Hill-Zayat, counsel, Hoban Law Group (, is active in the Pennsylvania cannabis industry. She was selected to participate in state Sen. Daylin Leach's "Regulatory-Palooza" convened to develop standards and methods for cannabis regulations in the Commonwealth. Hill-Zayat has testifi ed in front of the Philadelphia City Council to advise on strategies the city can employ to increase energy effi ciency, foster the cannabis market and help growers, processors and dispensaries thrive. Legal: Claims Substantiation Supplement Claim Types and Required Substantiation by Bridget Hill-Zayat

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