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Keyword: fda

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  • Will Trump Appoint a Great FDA Commissioner?

    01/23/2017 7:33:30 AM PST · by reaganaut1 · 4 replies
    Marginal Revolution ^ | January 23, 2017 | Alex Tabarrok
    As someone who has written about FDA reform for many years it’s gratifying that all of the people whose names have been floated for FDA Commissioner would be excellent, including Balaji Srinivasan, Jim O’Neill, Joseph Gulfo, and Scott Gottlieb. Each of these candidates understands two important facts about the FDA. First, that there is fundamental tradeoff–longer and larger clinical trials mean that the drugs that are approved are safer but at the price of increased drug lag and drug loss. Unsafe drugs create concrete deaths and palpable fear but drug lag and drug loss fill invisible graveyards. We need an...
  • Herbal And Dietary Supplements—Buyer Beware

    01/19/2017 10:58:30 AM PST · by Sean_Anthony · 57 replies
    Canada Free Press ^ | 01/19/17 | Jack Dini
    Of the fifty-one thousand products introduced since 1994, only 170 (0.3 percent) have any documentation of their safety Americans spend more than $32 billion a year on more than 85,000 different combinations of vitamins, minerals, botanicals, amino acids, probiotics, and other supplement ingredients. 1 While it costs millions of dollars to develop and substantiate a pharmaceutical product, selling supplements requires no such investment. And new products are easily sold as supplements. The only common feature among them, as defined by the FDA, is that these are edible things not intended to treat, diagnose, prevent or cure diseases. However, this is...
  • Surgeon General's Attacks On E-Cigarettes Are Hazardous To Your Health

    12/15/2016 5:14:26 AM PST · by IBD editorial writer · 30 replies
    Investor's Business Daily ^ | 12/14/2016 | Staff
    Safety: Shortly after the Surgeon General denounced e-cigarettes as a terrible public health threat to young people, a national survey showed that his fears are misguided, and his proposed "remedies" could cause more harm than good. The definitive Monitoring the Future survey found that "vaping" rates among teenagers dropped sharply between 2015 — the first year the survey asked about e-cigarette use — and last year. The share of high school seniors who reported vaping in the previous month, for example, went from 16.3% to 12.5%. At the same time, smoking rates among teens continue to fall. Just 10% of...
  • Trouble for the FDA?

    12/10/2016 8:27:47 PM PST · by MtnClimber · 33 replies
    Neurologicablog ^ | 9 December 2016 | Steven Novella
    There is persistent tension over the issue of drug regulations. On one side are those who think that before we sell drugs to the public with health claims, we should ensure there is a reasonable amount of objective quality scientific evidence to demonstrate that the drugs are safe and effective. I admit this is the side of the discussion on which I fall... The other perspective is that requiring too much research and regulation slows the passage of potentially new and lifesaving drugs to the public. Potentially useful drugs should be fast tracked as much as possible. In the extreme...
  • How Can You Tell A Good Trump Pick? By The Establishment Freakout

    12/09/2016 4:00:16 AM PST · by IBD editorial writer · 5 replies
    Investor's Business Daily ^ | 12/8/2016 | Staff
    Regulations: An easy way to tell whether one of Donald Trump's leadership picks is a good one is to gauge the freakout level among the left. By that measure alone, the person Trump is considering as head of the Food and Drug Administration would be an outstanding choice. Jim O'Neill, whose name got floated this week, is a managing director at of Trump pal Peter Thiel's Mithril Capital Management. In addition to private sector experience, O'Neill worked at the Department of Health and Human Services under President Bush. But he's also — gasp! — a libertarian! Thus, we're seeing headlines...
  • Senate Clears Bill to Ease FDA Drug and Device Approvals

    12/07/2016 2:50:18 PM PST · by oblomov · 11 replies
    7 Dec 2016 ^ | Thomas M. Burton
    WASHINGTON—Passage of legislation aimed at speeding up Food and Drug Administration approvals, combined with an incoming president who has pledged to “cut red tape” at the agency, is expected to usher in a new, more industry-friendly era of drug and device regulation. The Senate on Wednesday cleared the measure known as the 21st Century Cures bill, which lays out in detail speedier and more pro-industry methods for the FDA to approve new drugs and medical devices. Its supporters, such as PhRMA, the drug-industry association, and AdvaMed, representing device makers, praise it as a way to bring about more innovation and...
  • Walgreen's $140 Million Lawsuit Shows Theranos Is Way Worse Than We Thought

