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The Food and Drug Administration (FDA) is going to restart high-risk food inspections this week despite the partial government shutdown, which has forced the FDA to suspend most routine domestic food facility inspections. "We re-starting high risk food inspections as early as tomorrow," FDA Commissioner Scott Gottlieb tweeted on Monday, noting that the inspections will be performed by employees who have agreed to come back to work unpaid.

Routine food inspections aren't getting done because of the partial government shutdown, but checks of the riskiest foods are expected to resume next week, the Food and Drug Administration said Wednesday. The agency said it's working to bring back about 150 employees to inspect riskier foods such as cheese, infant formula and produce. FDA Commissioner Scott Gottlieb said the agency can't make the case that "a routine inspection of a Nabisco cracker facility" is necessary during the shutdown, however. The FDA doesn't oversee meat and poultry and those inspections are continuing. Gottlieb said FDA inspections would have ramped up this...

Among the U.S. Food and Drug Administration's responsibilities are approval and regulation of pharmaceutical drugs. In short, its responsibility is to ensure the safety and effectiveness of drugs. In the performance of this task, FDA officials can make two types of errors -- statistically known as the type I error and type II error. With respect to the FDA, a type I error is the rejection or delayed approval of a drug that is safe and effective -- erring on the side of over-caution -- and a type II error is the approval of a drug that has unanticipated dangerous...

Denver, Colo., Oct 25, 2018 / 04:30 pm (CNA/EWTN News).- A European online service that has been quietly offering mail-order abortion pills to women in the United States for several months is being investigated by the FDA for possibly violating abortion drug laws. Aid Access is a website that says it offers abortion-inducing drugs to healthy women who are nine weeks pregnant or less. If women qualify for the pills through online consultations, Aid Access writes them prescriptions for the two abortion-inducing drugs, misoprostol and mifepristone. These prescriptions are filled at a pharmacy in India, which mails the drugs to...

President Trump signed a bill Wednesday allowing terminally ill patients access to experimental medical treatments not yet approved by the Food and Drug Administration (FDA). Dubbed "right to try," the law's passage was a major priority of Trump and Vice President Pence, as well as congressional Republicans. "Thousands of terminally ill Americans will finally have hope, and the fighting chance, and I think it's going to better than a chance, that they will be cured, they will be helped, and be able to be with their families for a long time, or maybe just for a longer time," Trump said...

Scientific study to advance the well-being of humans is good – but not when it depends on the destruction of others. On Aug. 7, CNSNews.com, a division of the MRC, revealed that the U.S. Food and Drug Administration (FDA) is obtaining “fresh” aborted baby parts in the name of scientific research – or to create mice with human immune systems. But Americans wouldn’t know that by watching the network news shows that evening. ABC, CBS, and NBC didn’t mention the story once during their evening news shows Aug. 7. But all three reported on a the body parts of a...

The U.S. Food and Drug Administration signed a new contract on July 25 to acquire “fresh” human fetal tissue to transplant into “humanized mice” so that these mice will have a functioning “human immune system,” according to information published by the FDA and the General Services Administration. “The objective is to acquire Tissue for Humanized Mice,” said a June 13 FDA “presolicitation notice” for the contract. The contractor, the notice said, would “provide the human fetal tissue needed to continue the ongoing research being led by FDA. “Fresh human tissues are required,” said the notice, “for implantation into severely immune-compromised...

Several common drugs that contain valsartan, used to treat high blood pressure and heart failure, were recalled in the United States on Friday due to an "impurity" in the drug that poses a potential cancer risk. That impurity, N-nitrosodimethylamine or NDMA, is classified as a probable human carcinogen, based on results from lab tests. The medicines included in the voluntary recall are valsartan from Major Pharmaceuticals, Solco Healthcare and Teva Pharmaceuticals Industries, as well as valsartan/hydrochlorothiazide from Solco and Teva. Valsartan is off patent and is used as a component of other generic medicines, but not all medicines containing the...

The Trump administration wants to explore how to safely import pharmaceuticals from other countries in order to counteract major hikes in the price of drugs. Such a policy would represent a major shift from current procedure. Health and Human Services Secretary Alex Azar requested on Thursday that the Food and Drug Administration establish a working group to examine safe importation. The request is part of a larger effort by the Trump administration to tackle high drug prices, a growing driver of healthcare costs in the U.S. “We have seen a number of both branded and generic examples in recent years...

The recall of a common drug used to control blood pressure and help prevent heart failure was announced by the US Food and Drug Administration on Friday, a week after 22 other countries recalled it because the drug contains a chemical that poses a potential cancer risk. Valsartan is off patent and is used as a component of other generic medicines, but not all medicines containing the ingredient are involved, according to the FDA. The US recall includes the the versions of valsartan that are made by Major Pharmaceuticals, Solco Healthcare and Teva Pharmaceuticals Industries Ltd. as well as valsartan/hydrochlorothiazide...

