What is a structure/function claim, and can you make it with LifeinU™ BSCU1 in the US market? The short answer is YES! But don’t worry we will provide you with all the information you need to know about structure/function claims and how they relate to LifeinU™ BSCU1 for the US market.
But don’t worry we will provide you with all the information you need to know about structure/function claims and how they relate to LifeinU™ BSCU1 for the US market.
What is the legal framework in the US regarding claims for food and supplements?
The labeling for food and dietary supplements is regulated by the US Food and Drug Administration (FDA). The Dietary Supplement Health and Education Act of 1994 (DSHEA) established regulatory requirements and processes for structure/function claims and two other types of dietary supplement labeling claims, including, claims of general well-being and claims related to a nutrient deficiency disease (1).
This regulation covers three main types of health-related statements:
- Health claims,
- Structure/function claims,
- Nutrient content claims.
Structure/function claims have historically appeared on the labels of conventional foods and dietary supplements as well as drugs. According to the FDA, a structure/function claim may describe the role of a nutrient or dietary ingredient intended to affect the normal structure or function of the human body. An example of a structure/function claim would be, “supports immune health”. Additionally, structure/function claims may indicate how a nutrient or dietary ingredient acts to maintain such structure or function. For example, “fiber maintains bowel regularity”, or “antioxidants maintain cell integrity”.
Structure/function claims are applicable for:
- Functional food,
- Food supplements.
The structure/function claim describes the role of a nutrient or ingredient on the structure or function of the human body. In contrast, a nutrient content claim only indicates the level of a nutrient in a finished product at a substantial level.
A health claim refers specifically to how a nutrient or ingredient impacts a disease or health condition. This is also not the same as a structure/function claim that refers to how a nutrient impacts the structure/function of the body.
What are the FDA requirements for using a structure/function claim?
A structure/function claim may be made on the label of conventional foods and dietary supplements if it has a reasonable basis in science.
The scientific basis must be reasonably substantiated by being accepted by most experts in the field and the claim must be truthful and not misleading.
This type of claim does not have to be pre-approved by the FDA, however, the manufacturer must submit a notification with the text of the claim to the FDA no later than 30 days after marketing the dietary supplement with the claim.
If a dietary supplement label contains a claim, it is required to state in a “disclaimer” that the FDA has not evaluated the claim. Moreover, the disclaimer needs to state that the dietary supplement is not intended to “diagnose, treat, cure or prevent any disease,” as this is something only a drug can legally claim (2).
Which claims can be used for LifeinU™ BSCU1 and what is it based on?
LifeinU™ BSCU1, offered by Gnosis by Lesaffre, contains a specific strain of the bacterium Bacillus subtilis CNCM I-2745.
So, how does this solution meet a structure/function claim?
Keep in mind!
The difference between a nutrient content claim and a structure/function claim is that the second is more particular concerning the product. In this case, because Bacillus subtilis is not in fact a nutrient, but a probiotic with legitimately established effects, we are concerned only about structure/function claims.
Let’s review the requirements.
1. Does LifeinU™ BSCU1 affects the normal structure/function of the human body:
LifeinU™ BSCU1 may strengthen immune defenses by increasing the immune system’s SIgA antibody levels in the intestine and saliva.
2. Is there a scientific basis that is reasonable and substantiated for LifeinU™ BSCU1:
The effect of LifeinU™ BSCU1 on common winter infections in seniors was studied in a clinical trial conducted by Professor Philippe Marteau (Saint Antoine Hospital, Paris, France) (3). This randomized, double-blind, placebo-controlled trial showed immune stimulation, with the potential to decrease the frequency of winter infections. Furthermore, Gnosis by Lesaffre, in collaboration with Emulate, a Harvard start-up, has developed a new dynamic model that comes as close as possible to mimicking the human model in preclinical stages: the ‘intestine-chip model’. It allows for a deeper understanding of the clinically observed impacts of LifeinU™ BSCU1 on the gut immune system. This research showed that LifeinU™ BSCU1 contributes to reducing gut permeability (increased gut permeability has been associated with impaired immune responses). It also suggests that the probiotic affects the integrity of the gut mucosal barrier and confirms that LifeinU™ BSCU1 significantly increases the concentration of SIgA in the intestinal lumen, which is consistent with the human clinical trial.
3. Is the claim for LifeinU™ BSCU1 truthful and not misleading:
Because of the positive outcomes of human clinical studies and review of scientific literature, a truthful and non-misleading claim can be made in the following way, “Bacillus subtilis CU1 supports immune health.”
Therefore, the structure/function claims for LifeinU™ BSCU1 are based on the available scientific literature and the positive outcomes of human clinical studies with LifeinU™ BSCU1, making this probiotic eligible for different structure/function claims related to immunity.
3. Lefevre et al. Immunity & Ageing (2015) 12:24 DOI 10.1186/s12979-015-0051-y