    11/23/2016 11:10:50 PM PST · by CorporateStepsister · 15 replies
    Thrill List ^ | 11/23/2016, 2:58 PM | By Christina Stiehl
    <p>Theranos, the biotech company started by a 19-year-old Stanford dropout, has another hurdle to cross in its whole "we're totally a legit blood-testing company" campaign. This time, it turns out that tens of thousands of blood tests were voided, making them totally invalid. Whoops!</p>
  • Theranos's Insane Campaign To Punish Whistleblower, Who Happened To Be Famous Boardmember's Grandson

    11/21/2016 7:48:00 PM PST · by CorporateStepsister · 40 replies
    TechDirt ^ | Mon, Nov 21st 2016 5:13pm | by Mike Masnick
    We haven't really written much about the insane Theranos scandal, though we discussed it on our podcast. The whole story is pretty crazy -- involving a heavily hyped up company that appeared to basically be flat out lying to everyone about what it could do. The company still exists, but barely. The company's founder and CEO, who was plastered across magazine covers and compared frequently to Steve Jobs, has been banned from running a lab for two years, and the company is now facing a $140 million lawsuit from its biggest partner, Walgreens, who claims that Theranos repeatedly lied to...
  • Theranos and David Boies Cut Legal Ties

    11/19/2016 12:07:29 AM PST · by CorporateStepsister · 13 replies
    The Wall Street Journal ^ | Nov. 18, 2016 7:12 p.m. ET | By John Carreyrou
    Litigator David Boies and the law firm he founded, Boies, Schiller & Flexner LLP, have stopped doing legal work for Theranos Inc. after disagreeing about the strategy for handling ongoing government investigations of the blood-testing company, according to people familiar with the matter. Mr. Boies, 75 years old, has been one of the country’s best-known litigators since the late 1990s. He became Theranos’s outside counsel after being approached in 2011 by two investors in the Palo Alto, Calif., startup. He fiercely defended Theranos against questions about its technology and operations. Those efforts included threatening to take legal action against The...
  • Theranos and David Boies Cut Legal Ties

    11/18/2016 11:53:04 PM PST · by CorporateStepsister · 7 replies
    Wall Street Journal ^ | Nov. 18, 2016 7:12 p.m. ET | By John Carreyrou
    Litigator David Boies and the law firm he founded, Boies, Schiller & Flexner LLP, have stopped doing legal work for Theranos Inc. after disagreeing about the strategy for handling ongoing government investigations of the blood-testing company, according to people familiar with the matter. Mr. Boies, 75 years old, has been one of the country’s best-known litigators since the late 1990s. He became Theranos’s outside counsel after being approached in 2011 by two investors in the Palo Alto, Calif., startup. He fiercely defended Theranos against questions about its technology and operations. Those efforts included threatening to take legal action against The...
  • Why is Elizabeth Holmes still leading Theranos?

    11/18/2016 11:38:20 PM PST · by CorporateStepsister · 25 replies
    San Francisco Business Times ^ | Nov 18, 2016, 1:40pm PST | Ron Leuty Reporter San Francisco Business Times
    It's worth asking why Elizabeth Holmes is still leading the embattled blood testing company Theranos Inc. But there may be a good reason why she still is in charge, one that has little to do with the scandal-ridden company's performance to date. Forget what venture capitalist Tim Draper — one of the first to invest in the Palo Alto company — implied this week that Holmes is being attacked because she's a young, female entrepreneur. The simple fact is that Theranos has not been able to deliver on its technology from a commercial, scientific or regulatory standpoint, and that falls...
  • Theranos Whistleblower Tells All On Intimidation And Coercion Tactics Employed To Silence Him

    11/18/2016 12:05:55 AM PST · by CorporateStepsister · 26 replies
    Zero Hedge ^ | Nov 17, 2016 7:20 PM | by Tyler Durden
    2016 has not been too kind to Elizabeth Holmes, the Steve-Jobs wannabe in charge of fraudulent Theranos. She has thus far been banned for 2 years from operating labs, removed from hosting fundraisers for Hillary and lost her entire net worth. And now, the Wall Street Journal has published the "tell-all" story of the whistle-blower, 26 year old Tyler Shultz, who brought the the whole Theranos farce crashing down. It's a sordid tale complete with all the expected twists and turns of a Jason Bourne thriller including intimidation, coercion and private detectives. Tyler Shultz is the grandson of George Shultz,...
  • Monsanto Is Scrambling To Bury This Breaking Story

