Structure Function Claims: What They Are and How to Make One

Navigating the complexities of food and supplement labeling is an essential aspect of ensuring your product is both market-ready and compliant. While many terms and labels can be attached to food products, one that frequently raises questions is the “structure/function claim”. 

This article will unpack the basis of a structure function claim and how to make one on your product’s nutrition label. With increasing consumer demand for transparency and insight into the products they consume, understanding the intricacies of structure/function claims is paramount for any business in the food and supplement industry.

What is a Structure/Function Claim?

A structure/function claim is a type of dietary supplement labeling claim that describes the role of a nutrient or ingredient intended to affect the normal structure or function of the human body. Unlike drug claims that assert the product will diagnose, treat, cure, or prevent a disease, a structure/function claim speaks to how a product might help maintain the body’s normal, healthy structures and functions. For instance, “calcium promotes bone strength”. This outlines the mechanism through which a nutrient or dietary component maintains that structure or function.

Another example is if a supplement label states that it “supports heart health”. This is asserting that the supplement can help maintain the normal, healthy function of the heart but not that it can prevent heart disease or treat cardiovascular conditions.

It’s essential to understand the distinction between a structure/function and a health claim. While a statement like “Calcium promotes bone strength” is a structure/function claim, asserting that “Calcium reduces the risk of osteoporosis” would be a health claim, as it refers directly to a disease risk reduction.

Understanding US Legal Factors for Food & Supplement Claims

In the US, the Dietary Supplement Health and Education Act (DSHEA) of 1994 oversees the use of structure/function claims. These claims, when used, must be truthful and not misleading, supported by substantial evidence, and must contain a mandatory disclaimer. The disclaimer typically reads, “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.”

Interestingly, manufacturers don’t need the Food and Drug Administration (FDA) to green-light these claims beforehand. But, they are required to notify the FDA within a month after introducing the claim on a product. Any false or unsupported claim can prompt the FDA to intervene, tagging the product as misbranded. For enterprises wishing to embrace these claims, grasping these legal nuances is pivotal to ensure they remain on the right side of the FDA, maintain their product’s reputation, and build a rapport with discerning customers.

For businesses seeking to incorporate these claims into their labeling, understanding the legal requirements is crucial. It ensures compliance with FDA regulations, upholds product integrity, and fosters trust with informed consumers.

FDA requirements for structure/function claims

The Food and Drug Administration (FDA) has stringent requirements in place to ensure that structure/function claims on product labels are both accurate and not misleading to consumers. These requirements are pivotal in maintaining product integrity and trust within the industry. The main stipulations include:

1. Substantiation: Ensuring the claim’s authenticity is paramount. For this, the manufacturer should have solid evidence at hand, which can come from credible scientific inquiries, extensive research, or historically verified data. 

2. Notification: Within 30 days of marketing a product with a structure/function claim, the manufacturer must notify the FDA about the claim being used. This notification should include the exact wording of the claim and the name of the dietary supplement.

3. Mandatory Disclaimer: To make consumers aware of the boundary between dietary supplements and medications approved by the FDA, a mandatory disclaimer is essential on any product with a structure/function claim.

4. Truthful and Not Misleading: The claim must be accurate and not give any false impressions about the product’s capabilities. Misleading or deceptive claims can result in regulatory actions against the manufacturer.

Decoding the Types of Structure/Function Claims:

Structure/function claims can vary in nature, depending on the product and the intended effect. Some common types include:

1. Descriptive Claims: These relate to the effects that consuming nutrients at general, non-specific levels might have on the structure or function of the body. For instance, “Calcium supports bone health.”

2. Beneficial Effects: These claims highlight the beneficial effects of nutrient deficiency. For example, “Vitamin C prevents scurvy.”

3. Maintenance Claims: These describe how certain dietary ingredients can help maintain healthy functions. E.g., “Fiber maintains bowel regularity.”

4. General Well-being: These claims express how consuming a nutrient can affect general well-being. An example would be, “Multivitamins support overall health.”

