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	<title>Big Government &#187; Food and Drug Administration</title>
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		<title>Obama’s Regulatory Deja Vu: Dude, It’s Been Done, and It Flopped</title>
		<link>http://biggovernment.com/wshughart/2011/02/04/obamas-regulatory-deja-vu-dude-its-been-done-and-it-flopped/</link>
		<comments>http://biggovernment.com/wshughart/2011/02/04/obamas-regulatory-deja-vu-dude-its-been-done-and-it-flopped/#comments</comments>
		<pubDate>Fri, 04 Feb 2011 15:37:22 +0000</pubDate>
		<dc:creator>William Shughart II</dc:creator>
				<category><![CDATA[Economics]]></category>
		<category><![CDATA[Obama]]></category>
		<category><![CDATA[Politics]]></category>
		<category><![CDATA[Regulation]]></category>
		<category><![CDATA[Clinton]]></category>
		<category><![CDATA[corporate tax rates]]></category>
		<category><![CDATA[Environmental Protection Agency]]></category>
		<category><![CDATA[federal regulation]]></category>
		<category><![CDATA[Food and Drug Administration]]></category>
		<category><![CDATA[free market]]></category>
		<category><![CDATA[George Stigler]]></category>
		<category><![CDATA[Mark Crain]]></category>
		<category><![CDATA[medical devices]]></category>
		<category><![CDATA[Office of Information and Regulatory Affairs]]></category>
		<category><![CDATA[office of management and budget]]></category>
		<category><![CDATA[President Obama]]></category>
		<category><![CDATA[Reagan]]></category>
		<category><![CDATA[Small Business Administration]]></category>
		<category><![CDATA[State of the Union Address]]></category>
		<category><![CDATA[W. Kip Viscusi]]></category>

		<guid isPermaLink="false">http://biggovernment.com/?p=224784</guid>
		<description><![CDATA[President Obama, in his State of the Union address Tuesday night, was right to focus on the challenges the United States faces as domestic companies try to compete with low-cost global competitors. But he was wrong to suggest that the United States can “win the future” by getting Washington more involved in innovation and education.

As [...]]]></description>
			<content:encoded><![CDATA[<p>President Obama, in his State of the Union address Tuesday night, was right to focus on the challenges the United States faces as domestic companies try to compete with low-cost global competitors. But he was wrong to suggest that the United States can “win the future” by getting Washington more involved in innovation and education.</p>
<p><a href="http://biggovernment.com/files/2011/02/red-tape-man.jpg"><img class="aligncenter size-full wp-image-225000" title="red tape man" src="http://biggovernment.com/files/2011/02/red-tape-man.jpg" alt="" width="300" height="290" /></a></p>
<p>As the president conceded elsewhere, Washington is, in fact, a big part of the problem—with high corporate tax rates and excessive regulation.</p>
<p>Just a week earlier in a <em>Wall Street Journal</em> article, the president elaborated on this, rhetorically declaring a truce with business and laying out the administration’s strategy for moving “toward a 21st-century regulatory system.”</p>
<p>Mr. Obama said this new system would need to strike a balance between the innovativeness, job-creating capacity and robust growth produced by free markets and the responsibility of government to impose “common-sense rules” to protect the public. He called for a “government-wide review of . . . rules already on the books,” and said that “careful consideration” would be given to the costs and benefits of all pending regulations. But as Yogi Berra once said, “This is like deja vu all over again.”</p>
<p>Presidents Clinton and Reagan both signed executive orders requiring that proposed federal regulations be implemented only if their economic benefits exceeded the costs of complying with them. Reagan even established a branch within the Office of Management and Budget—the Office of Information and Regulatory Affairs (OIRA)—to make sure executive branch agencies complied. The executive orders by and large were ineffective.</p>
<p>In fact, the federal government has been expanding its control of the private economy since the 1890s, on the theory that vulnerable people must be protected from cradle to grave by an omniscient bureaucracy that knows what’s best for them. The growth in regulation typically has been justified by analyses, prepared by the regulatory bureaus themselves, which grossly overstate regulation’s benefits and understate its costs.</p>
<p><span id="more-224784"></span></p>
<p>Research by Vanderbilt University’s <a href="http://www.independent.org/aboutus/person_detail.asp?id=195">W. Kip Viscusi</a> has shown that the regulatory cost per life saved has ranged, in constant 1985 dollars, from $100,000—the cost of requiring air bags in passenger vehicles—to $812.7 million, the cost of preventing a single premature death from exposure to wood-preserving chemicals.</p>
