Disappointing Final Outcome of POM Wonderful Case

May 10, 2016
Category: Reform Healthcare

Medical free speech has been set back, but plaintiffs did win some parts of the long, protracted battle.
Last year, POM Wonderful petitioned the US Supreme Court to review a lower court decision that had partly sided with the Federal Trade Commission (FTC). The agency had tried to prevent the pomegranate juice company—and, by extension, other natural product companies—from advertising any “implied disease claims” without multiple random-controlled trials (RCTs) to back up those claims. (Implied disease claims are claims that imply a product can prevent, treat, or reduce the risk of a disease).
Even though POM had spent $35 million on scientific research in addition to relying on academic research to substantiate its claims, the FTC had outrageously called for two RCTs to back up any implied disease claim. The agency also contended that POM’s advertisements were “misleading” even though qualifying language was used to ensure the claims were factual and not misleading to consumers. The DC Court of Appeals said that requiring two RCTs would be unconstitutional—but one would be OK. On the question of whether the claims were misleading, the Court simply deferred to the FTC.
POM appealed to the Supreme Court to decide whether the D.C. Court of Appeals should have deferred to the FTC on whether the seventeen claims were protected by the First Amendment, or whether the Court should have done its own review of that issue.
The Supreme Court’s decision to pass on the case—meaning that the DC Appeals Court decision stands—leaves the half-bad decision in place.
It is reasonable to require evidence to back up health-related claims that are used to market products. But as we’ve discussed before, RCTs are inappropriate for food and supplement research because of the co-dependence of many nutrients (for instance, supplemental calcium should not be taken without supplemental K2, but isolating it for an RCT would miss that).
RCTs for drugs are also prohibitively expensive, costing billions of dollars on average. Drug companies can afford this massive investment because drugs are patentable and enjoy a period of market exclusivity, so companies can recoup the cost of RCTs. Natural products are not patentable, so requiring RCTs to make any specific disease claim—no matter how many studies support the claim—is a backhanded way of preventing all disease claims for natural products and thus preserving the monopoly of pharmaceutical drugs to treat illness.
In an amicus brief ANH-USA submitted in the POM Wonderful case, we also noted how the RCT standard was not made through a formal rulemaking process, where the public is allowed to comment on the rule, but instead was set in place, company by company, via punitive consent decrees. Companies find it difficult to fight these proposed consent decrees because the government has unlimited legal funds and the companies often have limited resources. Moreover, if the government wants to be retaliatory and vindictive, it can just keep raising one charge after another.
We suspect the FTC took its actions at the behest of the FDA. The FDA knew it could not get away with requiring drug standard tests for natural products so probably asked the FTC to do it for them. We believe this is all done to protect Big Drug Company profits.
ANH-USA will continue to fight for medical free speech about the benefits of natural health products, and will keep you updated of any developments.
 
 

Other articles in this week’s Pulse of Natural Health:

FDA Defies Congress, Slips Money to Hospitals, and Stiffs Consumers
Is Medicine Really the Third Leading Cause of Death in the US?
 
 

9 responses to “Disappointing Final Outcome of POM Wonderful Case”

  1. Tim Wallace says:

    Other countries allow the health benefits of Natural products to be included on their labels or to state that produce can help with certain health matters. It would appear that the US Government, supported by various Alphabet Agencies is unprepared to accept that non-patentable natural products can be beneficial for the health of the people.

    • Bruce Stewart says:

      Many other countries care about the health of their citizens while our government officials care about the wealth of their donors!

  2. jimmy midnight says:

    I’m fortunate in being able to face the overall insanity of a built in prejudice in favor of single-molecule drugs, as opposed to what Nature has to offer, with a Chemistry major’s knowledge and a scholar’s determination.
    I truly pity the overwhelming majority who don’t possess those things, and are essentially at the mercy of today’s Largest Racket on Planet Earth–the pharmaceutical industry.

  3. BR549 says:

    It doesn’t get any more corrupt than this. ………. or does it?

  4. jaybird says:

    I have taken herbs for approx. 7 yrs. for inflammation/arthritis. I can go without taking celebrex for pain from 1 a day to up to 1every couple of weeks. I hate taking drugs.

