US v. Vital Health Products, Ltd.
| Decision Date | 10 March 1992 |
| Docket Number | No. 91-C-363.,91-C-363. |
| Citation | 786 F. Supp. 761 |
| Parties | UNITED STATES of America, Plaintiff, v. VITAL HEALTH PRODUCTS, LTD., a corporation, and Conrad E. LeBeau, an individual, Defendants. |
| Court | U.S. District Court — Eastern District of Wisconsin |
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Stephen A. Ingraham, Asst. U.S. Atty., Milwaukee, Wis., Walter Stauffacher, Food & Drug Admin. Office of Gen. Counsel, Rockville, Md., Jay I. Bratt, Office of Consumer Litigation, U.S. Dept. of Justice, Washington, D.C., for U.S.
Wendy Alison Nora, Access Legal Services, Madison, Wis., for Vital Health Products, Ltd.
Conrad E. LeBeau, pro se.
DECISION AND ORDER
Before the Court are the plaintiff's motions for summary judgment and dismissal of the defendant's counterclaim, as well as a host of non-dispositive motions brought by the defendant. Since the non-dispositive motions will become moot once the summary judgment motions are resolved, the Court shall not address them.
Defendant Conrad LeBeau is a Wisconsin citizen who is engaged in the business of promoting hydrogen peroxide and other "natural remedies" as curative substances. He conducts his business as defendant Vital Health Products, Ltd. ("Vital Health"), a corporation over which he has complete control and is president. Vital Health sells and distributes 35% Hydrogen Peroxide, 17.5% Hydrogen Peroxide and Glycerin, Peroxy Gel, White Birch Mineral Water, Licorice Root Tea, and Lymph System, among other products. In addition, Mr. LeBeau is the author of a newsletter entitled "Vital Health News" ("News"), which is distributed by Vital Health Publications. News calls itself "a publication issued periodically to provide news and new developments in a wide range of health related areas including freedom of choice in medicine, holistic regimens, new health products and new uses for existing health supplements." News, Vol. 2, No. 1 at 2. It contains a warning that "persons with serious illness should seek the help of a medical professional and should not attempt self treatment solely on the basis of information contained in this newsletter." Id.
"35% Hydrogen Peroxide Solution" and "17.5% H202 and Glycerine" are liquid forms of hydrogen peroxide sold by Vital Health for ingestion. News describes the 35% solution as able to kill intestinal germs and bacteria on contact. The user is instructed to add 3 to 7 drops of the hydrogen peroxide to a glass of water and drink it on an empty stomach, and is warned that if excessive quantities are swallowed, blood sugar levels may be lowered, resulting in coma or death. News suggests keeping the 35% solution in the freezer, out of the reach of children. The label on the 4 ounce bottle has similar instructions and warnings, and instructs the user that the water/peroxide mixture may be taken every three hours. If intestinal gas occurs, the user is instructed to discontinue treatment. First aid procedures are listed for skin and eye contact as well as ingestion.1
News' paragraph on the 17.5% solution is shorter and merely describes it as a "no nausea formula," because it does not have an aftertaste or cause an upset stomach. The addition of glycerine slows the absorption of hydrogen peroxide into the bloodstream. Adults are instructed, by the labeling on the 4 ounce bottle, to add 7 to 14 drops of the solution to a glass of water and to take it on an empty stomach once a day. The warnings on the bottle are identical to those on the 35% solution, with one exception. The 17.5% solution's label warns, "Do not use for more than 10 days, except as directed by a doctor."
"Peroxy Gel" is a solution containing hydrogen peroxide, aloe vera, and glycerine, and is distributed for topical application. News endorses Peroxy Gel's healing powers by printing testimonials of parties who have used it to treat various ailments successfully. For example:
Several people claim to have had complete relief from the pain of arthritis and rheumatism. It is effective when used on sore muscles, aching joints, fungal infections, athlete's foot, insect bites, burns and bruises. It has been reported effective against Lyme's disease. Recently, the owner of a health food store in Sonora, CA reportedly shrunk a large tumor with adhesions by applying Peroxy Gel directly on the tumor. The tumor, which was "the size of a hen's egg" shrunk to a "half-dollar" and "all the pain is gone." Also, in Scottsdale, AZ, a registered nurse who was told eight months ago by her doctor that she had terminal cancer of the pancreas and had three months to live, now claims to be in excellent health. She said all she did was rub ½ tablespoon of Peroxy Gel on her skin three times a day and ate a natural diet of raw vegetables and fruits and yogurt with some flax oil ... In Jan. 1990, she had a catscan and all they found was a small indentation in the pancreas, no cancer was detected.