    11/16/2016 11:08:47 AM PST · by B4Ranch · 199 replies
    I am frankly shocked this information is not making front page news right now. Monsanto will do anything to bury this story… and as of right now, it’s working. Not a single mainstream media outlet has covered this appalling new report that shows millions of people being poisoned by a chemical that does not belong in our food. This chemical is ending up in processed foods like Cheerios, Ritz Crackers, and Oreos and being consumed by humans across the world. The health of millions of people is on the line and this news must go mainstream! That’s why I’m calling on every single one of you...
  • Blowing Bureaucratic Smoke

    10/07/2016 7:07:05 AM PDT · by DUMBGRUNT · 6 replies
    WSJ ^ | 6 Oct 2016
    ...In August a new FDA rule went into effect that forbids tobacco makers and distributors from handing out free samples. Some companies that have been donating cigars to service members for decades have now stopped for fear that this is now illegal... California Republican Duncan Hunter, who did combat tours in Iraq and Afghanistan before becoming a Marine reservist, says legislation shouldn’t be needed. In a Sept. 8 letter, he asked FDA Commissioner Robert Califf to clarify if the new rule really does ban cigar donations to soldiers. He’s still waiting to hear back.... The FDA’s bureaucrats are happy to...
  • The Nannystate Continues to Run Amuck

    09/29/2016 1:46:03 PM PDT · by Kaslin · 10 replies
    Townhall.com ^ | September 29, 2016 | Peter Roff
    Despite what many people think the left-liberal coalition’s decision to base so much of its effort on keeping the government out of our bedrooms is, long term, a losing strategy. Conservatives have a slight advantage where these issues are the only ones considered by people when deciding how to vote. If they could redirect their efforts to keeping government out of the kitchen they might have something. Uncle Sam has decided what we eat and drink is somehow his business. The government says it wants to bend the healthcare cost curve downward but really this is just another version of...
  • FDA Outlaws Free Cigars For Troops

    08/29/2016 2:39:37 PM PDT · by cgbg · 15 replies
    Tampa Bay Times ^ | August 28, 2016 | Tony Marrero
    New Food and Drug Administration regulations on cigars, e-cigarettes and other products that took effect Aug. 8. Among the regulations is what many interpret as a ban on the charitable donation of tobacco products.
  • The EpiPen Scandal Is Worse Than You Think: What You’re Not Being Told

    08/27/2016 11:45:21 AM PDT · by amorphous · 40 replies
    The Antimedia ^ | 26 August 2016 | Alice Salles
    Presidential hopeful Hillary Clinton urged Mylan to voluntarily slash the prices of its products while promising that, once she’s elected, her “plan to address exorbitant drug price hikes like these” will be finally implemented. This is a particularly empty promise considering Mylan has donated between $100,000 and $250,000 to the Clinton Foundation, which was recently revealed to be peddling influence in exchange for cash. Senators Susan Collins (R-ME) and Claire McCaskill (D-MO) are also pressuring the manufacturer to disclose more about its pricing. Even Senator Joe Manchin (D-WV) — whose own daughter, Heather Bresch, serves as Mylan’s CEO — weighed...
  • Dear Congress: Have You Received Money From These Pharma Companies

    08/25/2016 12:01:52 PM PDT · by amorphous · 11 replies
    Zero Hedge ^ | 25 July 2016 | Tyler Durden
    We have been following the latest melodrama involving a "greedy" Mylan, and numerous "humanistic" US politicians, all the way up to the Democratic presidential candidate, exchange blows over the company's dramatic price increases of its EpiPen anti-allergy medication, with a healthy dose of amusement for one simple reason: if Congress wants to crack down on someone, it should crack down on itself. After all, the only reason Mylan has been able to pass the kinds of price increases that Congress is now blasting it for, is because of US laws and regulations; laws which incidentally, have been determined in Washington's...
  • The Lack of EpiPen Competitors is the FDA's Fault

    08/25/2016 11:26:30 AM PDT · by amorphous · 25 replies
    There’s a new bout of outrage over an expensive medicine or medical treatment. While the good in question changes each time, the blame always seems to fall on greedy corporations who just aren’t regulated enough. Free markets and capitalism are the scapegoat, even when nothing remotely resembling unhampered markets in health care is in place in the United States. This time, it’s the EpiPen, a device that easily and safely injects epinephrine to quickly open up airways for people undergoing severe anaphylaxis because of an extreme allergy. It has saved the lives of countless people who are allergic to bee...
  • FDA bans e-cigarette sales to minors starting today

