Consumer Health Digest #05-23

Your Weekly Update of News and Reviews
May 31, 2005

Consumer Health Digest is a free weekly e-mail newsletter edited by Stephen Barrett, M.D., and cosponsored by NCAHF and Quackwatch. It summarizes scientific reports; legislative developments; enforcement actions; news reports; Web site evaluations; recommended and nonrecommended books; and other information relevant to consumer protection and consumer decision-making.

Ephedra ruling highlights DSHEA's pro-quackery intent. A Utah federal judge has limited the FDA's ability to enforce a ban against the selling of ephedra products as dietary supplements. [Nutraceutical Corporation and Solaray, Inc., v. Lester Crawford et al. Case No. 2:04CV409 TC] The ruling prohibits the agency from taking action against Nutraceutical Corporation, a Utah-based company that sued to block the ban. The 1994 Dietary Supplement and Health Education Act (DSHEA) states that to ban a product, the FDA must prove that it poses an "unreasonable risk of illness or injury." Ephedra products have been linked to several deaths and thousands of complaints from consumers, many of whom have filed lawsuits. The FDA has concluded that "in the absence of a sufficient benefit, the presence of even a relatively small risk of an important adverse health effect to a user may be unreasonable." But the judge ruled that to ban all ephedra products, the FDA would have to prove that they are unsafe "when used as recommended and suggested in the labeling." Concluding that a single dose of Nutraceutical's 10 mg product would not be dangerous, the judge ruled that the FDA could not stop the sale of dietary supplements containing 10 mg or less of ephedra alkaloids. He also ruled that DSHEA did not permit the FDA to compare benefits and risks as part of its evaluation of unreasonable risk. (In other words, whether a product is completely worthless is not relevant to judging whether it is reasonable to permit it to continue to be sold.) During Congressional discussion of DSHEA, the bill's main sponsor, Senator Orrin Hatch (R-Utah), said that the bill would protect consumers by ensuring that safe products would be available and that the FDA would still be able to ban dangerous ones by proving them to be dangerous. But it was clear then—as it is now—that DSHEA protects thousands of worthless products and makes it extremely difficult to ban dangerous ones. In response to the judge's decision, The New York Times stated in an editorial:

The ruling leaves the ephedra ban intact for products containing doses above 10 milligrams. But by dismissing the FDA's voluminous evidence of potential danger, the court set an unrealistically high threshold for agency action, and that could undermine the ban even for higher-dose ephedra products. Under current law, supplement manufacturers may sell products without first having to establish their safety or efficacy. But after the FDA found a significant hazard, it was only reasonable for the agency to weigh ephedra's lack of any real health benefits in deciding on a regulatory response. The agency should appeal, but the White House and Congress should not let the Food and Drug Administration do all the heavy lifting. The decision is their cue to move promptly to enact overdue legal revisions that will significantly strengthen the agency's power to monitor and police the supplement industry.

The ruling has no effect on the laws of states that have banned all sales of ephedrine alkaloids in dietary supplements. Curiously, the Utah Natural Products Association (UNPA), whose executive director helped to write DSHEA, responded to the ruling by voting to make "no sale of ephedra products" a condition of UNPA membership. It even stated in a press release that "UNPA is hopeful that ephedra will not derail the more than ten years of efforts to implement DSHEA and believes an ephedra-free market to be a key step toward those ends." Industry trade publications report that few if any manufacturers appear interested in resuming the marketing of ephedra products—presumably because they are afraid of lawsuits.

FTC curbs orange juice claims. Chicago-based Tropicana Products, Inc., has settled an FTC complaint it that it misled consumers by claiming that drinking 2 to 3 glasses a day of its “Healthy Heart” orange juice would produce dramatic effects on blood pressure, cholesterol levels, and homocysteine levels, thereby reducing the risk of heart disease and stroke. The challenged ads ran between 2002 and early 2004, on television and in publications such as Newsweek magazine. The ads claimed that drinking two to three cups of Tropicana orange juice each day would lower systolic blood pressure by 10 points, raise HDL cholesterol by 21% and improve the HDL to LDL cholesterol ratio by 16%, increase blood folate levels by 45% and lower blood homocysteine levels by 11%. Although foods such as orange juice that are rich in potassium and low in sodium can help reduce the risk of hypertension and stroke, the claims went far beyond what has been proven. Tropicana is prohibited from making similar similar claims in the future without scientific substantiation. [FTC puts the squeeze on Tropicana’s orange juice claims. FTC news release, June 1, 2005]

WaterOz founder receives 43-year prison sentence. David Roland Hinkson, who made millions of dollars selling mineral waters, has been sentenced to 43 years in prison. In January 2005, he was convicted of soliciting the murders of a federal judge, a federal prosecutor, and an IRS agent in retaliation for a prior criminal case brought against him. Hinkson ran a business in Granville, Idaho called WaterOz, which markets products through the Internet and a "buyer's club." In 2000, the IRS launched a criminal investigation based on evidence that Hinkson had willfully failed to file income tax returns or pay Social Security taxes for his workers. The investigation ultimately produced a 43-count indictment charging him with failure to file income taxes, failure to pay employment taxes, mislabeling his water products to overstate their mineral content, marketing adulterated drugs, selling misbranded and adulterated ozone generators, and structuring financial transactions to avoid bank currency reporting requirements. The indictment stated that from 1997 through 2001, WaterOz grossed $11.9 million, netted $7.4 million, and paid $2.4 million to Hinkson, who should have paid federal income tax of $938,602. In 2004, Hinkson pleaded guilty to two of the product-violation charges and a jury found him guilty on 26 counts related to the tax misconduct. His sentence also included a $100,000 fine and an order to settle his tax delinquency. At the hearing, the judge concluded that he owed between $1 and $1.5 million for the unpaid payroll taxes.

Archived versions of the WaterOz Web site show that from 2000 to 2002, the site contained "recommended protocols" for using 22 mineral products to treat about 100 "specific health issues" including AIDS, appendicitis, cancers, Down's syndrome, epilepsy, multiple sclerosis, and parasites. In 2002, the 60-page WaterOz Buyer's Club catalog offered about 200 products with false claims that more than 100 diseases and conditions are caused by mineral deficiency and can be effectively treated with the products. Despite the product-violation conviction, the site still advertises most of the mineral products with unsubstantiated health claims. Quackwatch has additional information about Hinkson.

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This page was posted on June 7, 2005.