Sen. Elizabeth Warren (D-MA) applauded FDA for funding research on durations of use for antibiotics in food animals.
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Sen. Elizabeth Warren (D-MA) applauded FDA for funding research on durations of use for antibiotics in food animals.
Stakeholders representing both industry and consumers called for a re-think of FDA’s generally-recognized-as-safe (GRAS) process, where companies can put a new ingredient in food without agency review.
FDA on Friday (March 15) finalized a rule that pushes back deadlines for farms to comply with agricultural water standards required in the Food Safety Modernization Act, despite calls from food safety advocates for the agency to implement interim rules to help prevent future foodborne illness outbreaks, such as the 2018 romaine lettuce E. coli outbreaks.
Food industry lawyers say that an agreement penned by FDA and the U.S. Department of Agriculture laying out how the two agencies will regulate cell-based meat and poultry products leaves several key questions unanswered, such as how the review process will work, what standards cell-based meats will have to meet for labeling and what the legal justification is for USDA’s role in regulating the non-traditional meat products
FDA experts applauded President Donald Trump’s fiscal 2020 budget request, which includes large increases for FDA, including a net $362 million boost for the agency’s taxpayer-paid budget authority, a $120 million increase for its user fee programs and $161 for new user fee programs.
FDA Commissioner Scott Gottlieb’s unexpected resignation leaves myriad agency policy and regulatory plans, many of which Gottlieb identified as key priorities, hanging in the balance.
Within hours of the announcement that FDA Commissioner Scott Gottlieb will be resigning from the agency in a month, an array of stakeholders sent out their near-universal applause of the commissioner’s leadership and policy initiatives.
FDA Commissioner Scott Gottlieb announced Tuesday (March 5) he will leave the agency within the next month and touted his agency’s many accomplishments during his 23 months as chief in a resignation letter to HHS Secretary Alex Azar, but he didn’t say why he was resigning.
FDA Commissioner Scott Gottlieb and Deputy Commissioner for Food Policy and Response Frank Yiannas on Monday (Feb. 25) promoted the agency’s food safety goals and programs in a statement that one food safety advocate believes is largely aspirational, as the agency does not have additional resources to help staff its foreign offices and conduct more import inspections.
FDA stakeholders are applauding the $269 million increase in FDA funding included in a government spending package to be voted on Thursday (Feb. 14) to avert another shutdown.
FDA stakeholders are applauding the $269 million increase in FDA funding included in a government spending package passed by Congress Thursday (Feb. 14) to avert another shutdown.
A food safety advocate said she was “crestfallen” that FDA’s final guidance detailing how the food industry and agency staff should issue public warnings and recall notifications does not require companies to disclose the names of retailers involved in the recall.
A week after the temporary end of a month-long partial government shutdown, the stakes are high for FDA as lawmakers and the White House resume talks on a possible deal to fund the government when the short-term spending bill ends Feb. 15.
A bipartisan group of 10 first-term House lawmakers wrote a letter to FDA Commissioner Scott Gottlieb on Wednesday (Jan. 30), urging the agency to not allow plant-based products to use dairy terms in their labeling, an issue the agency hopes to resolve as a part of its multi-year nutrition innovation strategy.
FDA drug center chief Janet Woodcock warned her staff on Monday (Jan. 28) that progress on rules and guidances might be slower than usual as the agency recovers from a month-long partial government shutdown that left 41 percent of its staff furloughed.
FDA Commissioner Scott Gottlieb said the month-old partial government shutdown “represents one of the most significant operational challenges in FDA’s recent history,” and he warned that more staff will be furloughed as the agency’s drug center runs out of Prescription Drug User Fee Amendment (PDUFA) funding.
As the partial government shutdown hits its third week, 33 Senate Democrats penned a letter to FDA Commissioner Scott Gottlieb on Friday (Jan. 11) asking the agency chief how his staff has scaled back oversight of food and medical products; how a shutdown could hinder approval of new medical products and what the agency is doing to address the financial hardship of its staff, 41 percent of whom are furloughed.
As the partial government shutdown nears its third week, FDA is working to restart inspections of domestic high-risk food facilities, though the furloughed workers who perform those inspections will likely go unpaid until the shutdown ends, FDA Commissioner Scott Gottlieb tweeted on Jan. 9
Over the holidays and the first days of January, FDA Commissioner Scott Gottlieb issued a steady stream of tweets in a bid to answer stakeholders’ questions about which agency activities are on hold during the partial government shutdown, including user fee-related application reviews, certain medical and over-the-counter product reviews, and non-emergency work on certain biologic products.
A bill that would have expanded the government’s definition of “natural cheese” to include additives and artificial ingredients, as well as exclude certain pasteurized process cheeses and plant-based cheeses from the definition, failed in the House on Thursday (Dec. 20) a few hours after Rep. Frank Pallone (D-NJ) called on fellow members to oppose the bill, which he said crossed into FDA's jurisdiction.
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