Tag Archives: substantiation

Your Competitors Are Making Outrageous Claims So Why Can’t You?

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:
  • 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.
What is the upshot? As it’s often costly and time consuming to perform a study on your actual product, it is important that you understand the strength of any studies that you rely upon to support your advertising claims. Just because others may be citing the same studies shouldn’t be the end of the discussion for you as it will unlikely make a difference to any inquiring local, state or federal regulator.

Take Your IP To The Next Level….

Companies often do not seek a coordinated strategy when approaching their IP and regulatory needs. Can this come back to haunt a company? Perhaps. We’ve all seen the following scenario. Many companies choose scientific-sounding names for their products to create an air of credibility with consumers. These products allegedly have been developed after or are based on “years of scientific research.” Understanding the value of a registered trademark, these companies instruct their counsel to file a trademark application with the U.S. Patent and Trademark Office for the product’s name.  After receiving an office action indicating that the mark is rejected because the mark is viewed as being descriptive, the company counters that the mark is fanciful and really doesn’t have any meaning in order to get the registration. Then, there is an FTC investigation over substantiation for some of the efficacy claims about the product. The company could be in a predicament. It needs to show the FTC that it has “competent and reliable scientific evidence” for its product’s claims.  However, it has now admitted to another government agency that it made up the name.  While this is certainly not damning evidence of deception, this may not help the company’s chances of convincing the FTC that it has complied with the law. You can see how this innocent act may be viewed by the FTC.  Not only did the company make up the suspect claims, it even made up the scientific sounding name to further deceive consumers. Certainly, companies should not forego making valid arguments to get trademark registrations. However, they should make sure that nothing is being said that could later detract from any arguments that they need to make should an FTC investigation arise.  Companies should harmonize their IP and regulatory strategies in order to minimize any later issues.