FDA

[LinksEtc]

I know this is a little OT, but to me, keeping an eye on the FDA makes sense for those of us with FA.

This is just a general thread about the FDA.

I'm going to save a few spots for later so I don't have to keep raising this thread.

[LinksEtc]

sesame seeds labeling: US specific (laws, loopholes)

CSPI Sesame Petition filed!!!

Docket FDA-2008-N-0429 - Advisory Labeling Comments & Info

New exemptions from Food Allergen Labeling

Survey on Thresholds from FARE

Docket Management Process - Draft Proposal 2
http://tinyurl.com/lmqaz9u

HELP! Studies as to X-contam, may contains, etc

FARE Submits Comment to FDA on Preventive Controls

Peanut Threshold Study

food fraud and allergies

[LinksEtc]

"FDA secretly retests 100 different drugs after testing company admits its work was all fraudulent"
http://www.rawstory.com/rs/2013/04/15/fda-secretly-retests-100-different-drugs-after-testing-company-admits-its-work-was-all-fraudulent/

100 drugs, including sophisticated chemotherapy compounds and addictive prescription painkillers, had been approved for sale in the United States at least in part on the strength of Cetero Houston's tainted tests

"If there are problems with the scientific studies, as there have been in this case, then the FDA's review of those problems needs to be transparent," said David Kessler, who headed the FDA from 1990 to 1997 and who is now a professor at the University of California at San Francisco. Putting its reviews in public view would let the medical community "understand the basis for the agency's actions," he said. "FDA may be right here, but if it wants public confidence, they should be transparent. Otherwise it's just a black box."

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Re: If you were an allergy researcher ...


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"Coalition Urges FDA To Improve Transparency in Releasing Data"
http://www.ihealthbeat.org/articles/2013/3/11/coalition-urges-fda-to-improve-transparency-in-releasing-data.aspx

On Friday, a coalition of public interest groups sent a letter urging FDA to overturn its policy of redacting certain information from federal documents before turning them over to journalists, regulators and others requesting the data, the AP/Washington Post reports.

http://www.openthegovernment.org/sites/default/files/MinorDeletionsComment.pdf

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"D.C. Circuit Decision May Force FDA and Other Agencies to Expedite Responses to FOIA Requests"
http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2013/04/dc-circuit-decision-may-force-fda-and-other-agencies-to-expedite-responses-to-foia-requests-.html


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"FDA Breaks Food Safety Law With Rule Delays, Judge Finds"
http://www.bloomberg.com/news/2013-04-22/fda-breaks-food-safety-law-with-rule-delays-judge-finds.html

U.S. District Judge Phyllis Hamilton in Oakland, California, said the agency has "admittedly failed to comply with the mandatory rule-making schedule" of the Food Safety and Modernization Act

[LinksEtc]

"Sequester to reduce FDA food inspections, official says"
http://www.usatoday.com/story/news/nation/2013/04/24/sequester-fda-food-safety-inspections-commissioner/2110503/

The Food and Drug Administration will conduct fewer food safety inspections this year because of the government sequester

delay the agency's implementation of the 2011 Food Safety Modernization Act

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"Food Safety Inspections Dodge the Sequester"
http://www.foodsafetynews.com/2013/05/how-food-safety-inspections-dodged-the-impact-of-the-sequester/#.UYq2PRG9KSM

as FDA figures out how to absorb the $209 million cut to food and drug regulation, the agency is saying food safety inspections will be spared too. FDA will scale back training and travel and not facility inspections

[LinksEtc]

Former FDA official on GMO labeling: 'Science doesn't always win'
http://www.foodnavigator-usa.com/Regulation/Former-FDA-official-on-GMO-labeling-Science-doesn-t-always-win

Whether the food industry likes it or not, when it comes to GMO labeling, the "train appears to have left the station", according to former FDA associate commissioner of foods Dr David Acheson.

