You have an awesome supplement you are ready to take to market. You know it will help tons of people improve their health. You have spent so much time making sure the production process is of the highest possible quality and you are meeting all the CGMP standards set by the Food and Drug Administration (FDA).
Now you are ready to get started on marketing your awesome product. But, how do you talk about everything your product does in an FDA compliant way? How can you be sure your structure function claims are compliant?
This is where you need a working understanding of the types of claims that dietary supplement brands can make and the types of claims that will get you fined by the FDA. Here are some of the basics of FDA compliant claims to help you get started.
What is a claim?
Dietary supplements are regulated under the Dietary Supplement Health and Education Act of 1994 (DSHEA). This legislation determines what can and cannot be said about supplement ingredients, including marketing claims.
When it comes to dietary supplements or food products a claim is a phrase relating to a nutrient, component, or ingredient that has an impact on health.
You may have seen claims on food or supplements like:
- Good source of calcium
- Helps maintain normal cholesterol levels
- Heart-healthy
All of these claims of the potential benefits of consuming the product are regulated by the FDA in one way or another. Food and dietary supplements are limited in the types of claims they can make. A company can get fined by the FDA if any non-compliant claims appear in marketing materials- including blogs, product descriptions, email marketing, social media, and product labels. Therefore, if you don’t want to get all of your marketing efforts shut down, you have to be compliant.
Types of Claims as Defined by the FDA
There are a few types of claims a brand might make about its product. These include:
- Nutrient content/Identity claims
- Structure-function claims
- Qualified health claim
- Authorized health claim
- Disease claim (usually not allowed for supplements)
Here is a breakdown of each type of claim with a few examples.
What is a nutrient claim?
A nutrient claim is a very basic claim that relates to the amount of a specific nutrient in the product. This can include claims like:
- High in vitamin C
- Good source of calcium
- Cholesterol free
These types of claims would be more common on food product labels. The FDA has specific requirements for when something can be called a “good” or “excellent” source of a nutrient.
What is a structure function claim?
There are two main types of FDA structure function claims. These include:
- General well-being claims
- Nutrient-deficiency disease claims
Most dietary supplement marketing must stick with general well-being claims. This can include claims like:
- Supports a normal inflammatory response
- Helps maintain cholesterol levels already in the normal range
- Promotes a balanced stress response
- Fiber maintains bowel integrity
Nutrient-deficiency claims related to the benefit of a specific nutrient for improving a deficiency. For example, a claim could be made about vitamin C and scurvy. But these types of claims can only be allowed if it is a deficiency that is common in the United States. Documentation must also be submitted to the FDA if this type of claim is made.
What is a qualified health claim?
A qualified health claim is a nutrient claim that has been approved by the FDA but does not have substantial scientific agreement to support the benefits of the nutrient. Therefore it needs to be “qualified” before it can be used for marketing purposes.
An example of a qualified health claim is:
“As part of a well-balanced diet that is low in saturated fat and cholesterol, Folic Acid, Vitamin B6, and Vitamin B12 may reduce the risk of vascular disease.*
*FDA evaluated the above claim and found that, while it is known that diets low in saturated fat and cholesterol reduce the risk of heart disease and other vascular diseases, the evidence in support of the above claim is inconclusive.”
You can find a complete list of qualified health claims here.
What is an authorized health claim?
There are a few claims about specific nutrients that the FDA has approved to be used on food and supplement labels due to the substantial scientific evidence around the benefits of these nutrients. These include specific claims around calcium/vitamin D and osteoporosis or fiber and cancer.
You can find a complete list of these authorized health claims here and information on how to use them correctly in your marketing efforts.
What is a disease claim?
A disease claim cannot be used for dietary supplements. This is a claim that states or implies that a product will cure or treat a disease. These types of claims tend to be where many supplement brands get in trouble because while they may not overtly say that their product cures a disease, even the implication of a disease can be a problem.
Examples of claims that are not allowed:
- Improves joint mobility and reduces inflammation- this implies that it treats arthritis
- Has function as an antiviral and antiparasitic- claims that it treats viral or parasites
- Lowers blood sugar- implies that it might help treat diabetes
Even if there is some evidence that the nutrient might actually have these types of functions, the FDA still does not allow disease claims. This can be frustrating for many who are passionate about the benefits of their products. But, it is always best to be cautious when it comes to making claims about your products.
Learning more about FDA compliance and claims
If you want your marketing efforts to be compliant with the FDA regulations, it is essential that you have a working understanding of each type of claim and what can/cannot be said about your product and its ingredients. The FDA maintains a portal with information about dietary supplements, but let’s be honest, it’s A LOT to understand and sort through.
Here are a few resources we frequently use to stay up to date on claims and other important information about dietary supplements:
Dietary Supplements Guidance Documents and Regulatory Information
Information for Industry on Dietary Supplements
FDA Continuing Education Portal
While it is vital that anyone working in the dietary supplement industry be aware of FDA claims and compliance, making sure every word in your marketing efforts is compliant can be a challenge.
Our team of expert RDs can help you create evidence-based marketing materials so you can effectively and compliantly sell your products. We offer FDA claims substantiation, product descriptions, label reviews, FDA-compliant blogs, email newsletters, and more! Reach out today for a quote!
