FTC has required some companies via consent decrees to have two clinical human trials in place in order to make health claims on their products. This rule penalizes some companies but not others, and has a chilling effect on the the ability of manufacturers of dietary supplements and functional foods to communicate the benefits of their products to their customers.
By Steve Mister, Esq., president and CEO, Council of Responsible Nutrition
It’s officially autumn, a season of tranquility when leaves fall and summer’s storms are just a memory. But there’s a nip in the air, and it’s not Jack Frost. Companies in our industry need to maintain their vigilance, as both of the principal agencies with oversight of our products continue actions that would potentially chill Constitutionally protected commercial speech and limit our ability to market innovative products to our consumers.
While most of us are preoccupied with FDA’s recent issuance of the long-awaited NDI guidance, the Federal Trade Commission is at work, too. I’m referring, of course, to FTC’s new standard in several of its consent orders that would require future claims made by that marketer to be substantiated by at least two well controlled, randomized clinical trials (RCTs).
In a couple of speeches I made this spring, I fear my remarks—intended to ease panic that the new standards were being enforced against the entire industry—may actually have bred some complacency that there was nothing to fear. But there is. Starting last year, following a stinging defeat in a New Jersey trial court in the Lane Labs case, FTC began this new course. When a marketer of dietary supplements is being investigated for making false or misleading claims to consumers, FTC has begun to require, as an element of the consent order to end the case, that the manufacturer agree that future claims regarding the health benefits of their products will be substantiated by at least two randomized, double blind, placebo-controlled clinical trials, conducted by different researchers independently of each other.
Previously, the standard for advertising claims was more flexible, allowing the use of any competent and reliable scientific evidence to substantiate a claim. In fact, health claims for many nutrients don’t permit testing through RCTs because the trials would be impractical, unethical or too costly. Sometimes, evidence-based nutrition must rely on observational data. Up to now, FTC seemed to understand the need for that flexibility of proof, too.
FTC doesn’t like to lose in court and the federal judge in Lane Labs held that reasonable minds could differ over what constitutes “reasonable and scientific evidence.” So, in a series of subsequent cases involving The Dannon Company, Nestlé Healthcare Nutrition and Iovate Health Sciences, FTC began “fencing in” the future conduct of defendants with the two RCT standard. I even commented this spring that the new standard only applies to the named defendants in those cases, so the best way to avoid the new standard is not to make claims that would attract an FTC investigation in the first place.
Cuts innovation, competition
But there’s more to the story. The new FTC standard chills free speech by imposing higher requirements on supplement marketers than the statute or the Constitution allows. Think of it like this: What if you got caught going 75 mph in a 55 mph speed zone, and in addition to paying your fines, the judge imposed a requirement that in the future you can’t drive more than 45 mph, regardless of the speed limit for everyone else. It would certainly limit your ability to keep up with traffic.
And what’s happening to Constitutionally protected health claims for dietary supplements and foods is just as concerning. For now, the new FTC standard for two RCTs to back up a claim only applies to the companies subject to the specific consent order. But it hampers their ability to compete, and over time, would subject more and more marketers to a requirement the First Amendment doesn’t allow. Commercial speech has protection if it is truthful and can be presented so that it does not mislead consumers.
This battle rages on two fronts right now. One is the litigation between FTC and POM Wonderful, which refuses to accept this provision in a settlement proposed by FTC in an investigation of its advertising. The other is a petition for rulemaking by FTC filed by the Alliance for Natural Health at the end of April. It alleges FTC’s new evidence requirement in these consent orders violates the First Amendment standard as delineated in Pierson v. Shalala. That case ordered the FDA to allow truthful information about dietary supplements to be presented to consumers with qualifying language even if the science isn’t so overwhelming that it reflects the consensus of scientific agreement.
Both these efforts are worth watching. Let’s hope that the supplement industry is aware that the chill is on, right under our noses. Note: What if your marketing language addresses mostly dietary supplements, but in a couple of cases you are talking about “food” products? You may want to add a sentence within your materials about how the nutrition science community is exploring ways beyond RCTs to validate claims given that RCTs may not be the best way to study nutrition.