<p>As examples of his administration’s common-sense approach to regulatory review, Mr. Obama touted a December 2010 Environmental Protection Agency decision to remove the artificial sweetener saccharin from its list of hazardous wastes (one can hear the sigh of relief from diet soft-drink consumers), the adoption of new fuel-economy standards for cars and trucks, and the Food and Drug Administration’s supposedly implemented promise to streamline the approval process for new medical devices.</p>
<p>Unfortunately, Mr. Obama‘s enthusiastic embrace of far-reaching new federal regulations affecting the financial services and health care industries belie his self-styled conversion to common-sense, centrist politics.</p>
<p>There is no doubt that <a href="http://www.independent.org/publications/tir/article.asp?a=816">federal regulations are a mess</a>: multiple departments and agencies, often working at cross-purposes, propose thousands of new rules and regulations each year. The compendium of these regulations, the Federal Register, now runs a mammoth 82,590 pages long.</p>
<p>According to an analysis by Nicole and Mark Crain of Lafayette College, published by the U.S. Small Business Administration last September, regulatory mandates already cost the economy some $1.75 trillion per year. For firms with fewer than 20 employees, the cost per employee was estimated at $10,585. And there’s more to come, with some 195 new regulations in the pipeline.</p>
<p>Don’t expect regulatory relief any time soon. The regulatory state is shaped by special-interest-group politics. Regulations rarely are adopted because consumers demand them or because they enhance society’s welfare. Rather, as the now-deceased Nobel laureate George Stigler once famously observed, private firms often lobby for regulations that they believe will give them an advantage over their competitors.</p>
<p>Federal regulations are as responsible as anything for America’s lagging competitiveness. The solution is not another dose of regulatory review, but a curb of Washington’s regulatory powers.</p>
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		<title>Food Fight: Will the Federal Government Control Our Food?</title>
		<link>http://biggovernment.com/sberry/2010/12/30/food-fight-will-the-federal-government-control-our-food/</link>
		<comments>http://biggovernment.com/sberry/2010/12/30/food-fight-will-the-federal-government-control-our-food/#comments</comments>
		<pubDate>Thu, 30 Dec 2010 14:35:54 +0000</pubDate>
		<dc:creator>Dr. Susan Berry</dc:creator>
				<category><![CDATA[Regulation]]></category>
		<category><![CDATA[Uncategorized]]></category>
		<category><![CDATA[Department of Health and Human Services]]></category>
		<category><![CDATA[Food and Drug Administration]]></category>
		<category><![CDATA[Food Safety Modernization Act]]></category>
		<category><![CDATA[Forbes Magazine]]></category>
		<category><![CDATA[Gregory Conko]]></category>
		<category><![CDATA[Monsanto]]></category>
		<category><![CDATA[organic farming]]></category>
		<category><![CDATA[small farmers]]></category>

		<guid isPermaLink="false">http://biggovernment.com/?p=209948</guid>
		<description><![CDATA[Amidst the hustle and bustle of the &#8220;lame duck&#8221; Congress, another law was passed that didn&#8217;t quite get the same media coverage as the Bush tax extension &#8220;package,&#8221; the repeal of Don&#8217;t Ask, Don&#8217;t Tell, and the new START treaty. The Food Safety Modernization Act was not steeped in the same level of popular controversy [...]]]></description>
			<content:encoded><![CDATA[<p>Amidst the hustle and bustle of the &#8220;lame duck&#8221; Congress, another law was passed that didn&#8217;t quite get the same media coverage as the Bush tax extension &#8220;package,&#8221; the repeal of Don&#8217;t Ask, Don&#8217;t Tell, and the new START treaty. The <a href="http://www.opencongress.org/bill/111-h2751/show">Food Safety Modernization Act</a> was not steeped in the same level of popular controversy as these other pieces of legislation. Nevertheless, its passage may affect our daily lives even more than these, and in a rather stealth manner.</p>
<p><a href="http://biggovernment.com/files/2010/12/usda_sm.png"><img class="aligncenter size-full wp-image-210680" title="usda_sm" src="http://biggovernment.com/files/2010/12/usda_sm.png" alt="" width="396" height="400" /></a></p>
<p>Yes, the week before Christmas, the 111th Congress of the United States gave Kathleen Sebelius, Secretary of Health and Human Services (HHS), quite extensive authority over food production in our country. That&#8217;s food- from the seeds that grow the plants and the animals that provide the meat and milk, to the Lean Cuisine you had for dinner.</p>
