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Keyword: fda

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  • E-Cigarettes Can Be Lifesavers

    01/24/2018 9:03:48 AM PST · by Kaslin · 15 replies
    Townhall.com ^ | January 24, 2018 | Jacob Sullum
    This week, the National Academies of Sciences, Engineering and Medicine weighed in on the question of whether e-cigarettes are a public health menace or a public health boon. The answer is yes, according to a NASEM report published on Tuesday. The report, which was sponsored by the Food and Drug Administration, concludes that "e-cigarettes cannot be simply categorized as either beneficial or harmful to health." While that is true in principle, the report gives too much weight to scenarios in which these products could be harmful, even while confirming that they dramatically reduce exposure to toxins and carcinogens for smokers...
  • FDA Announces Plans to Target Risky Homeopathic Remedies

    12/21/2017 1:42:58 AM PST · by vannrox · 107 replies
    PJ Media ^ | DECEMBER 20, 2017 | LAUREN SPAGNOLETTI
    Alternative remedies like homeopathic treatments have become popular in recent years and now make up a $3 billion industry. But the Food and Drug Administration will begin scrutinizing products that could be dangerous to vulnerable populations. Many homeopathic remedies are derived from plants and claim to treat everything from the common cold to serious diseases. But the FDA fears that these products can "bring little to no benefit in combating serious ailments, or worse — may cause significant and even irreparable harm because the products are poorly manufactured, or contain active ingredients that aren’t adequately tested or disclosed to patients,"...
  • FDA moves to end snortable chocolate, calling it 'street drug alternative'

    12/13/2017 9:39:24 AM PST · by deplorableindc · 41 replies
    Washington Examiner ^ | Dec. 13, 2017
    The Food and Drug Administration is warning a pair of Florida companies to stop distributing a snortable chocolate powder, claiming it's being sold as an unapproved new drug and as a “street drug alternative.” The regulatory action against Coco Loko comes six months after the product's debut, and after Senate Minority Leader Chuck Schumer, D-N.Y., called it “cocaine on training wheels.” FDA Commissioner Scott Gottlieb said in a statement that “[a]s a physician and a parent, I’m deeply troubled by the unlawful marketing of these potentially dangerous products, especially since they are so easily accessible by minors.”
  • FDA approves first-of-its kind antipsychotic that tracks whether patients are taking it

    11/13/2017 6:15:00 PM PST · by markomalley · 20 replies
    Washington Examiner ^ | 11/13/17 | Kimberly Leonard
    The Food and Drug Administration has approved an antipsychotic drug that carries a digital sensor to track whether patients are taking it, according to an agency announcement published Monday.The new drug, Abilify MyCite, is used to treat schizophrenia and manic episodes associated with bipolar disorder. After a patient has swallowed it and once the medication reaches the stomach, a sensor sends a message to a wearable patch, which then transfers information onto a mobile app. Patients then use the app to track whether they have taken their medication and they can give caregivers or doctors access to that information through...
  • FDA Delays New Nutrition Facts Label Unveiled by Michelle Obama

    10/03/2017 4:20:43 PM PDT · by ForYourChildren · 17 replies
    Washington Free Bacon ^ | 10/03/2017 | Elizabeth Harrington
    Feds regulate serving sizes of breath mints! The Trump administration is delaying a regulation championed by former first lady Michelle Obama to redesign the Nutrition Facts label. The Food and Drug Administration on Friday issued a rule delaying until 2020 the compliance date for regulations that will make listed calories on food larger in an attempt to fight obesity. Mrs. Obama unveiled the new label in May 2016 as part of her anti-obesity "Let's Move" campaign. Aside from increasing the font size of calories and the addition of "added sugars" on the label, the regulations even dealt with how to...
  • FDA approves Novartis' 'breakthrough' leukemia drug — with a price tag of $475k

    08/31/2017 9:33:02 AM PDT · by buckalfa · 48 replies
    Beckers Hospital Review ^ | August 31, 2017 | Alia Paavola
    The FDA approved Novartis' revolutionary CAR-T cell leukemia therapy, which uses patients' genetically modified immune cells to fight the disease — at the cost of $475,000 per treatment, according to STAT. The drug, Kymriah, is the first CAR-T therapy to come before the FDA and was approved for the treatment of patients up to 25 years old with relapsed acute lymphoblastic leukemia. A clinical trial of the leukemia drug deemed a "breakthrough" by physicians revealed 83 percent of patients treated with CAR-T cell therapy have gone into remission. While the price tag of $475,000 per treatment seems staggering, it is...
  • Cigar--Good News on the FDA Front

    08/09/2017 9:16:14 AM PDT · by cgbg · 11 replies
    Tampa Bay Times ^ | August 8, 2017 | cgbg
    Tampa's premium cigar dealers aren't ready to light a stogie in victory yet, but they have more time now to argue against proposed federal regulations that would add to their costs.
  • City of Chicago Taking the State of Illinois Down the Chute with It

    07/09/2017 8:52:31 AM PDT · by Oldpuppymax · 14 replies
    The Coach's Team ^ | 7/9/17 | Jean Tierney
    The real reason for Illinois' collapsing financial situation is being withheld from its citizens. According to the latest Natural News health blog, "When a single state in America must now pay over half a billion dollars per month just to barely keep up with what it owes the medical system, you know something has gone terribly wrong and the system is unsustainable." "Illinois is being bankrupted by Big Pharma," continues Natural News publisher Mike Adams who is an advocate of Natural Medicine and healing practices not acceptable to the Federal Drug Administration, “because Americans are being held captive by the...
  • Sam Girod Gets 6 years in Prison for Herbal Salve

    07/08/2017 12:51:11 PM PDT · by Twotone · 43 replies
    Redoubt News ^ | July 7, 2017 | Unknown
    Sam Girod was sentenced to six years in federal prison for making herbal salve without the king’s permission, plus $1300 in what are essentially court costs, plus over $14,000 in restitution to his victims. He will also have three years of supervised release, is barred from owning firearms, and is barred from making any product regulated by the FDA. Sam will not be forced to undergo court ordered drug testing. After a few brief opening remarks, Judge Danny Reeves described the sentencing procedure. It’s not a simple nor straight forward procedure. It seemed deliberately complicated, which in the federal government...
  • Now Hear This!