  5. HolisticDoc says:

    There is all sorts of corruption in medicine and I am aware of the strong drug industry bias of the FDA and FTC, but this article states some pretty blatantly false things – such as that RCTs cost “billions on average” and that an RCT could not be conducted using POM products since RCTs must use isolated compounds. Both of these statements are completely wrong.
    RCTs can be run for as little as a few thousand, though admittedly common drug trials cost in the hundreds of thousands and low millions. Only very complex and large RCTs ever run into tens of millions. The entire budget for the NIH is about $27B and they fund thousands upon thousands of trials. Certainly, for $35M, POM Wonderful could have run several very high quality and large RCTs. Though it is potentially true that the POM product might need to be consumed for a longer period than is generally allowed in an RCT (usually 4-8 weeks) – so this could indeed present a problem.
    Regarding the use of isolated compounds, there are thousands of RCTs testing whole herbs and other such substances. The intervention being tested could be literally anything (food, drug, lifestyle intervention, etc.) as long as there is a control (usually placebo, but often other types of interventions).
    The ANH does laudible work and I am a big supporter, but it is disappointing to see this sort of sloppiness in the writing. They need to run this stuff by a scientist or doctor before publishing it.

  6. CHARLES S says:

    MAYBE WE ALL SHOULD CONSIDER THIS: POW WONDERFUL
    As California’s epic drought wears on, Southern California farms are using an increasing amount of oil wastewater. In 2014, oil companies such as Chevron provided half the water that went to the 45,000 acres of farmland in Kern County’s Cawelo Water District, up from about 35 percent before the start of the drought in 2011. And California Resources Corp., the state’s largest oil company, recently announced plans to quadruple the amount of water it sells to farmers.
    Water officials praise the practice of using oil wastewater on farms as a model for water conservation at a time when California needs every drop, but there are unanswered questions about its safety. The State Water Resources Control Board requires periodic testing of oilfield water that is used for irrigation but has not set limits for many contaminants. Recent tests of irrigation water supplied by Chevron, for instance, turned up BENZENE, A CARCINOGEN, at higher concentrations than what is allowed in California drinking water. The state has not set a standard for benzene in irrigation water.
    The environmental group Food & Water Watch is calling for a moratorium on irrigation with oil wastewater until the safety questions are resolved. “We don’t think it should happen at all until the public can see after rigorous testing and analysis that these chemicals are not being transported into these crops,” says the group’s California Director, Adam Scow. “Consumers need to know what’s going on.”
    The Cawelo Water District blends oil wastewater with water from other sources such as the Kern River before sending it to farms. Last month, Food & Water Watch received from the district the names and addresses of companies that use its water. A few examples of the brands owned or supplied by those companies are listed below (though some of their fruits and vegetables may come from other parts of the state).
    Halos mandarins, formerly marketed as CUTIES, are grown by Wonderful Citrus, part of the farming mega-conglomerate owned by the Beverly Hills billionaires Stewart and Lynda Resnick. The Resnicks, who also own Fiji Water, POM Wonderful, and the world’s largest pistachio and almond growing operation, are major players in California water politics.
    Sunview, which did not return a phone call, grows table grapes, raisins, persimmons, and prune plums. Some of its raisins and grapes are certified organic. At least some of Sunview’s crops are grown in Cawelo Water District.
    BEE SWEET citrus, which sells oranges, mandarins, and lemons, would not confirm or deny irrigating with oilfield wastewater. “As I am sure you know, essentially all farming operations in the Cawelo Water District receive some water from the Cawelo Water District,” James Sherwood, the company’s VP of Operations, said in a short emailed statement. “I hope the focus of your article will be raising awareness for the need for more above ground water storage in California as our state’s population continues to grow and as California farmers feed our nation.”

  7. So now the question is, with the FTC currently considering the fate of homeopathy in the marketplace, shall we assume that, in spite of documented evidence in the HPUS since the 1920’s, suddenly, homeopathy will be facing the same sort of requirements now for any claims whatsoever?

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