<p>Originally proposed last year by Democratic Senator Dick Durbin,  the new law will cost about 1.4 billion dollars over a four-year period. It arrived, as much legislation does, in response to several major crises. Recent salmonella outbreaks in eggs and peanuts, as well as E. coli, in spinach, caused sickness, and some deaths, within the country. These outbreaks led to food recalls and much criticism of the Food and Drug Administration (FDA), which is under the authority of HHS, for its poor oversight of already known risky food producers.</p>
<p>The new law is intended to redirect the FDA from the position of crisis management of food-borne illness emergencies to that of preventing them. Under the new law, food manufacturers will be required to engage in detailed record-keeping of their processing systems and ways in which they can avoid bacterial contamination of their products. All of these records, and test results proving their systems to be effective means of eliminating contamination, must be shared with the FDA. The agency will now have the authority to order food recalls (currently, it only requests them). and will be required to perform inspections of food producers more often.</p>
<p>So, what&#8217;s wrong with this?</p>
<p>There are three issues that should concern us:</p>
<p><span id="more-209948"></span></p>
<p>1) Will this new law really make our food safer?</p>
<p>In an <a href="http://www.forbes.com/2010/12/02/fda-regulation-food-safety-opinions-contributors-gregory-conko.html">article</a> in <em>Forbes Magazine</em>, Gregory Conko provides a thorough assessment of this legislation. He asserts that the new law is a waste of tax-payer money and will not achieve its stated goals. Conko explains that, first, while &#8220;more frequent inspections may seem superficially appealing&#8230;the new law would merely require inspections for most  facilities every five years [instead of ten years], and once every three years for identified  “high-risk” facilities.&#8221; Clearly, alot can happen in three to five years.</p>
<p>Second, Conko points out that even more frequent inspections of the visual type performed by FDA and other agency inspectors cannot detect microscopic bacteria that cause food-borne illness. A food production facility may look clean, but is it really? Conversely, a cluttered area in a facility may be sterile, but just a little messy.</p>
<p>Conko goes on to observe that, as with many systems imposed by bureaucrats who have little knowledge of the industry they are regulating, the detailed risk-reduction record-keeping, required by the new law, may only serve to pile up more cumbersome paperwork on private food companies that could be using their time to develop more effective food safety practices.</p>
<p>2) How will the type of food we grow and produce be controlled?</p>
<p>This is probably the most important issue affecting us with this new legislation because the new law is vague in its language of what constitutes a &#8220;farm&#8221; (Is a garden a &#8220;farm?&#8221;), and how the Secretary of HHS can regulate the types of seeds that are planted and fertilizers used (Will &#8220;manure&#8221; be permitted?) And what about people who enjoy foods in their raw form, like milk and  honey? Will these be outlawed as well because we all now have to eat and  drink the same foods that are most easily regulated by the Secretary of  HHS?</p>
<p>The bill was supported by huge food companies like Campbell&#8217;s Soup and Cargill, and industrial seed companies like Monsanto, which spent millions of dollars lobbying for its passage. Large industrial seed companies are big producers of genetically modified seeds and, in recent years, have become increasingly threatened by the presence of small organic farms, farmers&#8217; markets, and the local food movement which celebrates the benefits of heirloom and genetically true vegetables and fruits, as well as organic farming methods and fertilizers. For the latter, the direct farmer to consumer relationship is what matters, and the government will be in the way.</p>
<p>According to Conko, industrial seed giants are wealthy enough to pay the huge costs associated with the more frequent inspections required by the new law.  In addition, they already have in place much of the expensive record-keeping system that will now be required of smaller farms that could be forced out of business by costs of the new procedures.</p>
<p>Enter another Democrat, Senator Jon Tester of Montana, himself a small farmer, to &#8220;appear to&#8221;  save the day. He produced an amendment to the bill which recognized that small farmers would have a difficult time complying with the requirements of the new legislation. His amendment, which was included in the law, sets a dollar amount, namely $500,000, as the cut-off between the definitions of &#8220;small farmer&#8221; and &#8220;big farmer,&#8221; a line that hardly seems easily defined. As is often the case, the Democrats produced a huge piece of legislation with far-reaching consequences, and tried to make it more popular by adding yet more legislation to it.</p>
