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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 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 has issued a notice clarifying that businesses that started producing hand sanitizers during the COVID-19 pandemic are not required to pay certain facility fees under the Food, Drug, and Cosmetic Act. These businesses, many of which normally produce alcoholic beverages, were allowed to make hand sanitizers due to a temporary policy by the FDA to address shortages. The Department emphasizes that imposing such fees would be inconsistent with the intent of the CARES Act and clarifies that these businesses are not considered drug manufacturing facilities under the law, unless they also engage in producing other over-the-counter drugs.

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 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) 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 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 a final rule establishing new guidelines for nonprescription drugs that require an "Additional Condition for Nonprescription Use" (ACNU). This rule allows drugs that can't be safely used with labeling alone to be sold without a prescription if the manufacturer implements an approved ACNU to ensure proper use. It aims to expand consumer access to certain drugs that would otherwise need a prescription and outlines specific requirements for drug application, labeling, and reporting failures of the ACNU process. The rule will take effect on January 27, 2025, and is intended to improve public health by making more medications safely available as nonprescription options.

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 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.