The rise in functional food and beverages – a market that is expected to grow from $364.18 billion in 2024 to $793.60 billion in 2032 around the world – reflects the preferences of health-conscious consumers seeking more from their products, according to Fortune Business Insights.
From nootropics and pre- and pro-biotics to protein and fiber, food and beverages are serving as vehicles for wellness as brands communicate claims like digestive support, mood enhancement and strengthened immunity through functional formulations.
For brands to meet the growing demand of functional foods, they must ensure that the claims they are making are appropriate for the product category, Jessica O’Connell, partner at international law firm Covington, explained to FoodNavigator-USA.
“Food can be marketed with certain structure/function claims or health claims, but cannot be marketed with drug claims,” O’Connell said. This means steering clear of claims that suggest the product can treat a specific disease or health condition.
Brands should be mindful of three types of claims allowed by FDA:
- Nutrient content claims: These are straightforward and based on specific nutrient levels (e.g. “good source of vitamin E”)
- Health claims: These refer to a reduction in disease risk and are more strictly regulated
- Structure-function claims: These can refer to claims like aiding digestion (e.g. a fiber snack bar), but must be based on the nutritional value of the product. Non-nutritional claims can lead to regulatory issues, especially for commercial foods.
Claims must be “adequately substantiated” and aligned with both FDA and FTC requirements, she added.
Brands must provide “competent and reliable scientific evidence” to support health benefit claims, typically through at least one well-controlled human clinical study, O’Connell explained. For structure/function claims on conventional food, no further FDA requirements apply, but for FDA-approved health claims, prior authorization and specific evidentiary standards must be met, O’Connell added.
“Generally, with novel ingredients, it is important to ensure that they have been sufficiently studied to meet the competent and reliable scientific evidence standard. Companies can work with suppliers to support research and development and/or perform their own research to support the claims they want to make. It is also important that brands are aware of research that was previously conducted on a particular ingredient,” O’Connell said.
If a brand receives regulatory or legal attention on a claim, they “should be prepared to provide substantiation for their claims and to demonstrate that the substantiation meets FDA and FTC expectations,” O’Connell advised.
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The regulatory landscape will hinge partly on whether brands have scientific evidence to back up the claims they make for their products, she added.
Support services for compliance and labeling
Brands can leverage services from firms like Registrar Corp, which helps companies navigate FDA requirements through labeling review, ingredient review and ensuring compliance with food safety and FDA regulations.
While guidelines for nutrient content claims and health claims are “hard coded” into the Code of Federal Regulations, structure-function claims can be trickier, Anna Benevente, director of product labeling and ingredient reviews at Registrar Corp, told FoodNavigator-USA.
Structure-function claims are allowed for conventional foods based on their nutritive value (like fiber content), but if the claim is based on a non-nutritive ingredient, there could be regulatory issues, Benevente advised.
While dietary supplements can make structure-function claims based on either nutritive or non-nutritive ingredients, conventional foods are limited to nutritive value, she added.
Because FDA does not offer specific guidance on what qualifies as adequate scientific support for structure-function claims, brands should work with consulting experts when making these claims, Benevente said.
“If you are making a structure-function claim, consult with someone who has the expertise to assure you that the level of data that supports the claim is adequate,” which can also include a medical or scientific advisory board, she added.
