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

The Environmental Protection Agency (EPA) has issued a final rule establishing tolerances for residues of the pesticide cyazofamid on various crops under the Federal Food, Drug, and Cosmetic Act. This rule was requested by the Interregional Research Project Number 4 (IR-4) and includes specific limits for residues on crops like chickpeas and parsnips. The EPA concluded that these tolerances are safe for the general population, including infants and children. Additionally, some existing tolerances on beans have been removed as they are now unnecessary.

The Environmental Protection Agency (EPA) has established a rule that exempts the microbial pesticide Beauveria bassiana strain BW149 from needing a tolerance level for residues on all food products. BioWorks, Inc. requested this exemption, arguing the pesticide is safe when used properly, with no harmful effects expected from exposure to humans, including children. The EPA determined that using this strain in agriculture following label directions does not pose health risks and thus does not require a specified permissible level for its residues. This rule is effective as of February 25, 2025.

The Food and Drug Administration (FDA) has amended regulations to allow the safe use of myoglobin as a color additive in plant-based ground meat and poultry alternatives. This rule comes in response to a petition from Motif FoodWorks, Inc., and establishes that the myoglobin used must not exceed 2% by weight of the uncooked product. The additive, produced through the fermentation of genetically engineered yeast, imparts a red color similar to raw meat. The FDA has concluded that this use is safe and does not require certification to protect public health. This rule takes effect on February 19, 2025, with a window for objections lasting until 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) has established tolerances for residues of the pesticide tetraniliprole in various agricultural commodities. This regulation, effective February 24, 2021, sets specific limits on the amount of tetraniliprole that can be present in foods like vegetables, fruits, and nuts, to ensure safety under the Federal Food, Drug, and Cosmetic Act (FFDCA). These tolerance levels were determined by evaluating the available scientific data and considering potential exposure risks, especially to infants and children. The EPA ensures that these tolerance levels are safe and align with international standards whenever possible.

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 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 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.

The Environmental Protection Agency (EPA) issued a final rule that provides an exemption from the requirement of a tolerance for residues of the Bacillus thuringiensis Cry1B.34 protein in corn. This means that the Cry1B.34 protein, used as a Plant-Incorporated Protectant (PIP) in various types of corn, does not require a specific maximum residue level. After evaluating the available safety data, the EPA concluded that the protein is safe and poses no significant risk to human health, including for infants and children. This exemption eliminates the need for numerical limits on Cry1B.34 protein residues, allowing its use without the traditional tolerance requirement.