Nanny State | Publications | Competitive Enterprise Instittue

DC City Council Pushes for Higher Taxes on Consumers

Michelle Minton — Fri, 04 May 2012 20:29:17 +0000

From ATR.org:

Don’t just take ATR’s word for it. In today’s Washington Times, Michelle Minton of the Competitive Enterprise Institute highlighted the problems that a liquor tax increase would pose for low income workers just trying to make ends meet:

“The tax actually will be assessed on wholesalers in one large sum. The prices that wholesalers charge bars, stores and restaurants subsequently will jump. This initial increase in expenses will hurt the smallest bars and restaurants, which will try to recoup the losses by increasing the costs of their food and drinks.

This means two things: First, people who aren’t even drinking alcohol likely will end up paying for the increase. Second, wait staff and bartenders likely will see their tips shrink. Most customers calculate tips by rounding up - the “keep the change” method. If the cost of a drink increases by 6 cents, customers aren’t likely to alter their tipping math. Thus, the tax is coming almost directly out of the tips on which many service workers depend.”

Michelle Minton

Thu, 2012-05-03

Citation Source:

ATR.org

http://www.atr.org/dc-city-council-pushes-higher-taxes-a6870#ixzz1tueVINCt

Letter to the Editor: D.C. Alcohol Tax Increase Will Hurt Servers

Michelle Minton — Fri, 04 May 2012 19:58:30 +0000

Council member Jim Graham’s proposal to increase the District’s liquor excise tax by 6 cents a drink is not as innocuous as he claims (“Graham proposes alcohol tax hike,” Web, Monday).

The tax actually will be assessed on wholesalers in one large sum. The prices that wholesalers charge bars, stores and restaurants subsequently will jump. This initial increase in expenses will hurt the smallest bars and restaurants, which will try to recoup the losses by increasing the costs of their food and drinks.

This means two things: First, people who aren’t even drinking alcohol likely will end up paying for the increase. Second, wait staff and bartenders likely will see their tips shrink. Most customers calculate tips by rounding up - the “keep the change” method. If the cost of a drink increases by 6 cents, customers aren’t likely to alter their tipping math. Thus, the tax is coming almost directly out of the tips on which many service workers depend.

Instead of increasing taxes, Mr. Graham should re-examine proposals to increase the hours and days of alcohol sales. That would increase revenue while actually helping businesses.

Michelle Minton

Wed, 2012-05-02

Citation Source:

The Washington Times

http://www.washingtontimes.com/news/2012/may/2/dc-alcohol-tax-increase-will-hurt-servers/

Sugar Program Isn’t Sweet for Consumers or the Economy

Nicole Ciandella — Mon, 23 Apr 2012 17:42:39 +0000

Don’t look now, but here comes the farm bill, one of those catch-all legislative behemoths littered with wasteful programs and supported by entrenched special interests. The bill comes up for reauthorization every five years and is a lobbyist’s dream — impacting everything from farm subsidies to food safety — and industry and interest groups are working furiously to protect their sacred cows, so to speak.

Given the inability of Congress to agree on much — and the fact that this is an election year — most observers give a new farm bill little chance of passing. Rather, it’s likely that Congress will kick the can down the road by passing an extension of current law. Wasteful spending on unnecessary programs will continue, and an opportunity will be missed — hurting U.S. consumers, taxpayers and workers.

An egregious example of a sacred-cow program that should be cut is the sugar program, which began during the Great Depression as a means to help domestic sugar farmers and refiners survive. Under this central planning scheme, the federal government restricts the sugar supply, fixes the domestic price at high levels and keeps out competition.

Despite record world prices for sugar, the program continues to impose unnecessary price supports, strict production and marketing controls and outdated import quotas. The program is counterproductive, antithetical to a free market economy and has long outlived its usefulness.

The program protects about 4,700 sugar farms in the U.S. These are not your small mom-and-pop farms. The average size of a sugar cane farm is over 1,000 acres, and almost 60 percent of production comes from farms over 2,000 acres.

