How do you define substantiation? Some believe having historical knowledge on an ingredient is good enough, while others believe having clinical trial data is the answer. Nonetheless, FTC and FDA have specific rules when it comes to substantiation. In fact, FTC came up with its definition several years ago. And despite being decades old, this document is well worth the read for those involved in the sales or advertising of dietary supplements.

The Reasonable Basis Doctrine

The “reasonable basis doctrine” appears to be central to understanding whether what you are saying about your product is within reason for the average consumer. The reasonable basis doctrine states that the substantiation be accumulated before the advertisement is placed. So let’s explore what FTC has said it will not accept—or at least has said publicly what it will not accept as product evidence.

Not surprisingly, FTC doesn’t like to review research that has been conducted after a company has received a query. And even though the agency has said it is happy to lend its discretion to review “post-hoc” data support, there is no document that states the circumstances in which it may, in its discretion, consider post-claim evidence in substantiation cases. Actually, in its substantiation challenges, “after the fact” studies have not been considered as support for the claims being made by the company.
 
Cost savings are greater if the R&D process includes these pre-marketing clinical research studies. In other words, sponsoring clinical trials when your product is in the ideation or creation stage is the most cost effective way to ensure you can deliver on your product’s promises.
 
‘The Pfizer Factors’

The substantiation doctrine was first articulated by FTC in 1972. At that time, it discussed the factors that determine what level of substantiation is appropriate in a particular case where no express claim has been made about the level of support. Looking at this further, this 1972 document set out to detail what level of support a product “should” have.

FTC essentially set six factors that are still used today in review and consideration of “substantiation.” The six “Pfizer factors” include: 1) the type of product; 2) the type of claim; 3) the benefits of a truthful claim; 4) the cost/feasibility of developing substantiation; 5) the consequences of a false claim; and 6) the amount of substantiation experts in the field believe is reasonable. For claims related to health or safety, the Commission has determined that these factors translate to “competent and reliable scientific evidence,” which has been defined in numerous consent orders as: “tests, analyses, research, studies, or other evidence based upon the expertise of professionals in the relevant area, that has 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.” FTC’s 1972 definition of substantiation remains relatively unchanged today.
 
The type of study a company uses to substantiate a product makes a difference. In other words, a pilot or proof of concept open-label study will not garner the same type of respect as the randomized, double-blind, placebo-controlled clinical trial.
 
As of February 2010, the FTC Directorship has indicated it would strive for better language in its communications and that the following was the working definition for calling a product “substantiated”:
 
1. At least two adequate and well-controlled human clinical studies
 
2. of the product at issue or substantially similar product

3. conducted by different experts independently of each other
 
4. that conform to acceptable designs and protocols and whose results, when considered in light of the entire body of relevant and reliable scientific evidence, are sufficient to substantiate the health claim

The moral of this column is: the cost of sponsoring two independent clinical trials is often much less than anticipated, and of course is always less expensive than if you are scrambling to gather the evidence “after the fact.” Stay ahead of the curve and plan your product-specific clinical trials now rather than later.
 
References furnished upon request.