    08/08/2016 12:06:45 PM PDT · by Drango · 34 replies
    cbs ^ | August 8, 2016, | DENNIS THOMPSON
    The sale of e-cigarettes to minors will be banned starting Monday, as part of the U.S. Food and Drug Administration's long-awaited plan to extend the agency's regulatory powers across all tobacco products. The new rules halt the sale of e-cigarettes and any other tobacco product to anyone younger than 18. The regulations also require photo IDs to buy e-cigarettes, and ban retailers from handing out free samples or selling them in all-ages vending machines. The rules also cover other alternative forms of tobacco like cigars, hookah tobacco and pipe tobacco. Electronic cigarettes are battery-operated devices designed to create an aerosol...
  • YOU'RE ALMOST DEFINITELY WASTING MONEY ON VITAMINS

    07/28/2016 8:37:55 PM PDT · by nickcarraway · 69 replies
    Thrillist ^ | 7/28 | JOHN MARSHALL
    By Up to three-quarters of American adults take some kind of vitamin or supplement, so there's a pretty good chance you're one of them. That's a lot of people purchasing substances that aren't evaluated by the FDA, and for the most part don't work. What's more, vitamins and supplements are only getting more popular, with sales growing 50% faster than those of over-the-counter drugs over the past several years. Basically, most of you are throwing money away on magical beans -- stop it already! There's not a whole lot of regulation, which is good for sales pitches One of the...
  • Unalienable ‘Right to Try’ Deserves Protection by Feds and All 50 States

    07/04/2016 8:53:52 AM PDT · by Kaslin
    Townhall.com ^ | July 4, 2016 | Michael Hamilton
    Every person, regardless of race, creed, or country, is born into the world with certain natural rights, including the right to live, the Second Continental Congress declared 240 years go this July 4. From the right to life, surely one can infer a right to try to extend oneÂ’s own life and improve its quality. For this reason, all 13 states that declared independence from Great Britain in 1776, and simultaneously declared unalienable each personÂ’s rights to life and liberty, either have passed or are considering passing legislation expanding the freedom of terminally ill patients to try to survive. Five...
  • Catfish, the Other Cronyism Meat?

    06/30/2016 8:44:18 AM PDT · by Kaslin · 43 replies
    Townhall.com ^ | June 30, 2016 | Veronique de Rugy
    Cronyism is the ugly marriage between special interest groups and politicians, which results in an abuse of the government's power to grant special privileges to a few winners -- for example, unfairly preventing competition or doling out subsidies and bailouts at the expense of taxpayers. Though cronyism is always outrageous, the way cronies go about achieving their goals is sometimes oddly funny. Case in point: the government's changing the definition of catfish to classify the fish as -- wait for it -- meat, not seafood. As Patrick Mustain reports in Scientific American, Sen. Thad Cochran, R-Miss., included an amendment in...
  • Wall Street has been rocked by an $8 billion hedge fund's implosion

    06/22/2016 8:05:53 PM PDT · by Lorianne · 24 replies
    Business Insider ^ | 19 June 2016 | Rachael Levy
    Visium Asset Management, a multibillion dollar hedge fund, has imploded in the biggest scandal to hit the industry in years. The fund told investors of its plan to close in a letter Friday. It’s the most high-profile shutdown since authorities forced Steve Cohen’s controversial SAC Capital to close in 2013. A slew of factors — from a brewing insider-trading scandal to a contentious investment by Visium’s founder that rankled investors and staffers alike — led to Visium’s demise. On top of all of that, Visium’s flagship fund had been reporting dismal performance. Visium is selling one of its better performing...
  • I Am a Gay Man From Orlando. Why Can’t I Donate Blood? (N.Y. Times)

    06/15/2016 9:35:06 AM PDT · by Faith Presses On · 86 replies
    The New York Times ^ | 6/15/16 | Blake Lynch
    ...This week we faced a new challenge: mass violence in the very place we felt most comfortable, accepted and secure. After the attack, the city of Orlando and the state of Florida mobilized. Officials called on people in the area to donate blood for those who were injured in the shooting. Thousands of people have reportedly lined up to donate. But some of them — gay and bisexual men — are unable to. As a registered nurse, I know the importance of donated blood... (snip) But many of the people who felt the tragedy most closely can’t offer their help....
  • Five Years and $500 Million Later, USDA Admits That 'Food Deserts' Don't Matter