The U.S. sugar program is a classic public choice case of concentrated benefits and dispersed costs and an example of how special interests can trump the public interest. A small number of sugar producers receive enormous benefits, while the costs are spread across the U.S. economy, hitting consumers and the sweetener-using industries.

Opponents of reform argue that the sugar program operates at no cost, but that is misleading at best. Essentially the sugar program operates as a cross-subsidy, with consumers paying the bills. It operates as a hidden, regressive tax on a vast array of food and beverage products — not only candy, but cereals, breads and other baked goods, canned fruits and vegetables, mayonnaise, dressings and sauces, jellies and preserves.

With U.S. sugar prices at an all-time high — 50 percent or more above the world price — the program is forcing U.S. consumers to pay an extra $3.5 billion per year for a wide variety of food and beverage products. In addition, estimates show that 125,000 American jobs in the food production industry have been lost due to high sugar prices and a consequent move to increased foreign production where prices for this key ingredient are far lower.

There are numerous examples of U.S. food manufacturers relocating to countries that do not artificially restrict access to sugar. In fact, the Canadian government is actively recruiting U.S. confectioners to relocate to that country. An official government brochure states: “Canadian sugar users enjoy a significant advantage — the average price of refined sugar is usually 30 to 40 per cent lower in Canada than in the U.S. Most manufactured products containing sugar are freely traded in the NAFTA region.”

When a government program becomes a recruitment tool for countries that are trying to lure away our manufacturers and move U.S. jobs abroad, revisiting that program makes sense.

The Senate Agriculture Committee seems poised to send the farm bill to the Senate floor in the next few weeks — and most agree there is little or no chance that senators will take on the powerful sugar lobby with its cane and beet growers and refiners in Florida and the Midwest. The House, however, may offer more hope. This is the first opportunity for many House members to vote on the farm bill, and if the freshman class remains focused on reforming big government, this is low-hanging fruit. In these tough economic times, with high unemployment levels, consumers deserve a break from the hidden taxes of the U.S. sugar program. At a minimum, policymakers should insist on reforms that will open the sugar market, help save and create jobs in the U.S. food industry and help consumers by keeping food prices down.

Fran Smith

Thu, 2012-04-19

Citation Source:

The Daily Caller

http://dailycaller.com/2012/04/19/sugar-program-isnt-sweet-for-consumers-or-the-economy/

Direct Alcohol Shipping To Minors Is Not a Public Safety Problem

Michelle Minton — Tue, 17 Apr 2012 17:48:35 +0000

(Also published by the Franklin Center for Government & Public Integrity)

If you’ve ever had a remarkable local beer while traveling, you may have experienced the frustration of knowing that you won’t be able to find that beer once you go home.

Most small craft breweries do not have national distribution contracts. However, Michigan craft beer fans might soon have reason to cheer. Later this month, as Gov. Rick Snyder considers suggestions from the Liquor Control Advisory Rules Committee on how to update the state’s alcohol regulations, one of its recommendations may likely be to legalize direct-to-consumer beer shipping.

Opponents, including beer wholesalers, claim that such a change would allow minors to have easier access to alcohol. That argument is baseless and a smokescreen for stifling competition.

Many states now allow the direct shipping of wine, but beer does not enjoy the same privilege. While the wine industry is traditionally comprised of small and family owned vineyards, the beer market has been dominated by a small number of large brewers and wholesalers. These large producers and distributors have dominated the market for the last century and they want to keep it that way. As wineries have slowly increased their ability to reach consumers, members of the National Beer Wholesalers Association have spent millions of dollars opposing any legislation that would allow brewers, retailers or consumers to get their beer without going through a distributor.

As the demand for craft beer has increased, consumers are no longer content to settle for the options provided by the big distributors. Support for direct shipping has been growing in almost every state, but entrenched and well-financed opponents have been largely successful in preventing change.

In Michigan, a direct shipping license from the Michigan Liquor Control Commission allows a winery to ship 1,500 cases a year to Michigan residents. Wholesalers and others may argue that extending this privilege to beer suppliers would increase minors’ ability to buy beer, but the available evidence indicates that direct shipping would have no effect on underage drinking in Michigan.