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"Court Extends Deadline for FSMA Rules"
http://www.foodsafetynews.com/2013/05/court-extends-deadline-for-fsma-rules/

In a ruling May 17, Judge Phyllis Hamilton of the Oakland U.S. District Court said FDA and CFS now have until June 10 to agree on a schedule for releasing the yet-unpublished food safety rules, mandated by the Food Safety Modernization Act of 2011.

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"House Sinks Farm Bill That Could Have Further Delayed FSMA"
http://www.foodsafetynews.com/2013/06/house-sinks-farm-bill-that-could-have-further-delayed-fsma/

amendment by Rep. Dan Benishek (R-MI) that would have required the U.S. Food and Drug Administration to conduct "a scientific and economic analysis" of FSMA regulations before they can be rolled out.

In May, Benishek introduced a separate bill, the Stopping Costly Regulations Against Produce, or the SCRAP Act, which seeks to altogether de-fund the implementation of FSMA produce safety rules.

[LinksEtc]

"FDA Won't Set Specific FSMA Deadlines Despite Court Order"
http://www.foodsafetynews.com/2013/06/fda-wont-set-specific-fsma-deadlines-despite-court-order/

Consumer advocates said they are dismayed by FDA's refusal to agree to a shorter timeline for many key food safety rules, many of which are already well passed the statutory deadlines set by Congress.

[LinksEtc]

"The F.D.A.'s Not-Really-Such-Good-News"
http://www.nytimes.com/2013/12/18/opinion/bittman-the-fdas-not-really-such-good-news.html?_r=0

it appears that the F.D.A. has once again refused to do all it could to protect public health.

I think we're looking at an industry-friendly response to the public health emergency of diseases caused by antibiotic-resistant bacteria, resistance that is bred in industrially raised animals.

Michael Taylor, the agency's deputy commissioner for foods and veterinary medicine (and — just in case you think the notion that there is a revolving door between the F.D.A. and the food industry is hyperbole — a former vice president for public policy at Monsanto)

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"FDA Underwhelms With Response to Super-Resistant Infections Rise"
http://www.huffingtonpost.com/david-wallinga-md/fda-super-resistant-antibiotics-farming_b_4442368.html

The replay of the December 11 FDA's teleconference, which I attended (available by calling 866-501-0089), gives the strong impression that the FDA's top priority is to not upset the pharmaceutical industry's apple cart.

[LinksEtc]

"FDA rulemaking process lacks transparency, efficiency"
http://www.cardiovascularbusiness.com/topics/healthcare-economics/fda-rulemaking-process-lacks-transparency-efficiency

Based on their findings, the authors called for more transparency in the rulemaking process.

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"Taylor: FDA Needs More Resources for FSMA Implementation"
http://www.foodsafetynews.com/2014/02/fda-needs-more-resources-for-fsma-implementation/#.UvRUTX-9KSM

Taylor said that the agency has enough resources to issue the final rules, but not to implement FSMA.

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"FSMA Gets New Deadlines for Final Rules"
http://www.foodsafetynews.com/2014/02/fsma-gets-new-deadlines-for-final-rules/#.Uwt4_X-9KSM

The U.S. Food and Drug Administration has reached a settlement with the Center for Food Safety (CFS) and the Center for Environmental Health regarding the deadlines for publishing final rules implementing the Food Safety Modernization Act (FSMA).

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http://blogs.fda.gov/fdavoice/index.php/2014/03/whats-new-in-the-fdas-2015-budget/

[LinksEtc]

"FDA Nutrition Label Shift Expected to Face Pushback"
http://www.rollcall.com/news/fda_nutrition_label_shift_expected_to_face_pushback-231940-1.html?pg=1

When the Food and Drug Administration unveiled its revision of the iconic Nutrition Facts label that appears on processed foods and beverages earlier this year, nutritionists and consumer groups applauded the changes.

industry has been reviewing the agency's proposal, preparing to mount what will likely be a hefty pushback.

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"Pompeo bill would preempt state GMO labeling"
By Maggie Hennessy, 09-Apr-2014
http://www.foodnavigator-usa.com/Regulation/Pompeo-bill-would-preempt-state-GMO-labeling

As was rumored last week, congressman Mike Pompeo (R-KS) introduced legislation Wednesday that would block the efforts in multiple states to require mandatory labeling of genetically modified foods.

