Search Results for keywords:"Federal Food, Drug, and Cosmetic Act"

The Environmental Protection Agency (EPA) has received a pesticide petition that asks to establish or change regulations for pesticide residues on various food commodities. The petition is being filed under section 408 of the Federal Food, Drug, and Cosmetic Act and the EPA is seeking public comments on it until March 29, 2021. This notice allows people, especially those involved in agriculture, food manufacturing, or pesticide production, to weigh in on potential changes. No specific actions are proposed yet, as the EPA will evaluate public feedback before deciding on any possible regulatory changes.

The Food and Drug Administration (FDA) is inviting public comments on the proposed collection of specific information related to dietary supplement labeling. Under the Paperwork Reduction Act, federal agencies must publish notices for any information collection activities, allowing 60 days for public feedback. The proposal involves manufacturers, packers, or distributors of dietary supplements notifying the FDA about claims made on supplement labels. Comments can be submitted electronically or in writing by February 18, 2025.

The Food and Drug Administration (FDA) has issued an order under the Federal Food, Drug, and Cosmetic Act to permanently ban Sunrise Lee from working with any person or company that has a drug product application. This decision follows her felony conviction for racketeering related to the regulation of a drug product. Lee, who previously worked in a leadership role at Insys Therapeutics, was found guilty of participating in a conspiracy to bribe medical practitioners to prescribe a fentanyl-based drug called SUBSYS. Despite being notified of the proposed ban and given a chance to contest it, Lee did not respond, resulting in a waiver of her right to a hearing.

The Environmental Protection Agency (EPA) has issued a final rule granting an exemption from the requirement of a tolerance for potassium polyaspartate when used as an inert ingredient in pesticide formulations, at a maximum of 10% concentration pre-harvest. This decision means that there is no need to set a maximum legal limit for residues of this chemical in food, as it has been deemed safe. The rule is effective from March 20, 2025, and the EPA has reviewed scientific data to ensure that there is a reasonable certainty of no harm from aggregate exposure to potassium polyaspartate. The regulation does not directly affect states or tribal governments and aligns with federal standards without imposing additional mandates.

The Food and Drug Administration (FDA) is inviting public comments on a proposed collection of information concerning device classification and regulatory requirements, as part of their responsibilities under the Paperwork Reduction Act of 1995. The information collection supports regulations and guidance under section 513(g) of the Federal Food, Drug, and Cosmetic Act, which outlines how people can request the FDA's views on device classification and applicable requirements. Individuals can submit comments electronically or by mail by March 15, 2021. Comments should focus on the necessity, accuracy, and potential improvements of the proposed information collection process.

The Food and Drug Administration (FDA) has released a final guidance document titled "Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act." This guidance outlines how the FDA plans to assess the public health significance of food allergens not already classified as major allergens, like milk or peanuts. It focuses mostly on allergies caused by IgE antibodies known to trigger severe allergic reactions. The FDA also made updates in response to feedback, including changes related to non-IgE-mediated allergies and new data references.

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) confirmed that RIOMET, a metformin hydrochloride oral solution, was not taken off the market for safety or effectiveness issues. This finding means that the FDA can continue approving generic versions of this medication if they meet legal requirements. RIOMET is listed as discontinued in the FDA's "Orange Book," but this is not due to any safety concerns. As a result, companies can still seek approval to produce generic versions of RIOMET, provided they comply with all necessary regulations.

The Environmental Protection Agency (EPA) has established an exemption from the requirement for a tolerance for the Bacillus thuringiensis Cry1Da2 protein used as a plant protectant in corn (field, sweet, and pop). This means that there is no need to set a maximum permissible level for these residues on corn products. Pioneer Hi-Bred International, Inc. requested this exemption, and the EPA concluded that the protein is safe, posing no significant risk of toxicity or allergenicity from exposure, including dietary intake. As a result, an analytical method for enforcement is not necessary.

The Environmental Protection Agency (EPA) has established new rules for the insecticide fluxametamide, allowing it to be used on dried and instant tea. This action was prompted by a request from Nissan Chemical Corporation and permits a maximum residue level of 5 parts per million. The EPA determined that there is a reasonable certainty of no harm to humans, including infants and children, from aggregate exposure to residues of fluxametamide on tea. As this is a final rule, it directly affects agricultural producers, food manufacturers, and pesticide manufacturers while adhering to existing regulatory standards.