Claims Substantiation

In some form we have all heard the classic cure-all statement of “this product will make you look ten years younger!” We want to believe it, we want to buy into it, but does the product truly perform as it claims? The Federal Trade Commission (FTC), National Advertising Division (NAD), Food and Drug Administration (FDA) and other government agencies (OGAs) take it upon themselves to make sure that these “too good to be true” claims are not misleading consumers into dangerous territory. 

It is very important for companies to make sure that what they are promoting about their products is truthful, not misleading and can be proven in a quantifiable way. If it turns out that a product can not meet the standard of its claims, or worse, a consumer gets hurt because of it, there will be severe consequences.

What is a Claim?

A claim is any representation that is made about a product. Unlike a label, a claim can be anywhere that the product is marketed, on a website, a flyer, a label, a radio talk show, basically there is no limit to how or where this representation can be asserted.

What Does it Take to Have a Substantiated Claim?

Claim substantiation in broad terms is all relative. The amount of evidence that is needed is directly related to the claim that is being made.All claims have to be truthful, not misleading and have to be adequately substantiated with competent and reliable scientific evidence about the benefits and safety of the product. So, what do these terms mean in relation to analyzing a company’s claims about their product? In truth there is a lot of research that goes into an analysis and a lot of grey area to navigate.

  • Truthful: This is usually the easiest claim to prove; for example, is the product green or not? A truthful statement is one that is easily identifiable with little to no research. When phrases like “well it is truthful, but….” begin to occur then a misleading an analysis needed.
  • Misleading: A claim that is not technically untrue but cannot be directly proven or backed up by quantitative evidence. In part, a misleading claims analysis relates to what reasonable interpretations of the statement will be made by a reasonable consumer. A lot of product owners or service providers will make narrowly focused claims to avoid both misleading content and having to prove specific substantiation.
  • Adequate claims substantiation: Otherwise known as cold, hard facts. There needs to be hard and unarguable data to back up the claim. If you want to say “this supplement lowers blood pressure” or “X amount of consumers say that their skin looks tighter and younger,” then there are many variables that need to be accounted for, i.e..  how many patients used the product, for how long did they use it, what other products did they use with it, did they have pre-existing conditions that could affect the outcome, etc.?

What are the Types of Claims?

One category under scrutiny for claims is the dietary supplements industry. Structure/function claims for dietary supplements may describe how a “nutrient or dietary ingredient is intended to affect the normal structure or function of the human body” or the way an ingredient acts to maintain a bodily structure or function. Health claims will be about a disease or disease condition and the relationship a nutrient may have to reduced risk of that disease. Any health claim statements must follow approved language and be supported by scientific evidence. Nutrition content claims relate to the level of a nutrient in the product. They use FDA-defined terms such as free, low, or high and comparative terms like more, reduced, or lite. Another health claim category for dietary supplements is a percentage claim, used to “describe the percentage level of a dietary ingredient” and “may refer to dietary ingredients for which there is no established Daily Value, provided that the claim is accompanied by a statement of the amount of the dietary ingredient per serving.”

Who is Regulating Whether or Not My Claims are Substantiated?

The FTC regulates advertising claims and expects advertisers to have a reasonable basis for the claims they make. State regulatory agencies and attorney generals and private litigation attorneys are also significant drivers of claims regulation and enforcement.

FDA also regulates claims, but in truth it takes very specific claims for them to become involved. Again, a claim is any representation of a product; therefore, FDA regulates certain specific claims relating to the products under their jurisdiction. For example, with nutrient content claims statements such as “this product is 20% higher in fiber than the average” is the type of claim that must be both truthful and substantiated. FDA has defined what certain words mean in relation to specific commodities that they regulate, like food. So, to be FDA compliant your claims also must meet the agency’s definitions.

Confused? We Can Help.

Interpreting marketing and internet claims requires experienced regulatory consultants. Our team works with companies to evaluate their marketing claims in light of FDA and FTC regulations. We review not only the claims made, but how they relate to the intended use of the product. Fill out the form below for assistance.

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