News at 15. One teaspoon of Peroxy Gel provides the equivalent of 15 drops of 35% hydrogen peroxide. According to its label, it may be used for aching joints, back massage, athlete's foot, minor infections, sore muscles, burns, bruises, and insect bites. It claims to soothe and heal skin and lessen pain. In addition, it may be used on one's teeth and gums. However, the label warns the user to keep it away from the eyes and to discontinue its use if a rash occurs.
Other products sold by Vital Health include "Lymph System," "White Birch Mineral Water" ("White Birch"), and "Licorice Root Tea." White Birch is a "trace mineral supplement made from the ashes of white birch trees grown in northern Wisconsin ... It can be applied topically on the skin or can be mixed with water and taken internally." News at 16. News cites two priests as believing that White Birch caused patients in Michigan with cancer and arthritis to experience remissions, while a man in Texas claims that it cured his genital warts. Lymph System is not discussed in Volume 2, Issue 1 of News. However, the label on a bottle of Lymph System instructs that it should be used "for the detoxification and purification of the lymph system." The dosage is 10 to 15 drops mixed with a teaspoon of water, taken three or four times daily. In acute cases, a patient may take a dose every two hours. Children may take one half the recommended dosage for adults. Licorice Root Tea is described as useful in treating stomach ulcers, AIDS, cancer, candidiasis, chronic infection, and weakened immune systems.
Mr. LeBeau has testified that he is not a doctor, nor does he have an extensive background in chemistry or biology. Transcript at 18-19. From his testimony and writings, it appears that he gained his knowledge about the health properties of hydrogen peroxide and other Vital Health products from self-experimentation and word-of-mouth. Plaintiff's Exhibit 2 at 3, 9; Transcript at 21. Many customers who have used Peroxy Gel and other hydrogen peroxide products have written to this Court, thrilled with its benefits and claiming it has cured everything from athlete's foot to skin cancer.
Mr. LeBeau also distributes a booklet entitled "Hydrogen Peroxide Therapy," which consists of reprints of several articles, written by himself and other proponents of hydrogen peroxide treatments. The chapters are entitled "Hydrogen Peroxide Therapy — New Hope for Incurable Diseases," "Interferon Produces H202 (Pneumonia disappears in 24 Hours)," "Infusion Therapy," "Ozone Stops AIDS," and "How To Rebuild Your Immune System." On the front inside cover of the booklet is a notice which states, "The material in this book is for educational purposes only and is not intended as a prescription for any illness."
The booklet contains second hand claims about the healing powers of hydrogen peroxide. For example, Mr. LeBeau writes about a conversation he had with Walter Grotz, during which Mr. Grotz told him about a doctor in Mexico who treated cancer patients with intravenous doses of hydrogen peroxide. "A terminal patient with prostate cancer made a complete recovery in 2 weeks, returned to his home in Minnesota and went back to work." Plaintiff's Exhibit 2 at 5. There are claims that hydrogen peroxide can be used to cure or treat pneumonia, Downs Syndrome, emphysema, tumors, cancer and arthritis, and may also be used for treating sick pets. Chapter Four discusses the intravenous use of ozone for AIDS patients and suggests that similar results may be achieved by bathing in water mixed with hydrogen peroxide.
The booklet, as well as the newsletter mentioned earlier, are available through Vital Health Publications ("Publications"). Publications has a different location than Vital Health, and the two companies distribute their products separately. Mr. LeBeau created Publications after the government brought an action against him in 1989 for selling misbranded drugs. Publications' literature was held to constitute labeling and transformed the products into misbranded drugs by law. By shipping the literature and the products separately, Mr. LeBeau believes that he is in conformity with government regulations. Transcript of Preliminary Injunction Hearing (hereinafter "Transcript") at 16.
The Federal Food, Drug, and Cosmetic Act of 1938 ("the Act"), 21 U.S.C. § 301, et seq., was designed to protect public health by regulating certain products moving in interstate commerce. United States v. Kordel, 164 F.2d 913 (7th Cir.1947); United States v. Two Bags, Poppy Seeds, 147 F.2d 123 (6th Cir.1945); Barnes v. United States, 142 F.2d 648 (9th Cir.1944). One of the Act's primary purposes was to ensure the safety of food and drugs before they became available to the public. United States v. Wiesenfeld Warehouse Co., 376 U.S. 86, 84 S.Ct. 559, 11 L.Ed.2d 536 (1964). Section 331 of the Act prohibits the introduction or delivery of a misbranded drug or an unapproved new drug...
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