<p>3) What will the costs of the new law be for Americans?</p>
<p>As already noted, farms and food producers will be paying more fees to the government for all the increased inspections and record filings. These will, ultimately, be passed on to consumers. So, if we are not paying more for food because of inflation caused by the Federal Reserve printing money, we will be paying more because of the Food Safety Modernization Act.</p>
<p>However, the real cost of the legislation will be the increase of tax-payer dollars needed to support the mounting number of FDA and other HHS personnel performing more inspections in the field. In fact, the legislation gives the Secretary of HHS the authority to hire 4,000 federal employees in 2011 alone in order to implement the law. By 2014, 5,000 federal employees will be hired by this agency in support of this law. Clearly, in this new legislation, the current administration underscores its belief that the only way to handle problems is by expanding the power of the federal government.</p>
<p>It remains to be seen whether the Food Safety Modernization Act will be on the &#8220;Defund&#8221; list of the new Republican House of Representatives.</p>
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		<title>Reason.tv: Raw Foods Raid &#8211; The Fight for the Right to Eat What You Want</title>
		<link>http://biggovernment.com/reasontv/2010/11/17/reason-tv-raw-foods-raid-the-fight-for-the-right-to-eat-what-you-want/</link>
		<comments>http://biggovernment.com/reasontv/2010/11/17/reason-tv-raw-foods-raid-the-fight-for-the-right-to-eat-what-you-want/#comments</comments>
		<pubDate>Wed, 17 Nov 2010 22:41:37 +0000</pubDate>
		<dc:creator>Reason TV</dc:creator>
				<category><![CDATA[Culture]]></category>
		<category><![CDATA[Regulation]]></category>
		<category><![CDATA[Food and Drug Administration]]></category>
		<category><![CDATA[food police]]></category>
		<category><![CDATA[food safety]]></category>
		<category><![CDATA[raw food]]></category>

		<guid isPermaLink="false">http://biggovernment.com/?p=197141</guid>
		<description><![CDATA[
This summer armed government agents raided Rawesome Foods, a Venice, California health food co-op. What were the agents after? Unpasteurized milk, it turns out.
Raw milk raids are happening all over the United States. The Food and Drug Administration warns that raw milk consumption can cause health problems, but a growing community of raw foods enthusiasts [...]]]></description>
			<content:encoded><![CDATA[<p style="text-align: center;"><object classid="clsid:d27cdb6e-ae6d-11cf-96b8-444553540000" width="425" height="340" codebase="http://download.macromedia.com/pub/shockwave/cabs/flash/swflash.cab#version=6,0,40,0"><param name="allowFullScreen" value="true" /><param name="allowscriptaccess" value="always" /><param name="src" value="http://www.youtube.com/v/ioN0ehlyyXI?fs=1&amp;hl=en_US" /><param name="allowfullscreen" value="true" /><embed type="application/x-shockwave-flash" width="425" height="340" src="http://www.youtube.com/v/ioN0ehlyyXI?fs=1&amp;hl=en_US" allowscriptaccess="always" allowfullscreen="true"></embed></object><br />
This summer armed government agents raided Rawesome Foods, a Venice, California health food co-op. What were the agents after? Unpasteurized milk, it turns out.</p>
<p>Raw milk raids are <a href="http://www.farmtoconsumer.org/farm-raids.html">happening all over the United States</a>. The Food and Drug Administration warns that raw milk consumption can <a href="http://www.fda.gov/Food/ResourcesForYou/Consumers/ucm079516.htm">cause health problems</a>, but a growing community of raw foods enthusiasts are ignoring government recommendations and claiming that they are getting tastier, more nutritious food by going raw.</p>
<p>Reason.tv visited Rawesome to examine the circumstances of the raid and discovered that this particular raw foods case stretches across county lines and involves at least five separate government agencies, despite the fact that not a single member of Rawesome has complained or been harmed by the raw foods. In fact, members have to sign a contract stating that they understand and accept the risks of consuming raw foods before they are allowed to step inside.</p>
<p>If members of a private club sign a waiver stating that they want to drink a certain type of milk, why is the government getting involved? As Jarel Winterhawk, a manager at Rawesome, puts it, &#8220;This is America. How are you going to tell me what I can and cannot eat?&#8221;</p>