    06/14/2016 7:01:33 AM PDT · by RightGeek · 56 replies
    Reason ^ | 6/13/2016 | Elizabeth Nolan Brown
    For several years, so-called "food deserts"—low-income neighborhoods devoid of nutritious food options—were an oft-cited culprit for America's high obesity levels. Everyone from state senators to Michelle Obama had ideas about how to fix the issue, from launching new farmer's markets in these neighborhoods to state grant programs designed to entice more fruit-and-veggie offerings to bans on new fast-food restaurants opening in these areas. The kicker was a multi-million dollar federal initiative, spearheaded by the First Lady, to promote farmer's markets and attract more grocery-store chains to food-desert neighborhoods. "Since 2011, the Federal Government has spent almost $500 million to improve...
  • FDA issues new guidelines on salt, pressuring food industry

    06/01/2016 6:43:16 AM PDT · by Olog-hai · 17 replies
    Associated Press ^ | Jun 1, 2016 9:15 AM EDT | Mary Clare Jalonick
    The Obama administration is pressuring the food industry to make foods from breads to sliced turkey less salty, proposing long-awaited sodium guidelines in an effort to prevent thousands of deaths each year from heart disease and stroke. The proposed guidelines released Wednesday are voluntary, so food companies won’t be required to comply. But the idea is to persuade companies and restaurants — many of which have already lowered sodium levels in their products — to take a more consistent approach. […] Some companies have worried that though the limits will be voluntary, the FDA is at heart a regulatory agency,...
  • FDA regulations could kill the vaping industry

    05/26/2016 1:18:21 PM PDT · by Oldeconomybuyer · 69 replies
    WVLT - CBS Local ^ | May 25, 2016 | By Lauren Davis
    Knoxville vape companies are fuming mad after the FDA passed new regulations this month. They say this new law will put an end to the vaping industry. They are shocked at how far reaching the regulations are, and now they're afraid the new restrictions will destroy the industry. Hunter Allison with Tri State Vape Company will have to submit an application for each new product. He says that would come with a hefty price tag. Allison says, "The absolutely lowest price I've seen is $300,000 per product and that's $4.5 million for me and there's no possible way. He's already...
  • Bone cement company accused of experimenting on humans

    05/21/2016 3:24:33 PM PDT · by Olog-hai · 11 replies
    Associated Press ^ | May 21, 2016 5:38 PM EDT | Martha Bellisle
    Reba Golden hurt her back after falling two floors while building an addition to her house in Honduras. But when she returned to Seattle for a routine spinal surgery, she suffered blood clots, severe bleeding and died in 2007 on the operating table. Joan Bryant’s back had bothered her since a 1990 car accident, so in 2009 she sought help from a Seattle spinal surgeon, but she bled out on the operating table and could not be revived. Like at least three spinal-surgery patients before them, Golden and Bryant died after their doctor injected bone cement into their spine and...
  • How Deep Will New Cigar Regulation Go?

    05/12/2016 9:24:07 AM PDT · by martin_fierro · 26 replies
    cspdailynews.com ^ | 5/11/16 | CSP Daily News
    WASHINGTON -- As part of its “deeming” regulations announced early this month, the U.S. Food and Drug Administration (FDA) included major decisions on cigars, namely the inclusion of premium cigars under its jurisdiction and a guidance suggesting an extension of the flavored-tobacco ban to include characterizing flavors in cigars. Before the deeming regulations were announced, an initial proposed rule contained an option to exempt cigars from FDA regulation altogether. That did not happen. “The FDA has concluded there is no appropriate public health justification for excluding premium cigars,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products (CTP)....
  • The FDA’s New E-Cigarette Rules Hand Big Tobacco A Big Win

    05/10/2016 3:57:24 AM PDT · by IBD editorial writer · 14 replies
    Investor's Business Daily ^ | 5/9/2015 | Staff
    Big Government: For decades, the federal government has been on a mission to create a “smoke-free society” — whether that involved stiff regulations, a massive lawsuit, or relentlessly higher taxes. So what’s the government’s response when private industry comes up with a product that actually could produce a smoke-free society? The government decides to regulate it to death.
  • FDA Neo-Prohibitionists Don’t Care About Your Health

