Wiley's Act prohibited manufacturing and shipping adulterated or misbranded
foods in interstate commerce.
Companies are being charged with the sale of misbranded
drugs, and the promotional advertising is relevant because it demonstrates a company's intent to introduce its drugs into interstate commerce for off-label uses.
total of 9,265 samples were found to be adulterated and misbranded
Food and Drug Administration nor the California Department of Public Health found TNS products to be safe for their intended use, and because TNS products omit required disclosures relating to safety concerns, the products have been misbranded
under both federal laws and parallel state laws.
District Court for the Eastern District of New York, a jury in 2008 found Caronia guilty of conspiracy to introduce a misbranded
drug into interstate commerce.
EPA inspections of the Daifuku Trading Corp.'s stores in Flushing, New York and Englewood, New Jersey revealed that the company was selling unregistered and misbranded
pesticide products, including insect repellents, laundry detergents and disinfectants.
If an entity that is subject to GDUFA's self-identification requirements fails to meet the requirements, all FDF or API products and all FDFs containing APIs manufactured at the facility will be deemed misbranded
. Shipment of misbranded
products in interstate commerce or importation of them into the U.S.
These two laws prohibit the marketing of adulterated or misbranded
cosmetics in interstate commerce.
The company pleaded guilty to two counts of introducing misbranded
antidepressant drugs Paxil and Wellbutrin and one charge of failing to report safety data about the diabetes drug Avandia to the Food and Drug Administration (FDA).
The FDA, however, disagreed, claiming the changes "could significantly affect the safety or effectiveness of the device." As a result, the agency deemed Merit Medical's guidewire adulterated and misbranded
, and said it did not have either premarket approval or an investigational device exemption to sell the product.
The bill would increase criminal penalties for companies and individuals that knowingly contaminate the food supply by distributing misbranded
or tainted food products.
The exclusion order was based on misdemeanor guilty pleas by each officer admitting that they had served as "responsible corporate officers" during a five year period for which the company had been convicted of marketing misbranded
drugs (OxyContin) with the intent to mislead the FDA.