Reviewed and Approved by Paula Brock, Ph.D., MSCI, Independent Senior Regulatory & Scientific Consultant, EAS Consulting Group, a Certified Group company
1-Minute Summary
- Substantiating dietary supplement label claims requires competent, reliable scientific evidence that matches your product’s dosage and formula.
- Different claim types (nutrient content, structure/function, health) demand varying levels of proof and carry unique regulatory risks.
- High-quality research (especially randomized controlled trials) provides the strongest support, while anecdotal testimonials offer no credibility.
- Avoid overstating benefits or cherry-picking favorable data; regulators expect accurate, balanced evidence.
Why Supplement Label Claim Substantiation Matters
Imagine launching a new dietary supplement. You know it has high-quality ingredients, and you’ve seen studies suggesting benefits. But before making label claims like, “Supports Immune Function” or “Enhances Cognitive Performance,” you need scientific evidence.
In the U.S., dietary supplement claims fall under the Dietary Supplement Health and Education Act of 1994 (DSHEA). This law requires manufacturers to have scientific evidence that their claims are truthful and not misleading.
The Federal Trade Commission (FTC) takes this further, demanding “competent and reliable scientific evidence” for any health-related claims. The Food and Drug Administration (FDA) also monitors supplement labels, issuing warning letters or taking enforcement action against unsubstantiated label claims.
Ignoring these requirements can lead to regulatory penalties, lawsuits, and reputational damage. The best way to avoid these risks? Understand what regulators expect and ensure your claims are backed by sound science. Let’s look at how that’s done.
What Kind of Claims Can Be Made on Supplement Labels?
Not all dietary supplement label claims are treated the same. Some are easier to support, while others require extensive scientific backing. The key categories include the following:
- Nutrient content claims, which describe the amount of a nutrient (e.g., “Contains 100% Daily Value of Vitamin C”).
- Structure/function claims, which explain how an ingredient supports normal body function or structure (e.g., “Supports heart health”).
- Health claims, which suggest a link between a nutrient and disease risk reduction (e.g., “Calcium may reduce the risk of osteoporosis”).
- General well-being claims, which are statements about overall health (e.g., “Promotes vitality and energy”).
Structure/function and well-being claims are the most common and can help attract the attention of buyers.
The Legal Standard: What Regulators Expect
If a claim appears on a supplement label, there must be evidence behind it. But what kind of evidence counts?
As mentioned, the FTC’s guidelines, updated in 2022, require health-related claims to be supported by “competent and reliable scientific evidence.” In most cases, this means human clinical trials – not just a single study, but well-conducted research published in peer-reviewed journals.
The FDA, meanwhile, keeps a close watch on dietary supplements to ensure they are not marketed as drugs. The agency has repeatedly issued warning letters to companies making disease-related claims. A statement like “reduces inflammation” could trigger enforcement action because it implies disease treatment.
The key takeaway? Every claim must be supported by credible, scientific data, and it must be specific, truthful, and not misleading.
What Qualifies as “Competent and Reliable” Evidence?
That raises the question of what type of studies meet the FTC’s guidelines.
Scientific studies vary widely in quality. Competent and reliable evidence has four main attributes:
- Type of Evidence
- Quality
- Relevance
- Quantity
Let’s look at each attribute more closely.
1. Type of Evidence
The most reliable evidence has low bias and is void of personal or financial conflicts of interest. It also must be scientific, not anecdotal, such as testimonials from customers or even doctors. This is not considered competent and reliable evidence to support a health claim on your supplement labels.
2. Quality of Evidence
Randomized controlled trials (RCTs) are the gold standard.
These studies divide participants into two groups, one receiving the supplement, the other receiving a placebo. They measure effects objectively, eliminating bias through randomization and blinding. If an RCT shows statistically significant benefits, it carries strong weight.
Other types of studies, like observational research, are acceptable depending on the type of ingredient and claim.
It’s best to use both types of data – RCTs and observational – for substantiation and explain how they relate to your product and claim.
Can I Use Animal or In Vitro Studies?
Animal and in vitro (test tube) studies, while useful as supporting evidence, are rarely sufficient to meet the threshold for reliable substantiation of health-related supplement claims. It depends on the type of claim and whether human studies are feasible.
Toxicity studies are a good example where animal or in vitro studies provide useful data, but they should be confirmed with safety studies in humans, if possible.
Another good example is for mechanistic claims, such as “Ingredient X acts by increasing neurotransmitter turnover in the brain”. This type of data can add strength to the overall case for a supplement label claim.
3. Relevance of the Data: The Evidence Must Match the Claim
Even a high-quality study is useless if it doesn’t match the product being sold. Regulators closely examine whether the dosage, ingredient form, and study population are relevant to the supplement in question.
Dosage is a common issue. If a study found that 1,000 mg of vitamin C helped reduce cold duration, a product containing only 90 mg cannot claim the same benefit. The numbers must line up.
The form of the ingredient also matters. Research on Ginkgo biloba EGb761, a hydroalcoholic extract, cannot be used to support claims for a water extract of the same plant.
Population is another concern. A study on omega-3s improving memory in elderly adults does not justify a claim for cognitive support in children. Likewise, a supplement marketed to women must be backed by studies on female participants, not just men.
Then there’s formulation. Many studies examine ingredient blends rather than single ingredients. If a clinical trial found that ginseng, fenugreek, and tribulus improved male sexual health, that does not mean ginseng alone has the same effect. Manufacturers need to be careful when extrapolating data.
4. Quantity: How Much Evidence Is Enough?
There is no fixed rule, but regulators expect a comprehensive review of all available data. A single, high-quality RCT may be enough if it is well-designed and published in a respected journal. But multiple studies from independent research groups carry more weight.
Importantly, conflicting data cannot be ignored. If some studies show an ingredient works while others do not, manufacturers must explain why. Selectively citing only favorable research, while ignoring studies with negative or neutral results, can be considered misleading.
Overall, quality of evidence is more important than quantity.
The best practice is to evaluate the totality of evidence and ensure claims reflect what the science actually supports.
Common Mistakes That Lead to Regulatory Action
Companies can get into trouble for overstating or misrepresenting the evidence. Some possible errors include…
- Claiming a supplement “promotes weight loss”, when the study only showed increased energy expenditure, not actual body weight loss.
- Making a cognitive function claim for children when the research was conducted on elderly participants.
- Suggesting that a botanical improves sexual performance when the study only measured increased blood flow.
As we’ve been saying, supplement label claims must be precise, truthful, and backed by relevant, high-quality research.
Final Thoughts: How to Stay Compliant
For supplement manufacturers, label claims substantiation is not optional. It is a legal requirement and a critical part of building trust with consumers. To avoid regulatory pitfalls…
- Maintain thorough records of all scientific studies used to support claims.
- Ensure studies match the product’s dose, formulation, and intended audience.
- Avoid misleading language – every word on the label must be accurate.
- Seek regulatory guidance before finalizing product claims from experts like those at EAS Consulting Group, a Certified Group company.
A well-substantiated claim helps ensure compliance, strengthens credibility, and protects long-term business success. With the right approach, supplement claims can be both compelling and legally sound.