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Saturday, January 08, 2005

Double Standard

So what else have we come to expect?

The FDA just must be in a state of brain fog -

NOVARTIS, the big pharmaceutical company uses Guar Gum in their product Benefiber. The FDA says that one person died from using this product in supplements.

T92-14, Guar Gum The article herein was written in 1992, maybe it is the money that makes one wonder what hasn't changed.

March 18, 1992

FDA ORDERS NATURE'S WAY GUAR GUM DIET PILLS OFF MARKET

FDA has received numerous inquiries about action taken recently by 10 states and the FDA against diet drug products containing guar gum. The following may help in responding to questions.

In a nationally coordinated effort, FDA and 10 states moved to stop the sale off a weight control drug product containing guar gum, an ingredient determined by FDA to be unsafe for weight control. FDA warned Nature's Way Products, Inc., of Springville, Utah, to stop distributing its East Indian Guar Gum capsules and to remove them from the market immediately.

Acting in concert with FDA, attorneys general in 10 states ordered General Nutrition Centers, the major distributor of the capsules nationwide, to stop selling them. They also ordered General Nutrition Centers to recall and destroy all other diet products containing guar gum. Failure to do so could result in civil penalties. The nationally coordinated action by FDA and the state attorneys general is the first of what are expected to be more joint enforcement actions against health fraud, deceptive practices and other violations of federal and state food and drug laws. FDA banned the use of guar gum in nonprescription diet drug products after numerous reports that the ingredient presents a health hazard. The agency also banned 110 other weight control ingredients in these products because none had proven effective. Guar gum was found to be neither safe nor effective. Guar gum is a complex sugar that swells when it becomes wet and is purported to create a sense of fullness when ingested. Diet drug products containing guar gum have caused numerous cases of esophageal, gastric and intestinal obstruction. Many people affected required hospitalization, and one eventually died as an indirect result of esophageal obstruction. Although the ingredient is banned in weight loss drug products, it is approved for use in small amounts in foods such as cheese, salad dressings and ice creams. This use is not a health concern.

In a letter to Nature's Way, FDA cited both use of a banned ingredient and claims on the label that make the product a new drug, requiring FDA approval before it can be legally marketed. East Indian Guar Gum capsules claim to promote weight control, regularity and digestion, and to control glucose and reduce cholesterol. Marketing a new drug without FDA approval is a violation of the Federal Food, Drug, and Cosmetic Act. FDA gave Nature's Way five days to advise the agency how it plans to comply with the law. Failure to do so could result in further regulatory action, such as seizure or injunction. FDA has moved against 14 manufacturers of guar gum diet drug products in the past couple of years. In July 1990, the agency told the marketer of Cal-Ban 3000 diet tablets and capsules to stop distributing those products and ordered distributors to recall supplies. U.S. Marshals subsequently seized more than 350,000 bottles of Cal-Ban 3000. In September 1991, a federal judge condemned the seized Cal-Ban 3000 as an unapproved new drug and ordered it destroyed.

http://www.fda.gov/bbs/topics/ANSWERS/ANS00386.html


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