Search Results for agency_names:"Food and Drug Administration"

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 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) 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) 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 (HHS) is updating an existing system of records, named Federal Advisory Committee/Subgroup Member, Subscriber/Registrant, and Guest Speaker Records. This update includes adding records about guest speakers at advisory committee meetings and changing the system's name. New routine uses for the records have been established, such as sharing limited information about guest speakers’ qualifications and financial interests. The update aims to enhance transparency and ensure compliance with federal advisory committee regulations. Comments on the new and revised policies are invited until January 27, 2025.

The Food and Drug Administration (FDA) has proposed a new rule that would require most packaged foods to display a front-of-package (FOP) nutrition label called the Nutrition Info box. This label aims to help consumers quickly find and better understand important nutrition information by providing easy-to-read details about saturated fat, sodium, and added sugars. The new rule also includes updates to regulations for low sodium and low saturated fat claims, and would allow businesses time to adjust, with compliance dates varying based on their annual sales.

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 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.

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 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.