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

The Environmental Protection Agency (EPA) has established new tolerances for the residues of the pesticide ethaboxam on sugar beet roots, allowing a maximum of 0.03 parts per million. This decision was made after evaluating the safety of the pesticide under the Federal Food, Drug, and Cosmetic Act (FFDCA), ensuring that there's a reasonable certainty of no harm to the general population, including infants and children. The EPA's ruling was in response to a petition by Valent U.S.A. LLC and is consistent with similar residue limits (MRLs) set by Canada. The new rule is effective as of February 9, 2021.

The Food and Drug Administration (FDA) has released revised guidance for industries regarding food allergen labeling, as outlined in the Federal Food, Drug, and Cosmetic Act, incorporating updates from both the Food Allergen Labeling and Consumer Protection Act of 2004 and the Food Allergy Safety, Treatment, Education, and Research Act of 2021. This guidance specifically addresses labeling guidelines for allergens like sesame, milk, and eggs, and explains how to handle certain additives and oils in labeling. The FDA emphasizes that while the guidance reflects current FDA thinking, alternative compliance methods are allowed if they meet legal requirements. Public comments on this guidance are welcome and can be submitted electronically or in writing. The guidance is publicly accessible online.

The Environmental Protection Agency (EPA) has announced a final rule establishing an exemption from tolerance requirements for Bacillus thuringiensis strain EX 297512. This strain can now be used as a non-active ingredient in pesticides for seed treatment without needing to meet specific residue limits, as supported by a petition from BASF Corporation. The EPA has determined based on scientific data that this exemption poses no harm to human health, including infants and children, as it involves low toxicity levels. The rule is effective from February 25, 2025, with any objections or hearing requests needed by April 28, 2025.

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 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 five Emergency Use Authorizations (EUAs) for drugs and biological products during the COVID-19 pandemic. These authorizations, allowed under the Federal Food, Drug, and Cosmetic Act, aim to help address public health emergencies by making medical products available when there are no adequate alternatives. The products authorized include those requested by Baxter Healthcare, the U.S. Department of Health and Human Services, Eli Lilly and Company, and Regeneron Pharmaceuticals. The FDA ensures that these authorizations are based on scientific evidence indicating that the benefits of using these products outweigh the risks.

The Environmental Protection Agency (EPA) is transferring certain pesticide-related information to the U.S. Department of Justice (DOJ) and other parties involved in specific legal cases. This includes details that might be considered Confidential Business Information (CBI) under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA). The transfer complies with regulations about disclosing such information in litigation. The documents may include sensitive data on the pesticide tetrachlorvinphos (TCVP), and extra precautions, like a Protective Order, will ensure confidentiality is maintained throughout the court process.

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) 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) has submitted a proposed information collection to the Office of Management and Budget (OMB) for review under the Paperwork Reduction Act of 1995. The information collection supports the establishment of the Advanced Manufacturing Technologies (AMT) Designation Program as authorized by the Federal Food, Drug, and Cosmetic Act. This program encourages the pharmaceutical and biologic industries to adopt new manufacturing technologies to help with the development and availability of critical medical products. The FDA has also published draft guidance for this program, inviting public feedback to refine and improve the implementation process.