by Marion Nestle
Jun 11 2010

Health claims: Should the First Amendment protect bad science?

I keep complaining about the health claims on Enfagrow toddler formula, a sugary product aimed at children from ages one to three:

These claims, for the uninitiated, are a special kind called structure-function.  Congress authorized such claims when it passed the Dietary Supplement Health and Education Act (DSHEA) in 1994.

Structure-function claims do not say that the product can prevent or treat disease. They merely suggest that the product can help in some unspecified way with some structure or function of the body.

When Congress passed DSHEA, it meant the claims to apply to dietary supplements, not foods. Enfagrow is marketed as a food, not a supplement.  It displays a Nutrition Facts label, not a Supplement Facts label.

Over the years, the FDA has issued cease-and-desist warnings about foods that bear structure-function claims.  In recent years, it has simply stated that manufacturers are responsible for ensuring that the claims are “truthful and not misleading.”

One reason for the shift is what the Courts have ruled.  The Courts say that structure-function claims are protected by First Amendment guarantees of free speech.  The most recent case is Alliance for Natural Health USA v. Sebelius. As described in Food Chemical News (June 7), a D.C. District Court judge ruled that the FDA cannot deny health claims that link selenium supplements to reduced risk of several diseases, or require those claims to be qualified, just because the claims lack adequate scientific substantiation.

In other words, supplement makers can say anything they want to about the benefits of their products—on the grounds of free commercial speech—whether or not science backs up the claim.

Recently, the FDA issued a warning letter to Nestlé, the maker of a Juicy Juice product aimed at toddlers, which displays a claim that its content of added omega-3 DHA improves brain development.  The FDA did not take on the claim, even though research seems unlikely to find that such drinks have any special benefits for brain development.  Instead, the FDA focused on a technicality:

The product makes claims such as “no sugar added,” which are not allowed on products intended for children under 2 yrs of age because appropriate dietary levels have not been established for children in this age range.

I’m guessing—this is speculation—that the FDA is reluctant to take on Enfagrow’s brain or immunity claims because Mead-Johnson has deep pockets and might well be willing to fight this one in court as a First Amendment case.

I am not a lawyer but I thought that intent mattered in legal cases.  Surely, the intent of the founding fathers in creating the First Amendment was to protect the right of individual citizens to speak freely about their political and religious beliefs.  Surely, their intent had nothing to do with protecting the rights of supplement, food, and drug corporations to claim benefits for unproven remedies, or to promote sales of sugary foods to babies.

I think it is time to give these First Amendment issues some serious thought.  How about:

  • FDA: Fire those lawyers and hire some who will protect the FDA’s ability to use science in its decisions.
  • FTC: Take a look a the immunity claim on the Enfagrow Vanilla toddler formula, now that the Chocolate is off the market.
  • Legal scholars: Surely there are ways to protect real First Amendment rights while restricting unsubstantiated health claims?

Other ideas are most welcome.  Your thoughts?

  • Anthro

    We (as a country) are in a sad state of affairs with a supreme court that, by one vote, is able to grant personhood to corporations and speech rights to snake oil salesmen.

    Would it be useful to revisit the 1994 statute that started a lot of this? Is there a member of congress who might be interested in this? It’s safe to say the Harkin, Hatch, Paul and some others would fight it, but still…..there must be some who are more interested in science.

    My children are long grown up, but I stopped in the baby food aisle the other day to purchase some little jars for a food bank drive and was shocked to the core at the array of idiotic products for babies and toddlers. I guess they want to get them hooked as soon as possible. Doesn’t the government’s responsibility to protect its citizens trump the right of corporations to profit from “consumers”? I guess it’s a rhetorical question.

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  • We already have other laws that protect consumers from losing money because companies lied to them about what they were getting. I don’t see this as any different.

  • JE

    The Alliance For Natural Health has a somewhat different take on their legal victory over the FDA:

    The lawsuit dealt with qualified health claims, not structure/function claims.

  • OK, lawyer hat on: Of course the founding fathers intended the First Amendment to apply to political and other types of individual speech, and had no clue that one day the Supreme Court would protect the likes of Enfagrow.

    Unfortunately, we are stuck with decades of legal jurisprudence in which the Supreme Court has afforded corporations numerous rights under the Constitution. So, the problem goes beyond the First Amendment. The problem stems from “corporate personhood,” the legal fiction that corporations are treated as individuals under the law, or at least under some laws.

    Now, what I’ve never been able to understand is how food companies get away with making any claims that are meant for supplements. I have seen some of the cease and desist letters you mentioned from FDA (I recall one about a cereal with St Johns Wort). If FDA says you can’t pretend a food is a supplement by making supplement-type claims, then how are any food/beverage companies still getting away with this? I wonder if this has less to do with the First Amendment than with politics?

    I am not sure FDA needs new lawyers, they may need better direction and leadership to be able to take stronger stands. Doesn’t how a regulatory agency acts come from the top?

  • Jo

    I am most certainly not a lawyer, but it seems to me, philosophically that is, that society has to decide to that are some situations in which to value public interest over the rights of corporations. If the FDA already has the stance that products claims must be truthful and not misleading, then this foundation is there, but somewhere along the way it is unraveling. As an American, I do appreciate the spirit of “corporate personhood”, but, as I said when I began, there has to be some situation when the rights of actual American citizens takes precedent. I also can’t believe that the majority of Americans would not agree that health claims should be treated more stringently. All these products with science fiction claims need to be nipped in the bud.

  • Neil

    This is the problem with the Daubert decision. Judges and lawyers who are not science experts get to decide what is science and what is free speech. A few people like you, Marion are willing to defend science in the public interest. Science must be humane ( tolerant of the human being on the recieving end of the science, be willing make adjustments for errors in measurement and be free of corporate influence to discover matters of truth. We, humans, are not corporate guinea pigs.

  • We need to clean up the FDA and fund it without the assistance of the pharmaceutical and food industries. There’s a revolving door of employees going back and forth, just like we’re seeing with BP and the oil regulators. You’ll never have unbiased decisions being made.

  • I think the First Amendment protection of claims not scientifically backed is correct. Having the government decide whether the conclusions of scientific studies are correct, or whether the study was properly executed or relevant to authorize a manufacturer’s claim is not what I want bureaucrats doing for me. If producers make a false and fraudulent claim, you and a bunch of attorneys general can sue the retailer and the manufacturer. Fair enough. Having the government decide what should be protected speech and what should not be is a slippery slope that will eviscerate the First Amendment. I do agree that products such as you describe can be better screened by educated parents who can understand the nature of the ingredients and who can decide not buy the product. But there is always a cost for freedom. This is one of those situations.

  • Unfortunately corporations have been considered “persons” under the law for a very long time.

    Free speech should be protected, period. But this is not free speech, it’s fraud. Snake oil shenanigans are illegal. I can’t package iced tea and sell it as a treatment for cancer so how do these idiots get away with this?

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