Taking the Stress out of Claims in the US

Insight and content provided by Ivan Wasserman & Jennifer Adams of Amin Talati Wasserman.

With the spotlight on balance and mental wellbeing, particularly in a post-COVID world, there is now greater focus on effective stress management techniques. Those looking to reduce stress often turn to functional foods and dietary supplements for support.
 

74% of American consumers indicated that managing their stress levels was an important aspect of their health ¹.

Food and supplement brands operating in this space must ensure their claims are substantiated to avoid a multitude of regulatory actions. For some markets, the company must seek prior approval for claims related to a product being ‘calming’ or ‘stress relieving’. This is not the case in the US, but it doesn’t mean you can get away with making unsubstantiated claims.

The regulatory space can feel like a minefield, but there are some helpful guideposts for talking about a product’s stress-mitigating qualities.
 

Understand the regulatory landscape before making bold claims
 

Before diving into stress-related claims, it is useful to understand the regulatory landscape in the US. 

The Federal Food Drug and Cosmetic Act recognises several categories of ‘food’. The most relevant for this topic is ‘conventional food’, which refers to regular food people eat every day. ‘Dietary supplements’, which refers to pills, capsules and powders that are used to supplement the diet, are also of relevance. Foods under both categories are allowed to make what is classed as a ‘structure / function’ claim. 

A structure / function claim is a statement that describes the role of a nutrient or dietary ingredient that is intended to affect the normal structure or function of the human body. At the most basic level, structure / function claims are about supporting or maintaining a healthy state. Classic examples are: ‘calcium builds strong bones’ or ‘fibre supports digestive regularity’. 

Where brands can get pulled up is by mistakenly going beyond a structure / function claim and making an express or implied disease claim. Foods and dietary supplements cannot claim to treat, diagnose, prevent, cure or mitigate any disease. Disease claims can be implied in many ways - proximity to other claims, imagery or even the name of the product.  A critical eye is needed, and claims should not be reviewed in isolation.

So what kind of stress can you talk about?
 

The Food and Drug Administration’s (FDA) position is that typical, common everyday stress is a normal, non-disease state suitable to be the subject of structure / function claims. However, ongoing chronic stress is not considered a normal or healthy state. Therefore, you’ll want to steer clear of making claims around severe stress and stress-related conditions such as anxiety. 

The critical thing to keep in mind is that the claim must be clearly tied, either directly in the claim itself or in the context of the product label, to common, everyday stress. In marketing, this could be illustrated as the stresses of juggling family obligations or work and school related issues, which were among the top factors found to cause stress in the recent IPSOS Nutiani Consumer Wellness Research ¹.

Difference in claims for foods and supplements

There are differences between the types of claims that can be made for conventional food items and dietary supplements. Dietary supplements have greater flexibility to make structure / function claims, as they can be based on a specific dietary ingredient in a product. Conventional foods are more limited – the FDA’s position is that structure / function claims for the category must be based on the ‘nutritive value’ of the food.
 

Over half of American Consumers turn to nutrition to manage stress ¹. The top ingredients are

• Vitamins & Minerals (36%)
• Dairy proteins (19%) 
• Probiotics (18%)
   

As an example, certain herbal ingredients may have little or no nutritive value. Basing stress related claims on herbal ingredients in foods may therefore create regulatory risk. However, herbs can form a structure / function claim for dietary supplements. 

Undertaking proper research and adhering to regulations will help prevent problems further down the line when it comes to introducing products with accompanying claims related to stress in the US market.

Disclaimer: The views expressed above are the opinion of the author, and Fonterra is not responsible for any decisions taken in reliance on the same.