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The white-marble Rayburn House Office Building, in Washington DC, looks like a giant courts building or a central bank, fully intimidating and imposing in its hulking stony blockiness. And the US Congress, of course, is an institution best known for its tedium, albeit a tedium that is regularly punctuated by fiery partisan combat. On a typical day, the Rayburn building--acronymed as RHOB--is a place where politicos and bureaucrats struggle for and against some special interest, yea or nay, on regulation or appropriation. And the biggest single activity in RHOB, or in any of the other five office edifices on Capitol...

The latest bad news concerns one more of the ill-fated thiazolidinediones (TZDs). This class of drugs was introduced in the late 1990s, and includes Avandia, Actos, and Rezulin. TZDs are PPAR-gamma agonists, meaning that they activate peroxisome proliferator-activated receptors, especially the “gamma” receptor. Such activation affects certain metabolic processes, and among other things, insulin resistance is reduced. Rezulin—notoriously fast-tracked by FDA—was withdrawn from the market in 2000, in the wake of scores of liver failures and deaths. Pfizer, the manufacturer, was on the hook for upwards of $750 million in damages. At the time, Dr. Janet Woodcock, director of FDA’s...

For reasons passing understanding, the FDA announced recently that it was moving forward with invoking its authority to regulate cigars, along with other forms of tobacco. It’s a part of the Tobacco Control Act, signed into law in 2009, which gave the agency the option of casting its net down on cigars at the time of its choosing. In other words – it was only a matter of time before bureaucrats decided to be bureaucrats. It’s not set into stone, yet. Between now and July 9 the FDA will accept comments on its proposals, at which point it will the...

The government bureaucrats who regulate and inspect our food for a living may be less than competent at scrutinizing their own meals. The national Food Safety Summit was attended by 1,300 food safety officials, including agents of the Food and Drug Administration and the Centers for Disease Control as well as a number of large businesses. Officials hired the Baltimore Convention Center and its food service provider, Centerplate, to host and cater the event. “A couple of our folks indicated that they had experienced symptoms associated with food poisoning after the summit,” said FDA spokeswoman Juli Putnam.

(Reuters) - A U.S. food safety summit in Maryland earlier this month has become a cautionary tale after more than 100 attendees came down with suspected food poisoning. Most of those affected complained of diarrhea, the Maryland Department of Health and Mental Hygiene said in a statement. Local health officials have heard from about 400 of the 1,300 attendees and are at a loss as to the exact cause of their illness. The April 8-10 meeting at the Baltimore Convention Center included representatives from the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention, and food...

Regulation of Electronic Cigarettes by the FDA By Mitch Zeller, the Director of the Food and Drug Administration's Center for Tobacco Products. Thank you for http://click.mail.whitehouse.gov/?qs=23150e34359d1e932f1289742b953a8f8e720edd2808049ece878ad77ece739c your petition on electronic cigarettes . First things first: While we are seeking to regulate products like electronic cigarettes, the proposed regulation would not ban them. Some background, which you may already know: The http://click.mail.whitehouse.gov/?qs=415c7a37f7f49244144907eba0707664a199c6968e1eda7adcc80fc526afbde7 Family Smoking Prevention and Tobacco Control Act that Congress passed in 2009 gave the FDA immediate authority to regulate certain tobacco products -- cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco -- under the http://click.mail.whitehouse.gov/?qs=8b835bfd0f3ef363fa53fcef37ebc441c01a390924a58f216c1aae96f51dadc2 Federal Food, Drug, &...

Regulation of Electronic Cigarettes by the FDA By Mitch Zeller, the Director of the Food and Drug Administration's Center for Tobacco Products. Thank you for http://click.mail.whitehouse.gov/?qs=23150e34359d1e932f1289742b953a8f8e720edd2808049ece878ad77ece739c your petition on electronic cigarettes . First things first: While we are seeking to regulate products like electronic cigarettes, the proposed regulation would not ban them. Some background, which you may already know: The http://click.mail.whitehouse.gov/?qs=415c7a37f7f49244144907eba0707664a199c6968e1eda7adcc80fc526afbde7 Family Smoking Prevention and Tobacco Control Act that Congress passed in 2009 gave the FDA immediate authority to regulate certain tobacco products -- cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco -- under the http://click.mail.whitehouse.gov/?qs=8b835bfd0f3ef363fa53fcef37ebc441c01a390924a58f216c1aae96f51dadc2 Federal Food, Drug, &...

