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FDA Issues Warning Letters to Online Cigarette Companies

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In April 2013, the U.S. Food and Drug Administration (FDA) issued warning letters to certain online cigarette retailers, finding many of their products adulterated and misbranded in violation of the Federal Food, Drug, and Cosmetic Act (FDCA). One of the companies is located in Indonesia but offers its cigarettes for sale to customers in the United States. It is unclear where the other company is based, as it is an internet retailer with no available address information. You can read the warning letters by clicking here and here. The FDA sent similar warning letters to other online retailers of cigarettes…
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FDA Publishes CPG on Food Facility Registration

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On April 4, 2013, the U.S. Food and Drug Administration (FDA) published its Draft Compliance Policy Guide Sec. 100.250 Food Facility Registration—Human and Animal Food. This compliance policy guide, when finalized, will provide a resource to FDA staff on the requirements of food facility registration under Section 415 of the Federal Food, Drug, and Cosmetic Act (FDCA) and aid the Agency in determining whether parties subject to food facility registration are compliant with all applicable laws and regulations. The draft is available here. Section 415 was added as an amendment to the FDCA by Section 305 of the Public Health,…
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