<p>Though no charges have yet resulted from the raid, Rawesome is threated with shutdown due to the involvement of yet another government agency, Los Angeles Department of Building and Safety, and the club&#8217;s raw goat milk supplier, Healthy Family Farms, has had its dairy license suspended.</p>
<p><span id="more-197141"></span></p>
<p>&#8220;Raw Foods Raid&#8221; is written and produced by Zach Weissmueller. Camera by Alex Manning and Weissmueller. Senior Producer is Ted Balaker. Music by Jami Sieber, Five Star Fall, and Kammen and Swan (Magnatune Records).</p>
<p>Approximately 7 minutes.</p>
<p>Visit Reason.tv for downloadable iPod, HD, and audio versions of this and all our videos, and subscribe to <a href="http://www.youtube.com/user/ReasonTV">Reason.tv&#8217;s YouTube channel</a> to receive automatic notification when new material goes live.</p>
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		<title>Reason TV&#8217;s Nanny of the Month: November 2009</title>
		<link>http://biggovernment.com/ngillespie/2009/11/30/reason-tvs-nanny-of-the-month-november-2009/</link>
		<comments>http://biggovernment.com/ngillespie/2009/11/30/reason-tvs-nanny-of-the-month-november-2009/#comments</comments>
		<pubDate>Mon, 30 Nov 2009 16:41:17 +0000</pubDate>
		<dc:creator>Nick Gillespie</dc:creator>
				<category><![CDATA[Culture]]></category>
		<category><![CDATA[Politics]]></category>
		<category><![CDATA[State Politics]]></category>
		<category><![CDATA[caffeinated alcohol drinks]]></category>
		<category><![CDATA[California Energy Commission]]></category>
		<category><![CDATA[fish pedicures]]></category>
		<category><![CDATA[Food and Drug Administration]]></category>
		<category><![CDATA[government busybody]]></category>
		<category><![CDATA[Jeff Klein]]></category>
		<category><![CDATA[nanny state]]></category>
		<category><![CDATA[Sen]]></category>

		<guid isPermaLink="false">http://biggovernment.com/?p=38522</guid>
		<description><![CDATA[Smoking, fast food, giant inflatable blue gorillas-no matter what it is, chances are some nanny wants to ban it. And this past month was no exception.
Reason.tv&#8217;s October 2009 Nanny of The Month Award went to New York State Sen. Jeff Klein for his efforts to rid the Empire State of fish pedicures.
Who is the Nanny of the Month [...]]]></description>
			<content:encoded><![CDATA[<p>Smoking, fast food, giant inflatable blue gorillas-no matter what it is, chances are some nanny wants to ban it. And this past month was no exception.</p>
<p>Reason.tv&#8217;s October 2009 Nanny of The Month Award went to New York State Sen. Jeff Klein for his efforts to rid the Empire State of fish pedicures.</p>
<p>Who is the Nanny of the Month for November 2009?</p>
<p style="text-align: center;"><object classid="clsid:d27cdb6e-ae6d-11cf-96b8-444553540000" width="560" height="340" codebase="http://download.macromedia.com/pub/shockwave/cabs/flash/swflash.cab#version=6,0,40,0"><param name="allowFullScreen" value="true" /><param name="allowscriptaccess" value="always" /><param name="src" value="http://www.youtube.com/v/xJ9rep_LtvY&amp;hl=en_US&amp;fs=1&amp;" /><param name="allowfullscreen" value="true" /><embed type="application/x-shockwave-flash" width="560" height="340" src="http://www.youtube.com/v/xJ9rep_LtvY&amp;hl=en_US&amp;fs=1&amp;" allowscriptaccess="always" allowfullscreen="true"></embed></object></p>
<p>The runners up include the California Energy Commission for banning big-screen TVs unless they conform to stringent new energy standards and the Food and Drug Administration, which is waging war against caffeinated booze drinks.</p>
<p>But only one can be Nanny of the Month, and this time it&#8217;s &#8230;</p>
<p><span id="more-38522"></span></p>
<p>Click the video to learn the awful truth.</p>
<p>Nanny of the Month is produced by Ted Balaker. The director of photography<br />
is Alex Manning and the associate produce is Paul Detrick. Approximately<br />
1.17 minutes.</p>
<p>Go to <a href="http://reason.tv/">http://reason.tv</a> for downloadable versions of this, past winners,<br />
related links, and many more videos.</p>
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		<title>Buzz Kill: The FDA Wants to Regulate How You Party.</title>
		<link>http://biggovernment.com/jtempleton/2009/11/17/buzz-kill-the-fda-wants-to-regulate-how-you-party/</link>
		<comments>http://biggovernment.com/jtempleton/2009/11/17/buzz-kill-the-fda-wants-to-regulate-how-you-party/#comments</comments>
		<pubDate>Tue, 17 Nov 2009 14:07:25 +0000</pubDate>
		<dc:creator>Joe Templeton</dc:creator>
				<category><![CDATA[Culture]]></category>
		<category><![CDATA[Justice/Legal]]></category>
		<category><![CDATA[News]]></category>
		<category><![CDATA[alcoholic energy drinks]]></category>
		<category><![CDATA[buzz beer]]></category>
		<category><![CDATA[drew carey show]]></category>
		<category><![CDATA[Food and Drug Administration]]></category>
		<category><![CDATA[national association of attorneys general]]></category>