    05/07/2016 5:21:40 AM PDT · by Kaslin · 43 replies
    Townhall.com ^ | May 7, 2016 | Kevin Glass
    The Food and Drug Administration this week came out with regulations that will force e-cigarette and vaping manufacturers to go through the same onerous process to qualify what they sell as "tobacco products" - despite not having one iota of tobacco involved.There's only one conclusion to draw here: the FDA doesn't care about public health."Vaping" is seen by government health nannies as yet another sinful behavior that irresponsible Americans are participating in when they could be eating kale salads instead. But that takes a fundamentally misguided point of view on the subject. What vaping really constitutes is a tobacco alternative...
  • FDA Regulates Cigars, E Cigs--Final Rule Issued

    05/05/2016 2:18:48 PM PDT · by cgbg · 45 replies
    Reuters ^ | May 5, 2016 | Reuters
    See the link for some coverage.
  • CRF Frozen Foods Expands Voluntary Recall to Include All Frozen Vegetable and Fruit Products (FDA)

    05/04/2016 1:03:09 PM PDT · by Dallas59 · 12 replies
    FDA ^ | 5/2/2016 | FDA
    PASCO, Wash. – As a precaution, CRF Frozen Foods of Pasco, Washington is expanding its voluntary recall of frozen organic and traditional fruits and vegetables. We are performing this voluntary recall in cooperation with the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) because these products have the potential to be contaminated with Listeria monocytogenes. The organism can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal...
  • FDA Campaign Aims to Help Young LGBT Adults Stop Smoking

    05/02/2016 5:28:53 PM PDT · by Loyalist · 24 replies
    Medscape ^ | May 2, 2016 | Pauline Anderson
    The US Food and Drug Administration (FDA) has launched a smoking prevention campaign aimed at young adult lesbian, gay, bisexual, and transgendered (LGBT) persons who are occasional users of tobacco. Young adult LGBT persons are nearly twice as likely to use tobacco as other young adults, said Mitch Zeller, JD, director, Center for Tobacco Products (CTP), FDA, during a press briefing to announce the campaign, called This Free Life. Of the more than 2 million LGBT persons aged 18 to 24 years in the United States, more than 800,000 are occasional or so-called social smokers, according to Dr Zeller. "Unfortunately,...
  • FDA launches public education campaign to prevent and reduce tobacco use among LGBT young adults

    05/02/2016 2:47:54 PM PDT · by catnipman · 34 replies
    FDA ^ | 5/2/2016 | Some Faceless FDA PR Flack
    The U.S. Food and Drug Administration today announced the launch of a historic public education campaign aimed at preventing and reducing tobacco use among lesbian, gay, bisexual and transgender (LGBT) young adults ages 18-24.
  • Congressmen Question FDA on Loosening of Abortion-Inducing Drug Standards

    04/26/2016 8:40:02 PM PDT · by Olog-hai · 2 replies
    Cybercast News Service ^ | April 26, 2016 | 4:53 PM EDT | Lauretta Brown
    Rep. Chris Smith (R-N.J.) and Sen. James Lankford (R-Okla.) sent a letter Monday, together with 73 of their colleagues to Food and Drug Administration (FDA) Commissioner Robert Califf, expressing concern and seeking information regarding the recent loosening of regulation of the abortion-inducing drug Mifeprex or RU-486. The FDA announced a change in their guidelines for Mifeprex in March. The new guidelines reduce the dosage from 600 milligrams to 200 milligrams, decrease the number of required doctor’s visits from three to two, and allow the pill to be taken later in pregnancy, at 10 weeks of pregnancy from 7 weeks. “We...
  • Trade group egged on FDA to act against vegan mayo

    04/07/2016 5:51:00 PM PDT · by Olog-hai · 13 replies
    Associated Press ^ | Apr 7, 2016 1:25 PM EDT | Candice Choi
    Mayonnaise impostors, beware! An industry group is patrolling the grocery aisles. The Association for Dressings and Sauces, which was founded in 1926, repeatedly urged federal regulators last year to take action against an upstart vegan spread that it said was masquerading as mayonnaise, despite its lack of eggs, according to emails obtained by The Associated Press. The Food and Drug Administration later sent a public warning to Hampton Creek about its “Just Mayo” spread, which triggered national headlines and ultimately led to the San Francisco startup and media darling tweaking its label. The efforts provide a glimpse into the influence...
  • Maine: New England's 1st 'right to try' experimental drugs

