Food and Drug Administration

The Food and Drug Administration is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs, vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices, cosmetics, animal foods & feed and veterinary products. The FDA was empowered by the United States Congress to enforce the Federal Food, Drug, and Cosmetic Act, which serves as the primary focus for the Agency; the FDA also enforces other laws, notably Section 361 of the Public Health Service Act and associated regulations, many of which are not directly related to food or drugs. These include regulating lasers, cellular phones, condoms and control of disease on products ranging from certain household pets to sperm donation for assisted reproduction. The FDA is led by the Commissioner of Food and Drugs, appointed by the President with the advice and consent of the Senate.
Latest trending news and information about the Food and Drug Administration.
  • USA Today

    FDA signs off on first medical device for treating ADHD in children

    A new study has found toddlers who spend two hours or more staring at screens on a daily basis are more likely to behave badly or have ADHD. As diagnosis rates of ADHD among children skyrocket, a new medical device for the treatment of the disorder could soon be hitting the market. The U.S. Food and Drug Administration announced Friday that it has permitted marketing for the first medical device to treat ADHD. The authorization has been granted to the life sciences company NeuroSigma Inc. based in Los Angeles.  Called the Monarch external Trigeminal Nerve Stimulation (eTNS) System, the prescription-only device is for children ages 7 to 12 who are not currently taking ADHD prescription medication.

  • Reuters

    Reuters Health News Summary

    China has detected new cases of African swine fever in six farms across four locations in Hainan province, the agriculture ministry said on Sunday, adding to two earlier cases of the contagious disease identified in the province on Friday. Generic drugmaker Teva Pharmaceutical Industries Ltd on Friday received approval from the U.S. Food and Drug Administration (FDA) to market its generic nasal spray for opioid overdose, the health regulator said.

  • How many cherries in frozen pie? FDA may soon drop rules
    KRIV

    How many cherries in frozen pie? FDA may soon drop rules

    President Donald Trump may soon be able to claim a sweet victory for his deregulation push, with officials preparing to get rid of the decades-old rules for frozen cherry pies. Emails show the Food and Drug Administration planned to start the process for revoking the standard for frozen cherry pies this week, followed by a similar revocation of the standard for French dressing.

  • Daily Mail

    Church claims its 'miracle potion' cures 95% of illnesses but FDA says it's just using bleach

    A controversial Washington State 'church' that claims to cure 95 percent of all illnesses with a miracle solution is holding a $450-a-ticket 'healing ceremony' on Saturday - despite the FDA previously slamming the potion as nothing more than industrial bleach.  The Genesis II Church of Health and Healing, which has been wholly discredited by scientists, is asking participants for 'donations' amounting to hundreds of dollars to experience 'Chlorine Dioxide Therapy.' Otherwise known as Miracle Mineral Solution (MMS), the snake oil treatment has been dismissed by the FDA, who have warned consumers to 'stop using it immediately and throw it away.' 'The FDA continues to advise consumers about the

  • How many cherries in frozen pie? FDA may soon drop rules
    KSAZ

    How many cherries in frozen pie? FDA may soon drop rules

    President Donald Trump may soon be able to claim a sweet victory for his deregulation push, with officials preparing to get rid of the decades-old rules for frozen cherry pies. Emails show the Food and Drug Administration planned to start the process for revoking the standard for frozen cherry pies this week, followed by a similar revocation of the standard for French dressing.

  • FDA Update: Recent Trends and a New Regime
    The National Law Review

    FDA Update: Recent Trends and a New Regime

    Norman E. (Ned) Sharpless, M.D., recently took the helm as Acting Commissioner of the US Food and Drug Administration (FDA). Dr. Sharpless most recently served as the director of the National Cancer Institute, part of the National Institutes of Health (NIH), which serves as the government's principal agency for cancer research. Dr. Sharpless's appointment comes on the heels of the resignation of former Commissioner Scott Gottlieb, M.D. on April 5, 2019. Dr. Gottlieb was an agent for change at the FDA. He led initiatives in combating the opioid crisis, curbing the marketing of e-cigarettes to youth, promoting innovative pathways for Digital Health, reducing drug prices by promoting generic competition,

  • Recall of blood pressure drug losartan expanded
    FOX 61

    Recall of blood pressure drug losartan expanded

    If you take blood pressure medicine, you'll want to double-check your bottle. Torrent Pharmaceuticals Ltd. has expanded its recall of losartan potassium and losartan potassium/hydrochlorothiazide tablets. Tests found trace amounts of a potentially cancer-causing impurity called N-methylnitrosobutyric acid in some of these drugs. The company is recalling 36 additional lots, it said Thursday. A full list of recalled drugs is available on the US Food and Drug Administration website. The company hasn't had any reports of users getting sick, but the impurity level in these pills is above what the FDA considers an acceptable daily intake level. Doctors prescribe losartan for patients with high blood

  • Ready for a CBD Hamburger?
    InvestorPlace

    Ready for a CBD Hamburger?

