Health claims unlocked: FoodChain ID highlights potential and regulation in the EU and US

06 Dec 2023 --- Food labels and associated health claims increasingly influence consumer purchasing decisions. Nutrition and supplement companies use claims to differentiate their products on the market. Still, they must navigate regulatory landscapes to determine which claims they are authorized to use and how to substantiate these.

We dive into health and nutrition claims in the US and EU with FoodChain ID’s Julie Holt, global advisory services director, and Jérôme Le Bloch, Ph.D., head of scientific affairs. FoodChain ID assists companies in tackling requirements for these claims.

Holt and Le Bloch tell Nutrition Insight that in the past, the regulatory agencies drove industry changes, while today, “regulatory activity is increasingly following consumer and NGO concerns.”

According to the experts: “Consumers became more mindful of ingredients, nutritional information and food labels in recent years during and after the pandemic. Another current driver of consumer product selection in the US is ‘clean label,’ however, this term is not legally defined.”

“With all the controversy around artificial sweeteners, many consumers pay attention to added sweeteners and look to balance added artificial sweeteners with reduced sugar in their favorite products. The food industry is now seeing legislation follow consumer concerns and issues raised by NGOs.”

Innova Market Insights data suggest that health claims or labels significantly influence the purchasing decisions of 61% of consumers.Differentiating products
Holt and Le Bloch explain that companies may use claims as a type of “advocacy marketing” to persuade consumers to buy their products.

“Product labeling, advertising and social media endorsements that highlight claims (excluding all natural) provide companies with opportunities to push specific messaging. It may be said that marketing claims help villainize some ingredients such as sweeteners, colors, flavors and preservatives and promote others.”

Le Bloch explains that the EU uses two main types of claims — nutrition and health claims. “Nutrition claims are claims which highlight the beneficial nutritional properties of the product, while a health claim indicates a relationship between the food and health. There are 30 authorized nutrition claims in Europe.”

“Food products mainly use nutrition claims to put forward the product’s nutritional benefits. Health claims are more used on dietary supplements to present the product’s benefits and to differentiate from competitors.”

He adds that while nutrition claims are not mandatory to put food products on the market, health claims on dietary supplements are essential to position the product due to the intense competition in this market. “Without claims, consumers do not know the product’s benefits and won’t buy them.”

“Consumers need a clear indication of the product’s benefits and rely on health claims. However, consumers are more and more informed, and claims alone are no longer enough to ensure the success of a product.”

Health claims in the US
Holt highlights that the specific health claims permitted in the US are set forth in Title 21 of the Code of Federal Regulations (CFR) 101.7 – 108.9. The requirements for the specific health claims are elaborated in the CFR.

“There are two types of health claims: authorized health claims, which have significant scientific agreement among qualified experts, and qualified health claims, which have some scientific evidence but are not enough to meet the authorized standard.”

She continues: “All health claims in the US must be based on scientific evidence and must undergo review by the Food and Drug Administration (FDA) through a petition process.”

In the US, companies can use authorized and qualified health claims, which have different levels of scientific evidence.The FDA defines explicitly and allows specific health claims, says Holt.

The 12 types of health claims are defined in terms of ingredient group and health benefit, for example, dietary lipids and cancer, sodium and hypertension, fiber-containing grain products, fruits and vegetables and cancer or soy protein and risk of coronary heart disease. In addition, the FDA specifies claims that are not authorized.

EU claim definitions
In the EU, nutrition and health claims are regulated by Regulation (EC) No 1924/2006 of 20 December 2006. Le Bloch explains that this regulation defines claims as “any message or representation, which is not mandatory under Community or national legislation, including pictorial, graphic or symbolic representation, in any form, which states, suggests or implies that a food has particular characteristics.”

He emphasizes the importance of differentiating authorized health claims — which can be used by any food product as soon as the conditions of use are respected — and on hold or pending claims.

“These claims have not been evaluated to date and can be used as the sole condition to demonstrate the product’s efficacy based on proprietary studies or scientific literature. A scientific dossier should be presented to authorities in case of control. To date, there are more than 2,000 pending health claims, mainly on botanicals.”

Using EU health claims
According to Le Bloch, companies have three options to use health claims in the EU.

“Firstly, they can use the authorized claims, mainly on vitamins and minerals. They just need to be compliant with the conditions of use. This solution ensures product compliance, but there is no differentiation among products. Claims are standard and sometimes not easy to understand for the consumers.”

“The second option is to use pending health claims. In this case, companies have more possibilities in terms of communication but should be able to substantiate the product’s efficacy. Generally, companies use both authorized and pending health claims on their products.”

As a third option, companies can submit a health claim application to obtain a proprietary health claim, Le Bloch continues. “Companies have to provide strong scientific data on their ingredients to obtain such claims. This is therefore risky and expensive, but it ensures a unique communication, different from competitors.”

In the EU, nutrition claims highlight the beneficial properties of a product, and health claims indicate a relationship with health.Claim substantiation
Companies should always do their due diligence before making any product claims, underscore the FoodChain ID experts.

Holt details that marketing needs are often at odds with regulatory requirements. She highlights: “The rigor to substantiate a claim is particularly necessary in the US where there has been litigation around inappropriate or unsubstantiated claims.”

“Claims language is also important as marketing superlatives can inadvertently exaggerate a product’s claim. It is important to ensure that any claims made do not veer into false advertising.”

Le Bloch adds that in the EU, companies must ensure they comply with the condition of use if they want to use authorized health claims. “For pending claims, they need to be able to demonstrate the product’s efficacy through the scientific literature or proprietary data. This is a large undertaking, but mandatory to be compliant with European regulation.”

He underscores that the main challenge is having enough scientific data to substantiate a European health claim.

“At least two clinical trials are mandatory, with absolutely no gaps or weaknesses in the study design and statistical analysis. A solid knowledge of European authorities is needed, too, to avoid getting lost in administrative difficulties. An expert with extensive knowledge of EFSA requirements is critical to obtain approval for a new health claim.”

By Jolanda van Hal

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