October 2003

Company petitions FDA to make claims for calcium benefits

A worldwide supplier and producer of coral calcium material has filed five petitions with the U.S. Food and Drug Administration’s (FDA) Office of Nutritional Products, Labeling and Dietary Supplements to allow health claims for calcium.

Marine Bio Co., Ltd. of Japan wants to be able to claim that coral calcium:

• May reduce risk of fractures of certain areas of the body;

• May reduce risk of certain cancers;

• May reduce risk of kidney and urinary stones;

• May reduce risk of certain types of hypertension, including pre-eclampsia;

• May reduce risk of certain gynecological disorders in women.

Coral calcium came under the scrutiny of the Federal Trade Commission and the FDA last June when the FTC charged the marketers of one coral calcium product, Coral Calcium Supreme, with making false and unsubstantiated claims about the product’s health benefits.

In a complaint filed in federal district court (Northern District of Illinois), the FTC alleged that marketers of Coral Calcium Supreme “violated the FTC Act by claiming, falsely and without substantiation, that [this product] can treat or cure cancer and other diseases, such as multiple sclerosis and heart disease.” Coral Calcium Supreme had been marketed primarily in an infomercial aired on cable television.

Concurrent to filing charges, the FTC sent an e-mail letter to Internet advertisers of coral calcium products and demanded immediate action. The letter said, in part, “This letter places you on notice that any claim that coral calcium is an effective treatment or cure for cancer and/or other diseases must be supported by competent and reliable scientific evidence. We are aware of no scientific studies supporting such claims … You also should be aware, if you are marketing a dietary supplement, that FDA law prohibits any labeling claims that a dietary supplement is intended to prevent, mitigate, treat or cure cancer or any other disease under the Federal Food, Drug and Costmetic Act as amended by the Dietary Supplement Health and Eeducation Act of 1994.”

Commenting on his company’s petition to the FDA, Vincent Hackel, vice president of Marine Bio, Inc., USA, a wholly-owned subsidiary of Marine Bio Co., said, “Our petitions are based on extensive scientific reports prepared by … a nutritionist and consultant to public and private companies.” Hackel said that more than 1,000 reports are being submitted to the FDA for review.”

Sources: Business Wire, Federal Trade Commission

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