Permissible vs. Impermissible Structure/Function Claims

It’s paramount for manufacturers to know the fine line between what’s allowed and what isn’t when it comes to structure/function claims. Here’s a brief overview:

Permissible Claims:

1. “Magnesium contributes to muscle relaxation.”
2. “Antioxidants maintain cell integrity.”
3. “Probiotics support a healthy digestive system.”

Impermissible Claims:

1. Any claim suggesting the product can diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases. For instance, “reduces the pain and stiffness associated with arthritis” would be impermissible.
2. Claims that have implications or inferences about diseases. E.g., “reduces cholesterol” implies a heart disease treatment or prevention claim, making it impermissible.

In essence, while structure/function claims offer a way for manufacturers to highlight the benefits of their products, they must be used judiciously and responsibly. Proper knowledge of FDA regulations and a commitment to accuracy and transparency are essential to making valid and trustworthy claims.

Who Determines the Validity of Your Structure/Function Claim

Determining the validity of a structure/function claim is a multifaceted process. While manufacturers are responsible for ensuring the truthfulness and accuracy of their claims, the Food and Drug Administration (FDA) plays a pivotal role in overseeing and regulating these claims to ensure they comply with established standards.

1. Manufacturer’s Responsibility: Before a product hits the market, the manufacturer must have evidence that the claim is truthful and not misleading. This usually entails having scientific evidence, which can include clinical trials, in-vitro studies, and even historical data or traditional use evidence.

2. FDA’s Oversight: While the FDA doesn’t pre-approve structure/function claims like they do for health claims, they closely monitor products in the market. If a product’s claim is found to be false or misleading, the FDA can issue warnings, demand corrective action, or even institute legal proceedings against the manufacturer.

3. Third-Party Validation: Sometimes, manufacturers seek third-party evaluations, such as from scientific panels or industry experts, to validate their claims. Although this is not mandatory, it can add an extra layer of credibility to the product.

Submission Made Simple: Where to Lodge Your Structure/Function Claim

After validating your structure/function claim, the next step is submission. The process may seem complex, but breaking it down can make it more manageable.

1. Notification Process: Within 30 days of marketing a product with a structure/function claim, manufacturers must submit a notification to the FDA. This submission includes the text of the claim, the name of the dietary supplement, and other relevant details.

2. FDA’s Online Portal: The FDA has streamlined the submission process by offering an online portal for electronic submissions. This ensures faster processing, easy tracking, and efficient communication.

3. Mail-In Submission: For those who prefer traditional methods, the FDA still accepts mail-in notifications. Ensure that you include all necessary documentation and follow the specified format to avoid processing delays.

How Food Label Maker Can Help With Your Nutrition Claims

Embarking on the journey of structure/function claim validation and submission can be daunting. That’s where Food Label Maker steps in to simplify the process.

1. Expert Guidance: Food Label Maker’s team of experts is well-versed in FDA regulations and can offer invaluable guidance, ensuring your claims are both compliant and scientifically sound.

2. Staying Updated: Regulations and guidelines evolve. Food Label Maker keeps abreast of all changes, ensuring that you’re always in compliance with the latest requirements.

3. Beyond Structure/Function Claims: Whether you’re looking to validate other types of health claims or need assistance with overall label design, Food Label Maker offers a comprehensive suite of services tailored to meet all your nutrition labeling needs.

While navigating the world of structure/function claims can seem overwhelming, with the right guidance and tools at your disposal, you can confidently market your product, knowing it adheres to the highest standards of compliance and integrity.

Final Thoughts

Navigating structure/function claims is essential for those in the food and supplement sector. These claims describe how a nutrient affects the body’s structure or functions, like calcium’s role in supporting bone strength. Knowing the legal aspects and FDA guidelines for these claims is vital. Differentiating between permissible and impermissible claims ensures compliance and accuracy. 

While the onus of verifying a claim’s validity lies with the manufacturer, expert guidance is invaluable. Platforms like Food Label Maker can streamline the submission process. Staying informed allows businesses to effectively and transparently communicate their product’s benefits, building consumer trust.