Special Diets

• By the Aisle7 Medical Advisory

Supplement Health Claims: What Can & Can't Be Said

Can a Company Say That Its Dietary Supplement Treats a Disease?

NO. In addition to regulating dietary supplement safety and manufacturing quality, DSHEA has strict rules regarding what companies can and can’t say about their products. In general, companies (which include distributors and marketers), cannot make any claim that their supplement treats or cures a disease. In fact, if a company does make such a claim, under the law, the supplement is considered an “unapproved new drug” and is subject to an enforcement action by the Federal Drug Administration (FDA) or the Federal Trade Commission (FTC). While there is an exception built into DSHEA so that providers of third party literature can make disease claims, those providers must meet several criteria and cannot endorse any particular brand.

There are many rules which manufacturers and companies must follow when they advertise the benefits of dietary supplements, either on product labels or in other types of marketing

If a Company Cannot Make a Disease Claim, Can It Say Anything About The Health Benefits of a Dietary Supplement?

YES. Companies are allowed to make “structure/function claims” on product labels and in advertising. The distinction between a structure/function claim and a disease claim is not always clear. On a general level, however, a structure/function claim describes how nutrients or dietary ingredients affect the structure or function of the body, while a disease claim describes how they treat or cure a specific disease. Examples of structure/function claims include:

• Helps promote restful sleep (valerian or melatonin)
• Supports the immune system (echinacea or vitamin C)
• Helps maintain good cardiovascular health (vitamin E)

Nevertheless, a company cannot make any structure/function claim that it wants. Far from it. A company must have evidence that the structure/function claim is truthful and not misleading, and it must submit a notice to the FDA that it will be making such a claim. Further, the company must place a disclaimer on the product which states that the FDA has not evaluated the claim and that the supplement is “not intended to diagnose, treat, cure or prevent any disease.”

Does the FDA and the FTC Regulate Other Health Claims Besides Those Relating to Disease and Structure/Function?

YES. There are a few other categories of regulated claims. For example, there are rules covering “nutrient content” claims, which manufacturers are allowed to make under certain circumstances. Nutrient content claims state something about the amount of an ingredient in a product, sometimes using comparative terms such as “free from,” “excellent source of,” or “low in.” Other examples include:

• “Gluten-free”
• “High in vitamin C”
• “High potency”

Companies can also claim that a nutrient or ingredient improves general well-being, or helps prevent a nutritional deficiency. For these last two types of claims, a company has to submit a notice to the FDA, have evidence that the claim is truthful and not misleading, and include a disclaimer on the product label, just like structure/function claims.

Does a Company Have To Include Certain Information on the Product Label?

YES. Federal law requires that companies include the following information on dietary supplement labels: a term describing the product as a “supplement”; the name and place of business of the manufacturer or distributor; a complete list of ingredients; the net content of the product; and, in most cases, a supplement facts panel. The supplement facts panel must list the names and quantities of the ingredients, the serving size, and the servings per container. Any ingredient not listed on the supplement facts panel must be listed on the “other ingredients” section of the label.

What Does This All Mean for Me?

Despite that some people state the supplement industry is unregulated, there are many rules which manufacturers and companies must follow when they advertise the benefits of dietary supplements, either on product labels or in other types of marketing. Nevertheless, while major brands and companies tend to follow these rules and have evidence for the claims they make, there are a few companies that are less scrupulous. They may make claims with no evidence at all, or ones based on poor evidence. Therefore, you should do your homework and research the science behind supplements yourself. And of course, always consult a qualified healthcare practitioner before adding a supplement to your health plan or changing supplements.

(FDA, http://www.fda.gov/Food/DietarySupplements/default.htm)