The Food and Drug Administration announced Friday it will convene a public meeting in October to review the risks of psychiatric and behavioral side effects with Pfizer’s anti-smoking drug Chantix. […] Since 2009, Chantix has carried the government’s strongest safety warning—a “black box” label—because of links to hostility, agitation, depression and suicidal thoughts. The warning was added after the FDA received dozens of reports of suicide and hundreds of reports of suicidal behavior among patients taking the smoking-cessation drug. …

https://s3.amazonaws.com/public-inspection.federalregister.gov/2014-09491.pdfThis is the docket reading

WASHINGTON – The federal government wants to ban sales of electronic cigarettes to minors and require approval for new products and health warning labels under regulations being proposed by the Food and Drug Administration. While the proposal being issued Thursday won't immediately mean changes for the popular devices, the move is aimed at eventually taming the fast-growing e-cigarette industry.

The Green Mountain State is poised to become the first to require food companies to label food products containing genetically modified ingredients.Vermont Gov. Peter Shumlin tweeted he will sign a bill state lawmakers passed Wednesday mandating that foods with GMOs be labeled as having been produced with "genetic engineering." The bill would also make it illegal for foods with GMOs to be labeled "all natural" or "natural."While Maine and Connecticut have already passed GMO labeling bills, those bills contain clauses that keep them from going into effect until surrounding states pass similar rules. Vermont's bill would go into effect on...

The federal government wants to extend its oversight of tobacco to include cigars, hookah, nicotine gels, pipe tobacco and dissolvable tobacco products. The Food and Drug Administration proposal being issued Thursday would ban sales to minors and require approval for new products and health warning labels. …

Does the Environmental Protection Agency really need armed agents? Outside of law enforcement, federal agencies now employ over 25,000 people as armed agents. They are more than guards. They’ve become like private armies that can push around private citizens. Over 70 non-military federal agencies now have their own armed agents. You expect armed agents with the FBI, the U.S. Marshal Service and the Border Patrol. But the EPA? The Fish & Wildlife Service, Bureau of Land Management, even the Social Security Administration and the National Institutes of Health? Even the Department of Education and the Department of Housing and Urban...

If something is either essential or good for the health, surely more of it must be good for you? Such at any rate is the reasoning of half the American population who, between them spend more than $30 billion on dietary supplements, that is to say $200 a head per annum. All things considered, these supplements must be pretty safe, unlike prescription drugs, for few people die or have serious side-effects from them. Whether they do any good, other than as placebos, is another question entirely of course.According to an article in a recent edition of the New England...

Congressman Thomas Massie (R-KY) and a bipartisan coalition of lawmakers have recently introduced legislation to allow for the sale of raw milk, i.e., unpasteurized milk. Their Milk Freedom Act of 2014 would make it legal for “certified dairy farmers” to sell unpasteurized milk products without harassment and criminal prosecution on the part of the FDA. If enacted, this would be a major victory for those who are health conscious and understand the grievous misperception by our medical establishment regarding the safety of raw milk. The distribution of raw milk has been banned in the U.S. since inception of the pasteurization...

It’s a surprisingly straightforward invention that could go a long way toward saving lives on the battlefield—a syringe-like device that essentially injects bandages into deep wounds to prevent bleeding. Developed by the Combat Casualty Care Research Program of the U.S. Army Medical Research and Materiel Command at Fort Detrick, Md., the XSTAT looks like a large syringe and contains small cellulose sponges that, once injected, expand to fill a wound. Designed for use against large, deep injuries, it’s intended to be used on wounds around joints such as the shoulder or groin, where medics couldn’t apply a tourniquet, or wounds...

<p>The U.S. Food and Drug Administration is "pushing very hard" to release a proposed rule that would establish its authority over e-cigarettes, the head of the agency said on Thursday amid concerns the products pose a risk to children.</p> <p>FDA Commissioner Margaret Hamburg told senators at a Congressional budget hearing that it has taken too long to move the rule forward and that she expects the proposal to be ready for release "very soon."</p>

Beer-makers in Colorado are upset about a proposal to keep them from recycling their used grain, and it could affect how much you pay for a beer this summer. The Food and Drug Administration wants to stop beer brewers from selling their leftover grain to ranches so it can be used as food for cattle. It’s not a requirement yet, but beer-makers make money off their used grain and say the new regulation would force them to dump millions of tons of it instead of recycling. The grains are used barley, wheat and other grains that are steeped in hot...

Friends and family will be able to take the first step to save a loved one from an overdose of heroin or powerful painkillers called opioids. The Food and Drug Administration on Thursday approved an easy-to-use device that automatically injects the right dose of an overdose antidote named naloxone before an ambulance arrives. Doctors could prescribe it for family members or caregivers to keep on hand, in a pocket or a medicine cabinet. Opioids include legal prescription painkillers, such as OxyContin and Vicodin, as well as illegal street drugs like heroin. …

Obama's & His Dark Sayings; The Wrath of God On America http://www.youtube.com/watch?v=Rrp6wUkTGjY