		<category><![CDATA[red bull]]></category>
		<category><![CDATA[Richard Blumenthal]]></category>

		<guid isPermaLink="false">http://biggovernment.com/?p=31854</guid>
		<description><![CDATA[Many remember a creation, or rather concoction of The Drew Carey Show, Buzz Beer. The delightfully titled beverage was a mix of coffee and a presumably dark beer&#8230; stout perhaps. Buzz Beer almost became a character of its own, as it evolved into an ongoing enterprise, run out of Drew’s garage. If the show were [...]]]></description>
			<content:encoded><![CDATA[<p>Many remember a creation, or rather concoction of <em>The Drew Carey Show</em>, Buzz Beer. The delightfully titled beverage was a mix of coffee and a presumably dark beer&#8230; stout perhaps. Buzz Beer almost became a character of its own, as it evolved into an ongoing enterprise, run out of Drew’s garage. If the show were still on the air, writers would be charged with the task of writing-in new federal regulations, regarding Drew’s side-business. Why? Because although fictional, Buzz Beer will soon be outlawed. While this would provide an interesting plot development for a sitcom, it will inevitably cause a slew of problems in real life. Go figure.</p>
<p style="text-align: center;"><img class="aligncenter size-full wp-image-32274" title="beer_buzz2" src="http://biggovernment.com/files/2009/11/beer_buzz2.jpg" alt="beer_buzz2" width="390" height="304" /></p>
<p>On Friday, the <a title="New FDA regulations" href="http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm190427.htm" target="_blank">Food and Drug Administration</a> notified <a title="27 beverage manufacturers" href="http://www.fda.gov/Food/FoodIngredientsPackaging/ucm190448.htm" target="_blank">27 manufacturers</a> of so-called “alcoholic energy drinks (AEDs),” that they have 30 days to prove the safety of such drinks. If the listed manufacturers fail to comply, or fail to prove the safety of their products, they will be forced to discontinue them. Many companies, such as Anheuser-Busch, MillerCoors, and Diageo have already stopped the sale and production of similar products, in anticipation of the FDA crackdown. Needless to say, in the midst of a recession this is not ideal.</p>
<p>Probes into the safety of AEDs were conducted by a task force, comprised of 18 State Attorneys General and one city attorney. The task force is called the National Association of Attorneys General (NAAG) Youth Access to Alcohol Committee… doesn’t that have a nice bureaucratic ring to it?</p>
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<p>The co-chairs of this committee sent a <a title="NAAG letter" href="http://www.fda.gov/downloads/Food/FoodIngredientsPackaging/UCM190371.pdf" target="_blank">letter to the FDA</a> on September 25<sup>th</sup>, detailing the apparent risks of AEDs. The letter also claims that “caffeine as an additive to alcohol is not generally recognized as safe (GRAS) under FDA regulations.” The letter then urges the FDA to “exercise its authority under the Federal Food, Drug and Cosmetic Act.”</p>
<p><a title="FD&amp;C Act" href="http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/default.htm" target="_blank">The Federal Food, Drug and Cosmetic Act</a>, originally passed by Congress in 1938, is a very interesting piece of legislation. In our legal system, we have something called “the burden of proof,” otherwise known as “the presumption of innocence.” This concept is best described by a Latin legal maxim: <a title="Legal Definitions" href="http://legal-dictionary.thefreedictionary.com/Ei+incumbit+probatio+qui+dicit" target="_blank">Ei incumbit probatio qui dicit, non qui negat</a>, which translates to: The burden of the proof lies upon him who affirms, not he who denies. Basically, if a man is charged with a crime, the State must prove he is guilty beyond a reasonable doubt… not the other way around.</p>
<p><a title="FD&amp;C Act" href="http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/default.htm" target="_blank">The Federal Food, Drug and Cosmetic Act</a> shifts the burden of proof onto manufacturers, by requiring that they prove the safety of an additive that is not generally recognized as safe. This is where the law gets a bit technical (as usual). Caffeine as an additive is generally recognized as safe by the FDA, but only when added to non-alcoholic soft drinks. So technically, the FDA has the authority to regulate AEDs. However, this will undoubtedly open a can of worms with regard to legislative intent.</p>
<p>Connecticut Atty. Gen. Richard Blumenthal, a co-chairman of the task force said <a title="LA Times article" href="http://www.latimes.com/news/nationworld/nation/la-na-fda-caffeine15-2009nov15,0,3934601.story" target="_blank">&#8220;The ultimate goal is a nationwide ban on alcohol-energy drinks marketed to young drinkers.&#8221;</a> While AEDs are relatively new, the idea behind them is quite old. AEDs stemmed from a classic, in every bartenders repertoire: the Vodka Red Bull. Once AEDs are made illegal, consumers who like to mix stimulants with depressants will likely go back to the cocktail that started it all. However, when that happens, the NAAG and the FDA will be waiting to save us from ourselves… again.</p>