    03/30/2016 6:16:41 PM PDT · by Olog-hai · 6 replies
    Associated Press ^ | Mar 30, 2016 7:50 PM EDT
    Maine is the first state in New England to give dying patients the right to use experimental drugs. Republican Gov. Paul LePage signed legislation Wednesday that allows terminally ill patients to use treatments that have not received final approval by the U.S. Food and Drug Administration. […] The legislation was sponsored by Rep. Thomas Longstaff, a Waterville Democrat who had worked as a hospital chaplain. …
  • Washington's Joke War On Tanning Salons Has Gone Too Far

    03/21/2016 10:57:21 AM PDT · by Kaslin · 30 replies
    Townhall.com ^ | March 21, 2016 | Nicole Neily
    During the debate over the Affordable Care Act, the Obama Administration and Democrats on Capitol Hill conspired to slip in a tax on tanning salons, widely derided as a useless gesture meant to poke fun at the perpetually-tan John Boehner, who at the time was Minority Leader of the House and the leader of the anti-Obamacare opposition on Capitol Hill. In the Affordable Care Act, a massive piece of legislation that carried a $900 billion price tag, there was a small provision projected to raise "only" $2.7 billion: a tax on tanning salons. The biggest reason that the provision got...
  • FDA wants new manure regulations for organic farms

    03/14/2016 4:13:02 PM PDT · by HomerBohn · 24 replies
    Personal Liberty ^ | 3/14/2016 | Sam Rolley
    While thousands of Americans continue to die each year from taking government-approved pharmaceutical drugs, the Food and Drug Administration is busy investigating actual bullsh*t. FDA officials announced last week that the agency isn’t so sure that fertilizing food crops with animal manure— something human beings have been doing since the advent of agriculture— is safe. “The FDA is planning to conduct a risk assessment to determine how much consumer health is put at risk by the use of raw manure as fertilizer in growing crops covered by the final [Food Safety Modernization Act (FSMA)] Produce Safety rule, and what can...
  • The FDA Looks to Crack Down on Manure (Again)

    03/13/2016 6:35:23 AM PDT · by Libloather · 40 replies
    Reason ^ | 3/12/16 | Baylen Linnekin
    Last week, the FDA announced it would investigate the use of manure and other biological matter. Manure is animal poop. Rich in nutrients, it's been used by farmers as fertilizer for thousands of years. But the agency is skeptical of the safety of the practice. "The FDA is planning to conduct a risk assessment to determine how much consumer health is put at risk by the use of raw manure as fertilizer in growing crops covered by the final [Food Safety Modernization Act (FSMA)] Produce Safety rule, and what can be done to help prevent people from getting sick," the...
  • Bayer, FDA accused of downplaying Essure fetal deaths, complications

    02/23/2016 6:29:20 PM PST · by Morgana · 4 replies
    liveactionnews.org ^ | February 23, 2016 | Rebecca Downs
    Essure, a permanent form of birth control which involves inserting coils into a woman’s fallopian tubes, has been in the news since last year, and not for a good reason. Women have reported experiencing horrific, debilitating side effects. Now comes news of another issue with the device. Women have become pregnant despite the use of the device (no form of birth control – besides abstinence – is 100 percent effective), and it is being blamed for the deaths of already conceived children. Bayer and the Food and Drug Administration (FDA) have, according to some, downplayed the issue, but Representative Mike...
  • FDA Finds Wood Fillers in Parmesan Cheese, Investigates Large Retailers

    02/18/2016 10:29:09 AM PST · by nickcarraway · 123 replies
    KPTV ^ | Wednesday, February 17, 2016 | JACQUELINE CUTLER
    Parmesan cheese from many top brands may contain wood byproductCare for some wood shavings on your pasta? Americans who think they’re sprinkling Parmesan over their spaghetti are also getting a hefty dose of cellulose - a wood byproduct — from many top brands. A study by Bloomberg News reveals that Walmart’s Great Value 100% Parmesan Cheese is roughly 8% cellulose and Jewel-Osco’s Essential Everyday 100% Grated Parmesan Cheese is almost 9%. The report follows a lengthy federal investigation into a Pennsylvania company called Castle Cheese, whose 100% “parmesan” contained no actual parmesan, but was comprised of Swiss, cheddar, mozzarella and...
  • FDA issues recommendations to reduce the risk for Zika virus blood transmission in the United States

