When an FTC Administrative Law Judge (ALJ) issues a 300+ page decision finding deceptive advertising of pomegranate juice it is wise to pay attention. The record included 14 experts, 24 witnesses, 3,200 pages of trial transcript, and nearly 4,000 pages of briefs and filings by the parties. If reading the Initial Decision has fallen to the bottom of your To-Do List, read on. We identify our “Top 5” take-aways most relevant to the daily challenges of developing and reviewing substantiation of diet-health related claims:
- Randomized, double-blinded, placebo-controlled clinical studies are not the only scientific evidence that can establish sufficient scientific support for a disease/health-related claim.
- A food’s safety had some bearing on the ALJ’s reasoning, but don’t expect this factor to lessen the rigor of the “competent and reliable evidence” standard.
- Your claims are only as good as the science.
- The FTC cannot condition compliance with an order on FDA claim pre-approval, in the ALJ’s view.
- If you are uncertain as to precisely how the FTC views the “competent and reliable evidence” standard, you are in good company. Developments over the past two years offer important clues marketers should heed.
Both parties have appealed the ALJ’s decision, but regardless of a final outcome, the Initial Decision provides many insights on a range of issues that inevitably arise when highlighting the health benefits of foods.
The FTC alleged in its 2010 false advertising lawsuit that POM Wonderful did not have enough scientific evidence to support claims that its pomegranate juice could prevent or treat heart disease, erectile dysfunction, and prostate cancer. Nearly every facet of the case was in dispute, from the implied claims conveyed and the meaning of the “competent and reliable scientific evidence” standard, to the weight of evidence, which involved a battle of the experts. Further, the FTC sought to condition future compliance, in part, on FDA pre-approval of disease claims. This remedy was even more exacting than the heightened standard the FTC has increasingly used in recent orders, which requires two so-called “gold-standard” clinical studies to support claims of health-related benefits.1
The judge found that POM lacked adequate evidence to substantiate its claims that the juice (or dietary supplement) could prevent, treat, or reduce the risk of heart disease, prostate cancer, or erectile dysfunction. The ALJ found that there was some evidence to support claims that the POM products generally support prostate and erectile health. In fashioning the order, the judge held that “competent and reliable scientific evidence” was sufficient to substantiate POM’s future advertising, rejecting the notion that future claims would require FDA pre-approval.2
Lesson #1: Two “gold-standard” studies are not always required for so-called establishment/health claims
The FTC and POM Wonderful disagreed on whether “competent and reliable scientific evidence” requires so-called “gold-standard” human clinical studies (i.e., randomized, double-blinded, placebo-controlled human clinical trials or “RCTs”).3 The ALJ rejected the FTC’s formulation of the substantiation standard, ruling that: “…competent and reliable evidence must include clinical studies, although not necessarily RCTs, that show that the POM Products did treat, prevent, or reduce the risk of heart disease.”4 POM cited, and the judge considered, a great many studies that might not constitute RCTs, but the ALJ found the science to fall short of substantiating the claims in question.
So who wins? Well, perhaps food marketers. The decision sheds light on an age-old question: how many studies do I need? The Initial Decision underscores that the requisite proof is driven by the nature of the claim: “Having crossed the line from making general and highly qualified health claims to making implied disease claims, ‘the level of proof sufficient to satisfy the relevant scientific community of the claim’s truth’ and ‘the amount of substantiation experts in the filed would agree is reasonable’ were necessarily heightened.”5 The decision further emphasized that clinical studies must support claims that a food treats, prevents, or reduces the risk of a disease. The “competent and reliable evidence” standard ultimately turned on an assessment as to the level of evidence experts in the relevant field would deem adequate.
The ALJ ruling suggests that supporting science may consist of evidence other than RCTs, yet the level of proof needed to support disease-related claims remains high. The precise formulation of the legal standard does not alter the advertiser’s burden to demonstrate strong science in support of “clinically proven” or disease-related claims that advertise the nutritional benefits of conventional foods (and supplements).
Lesson #2: Do foods have a lower standard of proof than drugs?
There is some suggestion in the decision that a claim for a “food” may be subject to a lower level of substantiation than for drugs. According to the assessment of expert testimony, “RCTs are needed for a nutrient supplement if one makes a claim that the product causes the effect of treating, preventing, or reducing the risk of a disease and one offers the nutrient supplement as a replacement to medical care to treat, prevent, or reduce the risk of diseases.”6 The ALJ seems to attach some significance when a food is safe, there is no material harm, and the product is not marketed as an alternative to following medical advice.7
So, do foods get a break under the FTC’s substantiation standard? Perhaps so, in terms of the ALJ’s willingness to examine evidence beyond RCTs, but don’t expect that the competent and reliable evidence standard will be applied with any less vigor. And, under FDA’s “intended use” doctrine, positioning a food for a use apart from taste, aroma, or nutritive value could create regulatory issues apart from the FTC.
Lesson #3: Your claims are only as good as the science
The POM decision provides detailed insight into how scientific evidence and competing expert opinions play out under the “competent and reliable evidence” standard. Here is a top-line summary, highlighting why the ALJ found that the science didn’t measure-up.
- Heart disease claims
- Due to flaws in its studies, POM lacked sufficient evidence to claim that POM products treat, prevent, or reduce the risk of heart disease.
