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

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 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 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) 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 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 Environmental Protection Agency (EPA) has finalized a rule that establishes an exemption from the requirement of a tolerance for certain fatty acids used in pesticide formulations. These fatty acids, specifically C16-18 and C18-unsaturated, esters with polyethylene glycol mono-Me ether, can be used safely as surfactants in pesticide products for crops and raw agricultural commodities, provided they do not exceed 25% of the formulation by weight. This rule responds to a request from Spring Regulatory Sciences on behalf of Sasol Chemicals (USA) and is effective as of December 2, 2024. The EPA determined that, under specified conditions, the exemption poses no harm to human health, including vulnerable populations like infants and children.

The Food and Drug Administration (FDA) has denied Yong Sheng Jiao's request for a hearing and has banned him from importing or offering to import any drugs into the United States for five years. This decision stems from Jiao's conviction for importing misbranded drugs, specifically dipyrone, by mislabeling them as sebacic acid. Jiao tried to argue that he was not responsible for the misbranding, claiming it was his supplier's fault, but the FDA maintained that his guilty plea in court provided enough basis for the ban. The FDA determined a five-year ban was appropriate after weighing the seriousness of his offense against the few mitigating actions he took.

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 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) 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.