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The National Center for Complementary and Alternative Medicine (part of the National Institutes of Health) echoed the FDA in 2004, adding that other potential side effects include seizures and kidney damage.
But that did not deter Hotze from making extravagant claims about the colloidal silver he sells through his dietary supplement store, Physicians Preference.In early June, the Physicians Preference Web site described colloidal silver as a natural antibiotic that "can heal burns, cut[s], rashes and sunburns. It can also be used for toothaches, mouth sores, eye infections, and as a mouth gargle to fight bad breath and tooth decay." (The range of fake qualities of these phony cures is astounding; consumers who want the best bogus treatment should skip Physicians Preference and get their fake cures from Utopia Silver, whose Web site shows cool drawings of silver colloid particles battling E. coli and Ebola microbes.)
Without mentioning that the product can turn your skin blue, the Physicians Preference Web site suggested children between the ages of six and 12 take a teaspoon a day, and children under six take half a teaspoon.
A representative of Physicians Preference told the Houston Press that Hotze's company gets its colloidal silver from a group in Tennessee that had studies to support the claims. However, that company, Natural Path/Silver Wings, made no claims for colloidal silver on its Web site.
Company president Liz Smith explained to the Houston Press that she was well aware of laws regarding false claims, which is why none of their products claim to treat any disease.
After that discussion, the Press sent an e-mail to Physicians Preference, asking why the added claims were legitimate. No one from the company replied, but overnight Hotze's colloidal silver lost its ability to fight infection. The claims on the Web site were changed, and not just for colloidal silver.
Magnesium citrate, which on June 9 could be used in the treatment of congestive heart failure and high blood pressure, is now "primarily taken to support cardiovascular and muscular health." (Also new is the disclosure that magnesium "may cause a laxative effect.")
Also on June 9, Iodoral could treat fibrocystic breast disease, hemorrhoids, ovarian cysts, thyroid disorders and excess mucous production. Now it possesses the power of extreme vagueness: "Using Iodoral could yield maximum benefits."
In 2001, the FDA and the Federal Trade Commission issued a statement declaring their intent to crack down on "unscrupulous marketers who use the Internet to prey on the sickest and most vulnerable consumers." But for every shark-cartilage manufacturer penalized for making cancer-curing claims, someone else pops up with spit from worker bees that wards off aging.
Karen Tannert, chief pharmacist with the Texas Department of State Health Services, says the marketers of colloidal silver are among the worst violators of labeling laws.
"The product's basically fraudulent from the word go," she says. "However, because of the loopholes in the laws, it can be marketed still as a dietary supplement, and they take advantage of that."
Tannert says hucksters play with people's health by distracting them from treatment that might actually work.
"Who is being affected through omission?" she asks. "That's really one of the big problems with a lot of these fraudulent products, is that people want to take care of their own treatment, their own therapy, so they don't seek, you know, the truly effective stuff How can you measure the harm because somebody postponed seeking chemotherapy for six months? How do you measure that?"
Hotze has gone to great lengths to sell his line of bioidentical hormones, which he trademarked under the name BellaFem. While Hotze's Web site doesn't directly list the sources of these hormones, the site repeatedly mentions soybeans and wild yams.
Bioidentical hormones for the most part are sold as dietary supplements. But Hotze prescribes them to his patients, who purchase them from his in-house pharmacy.
BellaFem's claims were criticized in a 2004 issue of The Women's Health Activist, the journal of the National Women's Health Network. Under a headline reading "BellaFem: Fulla False Claims," the brief article stated that "no hormone has been proven to be completely safe," adding that "All of the research done so far shows that natural hormones carry the same risks (including increased risk of breast and endometrial cancer) as synthetic hormones. Research has shown that natural hormones are beneficial only for the treatment of hot flashes and vaginal dryness." (The Washington, D.C.-based advocacy group does not receive funding from pharmaceutical companies.)
Under the 1997 FDA Modernization Act, compounded drugs were not subject to approval standards as long as pharmacists did not advertise them. But the U.S. Supreme Court overturned that part of the act in 2002, stating it violated pharmacists' First Amendment rights. In Texas, Senator Kyle Janek introduced a bill to reflect the court's ruling. With the green light to hawk BellaFem online, Hotze created an organization called the American Academy of Biologically Identical Hormone Therapy.