Legal Eagle

April 4, 2006

Jonathan Emord knows a thing or two about the Food and Drug Administration (FDA; Rockville, MD). He has defeated the agency in federal court a record six times and served as plaintiff’s lead counsel in the 1999 Pearson v. Shalala, 2001 Pearson v. Shalala, 2001 Pearson v. Thompson, and 2002 Whitaker v. Thompson cases.

Jonathan Emord knows a thing or two about the Food and Drug Administration (FDA; Rockville, MD). He has defeated the agency in federal court a record six times and served as plaintiff’s lead counsel in the 1999 Pearson v. Shalala, 2001 Pearson v. Shalala, 2001 Pearson v. Thompson, and 2002 Whitaker v. Thompson cases. Emord also wrote the Health Freedom Protection Act (HR 4282), introduced in Congress last year, which would limit the ability of FDA and the Federal Trade Commission (FTC; Washington, DC) to restrict health claims. He recently discussed HR 4282, which some see as controversial but others see as long overdue, with Nutritional Outlook.

Why is HR 4282 necessary?

FDA prohibits dietary supplement companies from informing consumers if their products treat disease. It does so to protect drug companies from competition, to preserve a monopoly on treatment information for those companies. The consequences of this censorship are profound. FDA censorship of how basic foods and elements in foods affect disease helps no one in the country except for drug companies. We all benefit from knowing about the effects of foods and dietary ingredients [on] disease. The Health Freedom Protection Act ends FDA censorship of this health information and forces FDA to abide by the strictures of the First Amendment to the United States Constitution. While the Health Freedom Protection Act leaves in place laws prohibiting fraud, it rips down those that are barriers to the publication and dissemination of truthful nutrient disease-treatment information.

FTC is also violating basic civil liberties. When it accuses a dietary supplement company of deceptive advertising, it presumes that company guilty until it proves itself innocent with proof to a near certain degree. Moreover, it rejects proof from publicly available scientific studies corroborating the effects of active ingredients, requiring a company to prove the effectiveness of its multiingredient product with studies performed on the product itself. That reversal of the burden of proof and imposition of Herculean burdens on the accused ensures that truthful, lifesaving information is suppressed. The Health Freedom Protection Act requires FTC to prove claims false before it condemns them as deceptive, and it requires FTC to presume the accused innocent until it proves the accused guilty. Those are basic Fifth Amendment rights of due process that this government violates every day.

Has consumer health been harmed by FDA and FTC enforcement activities? If so, how?

Yes. From 1990 to 1995, FDA censored the claim that folic acid (a B vitamin) reduces the risk of neural tube-defect births. FDA continued to censor the claim in the market despite the federal Public Health Service’s statement to all physicians that women of childbearing age should consume 400 mcg of folic acid per day before they become pregnant to reduce the risk of neural tube defects by 40% or more. An estimated 2400 neural tube-defect births (and more neural tube-defect abortions) could have been averted if FDA had allowed the claim into the market. Only after congressional pressure and litigation from my firm did FDA finally allow the claim. The number of neural tube defect births since the court ordered the claim to be allowed has dropped from 2400 per year to approximately 1700 per year. That’s about 700 babies who are healthy each year who would otherwise have survived in a horrible state of affliction or been aborted.

FDA prohibits the scientifically supported claim that fish oils (omega-3 fatty acids) reduce the risk of sudden-death heart attack. There are approximately 300,000 sudden-death heart attacks [in the United States] each year. Approximately 110,000 of those deaths would not occur if all adults consumed fish oil. FDA’s speech ban thus contributes to 110,000 sudden-death heart attacks every year.

FDA prohibits the scientifically supported claim that calcium reduces the risk of bone fractures. Thousands of Americans, particularly the elderly, suffer from bone fractures due to lack of adequate bone density. FDA’s speech ban thus contributes to the pain, suffering, and occasional consequential deaths of many elderly Americans each year.

FDA prohibits the scientifically supported claim that glucosamine and chondroitin sulfate treats osteoarthritis. Twenty million Americans suffer pain and joint stiffness due to osteoarthritis. FDA’s speech ban thus contributes to unnecessary pain and suffering in millions of Americans.

FDA prohibits the scientifically supported claim that saw palmetto treats benign enlarged prostates. Fifty percent of all men aged 50 and older suffer from an enlarged prostate. FDA’s speech ban thus contributes to unnecessary pain and debilitation in millions of American men.

Do the courts believe there is a difference between commercial speech and other kinds of speech? Should commercial speech involving public health be held to a different standard than other forms of speech?

The Supreme Court has held commercial speech protected by the U.S. Constitution. It prohibits government from censoring truthful commercial speech. It requires the government not to impose any restriction on commercial speech that is, at worst, only potentially misleading unless it can show that the government’s interest is substantial; that its regulation directly advances that interest; and that there are no obvious, less speech-restrictive alternatives. It requires the government to rely on qualifications or disclaimers as a less speech-restrictive alternative to outright suppression.

What is an example of an inappropriate enforcement action committed by FDA or FTC? What is an example of an appropriate enforcement action?

