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Determining where the FTC is-or has been-heading in terms of the scientific substantiation required for health claims.
FTC’s recent win over Lane Labs-when a federal judge found the company in contempt of an FTC court order not to make unsubstantiated health claims-brings to the forefront again the question of where the FTC is-or has been-heading in terms of the scientific substantiation required for health claims. As recent consent orders to certain companies have shown, the agency has been spelling out in very specific terms what its substantiation requirements are for future claims, with several consent orders stating that the companies under order should have two randomized, placebo-controlled human clinical studies to back any health claims.
“For decades previously, most orders on health-related advertising had included the traditional ‘competent and reliable scientific evidence’ standard….You can see that it’s a very flexible, very broad standard. What it came down to is that the orders required future claims to be backed by good, objective science, and the kind of science wasn’t specified….But last year, that all started to change,” said Katie Bond, associate, advertising and marketing practice, for the law firm Kelley Drye & Warren LLP. Bond and John Villafranco, partner, advertising and marketing practice, hosted a webcast today titled, “How ‘Competent and Reliable’ Is Your Scientific Evidence?”
Bond and Villafranco pointed to a 2009 quote by David Vladeck, director of FTC’s Bureau of Consumer Protection, who stated that if consent orders are more specific, the agency believes it might then be easier to prove whether or not companies abided by those specific injunction orders.
And the Lane Labs case likely played a role in this decision. The FTC initially lost the case because the court found that Lane Labs had at least met the requirements of the generally worded consent order. “The FTC decided that what they needed to do to get the results they want is to make their orders more specific, to lay out exactly what kind of evidence an advertiser needs to have,” Bond said. She said that six consent orders have been issued so far that reflect this new, more-specific type of FTC wording.
So, how can companies determine whether they have “competent and reliable” science? Bond and Villafranco gave some pointers:
Villafranco and Bond also covered the specific types of claims that have been included in recent FTC consent orders and the types of substantiation required.
“Those of us that are active in this area would probably agree that it’s the most difficult environment that we’ve seen in quite some time. In fact for me, in my more than 20 years of FTC practice, I can say that I have never seen a more active FTC when it comes to health-related claims,” said Villafranco.
He underlined that the requirements of consent orders only apply to the companies under order. “But that doesn’t mean you shouldn’t be concerned,” he added. “The first step would be to ask yourself, ‘How risk averse are we as a company?’ If you have a fairly conservative profile, it would be an intelligent decision to meet this standard before you go to market with a weight-loss claim-that is, you would have two randomized, double-blind, placebo-controlled clinical trials conducted by different researchers independently of each other.”
On looking forward to how FTC’s requirements could evolve in 2012, Villafranco stated: “The standards are not static; things are constantly evolving. Depending on who is the bureau director, who is the chair of the FTC, that will usually be a good predictor of how active the FTC is going to be. What’s it going to be like in 2012? It’s hard to say. There’s been some conjecture that we’ll have a new bureau director before year’s end, that Mr. Vladeck might move back into the academic world. And whoever that bureau director might be, it’s going to really determine what the agenda will be for the year. Certainly, looking even further ahead, so much depends on the elections, but until there’s a change along those lines, I expect what we’re going to continue to see is a very active BCP in the area of health-related claims.”