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Keyword: fda

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  • FDA Bans Pure Bulk Caffeine Products, Citing "Significant Public Health Concern"

    04/15/2018 7:58:02 AM PDT · by BenLurkin · 51 replies
    newsweek ^ | Kate Sheridan
    Companies can no longer sell bulk packages of liquid or powdered caffeine directly to consumers, the Food and Drug Administration announced Friday. The policy will take immediate effect “given the significant public health concern,” according to the agency’s statement released Friday. “Highly concentrated and pure caffeine, often sold in bulk packages, have been linked to at least two deaths in otherwise healthy individuals,” the agency stated. ... Between 10 and 14 grams of caffeine is considered life-threatening, according to the FDA’s guidelines, though people can have an irregular or rapid heart rate and seizures after taking just a gram. The...
  • 207 million eggs in nine states recalled over salmonella fears

    04/14/2018 10:42:55 PM PDT · by blueplum · 56 replies
    CNN via MSN ^ | 14 Apr 2018 | Faith Karimi
    A farm in Indiana is recalling more than 200 million eggs sold in nine states over salmonella fears. Rose Acre Farms voluntarily recalled 206,749,248 eggs due to potential contamination with Salmonella Braenderup, the Food and Drug Administration said in a statement. At least 22 illnesses have been reported so far, the FDA said Friday. The eggs were sold through retail stores and restaurants. They reached consumers in ...
  • Dairy Farmer Sues FDA for the Right to Label His Skim Milk as “Skim Milk”

    04/12/2018 1:42:32 PM PDT · by Red Badger · 36 replies
    modernfarmer.com ^ | April 10, 2018 | By Dan Nosowitz
    If we had an actual, physical folder of evidence that the food labeling system in the United States is broken, it'd be full to bursting. And we'd be adding "skim milk????" to the list right about now. Maryland dairy farmers Randy and Karen Sowers are, with the help of the Institute for Justice (a non-profit libertarian-leaning law firm), suing the Food and Drug Administration for essentially doubling down on a very silly law. The gist: South Mountain Creamery, the dairy producer owned by the Sowerses, want to sell milk without the addition of any synthetic chemicals. To do this, they...
  • Memo to FDA Administrator Gottlieb: Help Entrepreneurs, Don't Hinder Them

    04/05/2018 2:56:15 PM PDT · by Kaslin · 2 replies
    Townhall.com ^ | April 5, 2018 | Ken Blackwell
    Thanks in large part to President Trump’s aggressive deregulation agenda—through which the president has demonstrated a commitment to cutting or restructuring unnecessary, burdensome rules that hamper innovation and growth—the economy is booming. Unfortunately, one poorly considered rule that seems to have escaped his notice will hurt the businesses that provide one of America’s favorite foods: pizza.The U.S. Food and Drug Administration’s (FDA) rule, a byproduct of the Patient Protection and Affordable Care Act and slated to go into effect on May 7, will require businesses with 20 or more locations that sell highly customizable food items—such as pizza companies, convenience stores, supermarkets...
  • Reducing Nicotine in Cigarettes Is an Extremely Bad Idea

    04/05/2018 12:23:20 AM PDT · by kathsua · 43 replies
    Janitor's view ^ | 04/04/18 | Reasonmclucus
    The Food and Drug Administration's proposal to gradually reduce nicotine levels in tobacco to discourage smoking is an extremely bad idea which won't help anyone and could hurt some. Smoking may appear unattractive to non-smokers, but smokers may be doing what is best for someone with their genetic brain structure. I have never had any connection to the tobacco industry. I have never smoked, owned any tobacco company assets or worked in a facility that sold tobacco products. People I cared about have died from medical conditions associated with tobacco use. On a personal level I don't understand how people...
  • FDA takes first step in drafting rule to cut nicotine levels in cigarettes

    03/15/2018 10:14:39 AM PDT · by GIdget2004 · 36 replies
    The Hill ^ | 03/15/2018 | Lydia Wheeler
    The Food and Drug Administration (FDA) on Thursday took the first step in creating a new rule to reduce the level of nicotine allowed in cigarettes to nonaddictive levels. In an advanced notice of proposed rulemaking, FDA asked the public to submit comments over the next 90 days on the impact of a product standard for the maximum nicotine level in cigarettes. “Tobacco use causes a tremendous toll of death and disease every year and these effects are ultimately the result of addiction to the nicotine contained in combustible cigarettes, leading to repeated exposure to toxicants from such cigarettes,” the...
  • New Antibiotic for MRSA Infections is Ready for US Clinical Trials

    02/27/2018 9:53:11 AM PST · by nickcarraway · 15 replies
    Labiotech ^ | Alex Dale Alex Dale on 26/02/2018 | Alex Dale Alex Dale on 26/02/2018
    Destiny Pharma’s antibiotic for post-surgical infections will begin its clinical development after the FDA accepted its Investigational New Drug application. Destiny Pharma wants to combat the growing antibiotic resistance crisis by targeting post-surgical Staphylococcus aureus infections like methicillin-resistant Staphylococcus aureus (MRSA). The FDA has accepted an investigational new drug application (IND) for Destiny’s MRSA candidate, XF-73, which will allow the company to complete Phase I and finalize the design of a Phase II trial. XF-73 is a dicationic porphyrin molecule, which is a member of a new class of antibiotics called XF drugs. Interestingly, XF-73 is a nasal gel, which...
  • 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,...