FDA Structure Function Claims Pre-Market Notification

When it comes to food, dietary supplement, and cosmetic labeling, structure-function claims are statements about the effects that a product has on the body’s structure or function. This guide provides an in-depth look into FDA regulations surrounding these claims and how to ensure compliance. The FDA has strict regulations on these claims, and it’s important to understand them to avoid legal issues.

Gain the upper hand in preparing structure-function claim notifications for a successful pre-market notification to the FDA

Dietary Supplements & Conventional Foods

There are two main types of claims used to market dietary supplements and conventional foods: structure/function claims and health claims. Structure/function claims describe the role of a nutrient, dietary ingredient, or food component in maintaining physical structure or function.

For example, you might see a product that says “calcium builds strong bones” on the label. This is an example of a structure function claim because it describes how calcium maintains bone strength. Structure/function claims for conventional foods focus on effects derived from nutritive value, while structure/function claims for dietary supplements may focus on non-nutritive as well as nutritive effects.

Health Claims describe the role of a nutrient, dietary ingredient, or food component in reducing risk factors for disease or disorders. For example, you might see something like “Calcium builds strong bones and may reduce the risk of osteoporosis” on the label. This is an example of a health claim because it describes how consuming calcium reduces your risk for osteoporosis (a disease).

The Federal Food, Drug, and Cosmetic Act (the Act) requires that a manufacturer of a dietary supplement making a nutritional deficiency, structure/function, or general well-being claim have substantiation that the claim is truthful and not misleading.

What are FDA Structure/Function Claims?

A Structure-Function Claim is a key description made about nutritional supplements and vitamins. It explains how an ingredient or nutrient reacts to the structure or functions of the human body. Structure-function claims can appear on the labels for dietary supplements or drugs. FDA structure-function claims are any statement made in the labeling of a product that asserts or implies the product can affect the body’s structure or function. Examples include saying a product can “maintain bone health”, “support healthy joints and cartilage”, “enhance mood” or “improve digestion”. In order for a structure-function claim to be permissible on labeling it must not be disease specific and must be supported by scientific evidence.

Example: A product is classified as food. But, if its labelling contains disease claims, FDA will classify the product as a drug. Hence, understanding the type of claims used for your particular product is important when marketing an FDA-regulated product. The claims must be accurately worded and fit the structure-function claims.

What are the FDA regulations on structure/function claims?

In general, structure-function claims are not subject to premarket approval by the FDA. However, they must follow certain regulatory requirements and comply with relevant guidance. These requirements include that products making structure-function claims bear adequate directions for use and not be false or misleading. Additionally, the product labels must have the statement “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” Additionally, the claims must be accompanied by a disclaimer stating that the product is not intended to diagnose, treat, cure, or prevent any disease. It is important for businesses in the health and wellness industry to understand and comply with these regulations to avoid penalties and legal issues.

What are the differences Between Structure-Function Claims and Disease Treatment Claims?

Structure-function claims and disease treatment claims differ in the types of statements that are allowed. While structure-function claims can describe the effect that the product has on general well-being, disease treatment claims discuss specific health benefits related to a disease or medical condition. It is important to note that structure-function claims must be truthful and not misleading to ensure they are compliant with FDA regulations.

30-Day Notification to FDA

According to 403(r)(6) of the Federal Food, Drug, and Cosmetic Act, it is mandatory for any dietary supplement (that is marketed with at least one structure-function claim) to notify FDA within 30 days after the dietary supplement is first marketed in US.

Commonly used Structure Function Claims:

Structure/function claims are those that state a food or dietary supplement may affect the structure of cells or tissues. They are also known as physiological claims and performance claims. Such claims can be made on labels and in advertisements for conventional foods, dietary supplements, and other products that make health-related assertions about the product’s effect on the body. Common examples include:

Calcium builds strong bones
Copper is essential for red blood cell formation
Vitamin C helps the body absorb iron
Folic acid is essential for cell growth and division

FDA Regulation of Structure Function Claims:

The Federal Food, Drug, and Cosmetic Act (the Act) regulates the labeling of drugs, including dietary supplements. Under the Act, a product may be labeled as a drug only if it is intended for use in the diagnosis, cure, mitigation, or treatment of disease. The FDA has never considered foods that are labeled to affect the structure or function of the body to be drugs. Accordingly, claims about these types of health benefits have never been regulated by FDA. However, certain structure/function claims can be misleading if they imply that a product can diagnose diseases or treat symptoms without approval from FDA.

health claims—claims submitted by manufacturers or distributors to support their use of certain foods, food groups, nutrients, and/or dietary ingredients to reduce the risk for a disease or health-related condition;
nutrient content claims—claims that describe the level of particular nutrients in a product (e.g., “low cholesterol”).

How to properly word structure/function claims?

When wording structure/function claims, it is important to use language that accurately reflects the scientific evidence supporting the claim. Avoid using language that implies the product can treat or cure a disease, as this is not allowed by the FDA. Instead, focus on the specific function or benefit the product provides. Additionally, make sure to include the required disclaimer stating that the product is not intended to diagnose, treat, cure, or prevent any disease. It may be helpful to consult with a legal expert or regulatory consultant to ensure that your claims comply with FDA regulations.

Structure-Function Claims Pre-Market Notification offered by us

We help you prepare the structure-function claim notification, develop your product labelling, ensure your product labels comply with FDA regulations. Note that only electronic submissions receive confirmation from FDA of receipt.

We review your product labelling
Draft and submit a structure-function claim notification
Include a copy of your product labels with the notification
Submit the notification on your behalf
Act as your contact person with the FDA
Handle any communications with respect to the notification
Provide guidance with respect to any changes to your claims

How to avoid making false or misleading claims?

To avoid making false or misleading claims, it is important to have a thorough understanding of the scientific evidence supporting your product’s structure/function claims. Make sure to use language that accurately reflects the evidence and avoid making claims that the product can treat or cure a disease. It is also important to include the required disclaimer stating that the product is not intended to diagnose, treat, cure, or prevent any disease. Consulting with a legal expert or regulatory consultant can also help ensure that your claims comply with FDA regulations.

What are the consequences of violating FDA regulations on structure/function claims?

Violating FDA regulations on structure/function claims can result in serious consequences for businesses in the health and wellness industry. The FDA can take enforcement action against companies that make false or misleading claims, including issuing warning letters, seizing products, and pursuing legal action. In addition to legal consequences, violating FDA regulations can also damage a company’s reputation and lead to loss of consumer trust. It is important to ensure that all claims made about a product are supported by scientific evidence and comply with FDA regulations to avoid these consequences.

Why do I need an experienced FDA consultant?

The dietary supplement regulations are very technical. Staying compliant with FDA regulations or submitting a 30-day notification with federal law is complex. Consequently, marketers of dietary supplement products look for assistance from a team of experienced and talented FDA consultants.