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In the United States, a boxed warning (sometimes "black box warning", colloquially) is a type of warning that appears near the beginning of the package insert for certain prescription drugs, so called because the U.S. Food and Drug Administration specifies that it is formatted with a 'box' or border around the text [1] to emphasize it is of ...
Warning Letters should only be issued for violations of regulatory significance, i.e., those that may actually lead to an enforcement action if the documented violations are not promptly and adequately corrected. A Warning Letter is one of the Agency's principal means of achieving prompt voluntary compliance with the Act. [1]
In August 2004, the US Food and Drug Administration issued a Warning Letter to Flora, Inc. for violating section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)]. Flora made twelve unfounded health claims about the purported benefits of noni juice as a medical product, in effect causing the juice to be ...
The FDA has expanded an apple juice recall over concerns of harmful arsenic levels. 133,500 cases of apple juice sold in 27 states, as well as Washington D.C. and Puerto Rico, have been recalled.
An auxiliary label (also called cautionary and advisory label or prescription drug warning label) is a label added on to a dispensed medication package by a pharmacist in addition to the usual prescription label. These labels are intended to provide supplementary information regarding the safe administration, use, and storage of the medication. [1]
Jessica DeCristofaro was diagnosed with stage 4B Hodgkin’s lymphoma, a rare form of cancer, at 28 years old. Here, she shares her story and what doctors missed. ‘Doctors Dismissed My Chronic ...
New tests done by the Environmental Working Group have found 21 oat-based cereals and snack bars popular amongst children to have "troubling levels of glyphosate." The chemical, which is the ...
[8] [9] For example, Kordich stated that he was influenced by the Gerson diet and was cured of cancer when he was 20 by consuming 13 glasses of apple and carrot juice each day. [ 8 ] [ 9 ] Stephen Barrett of Quackwatch noted that Kordich made far-fetched, nonsensical, and unproven health claims about juicing. [ 8 ]
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