The FDA wants jurisdiction over your kitchen!
by Mary J. Ruwart
“Since the FDA only has jurisdiction over compounds involved in ‘interstate commerce,’ they have no jurisdiction over our kitchens—yet. Should my client lose this case, however, the FDA will have set a precedent to invade the privacy of our homes.”
- Attorney Nancy Lord, M.D.
Daniel Smith is between the proverbial “rock and a hard place.” For the last couple of years, he has been selling “MMS Professional,” a high-quality sodium chlorite solution used to purify water. He has also been selling citric acid, a food acid similar to that found in lime or lemon juice.
Daniel also sold books, CDs and DVDs produced by others that explained how mixing sodium chlorite and citric acid produce chlorine dioxide, a chemical commonly used to purify water. Chlorine dioxide also is an effective mouthwash (Compendium of Continuing Education in Dentistry Vol.21, pp. 241-248, 2000).
The books, CDs and DVDs claim that chlorine dioxide, when ingested at appropriate doses, may kill the parasite that produces malaria, as well as other disease-causing bacteria and viruses, such as the ones that are responsible for hepatitis, typhoid, MRSA, pneumonia, bronchial infections, and perhaps even HIV virus associated with AIDS. The material claims that there are over 75,000 documented cases of chlorine dioxide’s effectiveness against malaria alone.
In these days of high medical costs, a potential antiseptic that is inexpensive and can be made at home is certainly noteworthy. Safety studies with chlorine dioxide, undertaken in the 1980s because the compound is widely used in municipal water treatment system, raised no red flags (Environmental Health Perspectives Vol. 46, pp. 57-62, 1982). The FDA is concerned because chlorine dioxide, taken in excess, can cause diarrhea and dehydration. These are side effects that many FDA-approved drugs have, as well as over-the-counter Vitamin C and magnesium. Presumably, a person faced with such symptoms would simply decrease their dose.
So why is Daniel being threatened with the possibility of criminal charges and years in prison? The FDA claims that Daniel was “marketing a new, unapproved drug with labeling.”
However, Daniel was NOT selling chlorine dioxide, but the components that make it. The FDA, however, claims that Daniel is selling a new drug (chlorine dioxide) that has not gone through its regulatory process which costs, on average, over $1 billion dollars and takes 15 years of testing and evaluation. This is how potentially inexpensive treatments, already used by thousands of people, become so high priced.
The actual label on the bottle of sodium chlorite clearly states that it is to be used for water purification. Nevertheless, the FDA is calling the books, CDs, and DVDs that Daniel was selling “labeling” of the supposed new drug that customers make from sodium chlorite and citric acid. All such alleged “labeling” must be approved by the FDA.
What about free speech and the First Amendment? Well, the FDA doesn’t believe that the First Amendment applies to “commercial speech.” All of the side effects that come at the end of pharmaceutical commercials are dictated by the FDA, which reviews every single ad produced by a drug manufacturer.
In theory, the Dietary Supplement Health and Education Act of 1994 (DSHEA) exempts supplements from the FDA approval process to some extent. Chlorine dioxide, however, is not a supplement, but a water purifier, so it apparently isn’t protected.
The FDA asked Daniel to “voluntarily” recall his product. He did so in the hopes of avoiding further harassment and possible prosecution. “Many customers tell me that they won’t return the products because they love them so much,” Daniel told me. “Quite a few, though, are angry at me for not fighting the FDA. They don’t realize I have a beautiful six year old daughter that needs her father to be present while she’s growing up.”
Daniel’s attorney, Nancy Lord, the 1992 Libertarian Party Vice Presidential candidate, has advised Daniel against relying on the so-called “justice system” to vindicate him. “Anything can happen in the courtroom,” Dr. Lord explained.
Dr. Lord has a point. Years ago, she called me in as an expert witness in another case. The prosecutor convinced the judge to limit my testimony so much that I couldn’t get in any of our relevant points. Miraculously, the prosecutor then asked me questions which opened the door to the very points he had excluded. The jury did not convict the client on any of the 16 counts. However, that was a very close call for the client. Daniel’s clients should be aware that the judicial branch of government is not necessarily even-handed when the plaintiff is another governmental agency.
“Besides potential prison time for Daniel, this case could set a dangerous precedent,” Dr. Lord explained. “Will all vendors be held accountable for the way a customer uses their products or combines them to make something entirely different? Daniel isn’t selling what the FDA is calling a ‘new drug.’ The customers are making chlorine dioxide in their kitchens. Since the FDA only has jurisdiction over compounds involved in ‘interstate commerce,’ they have no jurisdiction over our kitchens—yet. Should Daniel lose this case, however, the FDA will have set a precedent to invade the privacy of our homes.”
“The problem,” Daniel explained, “is that most customers don’t understand why the FDA is demanding a recall. They think that something is wrong with the product or that it is unsafe in some way. They don’t understand that the FDA’s real complaint is the information which I sold. It teaches people how to make chlorine dioxide to kill pathogens in the privacy of their own home. The FDA calls this ‘labeling.’”
The FDA’s interpretation of “labeling” stems from the passage of the 1962 Amendments to the Food and Drug Act. Before that time, the FDA did not interfere with the sale of anything that was “safe for its intended use.” The Amendments, however, insisted that the FDA evaluate drug effectiveness and gave it unprecedented control over the entire drug development process. As a result, the FDA has insisted that no claim of effectiveness be made unless a drug went through an exhaustive—and continuously expanding— testing process. By the 1990s, the Amendments had added about 10 years to the development time of drugs.
The added decade of development time meant that the average new drug took 15 years to get to market. The terminally ill couldn’t wait that long. AIDS patients hired black market chemists to make the very drugs that pharmaceutical companies were testing (Kwitny’s Acceptable Risks, New York: Poseidon Press, c1992.). By the time the firm where I was working had FDA permission to test its first AIDS drug in people, every patient in the U.S. that wanted it already had taken it. In order to do the FDA-mandated testing, we had to wait until new patients were diagnosed.
Cancer patients became so frustrated that they sued the FDA for permission to buy new cancer drugs from pharmaceutical firms before their effectiveness had been fully established according to FDA guidelines. However, the courts ruled that even the terminally ill had no constitutional right to use drugs not yet approved by the FDA!
Thankfully, Congressman Ron Paul (R-TX), the Libertarian Party’s 1988 presidential nominee, has introduced two health freedom bills to insure that such atrocities don’t continue. Patients, along with their doctors, should be able to choose what’s best for them. They should not have to enter the black market to get their treatments. Vendors like Daniel Smith should not have to face prison for selling books along with a couple of chemicals that customers combine and use in the privacy of their own home.
Health care freedom is literally a matter of life and death. Go to the link in the above paragraph and support health care freedom. The life you save may be your own!
Mary J. Ruwart, Ph.D., is the author of Healing Our World: The Other Piece of the Puzzle, a liberty primer for liberals, Christians, New Agers, and pragmatists. She also wrote Short Answers to the Tough Questions: Sound Bites for the Libertarian Candidate after her Internet column (www.self-gov.org) of the same name.