Coral calcium scrutinized
WASHINGTON — Perhaps you’ve seen it touted in television infomercials as a wellspring of long life and a treatment for, among other things, colon cancer, multiple sclerosis, lupus and heart disease. Federal regulators too have seen the advertisements for coral calcium, and they’re not buying the claims.
They have, however, claimed some of the goods.
In late June, U.S. marshals, operating at the behest of the Food and Drug Administration, seized about $2.6 million worth of Coral Calcium Supreme, a dietary supplement hawked by entrepreneurs Kevin Trudeau and Robert Barefoot in paid advertising that aired until midsummer on cable channels including Discovery Channel, Bravo and the Comedy Channel. The FDA and the Federal Trade Commission went to court to make Trudeau and Barefoot stop making the claims for coral calcium’s health effects, and until the case comes before a judge in the spring, the infomercials touting its benefits may not air.
Coral Calcium Supreme, meanwhile, continues to be marketed, both on the Internet and in stores, costing about $17 for a one-month supply. One wholesaler selling the product online prominently advertised as of last week on its Web site: “Plenty of coral calcium in stock, ready to ship!â€
The Federal Trade Commission also has warned at least 18 firms that operate Web sites selling coral calcium that they should stop making unsubstantiated health claims for the popular calcium supplement or they too will be hauled into court.
Coral calcium contains calcium derived from crushed coral taken off the seabed near Okinawa, Japan, as well as magnesium and other minerals found in the skeletal remains of these reef-swelling organisms. Calcium plays a key role in regulating body chemistry, facilitating electrical impulses in the cells, and building and maintaining healthy bones.
But because roughly 90% of American girls and women and almost three-quarters of American men do not get enough calcium in their diet, supplements -- which derive calcium from sources as diverse as oyster shells and limestone deposits -- have become big business in recent years. According to the San Diego-based Nutrition Business Journal, calcium supplements commanded about $877 million in sales in 2002, a figure that has surged because of market interest in coral calcium.
Although other dietary supplement companies offer coral calcium, the federal actions focused specifically on Coral Calcium Supreme and its makers and distributors. Barefoot’s once-ubiquitous infomercial had made Coral Calcium Supreme the largest seller in this thriving cottage industry.
Calls for the FDA and FTC to clamp down on the marketing of Coral Calcium Supreme came from the dietary supplement industry itself. In a letter sent in May to the agencies, the Washington, D.C.-based Council for Responsible Nutrition, a trade group representing the dietary-supplement industry, appealed to the government to “take action against outrageous marketing claims for the dietary supplement product, Coral Calcium.â€
The council’s president, Annette Dickinson, called the supplement “one of the most aggressively and pervasively promoted dietary supplements on the market today,†adding that “the entire industry is tarnished when irresponsible companies appear to be getting away with making illegal claims.â€
In addition to their claims that Coral Calcium Supreme could treat or prevent several major illnesses, Trudeau and Barefoot told potential buyers that calcium derived from crushed coral found on the ocean floor is more easily absorbed into the system than supplements derived from other sources -- a claim the FTC also disputes.
Preliminary studies have suggested that adequate levels of calcium may provide some protection against the growth of precancerous intestinal polyps, protect against high blood pressure during pregnancy and reduce premenstrual symptoms. But claims made by Trudeau, Barefoot and many Web sites selling coral calcium “go far beyond existing scientific evidence regarding the recognized health benefits of calcium,†the FTC charged in court.
The FTC complaint was filed against Trudeau, Barefoot and two of the companies they formed to sell dietary supplements, Shop America and Deonna Enterprises Inc. Until the matter comes before a judge this spring, the makers of Coral Calcium Supreme may not air the infomercials that contain those claims. The court case stemming from the FDA’s seizure of Coral Calcium Supreme in a warehouse outside of Chicago will determine whether and how the product may be sold.
Wholesale distributors of Coral Calcium Supreme referred a reporter seeking comment from Barefoot to a Web site (www.cureamerica.net). Under the heading “Robert R. Barefoot, Wickenburg, Ariz. 85358,†a statement on the Web site suggests the controversy stems from a scientific debate in which the federal government has intervened unnecessarily. “The fact that critics, including the [Council for Responsible Nutrition], have chosen to side with one group of scientists in the debate over the benefits of coral calcium is no justification for government enforcement action that would bar Bob Barefoot from publicizing the views of those who take the other side,†the statement says.
The warnings and seizure are part of a stepped-up federal campaign against what the government says are false or baseless health claims made by the makers and marketers of dietary supplements.
Howard Beales, the director of the FTC’s Bureau of Consumer Protection, said the agency’s move against Coral Calcium Supreme “demonstrates that the FTC will take aggressive enforcement action, especially when, as alleged in this case, the products are marketed as cures for serious diseases like cancer and heart disease. Marketers who step over the line will find themselves between a rock and a hard place.â€
The FDA and the FTC have focused particular attention on halting fraudulent promotion of drugs and dietary supplements over the Internet, where the sale of coral calcium has been brisk. “This is emerging as an increasingly insidious way of trying to exploit the public,†said FDA Commissioner Mark B. McClellan, who launched the FDA-FTC initiative on dietary supplements in December 2002.
The federal actions against those who make and market coral calcium are among the more than 200 warning letters and advisories that FDA and the FTC have issued since then to companies they allege are marketing dangerous or fraudulent health products. Since December, the FDA has seized more than $10 million worth of improperly labeled supplements, issued recalls for many products and promotions the agency deemed unsafe and banned the import of hundreds of supplement products into the U.S.
Among the FTC and the FDA’s other targets under this initiative have been ephedra, the dietary supplement with potentially dangerous stimulant effects, and Seasilver, a multi-ingredient supplement purported to cure or treat cancer, AIDS, diabetes and 650 other diseases.
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Sales on the rise
Sales of calcium supplements in the U.S. have risen in recent years, with the most recent surge attributed to consumer interest in coral calcium.
*--* 1997 1998 1999 2000 2001 2002 Sales (mill) $507 $567 $681 $742 $775 $877 Increase from prev yr 12% 20% 9% 4% 13%
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Source: Nutrition Business Journal
Los Angeles Times
