Do I really need a clinical trial?

The short answer is “yes.” If you want to make claims about your product (as opposed to ingredients) or specific claims (i.e., “If you use this product, along with diet and exercise, you may lose five pounds in two months”), you probably should have a clinical trial on the finished product.

Why do I need a study? 

The Federal Trade Commission Act prohibits false and deceptive advertising. The FTC is the primary regulator for advertising of dietary supplements. The FTC has actively pursued dietary supplement advertising cases has filed numerous enforcement actions that have led to consent orders against advertisers, most notably Iovate and Nestle. 

The FTC, starting with In re Pfizer, sets forth the requirement articulated that advertisers must have a “reasonable basis” for making objective claims before the claims are disseminated (81 F.T.C. 23 (1972)). The FTC identified various factors used to determine the amount of substantiation necessary to constitute a reasonable basis for a particular claim: (1) the type and specificity of the claim made—e.g., safety, efficacy, dietary, health, medical; (2) the type of product— e.g. food, drug, potentially hazardous consumer product, other consumer products; (3) the possible consequences of a false claim—e.g., personal injury, property damage; (4) the degree of reliance by consumers on the claims; [and] (5) the type and accessibility of evidence adequate to form a reasonable basis for making the particular claims. 

In 1983, the FTC memorialized the reasonable basis standard in its Advertising Substantiation Policy Statement. The Policy Statement made clear that the standard was intended to be flexible.  (Source: Policy Statement Regarding Advertising Substantiation Program, 104 F.T.C. 648, 839, 840 (1984), aff’d, 791 F.2d 189 (D.C. Cir. 1986)). The FTC defined reasonable basis for health and safety claims to be “competent and reliable scientific evidence.”

The FTC set forth a new standard for health-related claims, i.e., dietary supplements, when it entered into the two consent decrees with Iovate and Nestle defining “competent and reliable scientific evidence” to be two double-blind, placebo-controlled clinical studies or randomized clinical trials on the product at issue. The 11th Circuit Court of Appeals recently rejected the two random clinical trials requirements, instead relying on the correct standard “competent and reliable scientific evidence.” (See FTC v. National Urological Group, Inc., 11th Circuit Court of Appeals, 1:04-cv-03294-CAP.)

Who has standing to take action against me for unsubstantiated claims?  

It’s a long list: FDA, the FTC, the NAD (the National Advertising Division), competitors, and consumers. The FDA and FTC share jurisdiction over dietary supplement marketing. Either or both can commence an action or investigation, which could result in a Form 483, Warning Letter, injunction, lawsuit, or other relief. The NAD can ask you to stop the advertisement if they feel, after investigation and an opportunity to submit evidence, that your claims are not substantiated. If you do not do as requested by the NAD, it will threaten to turn you over to the FTC. Competitors can sue for false advertising under the Lanham Act. Consumers can sue (often in a class action suit) for a myriad of consumer protection laws (depending on the state the lawsuit is filed in) for false and misleading advertising. There is a long list of potential plaintiffs; the remedies can be harsh and can close down a business. The smarter practice is to make sure your claims are substantiated with well thought-out clinical trials. 

So where does that leave me if I want to make claims and be reasonably assured that a lawsuit or administrative action will not succeed? 

You need competent and reliable scientific evidence. What does that mean? Depending on the claims, it may mean studies on the ingredients. However, if you want to make claims about the product as a whole or make specific claims about the results, you should have a study on the finished product. 

Why can’t I use studies on individual ingredients to support claims for a product?  

The FTC has generally taken the position that reliance on studies of individual ingredients is unacceptable when there is reason to think that the ingredients, when combined, may have a different effect. Oftentimes ingredients work synergistically when combined, giving that product a different (and often more powerful) effect. For instance, there are many ingredients that enhance the effects of caffeine. Thus, if you want to make claims on a specific product, it is best to rely on a clinical trial of the actual product and not trials on specific ingredients.

Tomorrow, I’ll get to the rest of the questions you need to answer.