The United States Court of Appeals for the District of Columbia has ruled that Pom Wonderful was engaging in deceptive advertising over health claims in ads urging consumers to “Amaze your cardiologist” and “Drink to prostate health.” The Court found that the company lacked the medical or scientific foundation to make such claims in upholding the actions taken by the Federal Trade Commission.
By 2010, the company had spent more than $35 million on pomegranate-related medical research, including the sponsoring more than one hundred studies at forty-four different institutions. From this research, the company made claims related to heart disease, prostate cancer, and erectile dysfunction. In a ruling in 2012 following administrative hearings, the FTC found that nineteen of POM’s advertisements and promotional materials contained implied claims that POM products treat, prevent, or reduce the risk of heart disease, prostate cancer, or erectile dysfunction.
Back in September 2010, the FTC filed a complaint against Pom Wonderful and its sister company, Roll Global, over the health claims. The FTC found no supporting clinical studies or research or trials to back up the claims. Administrative Law Judge D. Michael Chappell held a remarkably long adjudication of the dispute from May 24 to Nov. 4, 2011 with more than 2,000 exhibits. Chappell then produced a 330-page decision against the company. Pom offered at least 100 studies in the last decade on the health effects of pomegranates. However, that was not enough. The FTC found that Pom cannot claim that its juice or PomX dietary supplements treat, prevent, or reduce the risk of heart disease, prostate cancer, and erectile dysfunction because it lacks competent and reasonable scientific evidence to support its claims.
The DC Circuit, in an opinion written by Judge Sri Srinivasan, found that there is “no basis for setting aside the Commission’s conclusion that many of Pom’s ads made misleading or false claims about Pom products.” The opinion is an interesting one on the level of proof needed in such claims. For example, the company insisted that studies showed that increased blood flow to the heart by groups who drank pomegranate juice saw a 50 percent greater likelihood of improved erections. However, the court found that the difference was not actually statistically significant. Notably, however, the D.C. Circuit ruled that Pom need gain only the support of one randomized, controlled, human clinical-trial study to make the claims. The FTC insisted that two such trials were needed.
The Court says that if Pom wants to make claims, it will have to pony up for more trials:
We acknowledge that RCTs may be costly, although we note that the petitioners nonetheless have been able to sponsor dozens of studies, including several RCTs. Yet if the cost of an RCT proves prohibitive, petitioners can choose to specify a lower level of substantiation for their claims. As the Commission observed, “the need for RCTs is driven by the claims [petitioners] have chosen to make.” Id. at 25. An advertiser who makes “express representations about the level of support for a particular claim” must “possess the level of proof claimed in the ad” and must convey that information to consumers in a non-misleading way. Thompson Med. Co., 791 F.2d at 194. An advertiser thus still may assert a health-related claim backed by medical evidence falling short of an RCT if it includes an effective disclaimer disclosing the limitations of the supporting research. Petitioners did not do so.
Here is the opinion: POM Decision
Thanks, BarkinDog, for giving me a good excuse to ignore this thread. That said, “Pom Wonderful” is owned and operated by a husband & wife team (the Resnicks) whose combined medical and health research background are even less than mine. Meaning zero. They hustle “Pom Wonderful” solely as a business enterprise, aka “snake oil”, in a field where FDA approval is not usually necessary. Their health benefit claims are carefully parsed to avoid real scrutiny. I suspect they will win on this issue. I’ve tried their product, and well, it tastes like Pomegranate juice…voilà’ ….stunning I tells ya!
I saw a story on the web previously about this which reveals why the government got riled. It seems that John Boehner took some Pom drug for his erectile dysfunction. They had targeted him for ads because of a mis spelling of his last name : Boner. So the drug did not work and he then was drunk at the bar at the Hilton Hotel and complained to the head of some federal agency and they got right on it. Some hooker on K street confirmed the problem. Or is it C Street?
And now for today’s Obamacare debacle.