<p><a title="FD&amp;C Act" href="http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/default.htm" target="_blank">The Federal Food, Drug and Cosmetic Act</a>, does not limit the regulation of food additives to big beverage manufacturers like Anheuser-Busch and MillerCoors. In fact, sections <a title="Sec. 201" href="http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/FDCActChaptersIandIIShortTitleandDefinitions/ucm086297.htm" target="_blank">201</a> and <a title="Sec. 409" href="http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/FDCActChapterIVFood/ucm107843.htm" target="_blank">409</a> extend such regulation to individuals, partnerships, corporations and associations. Will your local bartender be their next target? Will the Vodka Red Bull become illegal? Will Jack and Coke become illegal? Will possession of coffee while intoxicated become illegal?</p>
<p>Keep in mind that all things illegal were once legal. A large and overbearing government systematically seizes power from its people, by preying on their fears. The transfer of power almost always comes in the name of “public safety.” <a title="Sweden warns public about Vodka Red Bull" href="http://news.bbc.co.uk/2/hi/health/1435409.stm" target="_blank">Officials in Sweden</a> have already taken action against the Vodka Red Bull, blaming the mixture for the deaths of two reportedly “healthy” individuals. U.S. Federal Laws regulating caffeine in alcohol are already on the books. AEDs were illegal from day one. Unless we the people demand an amendment from Congress, the NAAG will continue to <em>nag</em> the FDA, until bar menus across America are completely unrecognizable.</p>
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		<title>Another Gem From a 2,000 Page Bill: &#8216;Botox Carve-Out&#8217; Survives in PelosiCare Bill</title>
		<link>http://biggovernment.com/publius/2009/11/13/another-gem-from-a-2000-page-bill-botox-carve-out-survives-in-pelosicare-bill/</link>
		<comments>http://biggovernment.com/publius/2009/11/13/another-gem-from-a-2000-page-bill-botox-carve-out-survives-in-pelosicare-bill/#comments</comments>
		<pubDate>Fri, 13 Nov 2009 21:41:31 +0000</pubDate>
		<dc:creator>Publius</dc:creator>
				<category><![CDATA[Congress]]></category>
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		<category><![CDATA[Politics]]></category>
		<category><![CDATA[botox]]></category>
		<category><![CDATA[Food and Drug Administration]]></category>
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		<category><![CDATA[government carve out]]></category>
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		<guid isPermaLink="false">http://biggovernment.com/?p=30698</guid>
		<description><![CDATA[A provision within Speaker Nancy Pelosi’s health care measure passed by the House the other week rehashes a months-old intramural battle between powerful Democrats over how biologic drugs will face competition from generic drug manufacturers.

While the House bill provides a brand drug maker-backed 12 years of monopoly data protection for these next generation therapies, one [...]]]></description>
			<content:encoded><![CDATA[<p>A provision within Speaker Nancy Pelosi’s health care measure passed by the House the other week rehashes a months-old intramural battle between powerful Democrats over how biologic drugs will face competition from generic drug manufacturers.</p>
<p><img class="aligncenter size-full wp-image-30710" title="Botox_Injection" src="http://biggovernment.com/files/2009/11/Botox_Injection.jpg" alt="Botox_Injection" width="413" height="310" /></p>
<p>While the House bill provides a brand drug maker-backed 12 years of monopoly data protection for these next generation therapies, one component of the bill, buried on page 1,534, beginning on line 15 under the heading, “Restrictions on biological products containing dangerous ingredients,” might raise more than eyebrows.</p>
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<p>The provision states, “the Secretary shall not license the biological product under this subsection unless the Secretary determines, after consultation with the appropriate national security and drug enforcement agencies, that there would be no increased risk to the security or health of the public from licensing such biological product under this subsection.”</p>
<p>Hidden under all that national security talk of chemical warfare lays something far more typical of this particular Congress: Favors for preferred industries and donors.</p>
