Planned Claims Should Guide Product Development – FTC’s Cleland
This article was originally published in The Tan Sheet
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The first issue a firm should consider when formulating a dietary supplement is how to support the claims it intends to make, says Federal Trade Commission official Richard Cleland. “Understanding the regulatory limitations is going to affect how you go about putting together your product, what kind of experts you’re going to need, what kind of science you’re going to need,” Cleland, FTC’s assistant director of advertising practices, said June 9 during a United Natural Products Alliance webinar. Asked to explain how he would avoid running afoul of FTC regulations in developing a product, he said his work with a hypothetical company would start with a literature search to generate ideas not only for potential ingredients, but to be on the lookout for potential experts. As a fictional product, he proposed a probiotic with herbs marketed for cold and flu prevention. Paid Experts, Not Endorsers The company could either spend to keep subject matter experts in-house or hire them on contract, he pointed out. Either way, however, they “should not be people that [the founder] plans on using as endorsers in his future advertising. That will only diminish the value of those individuals as experts.” The literature search also would help the firm determine the kinds of studies that experts in the field generally require to support the claims the firm wants to make, which is the standard the FTC uses, Cleland noted. The firm also will need to decide whether it will test individual ingredients or the final product. Both options come with problems. Testing a final product “is a very expensive proposition” as it requires the firm to produce sufficient quantity to support testing with consistent batches, Cleland said. “That could be a challenge.” However, FTC "is becoming more aggressive on this issue of when individual ingredient studies are going to be sufficient,” he said. The more complex a product is, the more likely it will be the firm has to test the final version, he added. Begin In Vivo To begin substantiating the cold and flu prevention claims, the firm must begin with in vivo studies “demonstrating that our product has a significant positive effect on recognized immune system-related biomarkers,” he said. A critical step is finding the correct biomarkers to study, which Cleland acknowledged is “a question of a lot of controversy at this point.”
To determine what biomarker to study, he suggested a first step of using FDA’s guidance on providing “significant scientific agreement” for Nutrition Labeling and Education Act claims. He emphasized the basics of the study that should be considered: blinding, an adequately long study period and randomized groups with a representative population. Additionally, the study should be “conducted by real experts” in a university or independent research facility. He also noted there should be “some validation that people who are claiming to have cold or flu symptoms actually have cold or flu symptoms.” FTC has questioned studies that relied on self-reported symptoms or unclear symptom scales. Importance Of Protocol The protocol set for a study “is something that the FTC may ask to see” and the agency “may have serious questions about any deviations” between the protocol and study results, Cleland said. Researchers should not, for example, re-work data until it’s “all sliced and diced” to find a subgroup with the desired result. Finally, he recommended companies obtain copies of “all the data collection forms and other information.” FTC sometimes looks at that information and has been subpoenaing researchers for it. “We don’t want to be surprised by mistakes in data compilation or data collection,” Cleland said. Additionally, Cleland noted the agency does not think highly of studies conducted overseas because it is often difficult to obtain background information (Also see "FTC Sees Red Flags In Studies Conducted Overseas To Support Claims" - Pink Sheet, 13 Jun, 2011.). Conservative On Labels, Aggressive In Ads He explained while “it’s a no-brainer” that using disease or treatment claims on supplement labels will draw FDA enforcement, a firm will not draw FDA’s attention if it uses a prevention claim that it can substantiate. In its regulatory oversight of consumer product advertising, FTC does not prohibit disease claims for supplements, but the agency likely will find unsubstantiated claims in those materials. “We certainly want to be conservative on the labeling side. … We can perhaps be a little more aggressive in the advertising, but all of that of course depends on whether or not we can substantiate our claims,” he observed. |