FDA Warns Public that “Fat Zero” Contains Hidden and Dangerous Drug
The Food and Drug Administration (FDA) has issued a Public Notification advising consumers not to purchase or take “Fat Zero”, a weight loss product sold in various retail stores and websites.
The FDA provides that “FDA laboratory analysis confirmed that Fat Zero contains sibutramine. Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. The product poses a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. This product may also interact, in life-threatening ways, with other medications a consumer may be taking. Laboratory analysis also confirmed that Fat Zero contains phenolphthalein. Phenolphthalein was an ingredient in some over-the-counter (OTC) laxative products until 1999 when FDA reclassified the ingredient as “not generally recognized as safe and effective.””
In particular, the manufacturer’s website provides that “Fat Zero will give your body the jump start it needs to lose those unwanted pounds,” but the website provides that statements within the website “have not been evaluated by the Food and Drug Administration.” As reported by NBC News, Fat Zero is marketed as a safe, natural product, containing bee pollen and other ingredients like green tea and lotus seed. However, Fat Zero also contains sibutramine, a prescription diet drug that was so dangerous it has been pulled off the market in the United States by the FDA. Sibutramine affects several brain chemicals, including serotonin and norepinephrine.
Although supplements and herbal products are not regulated by the FDA before they are sold (unlike prescription drugs), manufacturers of supplements and herbal products can sell products made with ingredients that are “generally recognized as safe” – so long as manufacturers do not make specific healthy claims. However, the FDA is able to test these supplements and herbal products, and if the FDA finds potentially dangerous ingredients, the FDA can warn the public.
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