    06/13/2017 5:02:03 AM PDT · by Kaslin · 67 replies
    Townhall.com ^ | June 13, 2017 | Stephen Moore
    I'm technically disabled -- but not mentally disabled the way some of my foes on CNN seem to believe I am. No, my disability is hearing loss. In one ear I'm nearly deaf. I have to turn the TV up so loud the neighbors say they can hear it from their house next door. My friends complain that watching TV with me is like watching Garrett Morris on "Saturday Night Live" shout into the camera to provide news for the hard of hearing. There are some 30 million Americans like me suffering from severe to moderate hearing loss. Not being...
  • Jelly Belly sued by woman claiming she didn't know jelly beans contain sugar

    05/25/2017 9:13:51 AM PDT · by NohSpinZone · 93 replies
    Fox News ^ | 5/25/17 | Fox News Staff
    When it comes to food, it turns out you can sue over just about anything these days. A California woman is suing the makers of Jelly Belly jelly beans, claiming she was tricked into believing one of the company's candy products was free of sugar. The plaintiff, Jessica Gomez of San Bernadino County, first brought the case against the candy company earlier this year, blaming "fancy phrasing" for her confusion over the ingredients, according to Legal News Line.
  • Senate confirms Trump's FDA pick

    05/09/2017 2:53:57 PM PDT · by ameribbean expat · 9 replies
    The Senate on Tuesday confirmed Scott Gottlieb, President Trump’s nominee to lead the Food and Drug Administration (FDA). Gottlieb, a former FDA director and deputy commissioner under former President George W. Bush, was confirmed in a 57-42 vote. He will replace Robert Califf, the acting FDA chief who was appointed last year by former President Barack Obama. “As a practicing physician with a wealth of policy experience, Dr. Gottlieb has the necessary qualifications to lead the FDA at this critical time,” Senate Majority Leader Mitch McConnell (R-Ky.) said Tuesday on the Senate floor.
  • FDA May Make Too Many Pizza Toppings a Crime

    05/02/2017 5:26:41 PM PDT · by ForYourChildren · 67 replies
    The Daily Signal ^ | David Rosenthal
    Jenny Craig can’t arrest you if you miscount your calories, but the federal government could if a new calorie-counting rule takes effect. The U.S. Food and Drug Administration’s “Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments” (79 FR 71155) rule is scheduled to take effect on May 5. The 105-page rule implements Obama-era amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act), which sets national standards for the marketing and labeling of food products. .. To face one year in prison for putting too many pepperonis on a pizza? Everybody laughs and smiles,...
  • FDA officially bans Texas' attempted import of execution drugs

    04/21/2017 6:39:23 AM PDT · by GIdget2004 · 49 replies
    Texas Tribune ^ | 04/20/2017 | Jolie McCullough
    Almost two years after Texas tried to import an execution drug from overseas, the U.S. Food and Drug Administration ruled Thursday that the drug can’t be admitted into the United States. In July 2015, the Texas Department of Criminal Justice tried to import 1,000 vials of sodium thiopental, an anesthetic that the state has previously used in executions, but the FDA seized the drugs at a Houston airport and has held them ever since. The federal agency has maintained that the import of the drug is illegal because it is not currently approved in the U.S. In a statement, the...
  • A Fight Worth Having

    03/20/2017 6:11:59 PM PDT · by Beave Meister · 16 replies
    The Weekly Standard ^ | 3/27/2017 | STEPHEN F. HAYES
    One day in late spring in the early days of the George W. Bush administration, FDA inspectors visited the headquarters of Sargento cheese in Plymouth, Wisconsin—a routine visit as part of the federal government's efforts to ensure the safety of the food we eat. The inspectors took samples of cheese to test for bacteria. Sargento conducted tests on cheese from the same lot. A week later, the results from both sets of tests were in—the cheese was bacteria-free. Sargento, having gotten the all-clear from the government, shipped the cheese to stores across the country. Two months later, however, the FDA...
  • Dog food recalled after euthanasia drug found in can

    02/08/2017 7:43:13 AM PST · by ColdOne · 35 replies
    breaking911.com ^ | 2/8/17 | breaking911
    According to a U.S. Food and Drug Administration statement released Friday, Evanger’s, a family-owned and -operated cat and dog food business, decided to voluntarily recall five lots of the product – all of the Hunk of Beef products that were manufactured that same week. The products were distributed to retail locations and sold online in these states: Washington, California, Minnesota, Illinois, Indiana, Michigan, Wisconsin, Ohio, Pennsylvania, New York, Massachusetts, Maryland, South Carolina, Georgia and Florida. Hunk of Beef is Evanger’s best-selling food. Pets nationwide consume more than one million cans of the product each year, the company said in a...
  • 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...