Health Benefit Claims for Dietary Supplements

Product claims serve to provide consumers with information about the product and can help them in determining which products are most appropriate for them.

This guidance and starter guide has been issued in order to comply with Regulation (EC) 1924/2006 on nutrition and health claims made on foods.

Three basic types of legal claims are permitted:

  1. Nutrient content claims to characterize the level of vitamins and minerals in the product (e.g., “a good source of Vitamin C,” or “high in antioxidants”). Consumers are often confused by Recommended Daily Allowances (RDAs), serving units, and standard measurements (mg,mcg, I.U.). You can educate them, help them compare products and select ones that best meet their needs.
  2. Structure/function claims to describe the basic benefits of the product on a particular structure or function in the body (e.g., “helps support healthy joints,” “maintain strong bones,”); and
  3. FDA-approved health claims or qualified health claims that describe the relationship between a substance and reduced risk of a disease (such as calcium and vitamin D in relation to osteoporosis). Unlike nutrient content claims and structure/function claims, FDA must review the evidence for a health claim and approve its use. Note that FDA maintains a distinction between “reducing the risk” of a disease, which it views as an appropriate health claim for supplements if approved by the agency, and “prevents” disease, which it views as a disease claim that can only be made by an approved drug.

A simple rule of thumb would be to limit your discussions about a product’s benefits to what is listed on the label or in the manufacturer’s printed material. The language used there should already be within the scope of the law and should have been substantiated with credible scientific evidence by the product’s manufacturer/marketer.

DO:

  • Stick to the claims in the manufacturer’s written materials.
  • Discuss ingredient content of products, as provided on their labels.
  • Discuss structure/function claims based on the claims on the label.
  • Stick with only those health claims that are on the product (i.e., “reduces the risk of …”).
  • Suggest customers talk to a healthcare professional for diagnosis and treatment options.

DON’T:

  • Claim the product can treat, cure, mitigate, diagnose or prevent disease.
  • Instruct customers regarding prescription drug use unless you are a qualified healthcare professional.
  • Offer advice about drug supplement interactions (or lack thereof) unless you are a trained healthcare professional.
  • Practice medicine, nursing or dietetics (or any other medical specialty) without a license —don’t diagnose.
  • Don’t use testimonials unless they are typical of what consumers can expect or they are properly qualified as required by law.

Health Benefit Claims Examples

A benefit claim related to a classic nutrient deficiency disease.

For example, “An adequate intake of vitamin B12 prevents pernicious anemia.” For this type of claim, there are a few rules. First, the claim needs to state how common the disease is in the United States (disease prevalence). Next, you need to identify your target group, say mature adults. Finally, you need to avoid claims to reduce or prevent specific disease symptoms like nerve damage or mental confusion.

A benefit claim related to a statement of nutritional support.

This type of claim describes the effect of a dietary ingredient on the structure or function of the body in DSHEA compliant language.
For example, “Chromium helps maintain healthy blood sugar levels already within the normal range.”

A benefit claim describing a documented mechanism of action.

This type of claim describes how a dietary ingredient works to maintain the body’s normal structure or function. For example, one way zinc works to promote healthy immunity is by supporting the function of neutrophils, natural killer cells and other immune cells.

A benefit claim that is an approved health claim.

The FDA allows several so-called “Authorized Health Claims” for use on supplements. These include reducing the risk of osteoporosis with calcium and vitamin D, reducing the risk of neural tube defects with folic acid, reducing the risk of heart disease with plant sterols, and others. To use these claims, you’ll need to follow the rules, which are found in the Code of Federal Regulations (Title 21, Part 101 Food Labeling, Subpart E Specific Requirements for Health Claims).

A benefit claim that is a qualified health claim.

FDA allows several so-called “Qualified Health Claims” for use on supplements. These claims require extensive disclaimers about the limited evidence. For example, the claim “Selenium may reduce the risk of certain cancers” requires a disclaimer such as “Some scientific evidence suggests that consumption of selenium may reduce the risk of certain forms of cancer. However, FDA
has determined that this evidence is limited and not conclusive.” The hefty disclaimers tend to water down the claims. Nonetheless, FDA allows them and provides guidance for proper use on their website (www.fda.gov).

However, the law does limit the claims made on supplements’ labels and on the Internet (even in testimonials and website links). With only a few exceptions, they cannot assert that the supplements treat or cure disease. They may make only “structure/function” or “health maintenance” claims.

Here are some other examples:

  • A label can say “helps improve your mood” but can’t say “reduces depression.”
  • It can say “maintains a healthy circulatory system” but not “prevents cardiovascular disease.”
  • It can say “maintains cholesterol in a healthy range” but not “lowers cholesterol.”
  • It can say “supports the immune system” but not “helps prevent colds and flu.”

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