Substantiation: The Science of Compliance

By Lesley Fair

Most marketers are aware of their obligation to back up their advertising claims with what the FTC calls “competent and reliable evidence.” If the claims concern health, safety or product efficacy, the standard is “competent and reliable scientific evidence.” Here are some tips to help you avoid a “proof goof.”

  1. Put your reliance on science. By “competent and reliable scientific evidence,” the FTC means tests, studies or other research based on the expertise of professionals in the field who have been objectively conducted and evaluated by qualified people using procedures that give accurate and reliable results. Exactly what you’ll need will depend on the claims you’re making, but newspaper articles, letters from satisfied customers or other non-scientific material won’t be sufficient.
  2. Claims made through consumer testimonials also require scientific evidence. Some advertisers mistakenly think they can get around the substantiation requirement by couching efficacy claims as consumer testimonials – “My arthritis pain vanished!” or “This product relieved my allergy symptoms!” They’re wrong. Testimonials aren’t “competent and reliable scientific evidence.” If you don’t have solid science to prove the underlying representation, don’t try to “back door” it through a testimonial. Furthermore, don’t forget that by using a testimonial, you’ve made an efficacy claim that has to be substantiated. Whether your ad says “Increase your gas mileage by 35 percent” or “I increased my gas mileage by 35 percent,” you’ll need scientific substantiation to back up either claim.
  3. Not all experts are created equal. You wouldn’t hire a plumber to rewire your house. Finding the right expert is equally important when considering substantiation. Just because someone has a Ph.D. or M.D. after his or her name is no guarantee the person can give you sound advice about your product. Whether you consult with in-house experts or independent scientists is up to you. The crucial point is to make sure they have expertise in the right area.
  4. What’s not so fine about fine print. If the disclosure of information is necessary to prevent an ad from being deceptive, it must be “clear and conspicuous.” It’s unlikely that a fine-print footnote or fleeting superscript will do the trick – especially when it comes to conveying important information to consumers.
  5. Does the substantiation match the claim?  Make sure the science “fits” the claim. For example, if you have solid studies proving that your product will lessen the severity of back pain, make sure that’s what you say in your ads. Where companies get in trouble is by stretching the science and claiming that their product will cure back pain or prevent users from ever having back pain again.
  6. Keep your scientists and lawyers in the loop.  Get your technical people and legal counsel involved early. Once an ad is in the can, even minor tweaks can be costly.
  7. Avoid the “Ready, Fire, Aim” approach.  Some companies have been making hard-hitting claims for years and yet haven’t found themselves on the law enforcement radar screen. What’s their secret?  It may be as simple as their in-house compliance procedure. Savvy marketers evaluate their products first and then draft ad copy to reflect what the product has been proven to do. If you draft killer copy first and then send a staffer out to gather the science, you’re more likely to end up in hot water.

For practical staff guidance on this topic, read Dietary Supplements: An Advertising Guide for Industry at business.ftc.gov.

Lesley Fair is an attorney in the FTC’s Bureau of Consumer Protection who specializes in business compliance.