- POM did not commission any human studies to examine the effects on cardiovascular health, but only relied on animal and cellular models.
- In its blood pressure studies, POM only examined 19 patients for two weeks, and five subsequent RCTs showed no benefit from POM products.
- POM-sponsored studies on arterial plaque used a small sample size, found positive results at 12 months but faced unfavorable results at 18 months, and focused on post hoc sub-group analysis.
- POM stopped its studies on blood flow after only three months, used a control group with lower baseline values than the test group, unblinded some patients midway through, and lacked data for some patients.
- Prostate cancer and prostate health claims
- POM presented human clinical research (not a RCT) showing that POM products prolonged prostate-specific antigen (PSA) doubling time in men who had already had prostate cancer. The two studies at issue were not placebo controlled. The ALJ noted some support related to prostate health.
- POM lacked sufficient evidence to support its implied claim that POM products treat, prevent, or reduce the risk of prostate cancer because it only presented pre-clinical research, rather than human research, on the effect of pomegranate juice on cancer cells. In addition, experts controverted the significance of PSA doubling time, no studies were conducted on cancer-free men, and the study authors themselves testified that they could not conclude that POM products treat, prevent, or reduce the risk of prostate cancer.
- Erectile dysfunction and erectile health claims
- Based on in vitro, in vivo, and human studies, expert testimony supported a beneficial effect on erectile tissue physiology, health, and function.
- Given the absence of studies specifically related to the medical condition of erectile dysfunction, and because the authors of the clinical study did not make conclusions about that medical condition, POM did not present sufficient evidence that its products treat, prevent, or reduce the risk of erectile dysfunction.
POM purported to rely upon a great deal of science, and even referenced its science in advertising. The ALJ’s findings reveal the rigor by which the “competent and reliable evidence” standard is applied.
Lesson #4: The FTC cannot require FDA pre-approval as remedy
The ALJ rejected the FTC’s proposed requirement of FDA pre-approval — as an over-the-counter or prescription drug, or via health claim pre-approval for a food — for future unqualified disease claims. The FTC argued that FDA pre-approval is an appropriate “fencing-in” provision, reasonably related to the violation, and is clear and concise, providing a “bright-line” rule to judge future POM claims under the proposed consent order.
According to the opinion, the required level of substantiation is a case-specific question of fact, and is often lower than that required for FDA pre-approval. Prior FDA approval as a precondition for claims permitted under an order would “impose a different and/or higher level of substantiation for future implied claims” and was rejected as not reasonably related to the violation. The FTC’s case for a “bright-line” standard did not justify creating “a new level of substantiation, through a cease and desist order against Respondents, a fortiori, considering the level of substantiation found to be required in this case.” The ALJ further clarified that the requirement that FTC orders be “clear and precise” is designed to ensure that the party subject to an order understands what conduct is covered; and not “for the benefit of the FTC in litigating potential enforcement actions.”8 Thus, the ALJ held that a bright line rule was inappropriate and implementing the proposed FDA pre-approval requirement “would constitute unnecessary overreaching.”9
This question of remedies and restrictions on future speech raises a host of issues, and is included among the key issues on appeal. FDA approval as a pre-condition to a claim permitted by an order is novel and suspect for many reasons identified by the ALJ.
Lesson #5: Are heightened standards in FTC orders necessary?
The ALJ’s Initial Decision indirectly has a bearing on a recent trend in FTC orders to set a higher bar for substantiating future claims beyond the traditional “competent and reliable scientific evidence” standard. In four orders since 2010, the FTC has required “at least two adequate and well-controlled human clinical studies” as support for claims of health-related benefits. An “adequate and well-controlled human clinical study” is defined in the orders as one that is randomized, double-blind, and placebo controlled. The FTC has used this heightened, prescriptive standard for alleged weight loss claims in orders with Iovate Health Sciences and Central Coast Nutraceuticals. The FTC also applied the standard in consent decrees with Dannon, regarding alleged claims about relief of temporary irregularity and help with slow intestinal transit time, and with Nestlé, involving claims that a product reduces the duration of acute diarrhea in children up to age 13 and reduces absences from daycare or school due to illness.10
In the POM case, unlike in other recent orders, the FTC did not seek the heightened “two adequate and well-controlled human clinical studies” requirement for future advertising claims. Rather, the FTC sought FDA pre-approval for claims of disease treatment, prevention, or risk reduction, and the traditional standard of “competent and reliable evidence” for claims about “the health benefits, performance, or efficacy of any Covered Product” in its proposed consent decree. Having rejected the FTC’s proposed FDA pre-approval standard for disease claims, the ALJ chose “competent and reliable evidence” as the required level of support for both disease and other health-related claims in its order granting injunctive relief against POM. The ALJ might have considered requiring the heightened two adequate and well-controlled human clinical studies as support for disease claims in the order, but did not, instead choosing to apply the traditional standard.
Depending on how the appeals are resolved by the Commission, the POM case could have a bearing on the suitability and application of the heightened substantiation standard currently in favor at the FTC.
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The Commission will now weigh in on these and related issues raised by the parties’ appeals, with oral arguments scheduled for August 23, 2012. The ALJ’s Initial Decision should be consulted when evaluating nutrition and health related communications by food companies. Ever-growing consumer interest in diet and health places a premium on how the pieces of the FTC puzzle fit together, and on managing legal compliance accordingly.