Search Results for agency_names:"Food and Drug Administration"

The Food and Drug Administration (FDA) issued an order banning Jonathan Corbett Cosie from importing any drugs into the United States for 10 years. This decision follows his conviction for two federal felonies related to selling misbranded, unapproved drugs, including some that were falsely labeled and sold without a prescription. Mr. Cosie was notified of his debarment and given the opportunity to request a hearing, but he did not respond, waiving his right to contest the decision. The ban is effective as of March 13, 2025.

The Food and Drug Administration (FDA) has issued a final order denying Bernardo Garmendia's request for a hearing and has permanently banned him from providing services related to drug products. This decision stems from Garmendia's conviction for conspiracy to commit wire fraud while working at AMB Research Center, where he was involved in falsifying clinical trial documents. As of March 14, 2025, using Garmendia’s services in any drug application process incurs civil penalties for involved parties. This ruling highlights the FDA's commitment to safeguarding drug development processes.

The Food and Drug Administration (FDA) is releasing a draft guidance for the industry about labeling plant-based foods that are alternatives to animal-derived products, like plant-based meat and eggs, but not plant-based milk. This guidance aims to help companies label these products in a way that clearly shows what the foods are, especially because there are no standard naming guidelines for many of these new products. The FDA believes this guidance will help consumers make informed choices. Comments on this draft can be submitted by May 7, 2025, electronically or on paper.

The Food and Drug Administration (FDA) is updating the definition of the term "healthy" as it applies to food labeling to align with current nutrition science and dietary guidelines. This new rule outlines what food manufacturers must meet to label their products as "healthy," focusing on food groups and limiting certain nutrients like added sugars, saturated fats, and sodium. The rule aims to help consumers make better choices for maintaining a nutritious diet and to reduce diet-related chronic diseases. It is designed to ensure that foods labeled as "healthy" provide accurate and helpful information, promoting overall health and nutrition equity.

The Food and Drug Administration (FDA) is extending the comment period on the request for information about export lists for human food from other countries until February 21, 2025. This extension allows individuals and companies more time to provide input, especially regarding the potential fees for export certification services, which could affect businesses significantly. This decision follows requests for more time due to the overlap with the holiday season and the complexity of the proposed changes. Interested parties can submit comments electronically or via mail.

The Food and Drug Administration (FDA) has issued an order permanently banning Jerrod Nichols Smith from providing services related to drug product applications. This decision follows his conviction on multiple felony counts of mail fraud and obstruction of justice, connected with the unlawful distribution and misrepresentation of prescription drugs. Smith's company, Cumberland Distribution, was involved in distributing drugs illegally obtained from unlicensed sources, leading to significant profit from falsified documents and drug mislabeling. After being notified, Smith did not respond or request a hearing, resulting in his debarment which prohibits him from engaging in drug product services.