[LinksEtc]

"Sebelius Resigns After Troubles Over Health Site"
http://www.nytimes.com/2014/04/11/us/politics/sebelius-resigning-as-health-secretary.html

Kathleen Sebelius, the health and human services secretary, is resigning, ending a stormy five-year tenure marred by the disastrous rollout of President Obama's signature legislative achievement, the Affordable Care Act.

nominate Sylvia Mathews Burwell, the director of the Office of Management and Budget, to replace her

[LinksEtc]

"Hearing: Improving Predictability and Transparency in DEA and FDA Regulation"
Subcommittee on Health (Committee on Energy and Commerce)
Monday, April 7, 2014 (3:00 PM)
http://docs.house.gov/Committee/Calendar/ByEvent.aspx?EventID=102093


http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2014/04/congressional-hearing-on-improving-predictability-and-transparency-in-dea-and-fda-regulation-on-mond.html

The FDA has not approved a new sunscreen ingredient in almost two decades.

https://www.stgeorgeutah.com/news/archive/2014/03/20/senators-urge-clarity-transparency-fda-medical-mobile-apps/#.U0gvTn-9KSM

Sen. Orrin Hatch joined a bipartisan group of senators in urging the Food and Drug Administration, FDA, to provide further clarity and transparency in its policy regarding medical mobile apps.

"FDA rulemaking process lacks transparency, efficiency"
2/5/14
http://www.cardiovascularbusiness.com/topics/healthcare-economics/fda-rulemaking-process-lacks-transparency-efficiency

The FDA takes an average of 7.3 years to finalize rules that determine its regulation process, a study published in the February issue of Health Affairs found.

"Quantifying The Food And Drug Administration's Rulemaking Delays Highlights The Need For Transparency"
http://content.healthaffairs.org/content/33/2/309.abstract

The federal agency's rulemaking is controversial because of its perceived complexity, lack of transparency, and lengthy duration.

[LinksEtc]

"Food for thought: FDA pushes food transparency measures"
Lauren Caruba on March 18th, 2014 in Health
http://medillonthehill.net/2014/03/food-transparency/

Experts say the nutrition label should be revisited more frequently to keep up with research. But the FDA wants to make sure scientific evidence is solid before updating regulations. That can cause the government to lag behind research, said former FDA official Jim O'Hara, an original developer of the nutrition label and current director of health promotion policy at the Center for Science in the Public Interest.

[LinksEtc]

http://iflr.foodlaw.org

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"Senate HELP Committee Asks FDA to Explain its Use of Draft Guidances"
http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2014/05/senate-help-committee-asks-fda-to-explain-its-use-of-draft-guidances.html

[LinksEtc]

"Hamburg, FDA Get a New Boss in New HHS Chief Sylvia Burwell"
http://www.raps.org/regulatory-focus/news/2014/06/19421/Sylvia-Burwell-Confirmed-as-HHS-Secretary/

On Thursday, 5 June 2014 the full US Senate voted 78-17 to confirm Sylvia Matthews Burwell, former director of the Office of Management and Budget (OMB), to the position of secretary of the Department of Health and Human Services (DHHS).

[LinksEtc]

Tweeted by @bmarler

"Prolonged Procrastination on Petitions Compounds Agencies' Problems"
http://www.foodsafetynews.com/2014/06/prolonged-procrastination-on-petitions-compounds-agencies-problems/#.U6Bx_X-9KSN

Gone are the days when an agency received a petition, especially from a consumer organization, and the optimal course of action was to do nothing. Inaction today will buy you a greater resource burn down the road, along with media attacks and cries of inefficiency and inappropriate public health priorities.

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"Teva Sues FDA Over Failure to Substantively Respond to COPAXONE Citizen Petition"
http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2014/05/teva-sues-fda-over-failure-to-substantively-respond-to-copaxone-citizen-petition.html