Todd Harrison01.01.03
Important Tips For Infomercial Marketing
What companies need to know if using this medium to market products.
By Todd Harrison
Turn on late night television today and one cannot help but notice the amount of nutritionally related infomercials, which promise everything from reversing and preventing cancer to losing weight while you sleep. These infomercials have two themes in common—outlandish health claims and dubious scientific substantiation for the health related claims. It appears that the purveyors of these commercials fail to realize or do not care that the Federal Trade Commission Act (FTCA) requires that all advertising claims must be properly substantiated before they may appear in an advertisement, including infomercials. Indeed, the Federal Trade Commission (FTC) has started to turn up the heat on these marketers as well as others to substantiate health-related claims.In this regard, it’s important to remember that all claims must be truthful and non-misleading.
Advertising laws enforced by the FTC may be summarized by two principles:
(1) Advertising must be truthful and not misleading.
(2) Before disseminating an advertisement, the advertiser must have “adequate substantiation” for all objective product claims.
Substantiating a Claim
The FTC generally begins an analysis of an advertisement by identifying the messages that the advertisement conveys. This is more complicated than it seems. Advertisements are judged not only by their express meaning, but also by the implied messages that they convey. FTC examines the “net impression” of the advertisement (i.e., the text, product name and depictions/illustrations) and evaluates what messages could reasonably be inferred from the advertisement. Every message that may reasonably be inferred from the advertisement must be “adequately substantiated.”
For example, consider the claim: “physician tested.” FTC likely would not limit its analysis to whether or not the product was tested by physicians. It would also probably take the position that this implies that methodologically sound studies were performed and that the studies yielded statistically significant results establishing that the product is safe and effective for its intended use.
In general, the amount and type of evidence required to substantiate a claim depends upon the type of product and the nature of the claim. In other words, the standard is supposed to be flexible. For instance, in some cases, a single study may be sufficient, while other claims may require two or three randomized, double-blind, placebo-controlled human studies yielding statistically significant results that are attributable to the product.
Determining What is an Acceptable
Level of Evidence for Sustantiation
The primary criteria considered by FTC in determining the necessary level of evidence include several factors.
(1) The type of product. Generally, products related to consumer health or safety require a relatively high level of substantiation. The more serious the claim, the higher degree of substantiation the FTC will expect. For example, a claim that a product “strengthens the heart” would likely require more substantiation than a claim that a product “strengthens fingernails.”
(2) The verifiability of the claim. Claims that are difficult for consumers to assess on their own are held to a more exacting standard. Again, this generally does not bode well for dietary supplement marketers. For example, the average consumer cannot readily determine whether a product claiming to “support heart health” actually works. FTC therefore would expect solid scientific evidence to support the claim.
(3) The benefits of a truthful claim and the cost/feasibility of developing substantiation for the claim. These factors are often weighed together to ensure that valuable product information is not withheld from consumers because the cost of developing substantiation is prohibitive. This does not mean, however, that an advertiser can make any claim it wishes without substantiation, simply because the cost of research is too high. How much revenue a product may generate often factors into this analysis.
(4) The consequences of a false claim. The greater the injury a consumer would suffer from a false claim—either physical or economic—the more stringently the standard is applied. If, for example, a consumer’s reliance upon an unsubstantiated claim leads her to forego a proven treatment, the claim would likely be subject to a higher standard.
(5) The amount of substantiation that experts in the field believe is reasonable. In making this determination, the FTC gives great weight to accepted norms in the relevant fields of research and consults with experts from a wide variety of disciplines, including those with experience in botanicals and traditional medicines. Where there is an existing standard for substantiation developed by a government agency (e.g., the U.S. Food and Drug Administration) or other authoritative body, the FTC accords great deference to that standard.
Whether “adequate substantiation” exists depends upon both the quality and quantity of evidence. An advertiser might possess a dozen studies in support of a claim, but the studies will not constitute adequate substantiation if they are poorly designed. In contrast, a single, well designed human clinical study conducted in a competent and reliable manner to yield meaningful results often can substantiate powerful marketing claims. The design, implementation, and results of each piece of research are important to assessing the adequacy of substantiation.
Advertisers should consider the totality of the evidence—all relevant research relating to the claimed benefit of the supplement. If there are inconsistencies, plausible explanations, such as dosage, form of administration, the population tested, or other aspects of study methodology, they should be explored. The strength of the research, and the relevance of each piece of research to the claim should also be considered.
Research must be relevant to the claim. Some questions to consider are as follows:
• How does the dosage and formulation of the advertised product compare to what was used in the study?
• Does the advertised product contain additional ingredients that might alter the effect of the ingredient in the study?
• Is the advertised product administered in the same manner as the ingredient used in the study?
• Does the study population reflect the characteristics and lifestyle of the population targeted by theadvertisement?
• Are there are other significant discrepancies between the research conditions and the real life use being promoted?
• Does the claim reflect the strength of the research (i.e., is the research conclusive or preliminary evidence)?
Summary
There are many other factors that should be considered when determining whether a claim is properly substantiated. However, the key to not running afoul of the FTC is to ensure that it properly characterizes the available scientific evidence on a particular nutrient.NW