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

The Environmental Protection Agency (EPA) announced that it will transfer certain pesticide-related information, potentially considered Confidential Business Information (CBI), to the Battelle Memorial Institute. This is due to Battelle being awarded a contract to support the EPA's Office of Pesticide Programs (OPP) under specific regulations ensuring the information is properly secured and used only for intended purposes. Battelle will gain access to this information by February 16, 2021, and it will aid their work on the Endocrine Disruptor Screening Program (EDSP), covering areas like toxicological testing and computational toxicology.

The Food and Drug Administration (FDA) has released a draft guidance for the industry titled "Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway.” This guidance is aimed at describing how the FDA interprets the term "underway" in relation to confirmatory drug trials required after a drug has been granted accelerated approval. These trials are crucial for verifying the drug's effects on serious health conditions. The FDA is inviting the public to comment on this draft guidance by March 10, 2025, as part of their ongoing approval process requirements.

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 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 Environmental Protection Agency (EPA) has established a new regulation allowing a specific tolerance level for the pesticide cyprodinil on cranberries. This rule, requested by the Interregional Research Project No. 4 (IR-4), sets the maximum permitted residue level on cranberries at 0.4 parts per million to ensure safety in compliance with the Federal Food, Drug, and Cosmetic Act. EPA's assessment concluded that there is a reasonable certainty of no harm to humans, including children, from this exposure level. The regulation ensures that all necessary safety and risk assessments have been properly conducted and that the new tolerance standard does not exceed the established safe limits.

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 Environmental Protection Agency (EPA) established a final rule exempting specific proteins, Mpp75Aa1.1 and Vpb4Da2, used as plant-incorporated protectants in corn, from tolerance requirements. These exemptions mean the proteins, derived from naturally occurring bacteria, do not need to have their residue levels capped on corn as they pose no toxicity or allergenic risk to humans, including infants and children. The EPA's assessment ensures that no harm will result from these proteins in corn products, thus allowing their use without the need to establish maximum permissible residue levels. The agency employed validated detection methods and determined these actions won't significantly impact states, tribes, or power distribution between federal and state governments.

The Environmental Protection Agency (EPA) is extending time-limited tolerances for certain pesticides, including clothianidin, methyl bromide, and triclopyr, allowing their use on specific crops until December 31, 2023. These extensions are granted under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) due to emergency conditions. Additionally, the EPA is updating certain terminologies in its regulations to ensure consistency, and it is removing tolerances for flonicamid on prickly pear because the exemption is not renewed. The rule also aligns some U.S. tolerances with international standards and makes administrative revisions to existing regulations.

The Food and Drug Administration (FDA) has issued a priority review voucher to the sponsor of the rare pediatric disease product, CRENESSITY (crinecerfont). This voucher is awarded under the Federal Food, Drug, and Cosmetic Act, which allows such recognition for approved products meeting specific criteria. CRENESSITY is manufactured by Neurocrine Biosciences, Inc., and was approved on December 13, 2024, for the treatment of classic congenital adrenal hyperplasia in adults and children aged four and older. This announcement fulfills FDA's requirement to publish notice of such awards.

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.