Teens who try to order booze online face significant hurdles, such as the need for a credit card and the likelihood of parents being home when the delivery arrives. In addition, all the statistical data indicates that minors aren’t even trying to buy alcohol online. As reported in a four-year study from the Substance Abuse and Mental Health Services Administration (released in 2006), the vast majority of minors acquire their alcohol from parents or other adults who either give it to them or buy it for them.

According to the study, only 1.2 percent of minors bought alcohol themselves, while almost 35 percent received alcohol from their parents or other adults. Another 20 percent took the alcohol secretly from their or others’ homes.

There was not one report in the survey of a minor getting alcohol by buying it online. And why would they when it is easier and more immediate to steal alcohol from parents’ liquor cabinets or get an adult to buy it at the store?

Wholesalers might argue that perhaps once direct beer shipping becomes legal more teens will attempt to purchase online, and that shippers do not always check identification upon delivery and the state could not require them to do so. This is not so.

The claim that states cannot legally require common carriers to ID recipients of alcohol-containing deliveries comes as a result of a 2008 Supreme Court ruling, Rowe the Attorney General of Maine v. New Hampshire Motor Transport Association. In Rowe, the Supreme Court ruled that the state of Maine could not enact laws requiring mail carriers delivering tobacco products to check the ID of those receiving the package. The Court based its decision on the “supremacy clause,” which holds that in instances when federal laws conflict with state statutes the federal laws are supreme.

Because the Federal Aviation Administration Authorization Act of 1994 limits states’ ability to regulate delivery companies, Maine’s ID requirement was struck down. However, alcohol, as wholesalers are fond of saying, is a different kind of consumer good. In the case of alcohol, the federal right to regulate common carriers is negated by the fact that the most supreme document — the U.S. Constitution — explicitly gives the right to regulate alcohol shipping to states.

Currently, beer can only be purchased in Michigan at a licensed retail outlet, such as a liquor store, restaurant or bar. Unless the bar happens to be a brewpub, all of the alcohol sold in these locations comes from Michigan’s wholesalers. Direct shipping would allow consumers to buy their beer directly from producers — much like you might buy a book from Amazon or shoes from Zappos.

Wholesalers offer a valuable service to brewers, including a network of established contacts and a fleet of delivery trucks. They understandably fear that direct shipping would hurt their bottom line. Perhaps it would, but they are not entitled to the effective monopolies they currently hold; it should be up to consumers and brewers to decide.

Legalized direct shipping would be better for beer producers and beer lovers, and would have little or no effect on minors’ ability to buy alcohol.

Michelle Minton

Tue, 2012-04-17

Citation Source:

Michigan Capitol Confidential

http://www.michigancapitolconfidential.com/16785

Let States Regulate Internet Gambling

Michelle Minton — Mon, 19 Mar 2012 16:42:21 +0000

This country has many serious problems to address, but an activity that millions of people around the world voluntarily enjoy, mostly without incident, is not one of them and it certainly does not warrant a big new federal regulatory agency.

In a recent op-ed in The Washington Examiner, former Pennsylvania governor and Homeland Security chief Tom Ridge and former FBI Director Louis Freeh called for immediate federal regulation of Internet gambling.

Ridge and Freeh, who are employed by Fair Play USA a lobbying group funded by the largest Las Vegas casinos, argue that federal rules are necessary for law enforcement to be able to tackle interstate crime and to keep minors from accessing online games. This is far from the truth.

Ridge and Freeh assert that additional federal regulations are needed to shore up enforcement. The truth is that there are currently zero federal laws banning Americans from non-sports gambling online.

This was made clear when Assistant Attorney General Virginia A. Seitz announced that in the Department's opinion the 1961 Wire Act applied only to sports wagering.

Many countries around the world have had legalized online gambling for decades. In the United States, prior to the 2006 Unlawful Internet Gambling Enforcement Act that raised the question of a federal stance on the legality of online gambling, millions of Americans also wagered online; only a handful of incidents occurred prior to 2006 and droves of people were not losing their homes and sanity to online gambling.

