Search Results for agency_names:"Food and Drug Administration"

The Food and Drug Administration (FDA) has issued an order permanently banning John Warrington Kosolcharoen from working with companies that have approved or pending drug product applications. This decision resulted from his felony conviction for fraudulently selling an unapproved stem cell product, ReGen, and making misleading claims about its safety and effectiveness. Mr. Kosolcharoen was given the chance to challenge the debarment but did not respond in the provided timeframe, leading to a waiver of his right to a hearing on the decision. During his debarment, any business that employs him for related services could also face penalties.

The Food and Drug Administration (FDA) is proposing a new rule to set a maximum nicotine level in cigarettes and other combusted tobacco products. This measure aims to decrease the addictiveness of these products, making it easier for people who want to quit to do so, and to prevent youth from becoming addicted. The rule is expected to benefit public health by reducing the number of individuals who start smoking or continue smoking over time. The proposal could potentially improve health outcomes by reducing the overall harmful effects of tobacco addiction.

The Department of Health and Human Services and the Food and Drug Administration (FDA) are proposing to permanently waive certain premarket notification requirements for specific medical devices. This action follows temporary waivers provided during the COVID-19 pandemic to make medical devices more accessible. The proposal includes making seven class I devices and 84 class II devices permanently exempt from the 510(k) premarket notification requirement, which typically involves a costly and time-consuming process. The public is invited to comment on the proposed exemptions and suggest improvements to the regulatory system concerning medical devices.

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.

The Food and Drug Administration (FDA) has set January 1, 2024, as the uniform compliance date for food labeling regulations that were published between January 1, 2021, and December 31, 2022. This means any new food labeling rules released during this timeframe must be followed by the start of 2024 to reduce the economic impact of labeling changes on the food industry. The FDA states that while these regulations don't immediately introduce new costs, they allow businesses time to adjust their labeling practices. The rule also specifies that special circumstances may justify a different compliance date, which will be detailed as needed.

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) announced the user fee rates for fiscal year 2025 under the Over-the-Counter (OTC) Monograph Drug User Fee Program. This program allows the FDA to collect fees from manufacturers of OTC monograph drugs, which do not require a new drug application. For FY 2025, the fee for facilities manufacturing these drugs is set at $37,556 for monograph drug facilities and $25,037 for contract manufacturing organizations. These fees help the FDA cover the costs associated with regulating OTC monograph drugs.

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 proposing a rule to require testing of talc-containing cosmetic products to detect and identify asbestos, which is a known carcinogen. This rule would mandate the use of standardized testing methods involving both Polarized Light Microscopy and Transmission Electron Microscopy to ensure that cosmetics do not contain asbestos, which poses health risks to consumers. Manufacturers would need to test each batch or lot of their products or rely on certified analysis from suppliers, and they must maintain records of the testing. This rule aims to enhance consumer safety by reducing the risk of asbestos exposure from cosmetic products.

The Department of Health and Human Services (HHS) has issued a final rule that requires its regulations to be reviewed periodically, with most regulations set to expire automatically every ten years unless reviewed. This is intended to ensure that regulations stay up-to-date and relevant. The final rule also includes processes for public comments and specifies the criteria for reviews, which include assessing whether the regulations significantly impact small entities, and if they are still necessary or need amendments. Certain regulations, such as those mandated by federal law and the annual Medicare payment update rules, are exempt from these reviews.