    As public acceptance continues to grow, the investment gains keep coming -- and why if you haven't invested yet, it's not too lateCBD's popularity is reaching almost comical levels.Yesterday brought news that the fast-food restaurant, Carl's Jr., will be testing a CBD-infused burger at one of its Denver locations … for one day only. Can you guess which day?InvestorPlace - Stock Market News, Stock Advice & Trading TipsYes, April 20.(For anyone unaware, "4/20" is an homage to the marijuana culture, allegedly dating back to a group of high school students in the '70s who would meet at 4:20 to hunt for a rumored, abandoned stash of marijuana.)And in case you felt the dead horse required just a tad more beating, can you guess the price of the burger?Correct again. For just $4.20, you can buy two beef patties, jalapenos, pepper jack cheese -- and about 5 milligrams of hemp-derived CBD extract.***Why is Carl's Jr. willing to take the risk of selling CBD given all the gray area around federal legalization of CBD-infused products?In answering this, let's first make sure everyone's on the same page.As to CBD itself, here's how our own Matt McCall, editor of Early Stage Investor, describes it:CBD is shorthand for cannabidiol, which is one of more than 400 chemical compounds found in a cannabis plant. Of those 400, over 60 are unique to the cannabis plant, and they are referred to as cannabinoids.CBD is what's called a non-psychoactive compound found in both the cannabis and hemp plants. That's a fancy way of saying CBD will not get you "high."It's actually been used by wellness and medical professionals for years as an alternative to traditional pharmaceuticals to treat everything from anxiety and depression to chronic pain to the reduction of inflammation to childhood epilepsy. If it were a drug, we would call it a wonder drug.CBD made from hemp is now legal thanks to the 2018 Farm Bill. However, CBD made from marijuana is still illegal. That's because marijuana remains a controlled substance.Confusion around this topic, as well as the lack of formal guidance from the FDA has led state and local officials around the nation to shut down the sale of certain CBD-infused foods and beverages for fear of being in violation of federal law.For instance, in February, The New York City Department of Health began going after restaurants selling CBD. Starting this coming October, they'll officially begin issuing fines -- even potentially lowering a restaurant's health letter grade.On the other hand, retailers are taking more risks with CBD-infused lotions and creams. For example, Walgreens, Rite Aid, and CVS have all announced they're selling CBD-infused topicals. The idea seems to be there's less danger of complications if the CBD is applied externally versus ingested.But given the public demand for CBD-infused foods and beverages, politicians and the public have been pushing the FDA for more formal guidance. Given this, the FDA is holding its first public hearing on whether to allow CBD to be legally used as a food-and-drink ingredient on May 31.***Back to Carl's Jr. now …Yes, the fast-food company is taking a risk in selling the CBD-burger. The FDA is clear about this. Per the FDA's website:9\. Can THC or CBD products be sold as dietary supplements?A. No. Based on available evidence, FDA has concluded that THC and CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B) of the FD&C Act [21 U.S.C. § 321(ff)(3)(B)] …FDA is not aware of any evidence that would call into question its current conclusions that THC and CBD products are excluded from the dietary supplement definition …That said, Carl's Jr. has developed an irreverent brand, so this is in line with its public image. Plus, the company is privately held, so there's less fear of an uproar from investors.But Carl's Jr. is hardly the only food/beverage company willing to take this risk. As Forbes recently reported, the Beverage Trade Network is hosting its first Cannabis Drinks Expo this summer. The focus will be on canna-beverages, which last year had a market size of $89 million. But by 2023, that number is expected to clock in at $1.4 billion.Now, how is an industry going to go from $89 million in sales to $1.4 billion in just four years when its product is illegal?Well, it's going to do that by ignoring the enforcing body which, as of now, isn't doing much enforcing.The reality is it's the state governing bodies that have been cracking down on restaurants, not the FDA. In fact, the FDA hasn't done much of anything in terms of prosecuting companies in violation of CBD guidelines. The "crackdowns" have generally consisted of warning letters sent to companies making misleading marketing claims. To my knowledge, we haven't seen the FDA go after a specific restaurant or vendor selling CBD-infused food or beverages.So, as more restaurants and food/beverage distributors get in on the action -- and the FDA doesn't truly prosecute -- the agency runs the risk of becoming something of a paper tiger. ***The root issue is that marijuana policies appear to be outdated relative to collective public sentimentRecent national surveys reveal that a majority of American's now support marijuana legalization.The latest finding, from the recently released General Social Survey by NORC at the University of Chicago, shows that 61 percent of people supported marijuana legalization in 2018. That's up from 57 percent in 2016 and 31 percent in 2000 -- a rapid shift in public opinion in less than two decades.A Gallup poll shows support for marijuana legalization at 66% in 2018, and Pew puts it at 62%.If you break it down by party lines, 54% of Republicans support legalization, while that number climbs to 76% for Democrats.Plus, the outcry is even coming from politicians. For example, nearly every declared 2020 democratic presidential hopeful has come out in favor of some form of marijuana legalization.***Coming full circle, federal reform is on the way -- it's just a matter of when, and in what shapeAnd as we've discussed in the Digest, that means that the biggest investment gains from legalized marijuana are still ahead of us.If you've been watching from the sidelines so far, we're still in the early stages of investment gains, despite the huge returns that have been made so far.But I'll give you an example …As mentioned earlier, Matt McCall is our resident marijuana expert. As I write, since recommending Charlotte's Web, the stock has climbed 77%. IIPR has enjoyed 140% gains, and Ellixinol has soared 155%. But these gains have played out over the past several months.Is it too late for the rest of us?First, no -- as mentioned a moment ago, marijuana isn't legal yet on the federal level. That means the majority of national demand hasn't begun to be serviced.But even on a micro, investment-specific level, it's not too late. For instance, in Early Stage Investor, Matt recommends small marijuana stocks that are "jumping" to major U.S. exchanges. It's like going from the minor leagues to the majors. This is will not only allow more individual investors to buy marijuana stocks, but it will also allow the multi-trillion-dollar mutual fund industry to buy them as well.On February 20, Matt introduced Jumper Stocks to his Early Stage Investor readers. As part of it, he recommended one new stock to his portfolio. It's a Toronto-based cannabis producer.As I write, this jumper stock has soared over 60% in not even two months.Does that look like the gains are going away?But if you'd to hear directly from Matt on this, I can do you one better …Matt recently sat down with Managing Editor Dave Gilbert and addressed the biggest questions and concerns that many readers have about cannabis stocks and the industry as a whole.He even walked Dave through his Jumper Stock system step by step. You can watch the short Q&A by going here.There's no hype, or high-pressure selling … it's all education without the fluff.You'll walk away with a deeper understanding of this incredible opportunity and how Matt's system really works.Plus, he reveals a special development our publisher has agreed to for anyone who wants to dip their toes in the water.Again, you can watch this short, informative Q&A by going here.In the meantime, if any of our Denver readers want to give us the review on the Carl's Jr. CBD-burger this Saturday, we'd love to hear from you.Have a good evening,Jeff RemsburgCompare Brokers The post Ready for a CBD Hamburger? appeared first on InvestorPlace.