Adults ought to be able to choose whether or not they wish to engage in risky behaviors, so long as they are the only person taking on the risk. After all, plenty of people (including members of government) invest in the stock market, which is essentially gambling. The proper role for the government in the Internet gambling arena is to protect Americans from fraud, theft and other violations of their rights.

To that end, state governments are fully equipped to enforce minimum age limits and assertions of fraud. As Freeh and Ridge noted in their article, state-of-the-art technologies already exist to restrict minors, protect against fraud and secure data.

Private certification companies require online gambling sites to submit to mediation if a player asserts that he or she has been cheated. Individual States can experiment with different schemes for licensing and regulating to tweak their policy until they find the best outcome for residents, businesses and state budgets.

A federal monopoly regulatory agency would be less flexible and more likely to bow to the pressure of special interests.

New federal laws are not necessary. As proven by "Black Friday," the Department of Justice's shutdown of online gambling websites, law enforcement already has the necessary tools to track and prosecute illegal online gambling activity that crosses state lines.

Furthermore, federal and state tax codes are already in place for players and platforms to report earnings. The courts should answer questions of fraud and cheating.

Federal regulators should leave states and citizens to make their own choices about gambling and get back to addressing the many more pressing problems this nation faces.

Michelle Minton

Sun, 2012-03-18

Citation Source:

The Washington Examiner

http://washingtonexaminer.com/opinion/op-eds/2012/03/let-states-regulate-internet-gambling/384241

Too Fat? Too Thin? Progressive Policies Can Fix That!

William Frezza — Tue, 20 Mar 2012 22:32:17 +0000

Political projects that seek the perfectibility of man by using the coercive powers of the state have a long and checkered history - perhaps the most infamous being attempts to create the New Soviet Man. As the diverse milieu of social, religious, and cultural forces that compete to influence behavior are displaced by monolithic government bans, mandates, regulations, taxes, subsidies, fines, and prison sentences, we are left lamenting the demise of the experiment in limited government that was once the signature accomplishment of the United States.

Examples of overreach abound, but few are as ludicrous as the current campaign against gluttony and its mirror image, anorexia.

Let's face it, Americans are getting fat, with fully a third categorized as obese and another third overweight. Medical explanations abound, but a sedentary lifestyle, overeating, and improper diet are choices people make despite being bombarded with information about how harmful such behaviors are to their health - not to mention their looking in the mirror or stepping onto the scale.

Now, in an act of unintended irony, our burger-chomping First Lady has made fighting the obesity "epidemic" a crusade - one that will require dictating the content of school lunch programs. Meanwhile, her husband (the closet smoker) showers stimulus money on lunch box police to see that her "recommendations" are enforced.

How did we evolve from the land of the free and the home of the brave into a bunch of cowering weenies forced to eat our vegetables? Call it the progressive two-step, a time tested technique by which we are induced to become our brothers' keepers across ever larger sectors of our lives.

The first step is to define obesity as a "disease," thereby relieving its "victims" of personal responsibility. Any number of government-financed scientists can then be called upon to produce mountains of studies proving that self-control is no match for the actions of this or that chemical receptor in our brains. Those who stress personal responsibility are denounced for "blaming the victim," whose suffering is "no fault of their own."

Thus, the stage is set for public policies guided by "experts" empowered to act on behalf of the "public good," using any means at their disposal to achieve their noble ends.

The logic behind government efforts to control Americans' mass body index is as impeccable as it is insidious. If health care is a "right" to be paid for by the taxpayer, and "access" to this right is being jeopardized by the runaway costs associated with a "disease" called obesity, then the food that you stuff in your face is no longer a personal preference but a critical matter of fiscal necessity.

Sugar is the latest demon, since it appears that years of government advice on the consumption of saturated fats has turned out to be wrong. A broad-based campaign is underway, spearheaded by zealots like Professor Robert Lustig of the University of California, to get the federal Food and Drug Administration to regulate sugar as it does other "addictive poisons."

In addition, calls to introduce punitive taxes on sugary foods and beverages follow on the heels of the campaign to reduce smoking by driving up the cost of cigarettes. The fact that this has perversely turned state governments, increasingly dependent on tobacco taxes, into the silent partners of cigarette companies seems to bother no one. Is the soft drink industry next? Only your state's attorney general and the class action tort bar know for sure.