<p>The language is a holdover from a <a href="http://www.rollcall.com/issues/53_109/news/22629-1.html?type=printer_friendly">bill sponsored last year</a> by Reps. Anna Eshoo (D-Calif.) and Joe Barton (R-Texas) that was ostensibly designed to provide a “pathway” to approval for so-called “biosimilars,” another word for generic biologic drugs.</p>
<p>As Tim Carney <a href="http://www.washingtonexaminer.com/politics/The-backroom-brawl-that-could-sink-health-care-reform-7935721-50145892.html">explained in the Washington Examiner this summer</a>, “[t]he Food and Drug Administration says it lacks authority to approve generic biologics, handing this hot potato to Congress. The result is a lobbying battle royale. The most contentious issue: How many years should the FDA protect biologics from competition?”</p>
<p>Depending on who you ask (generic drug makers say it’s a pathway to nowhere), Eshoo’s bill establishes a marketplace for generic versions of biotech products to treat arthritis, MS, psoriasis, anemia and other conditions. Under such law, drugs that treat these ailments would eventually be subject to competition.</p>
<p>But one remarkable exception was an exemption for wrinkle treatment Botox. Eshoo’s so-called “Botox carve out” protects the drug and others like it (though none similar yet) from competition on national security grounds, suggesting the product’s development from “select agents and toxins,” such as Botox’s botulinum toxin type A, could be perverted and used in terrorist plots. The wrinkle is that while this would ostensibly keep dangerous chemicals out of the hands of terrorists, it would also give Irvine, California-based Allergan a special buffer even more generous than its biotech counterparts.</p>
<p>The bill did not move in 2008. But Eshoo introduced the same language again this year, which passed the House Energy and Commerce Committee over the objections of its Chairman Henry Waxman and wound up in Nancy Pelosi’s health care bill – which passed by a slender, Botox-worthy margin of two votes.</p>
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		<title>The Pork Report: October 14, 2009</title>
		<link>http://biggovernment.com/porkreport/2009/10/14/the-pork-report-october-14-2009/</link>
		<comments>http://biggovernment.com/porkreport/2009/10/14/the-pork-report-october-14-2009/#comments</comments>
		<pubDate>Wed, 14 Oct 2009 22:00:30 +0000</pubDate>
		<dc:creator>The Pork Report</dc:creator>
				<category><![CDATA[Congress]]></category>
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		<category><![CDATA[bug database]]></category>
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		<category><![CDATA[stimulus spending]]></category>
		<category><![CDATA[talking buses]]></category>

		<guid isPermaLink="false">http://biggovernment.com/?p=16510</guid>
		<description><![CDATA[Taxpayers foot the bill for office items lost or stolen by members of Congress
Half-a-million dollar NSF stimulus grant pays to search for alternatives to Facebook
Stimulus funds pay to create an online database of bugs
Stimulus funds to pay for talking buses in Ohio; Human voices to replace beeping sounds that alert pedestrians of approaching buses
Congressmen successfully [...]]]></description>
			<content:encoded><![CDATA[<p>Taxpayers foot the bill for office <a href="http://www.politico.com/news/stories/1009/28204.html">items lost or stolen by members of Congress</a></p>
<p>Half-a-million dollar NSF stimulus grant pays to <a href="http://www.sciencedaily.com/releases/2009/10/091013162746.htm ">search for alternatives to Facebook</a></p>
<p>Stimulus funds pay to create an <a href="http://www.lansingstatejournal.com/article/20091009/NEWS01/910090331/1001/NEWS ">online database of bugs</a></p>
<p>Stimulus funds to pay for <a href="http://www.cleveland.com/news/plaindealer/index.ssf?/base/news/1255509026101060.xml&amp;coll=2 ">talking buses in Ohio</a>; Human voices to replace beeping sounds that alert pedestrians of approaching buses</p>
<p>Congressmen <a href="http://www.nytimes.com/2009/09/25/health/policy/25knee.html?_r=2&amp;partner=rss&amp;emc=rss">successfully pressure the Food and Drug Administration </a>to approve medical device manufactured by campaign contributor</p>
<p>Spending bills stalled by decision of Appropriations Committees to <a href="http://www.rollcall.com/issues/55_40/news/39477-1.html">withhold government reports from the public </a>and other members of Congress</p>
<p>Political ‘scientists’ <a href="http://washingtontimes.com/news/2009/oct/14/political-scientists-fight-for-federal-funds/ ">lobby to keep millions of dollars </a>in federal science grants</p>
<p>Congress will spend more than <a href="http://www.philly.com/philly/news/breaking/20091013_N_J__wins_big_in_federal_beach-fill_program.html ">$100 million to put sand on beaches</a></p>
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