FDA is presently threatening cherry growers in Minnesota with product seizure and prosecution because they are making claims that their antioxidant-rich products reduce disease risk. Many claims being made are truthful, backed by solid science. The enforcement against such claims is improper because under our Constitution truth is to be protected against government action.

Every time FTC commences a deceptive-advertising investigation, its actions are oppressive and inappropriate. FTC demands that every company accused supply it with all of that company’s financial information, all of its business contacts, all of its trade secrets-all before it has levied any formal charge against the company. In a recent case, FTC v. Basic Research, FTC posted the company’s trade secrets on FTC’s Web site. That is a federal crime, yet no party responsible at FTC is being prosecuted. Indeed, FTC will not even allow an investigation into the matter to identify the culprits.

In addition, once a complaint is filed, FTC presumes the accused guilty until it proves itself innocent. That is contrary to the basic Fifth Amendment due process right of the accused. We are entitled to a presumption of innocence until the government proves us guilty of an offense.

Then FTC never defines its standard of review sufficiently for anyone out there to know what FTC requires to prove a claim. Under FTC’s fickle “competent and reliable scientific evidence” standard, any ad called into question can be proven deceptive because the agency redefines the standard in every case. Essentially, absent conclusive proof (something virtually impossible to achieve in science) you can never know whether anything you say about a dietary supplement will get you in trouble with FTC.

Some consumers fall victim to misleading claims. How would they be protected under the Health Freedom Protection Act?

The Health Freedom Protection Act leaves in place federal law prohibiting false and misleading labeling claims and deceptive advertising. Consequently, anyone who is victimized by misleading claims can still complain to the government and the government has all means available to it to prosecute those who defraud the public.

If Congress passed the Health Freedom Protection Act, would FDA and FTC have the resources necessary to conduct the research needed to disprove claims?

The budgets for FDA and FTC remain unchanged by the Health Freedom Protection Act. Those budgets are enormous and include ample resources for identifying, investigating, and prosecuting those who make fraudulent claims or sell unsafe products. The problem with both agencies is that they waste tax dollars in pursuits that have little or no effect upon protecting the public and let instances of fraud go by without prosecution. They also prosecute parties that are honest, well-meaning businesspeople who make true claims or claims that are, at worst, only potentially misleading for products that benefit the public. The agencies lack competent leadership and due respect for the First and Fifth Amendment rights of parties. They fail to perform the mission Congress set out for them. They are grossly inefficient and corrupt; hence, the need for HR 4282.

What is the best way to remove unscrupulous companies from the market?

In the first instance, the government has to do a better job of identifying unscrupulous companies. Right now it spends a considerable amount of time and tax dollars going after people for claims and not going after people who sell unsafe products. The first priority should be ridding the market of unsafe products. The second priority should be ridding the market of fraud.

The business of equating true nutrient-treatment claims with fraud preoccupies most of FDA’s and FTC’s time in this area. That preoccupation violates the First Amendment and Fifth Amendment rights of the accused, removes vital health information from the marketplace, and harms consumers. The only party it helps are the big drug companies. That ought not be the aim of our federal government.

First and foremost, the Constitution must be honored. The legacy of FDA and FTC is one of rights violation rather than rights protection and of missed opportunities to halt the sale of harmful products. There needs to be a total redirection of effort away from censoring truth and toward arresting the sale of unsafe products and arresting fraud in the market.

What would the dietary supplement marketplace look like if the Health Freedom Protection Act became law?

Consumers entering grocery stores, pharmacies, health food stores, and vitamin shops would have available to them government publications documenting the role of nutrients in treating disease (now censored); accurate summaries of those publications (now censored); peer-reviewed scientific articles on the role of nutrients in treating disease (now censored); accurate summaries of those publications (now censored); advisories for those with osteoarthritis, osteoporosis, heart disease, diabetes, and cancer, among others, to choose foods that contain nutrients that help combat those conditions and dietary supplements that contain nutrients that help combat those conditions. At the point of sale, consumers could discover with ease that fish and fish oil supplements provide omega-3 fatty acids that treat heart disease and reduce the risk of sudden-death heart attack; that glucosamine and chondroitin sulfate treat osteoarthritis; that calcium reduces the risk of bone fractures; that saw palmetto treats benign enlarged prostates, etc.

Consumers would be fully informed and would be able to make choices that reduce disease and disability. In the end, more Americans would be alive, fewer Americans will suffer from disease, fewer Americans would be drug dependent, and more Americans would live longer lives than ever before in American history. That is the promise of HR 4282. Every American should urge his or her congressman to support this vital bill.

The only way we can overcome the drug monopoly and the apologists for FDA and FTC regulation is if the consuming public stands up for its rights. To do so is simple and helps enormously. We urge all Americans to go to www.stopfdacensorship.org and through that site send an e-mail letter to Congress urging passage of the bill. That one step makes an enormous difference. If we do not act to protect our rights, we will forfeit them. The beneficiaries of our action are our families, children, and the next generation. The beneficiaries of inaction are the drug companies.