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This document presents current approaches and concerns regarding over-the-counter hCG devices. It is based on: 1) current science; 2) clinical experience; 3) previous submissions by manufacturers to the Food and Drug Administration (FDA); 4) the FDA Modernization Act of 1997 (FDAMA); and 5) FDA regulations in the Code of Federal Regulations (CFR). As advances are made in science and technology, and as changes in implementation of legislation occur, these Review Criteria will be re-evaluated and revised as appropriate. So that the draft may be revised as necessary, please send comments as instructed in the Preface.

Take a "natural" hormone the body makes during pregnancy -- and lose a lot of weight? That's the promise that's turned the hCG Diet -- named after that hormone -- into a craze that just won't quit. If you also go on an ultra-low-calorie diet, backers claim, hCG can “reset your metabolism” so you lose as much as a pound a day without feeling hungry or weak.

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