I was at the pediatric dentist office for our follow up appointment, complaining how Obamacare bundled dental in with medical, so we have to satisfy our $6,250 deductible before it will pay any benefit. Which makes it a scam brought to you by your helpful Liberals.
The office worker told me a mother was in there crying yesterday. She had heard how wonderful Obamacare was going to be. So she waited to have her child’s cleft palate surgically repaired until last January. Her previous insurance had a deductible and copay, and she thought she would save money, because Obama said it would save families money and cover everything.
Her Obamacare policy deemed cleft palate surgery cosmetic, and wouldn’t cover it at all.
She had no idea how she will afford the surgery. Now she doesn’t have any pediatric dental benefits at all until she meets her own huge deductible.
Way to go Liberals! You really care! Boy, I feel the love every time I or my family go to the doctor.
Liberals must really think people are foolish and naive and cannot add. I can think of no other explanation for why they would pull something so obviously disastrous.
The definition of a drug is that it is medicine, to treat a disease.
It is not that POM made a false claim. It is true that pomegranate has many health benefits. But they legally may not market their product as a drug by claiming it treats or prevents disease unless they spend millions of dollars on FDA clinical trials, which take many years.
A study on health benefits, even a RCT, is not the same thing at all as the lengthy, expensive process of proving a drug to the FDA. It makes no sense for health food companies to do it.
“FTC found that nineteen of POM’s advertisements and promotional materials contained implied claims that POM products treat, prevent, or reduce the risk of heart disease, prostate cancer, or erectile dysfunction.”
Unfortunately, the only way anyone can make a claim to treat, prevent, or reduce disease is through a clinical FDA trial, costing millions of dollars. And no one will ever do that for health foods, because you cannot patent a pomegranate. Everyone would say thank you for the clinical trial, and use your data.
We all intuitively know that eating healthy foods will make us healthier, make our immune system function more effectively, and basically optimize our baseline, as long as we avoid any allergens. But we can’t take the next logical step and make a claim that defines a drug for any health supplement because of this law.
The law is helpful in that it helps prevent snake oil salesmen, but it has an unintended effect on the health food industry. We don’t want over-inflated claims, but there are also plenty of studies verifying the health benefits of many foods and herbs.
It would be nice if we could find some middle ground where health food companies can cite extensive research showing health benefits, without promoting their products as a drug.
Reblogged this on Alina's Blog.
I didn’t see the company being required to pay a fine. Maybe I missed that. So perhaps it wasn’t so bad for the company in that they were able, presumably, to gain market share in the amount of time where the advertising in question was used.
For cases such as this, if there is no monetary disincentive to engage in what the FTC calls deceptive advertising it will continue.
Free Speech & Unintended Consequences
Hollywood should have to perform randomized double-blind-controlled trials on films they release before being able to advertise a movie as a “comedy” or a “drama.”
Similarly with automobile advertising.
Honda recently won awards for car ads that suggested “the impossible made possible.”
I demand proof. A meta-analysis of perhaps 20 or so studies should provide sufficient strength for a consensus recommendation.
Tony, That is an interesting take. There is an incredible amount of research being done in Israel on cannabis. Our Victorian laws, pushed by Big Pharma, make it impossible to do good research here in the US. They HATE cannabis and all herbal remedies and medicine. And, they own the duopoly.
Pogo, LOL!
I hope POM doesn’t mention anything about magic rings.
“Treat, prevent or reduce”; let’s assume for a moment it does none of those things. Is the POM product harmful? If the consumer is basing their entire cardiovascular health on this one product, shouldn’t they consult their physician instead of “surprising” them?
New York AG similarly questions herbal supplement content and efficacy. Is POM selling snake juice or not? Another case of “who can you believe?”.
Nonsense, there are nearly 50 peer reviewed studies supporting cardiovascular and anti-cancer benefits for pomegranate. Pom may be wrong but they’re not without evidence for their claims. Chalk another one up for the proponents of big pharma.