In the last several days I've had four different people in discussions about what is going on with cigar regulations. For whatever reason, this story has people talking. On the surface, that's great. The devastation that government regulation wreaks upon our society normally goes unnoticed. But my answer to solve the problem is one that nobody ever considers: Abolish the Food and Drug Administration. And I know what thoughts people have in their minds because I can see the look of surprise on their faces: "But what about our food?" "what about drug safety?" These and other questions just like...

U.S. regulators Friday approved the first treatment for smallpox — a deadly disease that was wiped out four decades ago — in case the virus is used in a terror attack. Smallpox, which is highly contagious, was eradicated worldwide by 1980 after a huge vaccination campaign. But people born since then haven’t been vaccinated, and small samples of the smallpox virus were saved for research purposes, leaving the possibility it could be used as a biological weapon. Maker SIGA Technologies of New York has already delivered 2 million treatments that will be stockpiled by the government, which partially paid for...

Office of Management & Budget Director Mick Mulvaney gave an intricate and often eccentric explanation of redundancy and overlap in federal bureaucracy in a presentation that stunned the president and the press. "I call this the 'drain the swamp' cabinet meeting," Mulvaney said, adding that it has been about 100 years since the federal government was reorganized at this scale. He criticized the "Byzantine nature" by which the government regulates, creating headaches for business owners, employees and taxpayers. "If you have a cheese pizza, it's governed by the Food & Drug Administration. If you put a pepperoni on it, it's...

President Donald Trump is slated to sign the controversial "right-to-try" bill on Wednesday, which would bypass drug regulators to give gravely ill patients access to experimental medicines. The legislation allows patients with life-threatening conditions to ask drugmakers for medicines that have cleared some testing but still haven't been approved by the Food and Drug Administration. Previously, people would need to ask the FDA for access to experimental treatments. Trump and Vice President Mike Pence had been major supporters of passing the measure, which supporters say gives patients hope they would not otherwise have. The House of Representatives approved the bill...

WASHINGTON -- Imagine the horror of learning you have a terminal illness for which science has not yet come up with a treatment. Now imagine receiving the same diagnosis, and then learning a promising new treatment exists that could save your life -- but you can't get access to it thanks to governmental obstacles. That is the nightmare that befell Andrea Sloan, an Austin lobbyist who gave up her job at a high-priced law firm to advocate for victims of domestic violence. In 2007, Sloan was diagnosed with ovarian cancer, and for more than six years tried every Food and...

EAST MONTPELIER – Producers of pure maple syrup and honey aren’t sweet on a plan to label their pure natural products as containing added sugars. The U.S. Food and Drug Administration will be requiring updated nutrition labels for products that are expected to say that pure maple syrup and honey contain added sugars, which the producers and officials say is misleading and confusing and could hurt their industries. "There are no added sugars. Maple is a pure product," said U.S. Rep. Peter Welch of Vermont, the top maple producing state in the country.

US government scientists have detected a weedkiller linked to cancer in an array of commonly consumed foods, emails obtained through a freedom of information request show. The Food and Drug Administration (FDA) has been testing food samples for residues of glyphosate, the active ingredient in hundreds of widely used herbicide products, for two years, but has not yet released any official results. But the internal documents obtained by the Guardian show the FDA has had trouble finding any food that does not carry traces of the pesticide. “I have brought wheat crackers, granola cereal and corn meal from home and...

In an ominous sign for patient safety, 71% of reusable medical scopes deemed ready for use on patients tested positive for bacteria at three major U.S. hospitals, according to a new study. The paper, published recently in the American Journal of Infection Control, underscores the infection risk posed by a commonly used endoscopes. It signals a lack of progress by manufacturers, hospitals and regulators in reducing contamination despite numerous reports of superbug outbreaks and patient deaths, experts say. "These results are pretty scary," said Janet Haas, president of the Association for Professionals in Infection Control and Epidemiology. "These are very...

Unlike other food establishments that have static menu options, pizza is highly variable: Domino’s offers consumers 34 million different combinations of pizza. (iStock Photo) _______________________________________________________________________________________________________ As the owner of 18 Domino’s stores in Texas, I do not cut corners, whether on pizzas or complying with the law. Unfortunately, on May 7 the law will become especially burdensome and unhelpful to my customers. That day, President Trump’s FDA Commissioner Scott Gottlieb will implement a nationwide, Obama-era menu-labeling rule requiring restaurants with 20 or more locations to post in-store menu boards listing the calories of every item sold. I fully support efforts...

Science writer Gary Taubes has a knack for subverting conventional wisdom. Sixteen years ago, he published a groundbreaking feature article in The New York Times Magazine arguing that decades' worth of government-approved nutritional advice was flat-out wrong, ideologically motivated, and contributing to rising rates of obesity and diabetes. Traditional dieting guidance attacking fatty food and praising carbohydrates, he wrote, was based on "a big fat lie." – The Man Who Hated Carbs Before It Was Cool Of course Dr. Atkins had been saying essentially the same thing for 30 years before Taubes wrote his article for the NYT. But...