Coral Calcium Claims Enforcement Action From FDA, FTC Urged By CRN

The Council for Responsible Nutrition advocates regulatory action against coral calcium marketers making "miracle cure" marketing claims in a May 15 letter to FDA and the Federal Trade Commission.

Coral calcium marketer and spokesman Robert Barefoot, whose books and infomercials have helped drive the burgeoning market for the supplement, and the many entities who use his name and claims, are primary targets of the trade group's letter.

CRN "requests that the FTC and the FDA take appropriate enforcement action to end Mr. Barefoot's highly visible and deceptive marketing campaign for coral calcium, and to prevent Mr. Barefoot from further fraudulent activities," the letter says.

"In addition, we urge the agencies to publicize this action and notify other entities marketing coral calcium through the use of such claims that they are in violation of federal law," CRN writes.

The letter was sent to FDA Commissioner Mark McClellan, MD/PhD, and FTC Chairman Timothy Muris.

Cancer, heart disease, diabetes and Alzheimer's are among the diseases Barefoot and competitors claim are caused by calcium and mineral deficiency and can be cured with coral calcium, the trade group says.

Coral calcium achieved its current popularity largely through infomercials Barefoot says he began running in late 2001. He estimates that since that time the number of people using the supplement has grown from around 200,000 to about 5 mil.

Barefoot's infomercial co-host Kevin Trudeau has been a defendant in an FTC case involving deceptive heath claims made on infomercials (¹ (Also see "Herbal supplement radio infomercial ad claims prohibited in FTC consent agreement." - Pink Sheet, 19 Jan, 1998.), p. 19). In a settlement with FTC, Trudeau agreed to pay $500,000 in consumer redress.

CRN cites rapid proliferation of coral calcium products with false claims as the reason for its initiative.

The letter characterizes coral calcium as "one of the most aggressively and pervasively promoted dietary supplements on the market today," and notes it is sold on thousands of Web sites, "many of which repeat Barefoot's claims."

Barefoot says he is concerned over the large number of unaffiliated marketers using his name and has authorized over 600 cease-and-desist letters to parties using his name without permission.

According to Barefoot, Coral Calcium "Supreme" is the only product he actually endorses. To reduce consumer confusion, Barefoot says he is launching the Bob Barefoot's Best line of coral calcium products. Featuring his image and signature, the products began reaching shelves at Wal-Mart and other retailers in early May, he says.

Mineral and vitamin content claims vary among coral calcium products, though many stress the ratio of calcium to magnesium. Many claim to be sourced from Okinawa, Japan and promotional materials often claim superiority over calcium derived from other sources.

The trade group does not take issue with the sale of coral calcium, only with the type of disease claims being made. "While coral calcium supplements undoubtedly provide the proven health benefits of calcium for bone health, the claims for coral calcium spread by Mr. Barefoot and his progeny go way beyond any existing scientific support," CRN says.

"Mr. Barefoot's promotional materials provide a textbook example of health fraud as described by the FTC and FDA," CRN maintains, pointing to the use of "undocumented case histories or personal testimonials by consumers or doctors claiming amazing results."

"Permitting the continuation of such highly visible and fraudulent claims does grave disservice to consumers who turn to the marketplace for information about their health," CRN asserts, adding the resulting disillusionment "undermines consumer confidence in the dietary supplement market as a whole, inevitably harming those responsible companies who provide quality products based on sound science."

According to Barefoot, he does not make health claims, but rather cites the experiences and research of others, including the medical community. He also says he has not heard from the FDA or FTC in reference to health claims.

CRN recently partnered with four other trade associations to issue an advisory to industry against the use of unsupported SARS claims for dietary supplements (² (Also see "SARS Prevention, Treatment Claims Inappropriate For Supplements – Industry" - Pink Sheet, 28 Apr, 2003.), p. 17).