At the other end of the scale, "scientists" are urging government action to ban skinny models to curb anorexia, a self-induced malady that affects far too many young women with self-esteem problems. Apparently, the fashion industry's penchant for thinness, which you might think would be hailed by obesity warriors, is a public menace that needs to be controlled. First Amendment be dammed, we have a crisis here and we cannot let corporate greed trump public safety!

Following in the footsteps of the so far unsuccessful campaign to ban violent video games, it's just a matter of time before an activist judge somewhere buys into the ends-justifies-the-means argument to curb speech for the public good. Punitive income taxes on skinny models and excise taxes on small dress sizes have yet to be proposed, but give it time.

All of this is part and parcel of the slippery slope we have been sliding down for years as we are slowly trained to kowtow to the self-appointed nannies who have grabbed the levers of power. Turning back the tide will not be easy, though perhaps our impending federal bankruptcy will help focus voter's minds on what is and what is not the proper scope of government.

William Frezza

Mon, 2012-03-05

Citation Source:

Real Clear Markets

http://www.realclearmarkets.com/articles/2012/03/05/too_fat_too_thin_progressive_policies_can_fix_that_99548.html

Is Drug War Driven Mass Incarceration the New Jim Crow?

William Frezza — Tue, 20 Mar 2012 23:03:31 +0000

Once in a great while a writer at the opposite end of the political spectrum gets you to look at a familiar set of facts in a new way. Disconcerting as it is, you can feel your foundation shift as your mind struggles to reconcile this new point of view with long held beliefs. Michelle Alexander has done just that in her book, The New Jim Crow.

A liberal ideologue with impeccable leftist credentials, Alexander was Director of the Racial Justice Project at the American Civil Liberties Union before moving on to an appointment in Race and Ethnicity studies at Ohio State University. Her thesis pushes disparate-impact logic to an extreme, ascribing deeply racist motives to a society that has traveled a very long way since the system of legal and cultural discrimination known as Jim Crow stained the land.

Yet there is no denying that if your goal were to consign African Americans to a permanent underclass—one which the rest of us would be culturally and legally permitted to discriminate against in employment, housing, voting rights, and government benefits—the war on drugs would be a great way to do it.

Alexander spouts statistics with which we are all familiar. Approximately half a million people are in prison or in jail for a drug offense today, compared to around 41,000 in 1980. Four out of five drug arrests are for simple possession, 80% for marijuana. Most people in state prison for drug offenses have no history of violence.

At the end of 2007, more than 7 million Americans were behind bars, on probation, or on parole, many whose initial violation of the drug laws spiraled into a life of crime. This is a level of mass incarceration unprecedented in history. And despite the fact that surveys show that whites are just as likely to use illegal drugs as blacks, one out of every 14 black men was behind bars in 2006, compared to one in 106 white men.

It is that last bit that deserves attention. Through a series of anecdotes accompanied by a steady drumbeat of statistics, Alexander makes a compelling case that one of the key pillars of the fruitless war on drugs is selective enforcement coupled with plea bargain-driven judicial railroading.

Police patrols of inner-city African-American neighborhoods are characterized by a degree of hyper-aggressive vigilance, constitutionally dubious intrusiveness, and occasional brutality that would absolutely not be tolerated in the white suburbs. The vast majority of the people I went to college with smoked marijuana. Were law enforcement evenhanded, instead of growing up to be doctors, lawyers, engineers, and entrepreneurs, we would all be unemployable former felons.

It is this mark of Cain, the brand of the former felon, which Alexander claims is the tool that a racist society uses to turn young black men foolish enough to get involved in drugs into permanent members of the underclass. Unable to re-integrate into society because of the legal and cultural barriers that permit former felons to be treated the way Jim Crow treated African Americans, the 650,000 people released from prison every year are virtually driven into a life of crime through the systematic elimination of other options.

