By: Brian J. Meli
The healthcare industry is hands down the most regulated on the planet; and for many a good reason. As healthcare costs seem to be on an irrevocable ascent into the firmament, cracking down on anti-competitive behavior among healthcare providers is priority 1A of regulators. Last year, nearly half of all antitrust enforcement actions filed were against healthcare companies, according to the Federal Trade Commission’s annual report. But unfair competition is only part of the government’s oversight of the industry. Regulatory priority 1B, if you will, is protecting consumers from deceptive trade practices; a pursuit that extends well beyond the boundaries of the traditional healthcare sector.
Oversight of pharmaceuticals and medical devices is the exclusive domain of the Food and Drug Administration (FDA). But the policing of advertising for over-the-counter drugs, food supplements and diet and weight loss products falls largely to the Federal Trade Commission (FTC). And it’s a responsibility that the consumer protection agency takes very seriously; collecting millions in fines and disgorged profits from deceptive health, safety and efficacy claims every year.
Health and wellness claims are at the top of the FTC’s advertising watch list because they’re highly susceptible to manipulation, and are commonly relied on by even the most skeptical consumers. But more importantly, just about anyone with a product to promote, and a media budget to promote it with can make them. Case in point: Pom Wonderful, Dannon, Orek and Sketchers—names not typically associated with healthcare products—top the list of companies that were subject to FTC investigations in recent years; all of them for making dubious claims about the health benefits of their products.
Before making any health claim, the most important thing you can do to avoid unwanted FTC scrutiny is to make sure you have prior substantiation; or objective evidence supporting that your product actually delivers the health benefit you say it does. The keyword here is prior, as the evidence must be obtained before any ad containing a health claim runs. So going to air with a spot that claims a steady diet of your product helps reduce the risk of heart disease before you’ve proven that that’s actually true, will only increase your chances of going into cardiac arrest yourself.
The other requirement for prior substation is that an advertiser must have a reasonable basis to rely on it, and for health claims the bar for substantiation quality is very high. In order to be reasonable, a health claim must be based on competent and reliable scientific evidence. In other words, not all scientific evidence is created equal. Your back-up need not always be obtained from a top-flight research institution, or even be universally accepted among the relevant medical peer group, but it must be more than informal or anecdotal. If you’re unsure whether you have evidence that’s reasonable to rely on, ask yourself: Is this a test, analyses, research finding or study that’s based on the expertise of professionals in the relevant area, and that’s been conducted and evaluated in an objective manner by professionals qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results? If the answer’s no, then put your marketing on hold until you have one.
There are as many forms of substantiation as there are types of claims to substantiate, but while there’s no one test or study that’s right in every circumstance, the one universal rule is that evidence must relate back directly to the claim or claims you’re making. If it’s an express claim, such as “Product X is clinically proven to lower cholesterol,” “Doctor’s recommend product Y four to one for high blood pressure,” or “Studies show product Z is 20% more effective than the leading brand for treating migraines,” then you must have a specific test, survey or study that corroborates those claims.
Express claims aren’t the only types of claims requiring direct substantiation either. If an ad makes an implied health claim, or a health claim that is indirect or inferred through context, such as “Product A removes 99% of asthma-realted airborne particles” or “Product B kills the germs that cause the common cold” (the implication being that product A prevents asthma attacks and product B stops colds) then it must be backed by hard, objective evidence that it actually provides the implied health benefit.
Even if your advertising doesn’t contain express or implied health claims, if you’re positioning your product so that a reasonable consumer would believe it’s good for her health, then you need to substantiate. That means simply claiming that it’s “healthy”, “low-fat”, or “all-natural” will require you to have enough evidence to support a reasonable basis for making those statements. Otherwise your advertising runs the risk of being deceptive.
Just how pervasive and nuanced is today’s regulatory environment when it comes to advertising health and wellness products? So much so that even an ad containing the mere inference that it’s recommended by medical professionals can be found deceptive. Television network rules (based on FTC input) prohibit healthcare professionals—or actors portraying healthcare professionals—from appearing in ads for anything but prescription medications. Informally known as the “white coat rule” because it effectively bans white lab coats from commercials (the thinking being that anyone wearing a white lab coat could reasonably be interpreted as being a medial professional), its one of several seemingly minor points that can cause serious legal and PR headaches for the unsuspecting advertiser.
Given how complex today’s regulatory environment is, it’s advisable that any advertising containing statements related to health and wellness—even for products not traditionally associated with healthcare—be cleared by a qualified professional prior to the commitment of significant time and financial resources. Usually the best time to review creative for this purpose is between the concept and production phases. After all, storyboards and comps can be revised a lot more easily than finished campaigns can be.
The content of this blog is intended for informational purposes only. The information provided in this blog is not intended to and does not constitute legal advice, and your use of this blog does not create an attorney-client relationship between you and The Law Firm of Brian J. Meli. Under the rules of certain jurisdictions, the material included in this blog may constitute attorney advertising. Prior results do not guarantee a similar outcome. Every case is different and the results obtained in your case may be different.