The Alliance For Natural Health

Free Speech Win in Federal Court

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free-speechJudges rule that excerpts from scientific/medical journal articles can be used in advertising and promotional materials, protected by the First Amendment and New York state law.

A three-judge panel of the Second US Circuit Court of Appeals in New York has ruled unanimously that researchers cannot be sued for stating the scientific conclusions made in journal articles about matters of scientific debate.

In this case, the manufacturer of a lung surfactant—a detergent-like agent that reduces the surface tension of the liquid film covering the inner lining of the lung’s small air sacs (alveoli) to help keep lungs from collapsing and help patients breathe better—brought a false advertising suit against a competitor. The lawsuit alleged that the competitor paid for research designed to show that the competitor’s product was superior; that the findings were false and deceptive; and that the competitor disseminated those findings through an article published in a scientific journal and through promotional material citing the article’s conclusions.

The plaintiff didn’t claim that the competitor distorted the article’s findings, but that the findings themselves were inaccurate, and by publishing them, the plaintiffs suffered damage. The main question was whether the defendant’s statements about the study were false and misleading under the Lanham Act, which is the primary federal trademark law in the US (the court also looked at this under NY state law). They didn’t consider the question of whether the study findings themselves were false—only whether their statements about the study were false or misleading. The panel ruled against the plaintiff and found that the defendant did not misrepresent the research findings, and ruled the defendant’s statements to be scientific “opinion,” not fact, and therefore protected speech under the First Amendment.

This sets a significant precedent. A federal appeals court found that opinions about scientific studies, at least when two private parties are involved in cases involving the Lanham Act, is protected free speech.

Whether this ruling can be applied against the Federal Trade Commission’s recent actions toward supplement makers for making alleged “false and misleading claims” by citing scientific studies remains to be seen, as the laws involved are different. You may recall the FTC’s lawsuits against companies such as POM Wonderful for false advertising, even though POM cited scientific articles and studies.

Increasingly, the FTC appears to be applying the FDA’s pharmaceutical approach toward all health claims, including those for food or supplements, via consent decrees, as we discussed last year. These consent decrees are requiring manufacturers to obtain the FDA’s approval of any health claims prior to making them in advertising, and are insisting on a standard of double random controlled studies. In effect, the FTC seems to be doing what the FDA itself would like to do but is barred from doing. It seems to be an end-run around FDA law.

Given this background of increasing government censorship of science, this latest court ruling is very welcome. Companies cannot afford the millions of dollars needed to take a natural, non-patentable product through the FDA drug approval process in order to establish health claims. However, there is a lot of valid scientific literature explaining benefits of natural products, and companies should be able to use it for advertising purposes to inform the public without threat of fines or even jail.

This is the logic behind our push for Free Speech About Science (FSAS). A bill to reintroduce the Free Speech About Science Act is currently being redrafted. We will keep you posted as things progress.

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  • Robert Cruder

    Fitness stores have shelves filled with “proprietary blend” products.

    A manufacturer may compound one or a dozen raw materials into a product and then reference the research associated with each one of the raw materials (raws).

    Research may use a standardized German raw but the product compounded from an inconsistent and sometimes contaminated Chinese raw.

    The research may be in-vitro and never tested on a complete organism.

    It may be rodent based and never tested on humans.

    It may be tested on young male humans but marketed to women or the elderly.

    The ingredients may never have been tested in a combination similar to the product.

    The quantity of each ingredient may be based entirely on relative cost with no concern for the dosage that the research showed to be effective.

    Along with the research references for the individual raws, the marketing assets show only the combined weight of all ingredients as “proprietary blend containing…”.

    The manufacturer expects the consumer to associate the maximal benefit documented for each raw with the unknown quantity in the product.

    Free Speech About Science does not address that issue. If it increases the volume of research references without improving the product description it could further mislead the customer and invite FTC ire.

    Perhaps a manufacturer member would like to comment further.

    • Tyler

      @ Mr. Cruder -These are all excellent points and make a great argument why some companies are preferable to others. Don’t buy proprietary blends and review the research behind claims yourself if you are serious about a given supplement or health product. Ask the company outright if they’re using the clinical dosage and double check them on it! Keep in mind these “claims” often read “may help support cholesterol already within a normal range” or “supports heart health”. These are far from what I would call claims -more of an association really.

      I agree that there is a danger of poor studies being sited, but is zero information better than the risk of misinformation? If legitimate information cannot be shared, isn’t that unconstitutional? Preventing the sharing of knowledge that may help someone’s health?

      Due to the fact that these are for-profit companies obvious caution should be used.. but so are most hospitals, doctors and pharmaceutical companies. In fact, one of your bullet points, “It may be tested on young male humans but marketed to women or the elderly.”, is frequently practiced by MD’s. Statin medications were primarily studied on older men for cholesterol management. Now they are also prescribed to women and children of all ages, even children under the age of four!

      I must say I favor a system of regulation that has basic safe guards; child resistant caps, required testing for harmful substances and FDA GMP inspections (good manufacturing inspections) ….. but still allows for fairly free sharing of information. I prefer personal responsibility to censorship.

      All that is to say, buy from companies you can trust. Buy from companies who are falling over themselves to provide quality control testing, proof of potency, clinical testing/dosing, etc. There are many good companies!

      Good Luck,

      Tyler

  • Carol

    There is a lot of valid scientific literature explaining benefits of natural products, and companies should be able to use it for advertising purposes to inform the public without threat of fines or even jail.
    Please support free speech, and allow valid scientific research to be used when applicable to endorse certain products. Free speech is the foundation of our Constitution, and SHOULD be allowed. People deserve to be completely informed, even when this goes against pharmaceutical companies bottom line, maybe especially so. Keep free speech in our laws and do NOT censor it.

  • When the natural products industry began to mature and started using science based claims for their ingredients, formulations and products, they gave up a very big advantage they had. That advantage was in the obvious connection between good food and good health. This food as medicine connection has been deeply rooted throughout human history. Food and nutrition were the basis for ‘natural’ products.

    As the market grew, it became necessary to address convenience, efficacy and safety factors. In order to distinguish natural remedies as ‘just as good as’ or ‘better’ than pharmaceuticals, the need for scientific validation for the claims to good health being made became more important than the common sense experiences traditionally associated or attributed to their use.

    The results have been mixed. We have a treasure trove of existing and ongoing science supporting food as medicine. Yet we can’t say so for fear of running afoul of some Federal regulation.

    Drug companies buy up nearly every inch of ad space in scientific journals so the argument persists that there’s little scientific basis for natural product claims.

    We have good manufacturing practices and we have dozens of third party certification organizations. The message to the consumer is that there’s a problem with standards.

    In the meantime, we’ve seen a proliferation of new ingredients, formulations and products clamoring for shelf space. Consumers have never had so many choices yet confusion has never been greater. They don’t understand the rational for pricing of the same item from different manufacturers and the shopping experience can be overwhelming and intimidating.

    Most of this confusion could have been avoided. Had the industry led with nature as the gold standard, we could have more easily validated our claims to efficacy and safety. Instead of copying big pharma’s model, we could have copied nature’s. Most pharmaceuticals ware derived from plants in nature too. We could have framed big phama copying of nature as following us instead of playing catch up with their model and budgets. .

    Now we have an arms race to invent and patent more and more products designed for a specific effect. We pile on tons of scientific evidence and expect consumers to feel secure in their purchases. We can’t say ‘ask your doctor’ if product ‘X’ is right for you. There are too few doctors who know what to answer. We can’t say ask your nutrition coach or natural…