Why the FDA withholds information about nutritional supplements
By Jonathan W. Emord
Some say ignorance is bliss, but when it comes to your diet, it’s anything but. Over the last 60 years, scientists have investigated the healing power of certain dietary ingredients found in nature and published their findings in peer-reviewed scientific literature. Among them: folic acid can reduce the risk of neural tube defect births; omega-3s can reduce the risk of heart attacks; glucosamine and chondroitin sulfate can rebuild cartilage and lessen the progression of, or reverse, osteoarthritis; co-enzyme Q10 can lessen the progression of heart failure; and SAMe (s-adenosylmethionine) can relieve the pain of osteoarthritis as effectively as nonsteroidal anti-inflammatory drugs, and can treat mild depression as effectively as prescription antidepressants. That information, however, is kept from us by federal censorship.
Constitutionally Incorrect
In 1789, when James Madison introduced what would become the First Amendment to the Constitution, he explained that the speech and press amendments were intended to confirm that the federal government had no power over speech and press. He declared, “The right of freedom of speech is secured; the liberty of the press is expressly declared to be beyond the reach of this government . . .”
Under our Constitution the government has no power to impose a restraint on the communication of truthful information to the public, or second guess whether the public ought to have access to science, yet that is the role the FDA has assumed. No statement that associates a nutrient with a disease, regardless of its validity, can be lawfully communicated in the marketplace unless the FDA approves of the statement in advance. For example, if a company sells prunes, it’s illegal to state on the label that the fruit can help chronic constipation, although that is undoubtedly true. If a prune company were to put that on the label, the FDA could declare the prunes unapproved new drugs, stop their sale and prosecute the packager under federal civil and criminal laws.
The First Amendment presupposes that the citizen is best left to weigh the relative value of such information, and that government may not withhold it on the arrogant presumption that it knows better than the consumer what is in the consumer’s best interest.
The FDA starts from the opposite premise. In 1999 in the case of Pearson v. Shalala, a U.S. attorney arguing against me declared in so many words that the First Amendment did not apply to the FDA. She went on to explain that consumers couldn’t be trusted with scientifically proven information (in that case, claims concerning birth defects and folic acid; heart disease and omega-3; and the cancer risk reduction effects of antioxidant vitamins) because if given that information, consumers might make unhealthful choices, consume too much of the nutrients, or neglect prescription drug treatments the FDA favored.
In short, the FDA then and now argues that consumers are too ignorant to evaluate nutrition science and cannot be trusted with the information to make the choices the FDA thinks are in their best interest. This directly contradicts the First Amendment, which disarms the FDA of any power to prohibit our access to such basic information as the effect of dietary ingredients on health and disease.
Fortunately, in a lawsuit filed last summer (and in four other suits brought by my firm), we have defeated the FDA’s censorship of nutrient-disease prevention claims in U.S. District Court for the District of Columbia. Unfortunately, the FDA brazenly refuses to abide by the orders of the federal courts, and continues to censor many of the claims the federal courts require to be allowed. It most recently reversed a prior decision to allow claims of cancer risk reduction by selenium and antioxidants.
Above the Law
The FDA considers itself above the law, restrained by neither the Constitution nor federal courts. It is an all powerful bureaucracy largely unaccountable for its actions, yet it regulates one quarter of every dollar spent and the entire food, drug, dietary supplement, medical device, biologics and cosmetics industries. As many an FDA whistleblower has testified to Congress (including associate director of the FDA Office of Drug Safety Dr. David J. Graham; former FDA medical reviewer Dr. David B. Ross; and former FDA medical reviewer Dr. Andrew D. Mosholder), the FDA views the drug industry as its client, and its decision-making furthers the interest of that client.
Perhaps this is why the FDA, an agency that presents itself as the guardian of public health, withholds vital truths about effective dietary ingredients from consumers. It polices the market to prosecute civilly and criminally any who claim that a product not approved as a drug or medical device can successfully treat, mitigate or prevent a disease, thus effectively protecting the drug industry’s interests. Since the cost of bringing a drug from discovery to FDA approval is about $800 million—the filing fee alone exceeds $200,000—only the wealthiest monopolies can play the drug approval game. No independent scientist at a university who discovers that a nonpatentable food element treats a disease can get that information into the commercial marketplace.
Two bills now pending in Congress would end federal censorship of scientific information regarding nutrients and disease. Encourage your representatives to vote for the Health Freedom Act (HR 3395), which would end FDA censorship of nutrient-disease links; and the Freedom of Health Speech Act (HR 3394), which would end FTC censorship of health information.
In a letter to Dr. Benjamin Rush dated September 23, 1800, Thomas Jefferson referred to a personal oath he had taken: “I have sworn upon the altar of God eternal hostility against every form of tyranny over the mind of man.” There is no doubt as to how Jefferson would feel about the FDA’s tyranny.
Attorney Jonathan W. Emord (Emord.com) has defeated the FDA more times in federal court than any other attorney in American history. His 2008 book, The Rise of Tyranny, reveals FDA corruption and knowing approval of unsafe drugs.
