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The FDCA prohibits misbranding, or "the introduction or delivery for introduction into interstate commerce of" a misbranded drug.
The misbranded drugs included nutropin, a human growth hormone, and actovegin, a substance derived from calf's blood.
Manufacturers will be required to characterize the identity, purity, strength and composition of their dietary supplements, and supplements that contain contaminants or incorrect ingredients will be judged by the FDA as adulterated or misbranded.
In the 73-page order, FDA writes, "After review of the comments and finding no additional scientific evidence to alter the proposed categorization, FDA accepts the Panel's recommendation and adopts Category I as the final category for AVA and determines AVA to be safe and effective and not misbranded.
2345 would make it a crime to knowingly cause a prescription drug to be adulterated, misbranded, or misrepresented as an approved drug and then sell or trade that drug.
There were an alarming number of websites of companies that were selling misbranded pesticides, unregistered pesticides, and restricted chemicals being sold to uncertified applicators," says Tim Creger, a program manager with the Nebraska Department of Agriculture.
Products labeled as "meat" found to contain spinal cord tissue are considered misbranded under FSIS policy.
He and his company are each charged with one count of offering a misbranded drug or device for sale and one count of offering an adulterated drug or device for sale.
The cases generally involve foods, drugs, devices, or cosmetics alleged to be adulterated or misbranded or otherwise violative of the law when introduced into and while in interstate commerce or while held for sale after shipment in interstate commerce.
BMPEA is none of these, rendering misbranded any products that declare BMPEA as a dietary supplement.
The indictment alleges that Vascular Solutions and its CEO introduced adulterated and misbranded medical devices into interstate commerce, and conspired to introduce adulterated and misbranded medical devices into interstate commerce.