    02/17/2016 1:39:14 AM PST · by deks · 17 replies
    U.S. Food and Drug Administration ^ | February 16, 2016 | FDA
    While there have been no reports to date of Zika virus entering the U.S. blood supply, the risk of blood transmission is considered likely based on the most current scientific evidence of how Zika virus and similar viruses (flaviviruses) are spread and recent reports of transfusion-associated infection outside of the U.S. Furthermore, about 4 out of 5 of those infected with Zika virus do not become symptomatic. For these reasons, the FDA is recommending that blood establishments defer blood donations from individuals in accordance with the new guidance.
  • Why a top food poisoning expert won’t ever eat these foods

    02/03/2016 3:00:03 AM PST · by afraidfortherepublic · 63 replies
    The Washington Post ^ | 2-3-16 | Robert A. Ferdman
    In the aftermath of an E. coli outbreak at Chipotle that sickened dozens of people across the United States last fall and led to an overhaul of the company's food safety practices, Americans reacted by avoiding the beloved fast-food chain. Restaurants that once sported long lines were suddenly empty, a phenomenon that was almost surely happening nationwide. The risks, in other words, were simply too great in people's minds for them to continue frequenting the Mexican-inspired favorite, because Chipotle had a food safety problem. But the outrage was at least partly misplaced, according to Bill Marler, a lawyer specializing in...
  • New Sunscreen Protects Against Skin Cancer, Allows Body To Produce Vitamin D

    02/01/2016 9:24:41 PM PST · by nickcarraway · 18 replies
    CBS Boston ^ | February 1, 2016 | Dr. Mallika Marshall
    Many people are getting the message loud and clear. That sunscreen helps protect you against skin cancer. But some experts say all that sunscreen is creating another problem. “That is the major cause for the vitamin D epidemic worldwide,” says Dr. Michael F. Holick, an endocrinologist at the BU School of Medicine. “Sunscreen absorbs ultraviolet light and ultraviolet light makes vitamin D in your skin, and if you put a sunscreen on with an SPF of 30 and it absorbs about 97-98% of the UV light, it will reduce the ability to make vitamin D in your skin by 97-98%,”...
  • Right to Try: The FDA Has the Blood of Millions of Americans on its Hands

    01/11/2016 11:00:25 AM PST · by Kaslin · 20 replies
    Townhall.com ^ | January 11, 2016 | Rachel Alexander
    Darcy Olsen, CEO and president of the Goldwater Institute, has written a must-read book for anyone facing a serious ailment, The Right to Try: How the Federal Government Prevents Americans from Getting the Life-Saving Treatments They Need.It is common knowledge there is a problem with the FDA delaying the approval of drugs. But until now, most Americans did not realize just how bad the situation is  — hundreds of thousands of people, including children, needlessly lose their lives every year because new, breakthrough drugs that have worked in clinical trials and are legal in other countries are not approved here....
  • Golden Hammer: Feds Spending Millions to Arm Agencies that Don't Need Guns (EPA, FDA, VA, etc.)

    01/09/2016 4:01:44 PM PST · by DogByte6RER · 37 replies
    The Washington Times ^ | Thursday, January 7, 2016 | Kellan Howell
    <p>As the U.S. engages in a national debate over the militarization of the police, federal data shows that government agencies charged with largely administrative roles are spending tens of millions of taxpayer dollars to purchase SWAT and military-style equipment.</p> <p>Since FY 2006, 44 traditionally administrative agencies have spent over $71 million on items like body armor, riot helmets and shields, cannon launchers and police firearms and ammunition, according to federal spending data from watchdog group OpenTheBooks.com.</p>
  • FDA Cancels Ban on Blood Donations from Gay Males

    12/22/2015 8:35:27 AM PST · by chuckee · 33 replies
    Breitbart ^ | December 21, 2015
    The Food and Drug Administration (FDA) nullified a 30-year ban on blood donations from gay and bisexual men. The FDA ban, which went into effect during the 1980s AIDS crisis, prohibited blood from gay men as a way to stop transmission of HIV. Many early cases of AIDS and HIV resulted from blood transfusions, as was the case with tennis superstar Arthur Ashe. However, the new policy will not accept “donations from men who have had sex with another man in the previous year.” Australia and the United Kingdom also use the 12-month window. “Ultimately, the 12-month deferral window is...