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Vigilance in food illegal to add sibutramine hydrochloride and phenolphthalein

Recently, the food and drug regulatory authorities found that weight loss products add sibutramine hydrochloride and phenolphthalein violations and the violations were investigated. What is sibutramine hydrochloride and phenolphthalein exactly? Whether you added to food? What are the relevant standards and regulations? Recently, the China Food and Drug Administration released the 2016 first nine "Food Safety Risk Analysis", organization of expert interpretation of sibutramine hydrochloride and phenolphthalein.


Sibutramine hydrochloride worked for prescription drugs, but has been discontinued in most countries worldwide


Sibutramine hydrochloride (Sibutramine Hydrochloride) is sibutramine (Sibutramine) chloride, is a central nervous system-suppressing drugs, has been used for the treatment of obesity.


Sibutramine hydrochloride in 1997 by the US Food and Drug Administration (FDA) approved the listing and subsequently approved in the European Union, Australia, Canada, Japan and other countries listed, listed in 2000 in our country.


December 2009, the European Medicines Agency (EMEA) released research report, compared with placebo, patients taking sibutramine hydrochloride Ming severe, increasing the risk of non-fatal cardiovascular events. EU, UK and other countries and regions have to stop using drugs sibutramine hydrochloride. Former State Food and Drug Administration also organized relevant experts to the use of sibutramine in our safety was assessed that the risk is greater than the benefit of its weight loss treatment, and in October 2010 notice to stop production and sales of sibutramine use formulations of drugs and raw materials. Currently sibutramine hydrochloride as a weight loss drug has been discontinued in most countries worldwide.


Phenolphthalein is chemical and clinical prescription drugs, there are strict indications, should be applied under the guidance of a doctor, if the long-term overdose may cause serious side effects


Phenolphthalein as pharmaceutical raw materials in the pharmaceutical, the drug name is phenolphthalein tablets (Phenolphthalein Tablets), primarily for the treatment of habitual stubborn constipation. Long-term abuse or overdose can cause the body electrolyte metabolism disorders, severe cases can induce arrhythmia. Disabled infants and lactating women, young children and pregnant women with caution.


China's relevant laws and regulations expressly prohibit the addition of hydrochloric acid sibutramine and phenolphthalein in food (including health food) in


China's current Food Safety Law Article 38 clearly stipulates that "the production and operation of food shall not add drugs, but may be added in accordance with both food and traditional Chinese medicinal materials." Sibutramine hydrochloride and phenolphthalein does not belong to both food and Chinese herbal substances is prohibited to add in food (including health foods) in. Regulators will monitor and sampling as routine regulatory focus, once found food (including health foods) added its hydrochloride sibutramine or phenolphthalein components will be given severe punishment, suspected of a crime, they will be transferred to public security organs.


Therefore, experts recommend: First, the production enterprises should strictly abide by state laws and regulations to implement the main responsibility for food safety must not be in the food (including health food) in illegal drugs added. Recommendations indicate health functions related to the interpretation manual on health food products to consumers on the correct understanding of the function of health food. Second, the addition of hydrochloric acid sibutramine and phenolphthalein in food (including health foods) are part of a serious offense, regulators should increase the drug added to food such violations daily supervision and sampling, once discovered, severely crack down strict punishment, seriously. Third, consumers should take a rational diet health food. In strict accordance with the approved instructions to take, can not replace the normal diet. Qualified health food should be purchased through formal channels. Consumers and health food rational knowledge to enhance self-protection awareness, timely landing State Food and Drug Administration website "data query" column query to obtain information on state registration of health food. Found food (including health foods) has illegal behavior, please call 12331 to the local food and drug administration departments to report.

(State Food and Drug Administration Web site)