FDA Says Don’t Use Cal-Ban 3000
WASHINGTON (AP) _ The Food and Drug Administration said Friday it wants Cal-Ban 3000 diet tablets and capsules taken off the market because they can cause throat obstructions and their weight-loss claims are unproven.
The agency advised consumers to stop using Cal-Ban, whose main ingredient is guar gum, a complex sugar that swells with water and creates a sense of fullness when eaten.
The FDA sent a letter to Cal-Ban’s distributor, Health Care Products Inc. of Lutz, Fla., saying the agency would take legal action against the company if it does not stop distribution of the product.
The agency called Cal-Ban ″a health hazard″ based on reports of 17 cases in which people experienced throat obstruction after eating Cal-Ban 3000. Ten were hospitalized and one died as an indirect result of the obstruction when a blood clot reached the lungs during surgery, the FDA said.
Last week, Florida stopped state sales of the product because it had reports of 50 cases involving injuries. The FDA said it has asked to review those cases.
Company officials could not be reached for comment. The telephone number for the company, which also does business as Anderson Pharmacals of Tampa, Fla., reached a recording that said the line had been disconnected.
Cal-Ban is distributed nationally, the FDA said.
The FDA said guar gum has not been demonstrated to be an effective weight- loss ingredient. The agency has been moving to ban the substance for this use.
Use of guar gum is permitted in small amounts in foods such as cheese, salad dressings and ice creams. The FDA said it poses no health problem when used that way.
Health Care Products is currently under a temporary restraining order issued by a federal court in Tampa that prohibits the company from selling Cal-Ban 3000 by telephone or mail, said Jeff Drucker, an attorney in the consumer protection division of the Postal Service.
He said the order stems from a Postal Service action several years ago in which the agency alleged the company falsely advertised that Cal-Ban was an effective weight-loss product.