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Food Safety

January 11, 2018 | Daily News

In 2018, FDA will focus on making the process for developing and approving biosimilar drugs more efficient, modernizing its own internal processes and technologies, and developing a comprehensive plan to encourage development of healthy foods, the agency announced in its 2018 Strategic Policy Roadmap released on Thursday (Jan. 11).

January 09, 2018 | Daily News

In response to comments from food industry stakeholders, FDA won’t subject certain entities and activities to some provisions of the Food Safety Modernization Act (FSMA) that pertain to current good manufacturing practices (CGMPs) and risk-based controls for human and animal food; foreign supplier verification; and produce safety standards for growing, harvesting, packing and holding produce intended for humans, the agency explained in guidance document and press announcement on Thursday (Jan. 4).

December 14, 2017 | Daily News

FDA is planning a number of deregulatory moves in 2018, including expanding access to some drugs currently requiring prescriptions without the intervention of a health care provider, so long as they are coupled with safe guards to aid in self-selection and safe use, the agency announced in the White House Office of Management and Budget's Fall 2017 Unified Agenda released Thursday (Dec. 14).

November 17, 2017 | Daily News

FDA issued long-awaited guidance answering industry questions about how to comply with its menu labeling rule, slated to go into effect May 7, 2018, but the industry noted it will exercise enforcement discretion for out-of-compliance companies to help them comply with the law.

October 30, 2017 | Daily News

FDA Monday (Oct. 30) for the first time moved to revoke an FDA-authorized health claim, issuing a proposed rule, which if finalized, would revoke the authorized health claim linking consumption of soy protein to lower risk of heart disease.

October 18, 2017 | Daily News

The ranking Democrat on the Senate health committee Monday (Oct. 16) slammed FDA Commissioner Scott Gottlieb's proposal to delay implementation of the agency's updated nutrition facts rule, saying the move is detrimental to public health and creates uncertainty for industry and consumers.

October 17, 2017 | Daily News

As the FDA continues to delay several food-related regulations, it appears that the agency is still committed to taking steps to evaluate how the agency regulates 'healthy' and other food claims.

October 11, 2017 | Daily News

FDA's top lawyers argue that the U.S. International Trade Commission should not take up a recent unfair competition case filed by Amarin Pharma asking the commission to block importation and essentially freeze U.S. inventory of certain synthetic omega-3 products being sold as dietary supplements.

October 04, 2017 | Daily News

Consumer advocacy groups and members of the dietary supplement industry sparred over whether FDA has exerted enough authority to pull supplements off the market when they contain unsafe ingredients and whether the adverse event reporting system is adequate for finding unsafe ingredients.

September 29, 2017 | Daily News

FDA proposed Friday (Sept. 29) to extend the compliance dates for its nutrition facts regulations, citing a need to issue guidance on added sugar and dietary fiber for manufacturers to be able to successfully update their nutrition facts labels.

September 27, 2017 | Daily News

The HHS Office of Inspector General raises new questions about FDA's ability inspect domestic food facilities and meet inspection mandates under the Food Safety Modernization Act.

September 21, 2017 | Daily News

FDA, Centers for Disease Control and Prevention and United States Department of Agriculture will hold their first public meeting in three years on the National Antimicrobial Resistance Monitoring System (NARMS), the agencies announced Tuesday (Sept. 20).

September 19, 2017 | Daily News

The Center for Science in the Public Interest, National Consumers League and FDA agreed Friday (Sept. 15) to ask the United States District Court for the District of Columbia to stay the advocacy groups' menu labeling lawsuit, citing FDA Commissioner Scott Gottlieb's promise to issue new guidance on menu labeling by the end of the year and not alter the underlying rule as instrumental to reaching the agreement.

September 15, 2017 | Daily News

FDA last week approved the first-ever qualified health claim urging consumption of a food at an early age, in this case peanuts, to reduce a future allergy risk and signaled the agency backs more research on how to introduce allergenic foods to prevent and treat food allergies.

September 15, 2017 | Daily News

FDA proposed to delay by an additional two to four years the compliance dates for non-sprout produce to meet the food safety law's agricultural water requirements, stating in a proposed rule out Tuesday (Sept. 12) that the delay will give the agency time to simplify the requirements to make them less burdensome and less costly for farmers.

September 14, 2017 | Daily News

FDA Commissioner Scott Gottlieb Thursday (Sept. 14) beat back characterizations of actions being taken by the Trump-FDA as deregulatory, and argued he put the nutrition fact's regulation on ice shortly after taking the agency's helm because FDA wasn't prepared to implement it after the Obama administration pushed up the implementation deadline in the 11th hour.

September 11, 2017 | Daily News

FDA Commissioner Scott Gottlieb told stakeholder Monday (Sept. 11) he wants to see the agency more systematically review existing regulations.

September 11, 2017 | Daily News

FDA announced Tuesday (Sept. 5) it will hold a public meeting Oct. 3 to gather stakeholder input on the agency's plan to develop a list of dietary ingredients that existed before the Dietary Supplement Health and Education Act of 1994 went into effect and thus are exempt from supplement notification requirements.

September 07, 2017 | Daily News

FDA is asking stakeholders to suggest regulations they feel should be cut pursuant to President Donald Trump's deregulatory executive orders.

August 28, 2017 | Daily News

FDA has provided commissioned corps officers as part of the overall HHS deployment of medical equipment and resources to help address public health needs and assess critical health infrastructure needs in the wake of Hurricane Harvey.