Category Archives: Food & Drug Recalls

The AMPT Life, LLC Issues Voluntary Nationwide Recall of AMPT Coffee due to the Presence of Undeclared Active Pharmaceutical Ingredients and Undeclared Milk

The AMPT Life, LLC is voluntarily recalling all lots of AMPT Coffee to the consumer level. FDA laboratory analysis confirmed the presence of Sildenafil and Tadalafil, the active ingredient in Viagra, an FDA-approved prescription drug for Erectile Dysfunction (ED). AMPT Coffee also contains undeclared milk.

FDA approves new targeted treatment for relapsed or refractory acute myeloid leukemia

The U.S. Food and Drug Administration today approved Idhifa (enasidenib) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation. The drug is approved for use with a companion diagnostic, the RealTime IDH2 Assay, which is used to detect specific mutations in the IDH2 gene in patients with AML.

FDA announces comprehensive regulatory plan to shift trajectory of tobacco-related disease, death

The U.S. Food and Drug Administration today announced a new comprehensive plan for tobacco and nicotine regulation that will serve as a multi-year

roadmap to better protect kids and significantly reduce tobacco-related disease and death. The approach places nicotine, and the issue of addiction,

at the center of the agency’s tobacco regulation efforts. The goal is to ensure that the FDA has the proper scientific and regulatory foundation to

efficiently and effectively implement the Family Smoking Prevention and Tobacco Control Act. To make certain that the FDA is striking an appropriate

balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes, the agency is also

providing targeted relief on some timelines described in the May 2016 final rule that extended the FDA’s authority to additional tobacco products.

The agency will also seek input on critical public health issues such as the role of flavors in tobacco products.