The Federal Trade Commission says consent orders that require more clinical tests to substantiate health claims than are required for other product categories are fair because they are based on the nature of the claims, agency officials say.

David Vladeck, director of FTC’s Bureau of Consumer Protection, says supplement and drug claims about health and disease prevention may require more substantiation.

“The level of substantiation is entirely dependent on the nature of the claims,” Vladeck said Oct. 3 at the National Advertising Division’s annual conference in New York.

“What we try to do is categorize the nature of the claim and then require the kind of substantiation experts say is needed in order to substantiate the claim,” he said in response to complaints that FTC let athletic apparel and gear maker Reebok off easy in a consent order compared to recent consent orders with drug and supplement firms.

FTC’s Sept. 28 announcement that Reebok must substantiate toning and strengthening claims for Easytone and Runtone shoes and any apparel with one clinical study – not two – rankled some in the drug and supplement industries because, in 2010, the agency began ordering two well-controlled clinical trials for health claims in consent orders.

Specifically, FTC required Iovate Health Sciences and Nestle HealthCare Nutrition to support claims for weight loss products and Boost Kid Essentials, respectively, with at least two well-designed human clinical trials. The orders also require FDA pre-approval for disease claims (Also see "FTC Raises Claim Substantiation Bar For Dietary Supplements In Settlements" - Pink Sheet, 19 July, 2010.).

Those settlements marked the first time FTC specified the need for two clinical trials to support health claims and for FDA approval in a consent order.

The change prompted “a lot of bellyaching” from industry stakeholders, John Villafranco, an attorney at Kelley Drye & Warren, said at the conference.

He said some in the industry characterized the shift as a “frolicking detour” from the previous standard order language that simply required “studies that have been conducted and evaluated in an objective manner by qualified persons generally accepted in their profession to yield accurate and reliable results.”

Vladeck explained the different test requirements in the Reebok, Iovate and Nestle orders are not a double standard.

“The stronger the claim and the more the claim talks about issues like disease prevention that our experts and other experts agree cannot be substantiated absent two well controlled studies, then the order requires two well-controlled studies,” he said.

“In the Reebok order, we only required one study in order to make toning and strengthening claims because that is what experts told us would be needed in order to substantiate those ads.”

“The level of substantiation is entirely dependent on the nature of the claims.” – David Vladeck, FTC Bureau of Consumer Protection director

Leslie Fair, a senior attorney with FTC’s Division of Consumer and Business Education, pointed out the agency has not changed its regulations on claim substantiation.

The more specific orders do not represent “a new law, but a new sense of transparency. We are trying to make things as clear as possible,” Fair said the next day at the conference.

“These new orders that we are seeing really reflect the internal discussions the FTC has been having for years both in-house with our colleagues and at FDA and other regulatory agencies,” she said.

Risk Going To Market?

Vladeck emphasized the two test requirement applies to only the specific firms in the consent orders.

Even though FTC has required two tests for health claims in multiple consent orders, Vladeck insists the commission has “not changed the competent and reliable scientific evidence standard that has historically governed how companies are making decisions when they are not under an order.”

That may be, but whether a firm willingly goes to market without at least two clinical tests to support a health claim is a question of risk tolerance, Villafranco said.

“If you are a conservative company and you don’t want to be the low-hanging fruit and you have studies that are low-powered, very small population, then you need to think very hard about whether you want to go to market in this environment with one study,” he said.

Villafranco added that a firm could go to market confidently with one study if it were a “gold standard” randomized, controlled trial with a large study population, no confounding variables tested and in the population for which the product is aimed.

“You could go to market on one study if it was that good. But often those studies, especially in the supplement industry, don’t exist. That means if you really want to tempt fate in certain categories, clearly supplement advertising and health claims, and if you have a conservative risk profile, then you probably need to have two studies,” he concluded.

Defining Competent And Reliable

Stakeholders at the conference said FTC’s stance that it has not changed its claim substantiation policies begs the question, when does the commission consider health claim substantiation to rise to the level of competent and reliable scientific evidence?

The stronger the claims, the more likely that multiple studies are needed, said Mark Levine, a NAD senior staff attorney.

“I don’t think we want to say you need two studies in every case, but the first thing we look at is the claim you make and if you are dealing with a strong health claim … the odds of finding one study in the supplement area that would support those types of strong health claims is not that high of a probability,” Levine said.

Most RCTs often “are poorly suited … to test the effects of nutrients on maintaining health or from reducing the risk of disease” partly because it is “unethical or impossible” to withhold a nutrient from participants to establish a true placebo group, said Douglas “Duffy” MacKay, VP of scientific and regulatory affairs for the Council for Responsible Nutrition.

In these cases, other types of well-powered studies can apply as long as claims are clearly qualified to reflect the actual study results, said Nancy Dowling, general counsel at The Dannon Co. For example, she said, studies should be on the same population at which the product and ad are directed and the correct dose should be examined.

“The odds of finding one study in the supplement area that would support … strong health claims is not that high of a probability.” – NAD attorney Mark Levine

Similarly, studies that test the actual product and not an ingredient alone are “always important,” Levine said.

But, Villafranco added, tests on a key ingredient alone are appropriate as long as specific guidelines are followed. These include testing the same dosage, method of administration, concentration, ingredient form, extract and extraction method as that in the product.

He added, FTC orders discussing ingredient testing dictate firms also conduct ingredient interaction analysis to ensure other ingredients in the product do not inhibit the effect of the tested ingredient.

“Finally, your advertising has to tout the ingredient. It can’t tout the product. You can’t in any way imply that your product has been tested when, in fact, you are relying on testing of the actual ingredient,” Villafranco concluded.

By Elizabeth Crawford

Fair Standard Remains For Supplement, Drug Claim Substantiation – FTC

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