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Structure and Function Claims: How Supplement Companies Can Market Safely Without Triggering FDA Action

Updated: Dec 17, 2025



Structure and function claims are essential for dietary supplement marketing. They allow companies to explain how a product supports normal body function without making disease claims that would classify the product as a drug. The problem is that the distinction between the two categories is easy to blur, and many companies cross the line without realizing it.


The FDA and FTC both monitor supplement marketing closely. When structure and function claims are used incorrectly, companies can face warning letters, delisting from platforms, account termination, and class action exposure. Understanding the rules behind these claims is critical for long-term compliance and brand protection.


What Counts as a Structure and Function Claim

A structure and function claim describes how an ingredient affects normal body structure or function. The claim must avoid any reference to a disease or condition.

Examples of compliant structure and function claims include:

  • Supports immune health

  • Helps maintain healthy digestion

  • Supports joint mobility

  • Promotes healthy energy production

These claims focus on normal biological functions, not diseased states. That distinction is the legal line that keeps supplements from being regulated as drugs.


Where Companies Make Mistakes

The most common issues fall into three categories.

Disease-related claims disguised as wellness. A claim such as Helps lower blood pressure is a disease claim, even if phrased gently. The same applies to statements involving cholesterol, blood sugar management, mood disorders, or inflammation-related conditions.

Influencer and testimonial claims. When an influencer states that a supplement helped with migraines, anxiety, or arthritis, the FDA considers that a claim made by the company. Testimonials are not a shield from enforcement.

Implied claims through visuals or context. Images of people in pain, medical settings, health statistics, or before-and-after graphics can turn a structure and function claim into a drug claim. The FDA evaluates claims in context, not in isolation.


How Claims Must Be Substantiated

A lawful structure and function claim must be backed by competent and reliable scientific evidence. This is a legal standard, not a marketing preference.

Acceptable substantiation includes:

  • Peer-reviewed human clinical trials

  • Meta-analyses and systematic reviews

  • Mechanistic evidence that aligns with human outcomes

  • Safety data and toxicology evaluations

  • Ingredient-specific research at the relevant dose

Unsupported assumptions, anecdotal evidence, influencer experiences, or in vitro data alone do not meet the standard.

Substantiation must also match the specific claim. Evidence that an ingredient supports immune health does not automatically support a claim related to recovery from viral infections. Each claim requires its own evidence base.


FDA Notification Requirement

Many companies overlook a key step. When a structure and function claim is used, the company must notify the FDA within thirty days of marketing the product. This is a required compliance action.

The notification includes:

  • The exact structure and function claim

  • The product name

  • The required DSHEA disclaimer

  • Company contact information

Failure to provide timely notification is a regulatory violation.


Required Labeling Language

All structure and function claims must be accompanied by the DSHEA disclaimer: “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.”

The disclaimer must be clear, easy to read, and properly placed.


Building a Compliant Structure and Function Claim Program

Supplement companies should create structured internal processes to avoid regulatory risk.

Develop a substantiation file for each claim. Include all scientific evidence, summary analyses, dosage rationale, and citations.

Review digital materials with the same scrutiny as product labels. Websites, Amazon listings, email marketing, influencer content, and social media posts must all be aligned.

Train marketing teams and contractors fastest way to get a warning letter is through unmonitored marketing content.

Reevaluate claims annually. Products evolve and new research emerges. Claims should be updated or removed if evidence changes.


The Bottom Line

Structure and function claims are not a casual marketing choice. They are a legally defined category that requires scientific support, precise language, and accurate regulatory filings. Companies that handle these claims correctly can market confidently and avoid enforcement risk. Companies that treat them casually will eventually face regulatory and commercial consequences.

A disciplined claim review process is not only protective, it is a competitive advantage in a crowded supplement market.


Sources

FDA: Structure/Function Claims overview. U.S. Food and Drug Administration

 
 
 

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