ISSA SN Chapter 11: Label Claims for Conventional Foods and Dietary Supplements

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Chapter Goals:

• 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 and the structure claims and the scientific evidence that relates.
• 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 simply be truthful and not mislead consumers. 

Nutrient Content Claims

This is a claim made by the product that characterizes the claims for the nutrient contained within the product. This is seen with things like low fat, high in oat bran, and great source of some vitamin. 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

Health claims describe a relationship between some food substance and the reduced risk of disease, or a condition related to health. A statement that lacks either the substance or the reduction in disease or a condition will not be a health claim by definition. Some example of claims are the improvement of performance, improvement in appetite, and the increase muscle growth.

Function and Structure Claims and Related Dietary Supplement Claims

These has historically appeared on 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.

Interventional studies

Investigators will control if the subject receives treatments or interventions and whether they support the predetermined hypothesis.

Observational studies

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 that 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 who do not have that same condition. 

Cohort studies are compared to the outcome of subjects that have been exposed to some substance and the subjects 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 condition in different populations. 

Useful background info for supporting a claim but not adequate enough to substantiate it.

Animal studies

In vitro studies

Testimonials and other evidence that is anecdotal

Meta analyses

Review articles that summarize the findings of the main reports

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Comments and letters to editors focused on issues from a study, meeting presentation, and substantiations for the claim

Product monographs

Factors that contribute to higher quality in studies:

• The adequacy and clarity of their design. 
• The questions answered in the study are described clearly as the outset.
• The method of study will be clearly described and have appropriately been answered according to the study.
• The time of the study intervention or the period to follow detects and effect on the outcome of interest.
• Potential confounding factors are identified, assessed, and also controlled. 
• Subject attrition is assessed, explained, and reasonable. 

Populations studied

The sample size needs to be big enough to give the 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.

Conclusion

There is a lot that goes into the regulation of the dietary supplements and foods and their advertising and labeling. It is important to have some base knowledge of all 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 through this chapter.