  • The Helmet That ‘Resets’ Your Brain
    The Atlantic

    The Helmet That ‘Resets’ Your Brain

    Magnetic stimulation is helping some people with depression—but the $12,000 treatment is also being unleashed in untested ways.

  • Anderson Advanced Ingredients commends the FDA's updated allulose guidelines
    PR Newswire

    Anderson Advanced Ingredients commends the FDA's updated allulose guidelines

    IRVINE, Calif., April 19, 2019 /PRNewswire/ -- Anderson Advanced Ingredients® commends the most recent draft guidance by the U.S. Food and Drug Administration (FDA) titled "The Declaration of Allulose and Calories from Allulose on Nutrition and Supplement Facts Labels". The draft guidance provides the FDA's current view of the declaration of allulose under the newly modified U.S. Labeling Laws. The guidance is one of a series that has been released and it marks the first time the FDA has stated its intent to allow a sugar to not be included as part of the total or added sugars declarations on labels.

  • Reuters

    Reuters Health News Summary

    Researchers examined survey data from 4,428 men and women aged 65 and older in Washington State. Generic drugmaker Teva Pharmaceutical Industries Ltd on Friday received approval from the U.S. Food and Drug Administration (FDA) to market its generic nasal spray for opioid overdose, the health regulator said. This is the first approval of a generic naloxone nasal spray for use in a community setting by individuals without medical training, the FDA said in a statement.

  • How Many Cherries in Frozen Pie? FDA May Soon Drop Rules
    NBC New York

    How Many Cherries in Frozen Pie? FDA May Soon Drop Rules

    President Donald Trump may soon be able to claim a sweet victory for his deregulation push, with officials preparing to get rid of the decades-old rules for frozen cherry pies. Emails show the Food and Drug Administration planned to start the process for revoking the standard for frozen cherry pies this week, followed by a similar revocation of the standard for French dressing. Plans to get rid of the obscure rules had been tucked into the Trump's administration's deregulation agenda. Standards for an array of foods including cottage cheese and canned peas were put in place decades ago partly to ensure a level of quality. They spell out how products with specific names can be made, including

  • Ethicon Prevails in Latest Pelvic Mesh Trial
    ALM Media

    Ethicon Prevails in Latest Pelvic Mesh Trial

    The defense win in 'Krolikowski v. Ethicon Women's Health and Urology' was handed up Wednesday after more than three weeks of trial.

  • Ben & Jerry's Recalls 2 Ice Cream Flavors Due to Undeclared Nuts
    People

    Ben & Jerry's Recalls 2 Ice Cream Flavors Due to Undeclared Nuts

    Ben & Jerry's Recalls Two Ice Cream Flavors Due to Undeclared Nuts