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Food Safety

Tuesday, 14 March 2017

Newly confirmed CMS chief Seena Verma and FDA chief-nominee Scott Gottlieb, if confirmed, face immediate orders from the White House to craft plans to reorganize their agencies to improve efficiency, shift functions to the states or local governments, and merge or shut down any functions for which costs aren't justified by public benefits or are redundant with work of other agencies.

Monday, 06 March 2017

States can use alternative payment models to bring prescription drug companies to the negotiating table and lower prices of drugs in the Medicaid drug rebate program without changing laws, researchers from Oregon Health & Science University told congressional advisers on Friday (March 3).

Tuesday, 28 February 2017

Congress' investigative arm is calling on the Trump White House to develop a national strategy to coordinate food safety oversight, which now spans across 16 federal agencies and 30 federal laws, saying in a recent report that a similar request made six years ago to the Obama White House fell flat.

Monday, 30 January 2017

President Donald Trump on Monday (Jan. 30) signed an executive order declaring for every new regulation introduced, two must be eliminated in a bid to cut regulations by up to 75 percent, and said any new regulatory burdens must be offset by other deregulatory policies so there are no new regulatory dollars spent during the remainder of fiscal 2017.

Tuesday, 24 January 2017

President Donald Trump put heads of executive departments and agencies on notice that no new rules or guidances should be sent to the Office of the Federal Register (OFR) until a Trump-appointed or designated agency head reviews and approves them, potentially putting controversial FDA draft guidances and notices on such hot-button issues as off-label use, new dietary ingredients, compounding and biosimilars on hold.

Tuesday, 17 January 2017

FDA rules didn't make the short-list of regulations targeted by a conservative think tank in ongoing meetings with congressional Republicans for repeal under the Congressional Review Act, but Freedom Partners is separately pushing an FDA reform agenda that includes state passage of right-to-try legislation and expediting U.S. approval of drugs cleared by other countries, sources with the group tell Inside Health Policy.

Tuesday, 03 January 2017

House Republicans are planning to vote on a set of bills this week that would increase Congress' ability to roll back rules passed in the final 60 legislative days of President Barrack Obama's administration, and pledged to dedicate much of the next two months toward overturning administrative rules finalized by the Obama administration.

Friday, 30 December 2016

Rep. Mark Meadows (R-NC) includes an FDA Food Safety Modernization Act final rule aimed at preventing terrorism attacks against the food supply on a list of more than 200 rules and regulations that he says “conservatives are requesting to be rolled back” in President-elect Donald Trump’s administration within the first 100 days in office, in a report published by his office Dec. 14.

Monday, 12 December 2016

The Justice Department's recent $2.2 million settlement with dietary supplement retail giant GNC Holdings Inc. should send a “wake-up call” to the industry not to engage in illegal activity, DOJ told Inside Health Policy.

Friday, 09 December 2016

FDA is making data from adverse event reports for food, dietary supplements and cosmetics regulated by the Center for Food Safety and Applied Nutrition available to the public.

Monday, 14 November 2016

The Council for Responsible Nutrition (CRN) put FDA on notice it has legal concerns with the agency's tentative decision to ban vinpocetine as a dietary ingredient.

Thursday, 10 November 2016

Though Donald Trump has said little about his plans for FDA, food safety advocates are bracing for the possibility of regulatory rollbacks and budget cuts that could crimp implementation of the food safety law given the president-elect's regulatory reform and deficit-cutting pledges.

Thursday, 03 November 2016

A food safety advocate worries a new draft FDA guidance outlining how food suppliers should disclose when specific hazards have not been controlled in food may put public health at risk, as suppliers can make a general disclosure for microbial hazards rather than detailing a specific hazard.

Tuesday, 18 October 2016

FDA's recently issued guidance on modifications to food product categories for food facility registration includes language that is binding on industry, to the surprise of industry lawyers and advocates.

Friday, 14 October 2016

FDA is gathering input on how to redefine "healthy" for food labeling claims in a move that could lead to a broader overhaul of food claim regulations. The agency is easing up on its enforcement as it gathers input on how to redefine "healthy" in response to a citizen petition from KIND requesting the claim be aligned with proposals from the 2015 Dietary Guidelines Advisory Committee and the 2010 Dietary Guidelines for Americans.

Monday, 03 October 2016

FDA's recent move to ban vinpocetine as a dietary ingredient after 20 years of it being marketed in supplements, coming soon after the agency updated its NDI draft guidance, should be a wake-up call to industry that FDA plans to consign dietary ingredients in supplements to "a more limited market than for conventional foods," according to an industry lawyer.

Friday, 16 September 2016

FDA food inspections, user fees and regulations governing food production hygiene, packaging and temperatures are overkill and should be eliminated, according to a now-deleted fact sheet published by Republican presidential nominee Donald Trump's campaign Thursday (Sept. 15).

Friday, 19 August 2016

Dietary supplement makers, facing a new FDA draft guidance requiring they notify the agency before marketing supplements with new dietary ingredients, might turn to the recently finalized voluntary generally recognized as safe notification process for food as a less onerous path to market, according to industry attorneys and a trade group CEO.

Friday, 12 August 2016

FDA released a long-awaited final rule officially replacing the voluntary generally recognized as safe affirmation petition process with a voluntary GRAS notification procedure for substances used in food, drawing strong protests from food and consumer safety stakeholders who say FDA is handing off responsibility to regulate the food supply to industry and leaving one advocacy group to explore legal options.

Friday, 12 August 2016

FDA clarifies when manufacturers or distributors of new dietary ingredients (NDI) must submit a premarket safety notification, in a reissued draft guidance replacing a contentious draft guidance first issued in 2011.

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