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- Describe and define the main terms that relate to the dietary and food supplement claims.
- Know the types of evidence needed for the FDA to support certain claims.
- Be able to talk about the function, structure claims, and related scientific evidence.
- Find the difference in function and structure claims and drug and disease claims.
Claims for Foods and Dietary Supplements
There are three categories of claims: health, nutrient content, and structure/function.
A main requirement is generally that the claim is truthful and does not mislead consumers.
Nutrient Content Claims
This claim by the product characterizes the claims for the nutrient contained within the product. This is seen with things like low fat, high in oat bran, and a great source of some vitamins. Those are some of the most common that we see. There are some large charts in this chapter showing the different claims based on the nutrients that are discussed, so it is important to look through those.
Health claims describe a relationship between some food substances and reduced disease risk or health-related conditions. A statement that lacks either the substance or the reduction in disease or a condition will not be a health claim by definition. Some examples of claims are an improvement in performance, an improvement in appetite, and an increase in muscle growth.
Function and Structure Claims and Related Dietary Supplement Claims
This has historically appeared in dietary supplements and conventional foods. These describe the role of a nutrient or some ingredient in the diet that intends to affect the standard structure or function of the human body. One claim that is quite popular would be the claim that calcium will build strong bones.
Review of FDA’s Guidance Related to Structure and Function Claims for Dietary Supplements
There is a comprehensive review of these claims on the FDA website.
Investigators will control if the subject receives treatments or interventions and whether they support the predetermined hypothesis.
Here, the investigator does not have control over the exposure to treatment or the intervention of interest. It is simply observational.
Case reports describing single subjects and small numbers of subjects together.
Case series studies are descriptive on the account of a series of outcomes seen over time and reported for groups or subjects. There is no control group described.
Case control studies will compare the subjects that have conditions to subjects that do not have that same condition.
Cohort studies are compared to the outcome of subjects exposed to some substance and those not exposed.
Cross sectional studies are the ones that look at a single point in time compared to people that have been exposed to substances and the number of people that do not have the condition and were not exposed to some substance.
Time series studies are looking to compare the outcomes of different time periods.
Epidemiological studies look to compare the rate of conditions in different populations.
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Useful background info for supporting a claim but not adequate enough to substantiate it.
In vitro studies
Testimonials and other evidence that is anecdotal
Review articles that summarize the findings of the main reports
Comments and letters to editors focused on issues from a study, meeting presentation, and substantiations for the claim
Factors that contribute to higher quality in studies:
- The adequacy and clarity of their design.
- The questions answered in the study are described clearly at the outset.
- The study method will be clearly described and appropriately answered according to the study.
- The time of the study intervention or the period to follow detects an effect on the outcome of interest.
- Potential confounding factors are identified, assessed, and also controlled.
- Subject attrition is assessed, explained, and reasonable.
The sample size needs to be big enough to give a sufficient level of statistical power for detecting a significant effect.
The population studied is representative of the population the claim will target.
The inclusion criteria and exclusion of the subjects studied were clearly appropriate and stated well.
The study used procedures of recruitment that minimize the levels of selection bias.
For the controlled interventions, the subjects are random.
A lot goes into regulating dietary supplements and foods and their advertising and labeling. It is important to have some base knowledge of everything that goes into it, but do not get obsessed with knowing every piece of information, as it can be quite a lot once you read this chapter.