Law Firm Discusses How FTC Now Defines “Competent and Reliable” Scientific Evidence 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:

• As FTC has said, there’s no set protocol for what makes a study of adequate quality and internally valid, but studies should reflect principles generally accepted in the scientific community.

• What will count as valid research really does depend on the strength of the claim that you’re making.

• In vitro and animal trials, and anecdotal evidence such as consumer testimony are rarely considered adequate.

• FTC still considers the “gold standard” for substantiating a health claim to be a double-blind, placebo-controlled, human clinical trial.

• If there is a lot of peer-reviewed and published research available that supports your claim, FTC may consider that acceptable. However, in a case where there are only a few studies in existence, and they have been conducted by the same institution or researcher and have been commissioned by the same company, FTC would really scrutinize those studies. “A company would want to dig down deeper and really make extra sure that the underlying data is solid,” said Villafranco.

• For clinical trials conducted internationally, “Although the FTC will accept any competent and reliable scientific evidence as substantiation, [the agency has also noted that] many of the studies conducted overseas don’t seem to necessarily have the same rigorous standard as the research that’s conducted in the U.S,” said Bond. Villafranco added: “On the foreign trial issue, I think it’s important that the test subjects bear some relation to the test subjects in the United States….I think you want to be aware that the FTC might not consider results achieved in a different country to relate and be applicable to the United States.”

• Monograph and review articles are considered secondary evidence only.

• The research relied on needs to be relevant to the specific product being promoted and the specific benefit being advertised. Companies should ensure that a study’s endpoint matches the product claims being made.

• Studies should also be done on the same dose and product form as the product being sold.

• Companies must focus on the totality of the evidence and not only focus on the research that supports their claim.

• If you only have one clinical trial, it had better be a very, very strong trial, with a very large sample group, and be well-designed by reputable researchers. “If you don’t have that sort of test to support your claim, then you probably will need two clinical trials,” Villafranco stated.

• When looking at the totality of the evidence, using charts can be a good way to keep track of the validity and relevance of studies. (E.g., use a chart to keep track of which studies tested the correct endpoint, which studies did not reach statistical significance, and to keep track of the doses and study populations used.)

• Ingredient-based research must be presented as ingredient claims rather than product claims. Additionally, “The old standard from the 1990 FTC guidance is that at a minimum, a review of the available, relevant scientific evidence must show that there is not reason to suspect that ingredients other than the tested ingredient will interfere with the safety or efficacy of the tested ingredient.,” said Bond. “That standard was not used in recent FTC orders. Instead, they’ve made a more-specific and stringent standard that companies under order are having to comply with. That new standard says that the advertiser must present reliable and scientific evidence generally accepted by experts demonstrating that the amount and combination of added ingredients are unlikely to impede or inhibit the effectiveness of the tested ingredients. The real difference between these two standards is that the 1990 one is proving a negative. [Under the new standard], you have to prove a positive.”

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.

• “Establishment” Claims, such as “Clinically tested,” “Medically proven,” “Research proves”: These typically require two well-designed trials

• Disease Claims: These obviously require a very high level of substantiation

• Cold, Flu, and Allergy Claims: Recent orders have stated that these must be approved under the FDA drug-approval process, allowed under a draft or final FDA monograph (such as OTC drugs), or be allowed under an FDA rule (such as approved health claims).

• Weight-Loss, Certain GI Claims: Recent orders have asked for two randomized, double-blind, placebo-controlled clinical trials, conducted by different researchers, independently of each other

Looking Forward
“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.”