- The study is on animals and not humans. It is difficult to convince regulators that results shown for mice necessarily translate to humans.
- The study is on humans, but does not involve the audience that the advertising targets. For example, the claims in the advertising pertain to ordinary people gaining muscle and the study shows an increase of muscle mass for burn victims, who inherently recover faster and achieve quicker results than ordinary individuals due to their pre-existing condition.
- The study is on the correct audience. However, the product-at-issue does not have anywhere close to the amount of the active ingredient in it as was used in the study. Sometimes the differences can be orders of magnitude.
- The study is not on your product, but just on an ingredient in your product. As many products also have other ingredients, it will not be uncommon for regulators to inquire about whether any beneficial results may be offset by any potentially negative effects of the other ingredients.
- The advertising promises instant results and the study involved weeks of use before any results were achieved. For example, the study is based on six weeks of use and the advertising promises “immediate” or “instant” results.
- The study does not follow generally accepted scientific protocols. For example, no control group or placebo was used in the study, thereby making the results inherently suspect.
As I tell my kids, it doesn’t matter what everyone else on the playground is doing, if you get caught, there may be serious consequences for you. The FTC takes the same approach when reviewing substantiation for companies’ claims. It doesn’t matter what anyone else is advertising in the industry. The FTC will want to see what substantiation you have for your claims. Here are six issues that I commonly saw with studies relied upon by companies: