The best formula in the world holds little value unless you have compelling claims that impel your customer to buy again and again. Equally important to a product that sells is the assurance that you will be able to retain the money you make from the sale of that product — your sales pitch must be honest. With that in mind, it is crucial to have science, marketing, and legal in sync at the outset.
After the passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA), the Food and Drug Administration (FDA) issued regulations that allow dietary supplements to make three types of claims: health claims, nutrient content claims, and structure/function claims. The difference between each is important to understand.
Health claims describe a relationship between a dietary supplement ingredient and reducing the risk of a disease or health-related condition. These types of claims require the most concrete scientific evidence (and most expensive evidence) and need to be approved by the FDA. The difficulty in obtaining approval is reflected by the few claims that have passed the FDA’s scrutinizing eye. Less than ten exist and one example is the relationship between folic acid supplementation for pregnant women and the reduced risk of birth defects.
The second type of claim is a nutrient content claim, which describes the relative amount of a nutrient or dietary substance in a product. For example, when the product contains twenty percent or more of the Daily Value of a nutrient, the product can make a claim such as “high in calcium” or an “excellent source of Vitamin C.”
The third type of claim, a structure/function claim, is a statement describing how a product may affect the organs or systems of the body, but it cannot claim, even implicitly, to diagnose, treat, cure or prevent a disease.
Each type of claim has specific requirements that must be met in order to make that claim, and ultimately earn the trust of your customer. Understanding these requirements at the time your product is being formulated is vital. Otherwise, you run into trouble. You may not have enough of an ingredient to substantiate your desired claim or you may be making a claim that makes your product adulterated (a fancy word for illegal).
Both the Federal Trade Commission (FTC) and the FDA share jurisdiction for regulating the claims made for dietary supplement products. The FDA looks after labeling. The FTC looks after advertising. The difference between the two is a little obscure. We would probably need another article to explain it. What’s important to understand is that if either the label for your product or its advertising is misleading, a scary federal agent may eventually show up to punish you.
How do you avoid punishment?
For health claims, we spend profuse amounts of money on obtaining approval for the desired claim. For nutrient claims, we simply make sure our product contains enough of the nutrient in question to warrant the label mentioning that the product is a high source of it. Structure/function claims are where the situation gets interesting. It’s here where the marketing team can get creative, but also where legal and science must together meet a common ground.
Any structure/function claim you choose must be supported by what the FTC refers to as “competent and reliable scientific evidence.” They go on to define what this precisely means with "tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area, that have been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results." There is no fixed formula for the number or type of studies required or any specifics offered on parameters like sample size and study duration. Each case is treated differently, and many factors are taken into account. These include the amount and type of evidence, the quality of the evidence, the totality of the evidence and the relevance of the evidence to the claim in question.
Relevance of science : claim
Science can be a boring and transferring the findings of a scientific study directly to a label could easily confuse consumers or simply turn them off. We want to craft a compelling claim based on the science. The best claims, of course, are those that push the limits to the very line but don’t cross over. This is achieved when claims are pushed back and forth between marketing and legal until a compromise is reached and we end up with a captivating claim that still lies within the realm of compliance.
The time and money invested in this initial process is well spent. You go to market with a great claim with the confidence that there will be no trouble down the road with the FTC or FDA. Punishment from that scary federal agent could range from changing your labels to consent decrees, product seizures, injunctions to shut your business doors, consumer redress, punitive damages and even criminal penalties.
Of course we do not all have legal departments, scientific claim substantiation experts (is that a real job description?) or libraries of tens of thousands of research articles at our fingertips to reference in developing a competitive claim. But there are resources out there. Our industry has many legal experts, regulatory consultants and associations that can point you in the right direction. Take advantage of this and start your product launch off on the right foot. Take it to the limit.
Visit www.dicentra.com for more information.
Every Claim Substantiation Dossier Should:
· Name the exact ingredient/food/extract that is the subject of the dossier
· List the claim(s) or categories of claims and all wording variations
· Define the intake level to which the claims pertain, as derived from literature
· Provide pertinent scientific background on the ingredient, the health area it is affecting or the specific value-adds of the ingredient
· Detail and cite the papers that substantiate the claim, summarizing them concisely but with the necessary detail
· Include the full spectrum of the literature
· Supply a solid, comprehensive, readily available justification of your claims
-- Risa Schulman, PhD. www.tap-root.biz