Yes, the book gives short shrift to the role that personal responsibility plays in all this. If you lived in a police state with half your friends in jail, knowing you might be pulled over on a pretext at any moment, why in the world would you drive around with marijuana in your car? Despite that caveat, it’s hard to lay claim to rationality and still support drug prohibition, the results of which mirror the horrors of our country’s ill-fated experiment with alcohol prohibition.

Opinion leaders, on both the right and left, have spoken out against the insane war on drugs for as long as politicians have been hiding their heads in the sand while they compete to see who is the toughest law and order advocate. An enormous police and prison industrial complex has grown up that is completely dependent on keeping the mass incarceration movement alive. Our country cannot seem to find a way to stop the madness, as we did when we repealed the 18th Amendment, which had imposed nationwide alcohol prohibition. Of the leading presidential candidates, only Ron Paul has stepped up to address the issue, with a snowball’s chance in hell of anyone else picking up the call for drug decriminalization.

It’s as chilling to believe that drug warriors are perpetrating non-racial means to marginalize African Americans as it is to believe that Planned Parenthood is practicing genocide by playing a leading role in terminating 40% of black pregnancies, making abortion the leading cause of death among African Americans. But the logic of disparate impact analysis inevitably leads you to both those conclusions.

Whether you agree with her thesis or not, Michelle Alexander makes you think about mass incarceration in a new way. The pro-life movement could take a lesson from her if they hope to inject some fresh thinking into their advocacy.

William Frezza

Tue, 2012-02-28

Citation Source:

Forbes

http://www.forbes.com/sites/billfrezza/2012/02/28/is-drug-war-driven-mass-incarceration-the-new-jim-crow/

The Anti-GM Food Circus Rolls Through Connecticut

Gregory Conko — Mon, 27 Feb 2012 17:37:45 +0000

From the American Council on Science and Health's "Health Facts and Fears":

But as Gregory Conko, a senior fellow at the Competitive Enterprise Institute, argues in his latest op-ed, there’s no need to label GM foods: A myriad of highly accredited scientific bodies, such as the American Medical Association and the World Health Organization, have already deemed them safe. In fact, he says, biotech produce may actually be safer than plants developed with conventional methods.

Something few people know is that, since the 1930s, conventional crops have been intentionally mutated with ionizing radiation and highly toxic, carcinogenic chemicals in order to produce the best possible species. Many anti-biotech activists may be surprised to learn that, nowadays, these mutant varieties may actually be categorized as “organic.” Alhough these mutant or cross-bred plant varieties are safe and not a cause for concern, Conko does point out that the imprecision and unpredictability of these methods is one reason that scientists say GM foods are at least as safe as, if not safer than, conventional plant varieties.

But facts aren’t what matter to most anti-biotech activists, given that they are frequently uninformed about the science behind the practice. For instance, the results of a poll against GM foods called “Just Label It” demonstrate that, although these folks are nominally opposed to agricultural biotechnology, the large majority have little knowledge about the process in general or about how these foods are regulated.

This is another reason, Conko says, why such products should not be subject to labeling. And according to the U.S. Constitution, the government does not have the right to mandate product labeling unless the added information affects consumer health or safety. But since plants developed with biotechnology, as the FDA has determined, are not inherently more risky than those bred with conventional methods, they need not be subject to special labels. In fact, a U.S. Second Circuit Court of Appeals followed this logic when striking down a Vermont statute that would have required labels on milk derived from cows treated with bioengineered growth hormones. “[W]ere consumer interest alone sufficient, there is no end to the information that states could force manufacturers to disclose,” the court concluded.

Gregory Conko

Fri, 2012-02-24

Citation Source:

American Council on Science and Health

http://www.acsh.org/factsfears/newsID.3419/news_detail.asp

The FDA Has It Dead Wrong

Michelle Minton — Thu, 02 Feb 2012 16:49:02 +0000

When policy makers responsible for writing a bill send a letter telling an enforcement agency that it is out of line, one would hope the agency would sit up and listen. This week, Senators Tom Harkin (D-Iowa) and Orrin Hatch (R-Utah) wrote to the Food and Drug Administration (FDA) claiming that the agency's recently released guidelines on dietary supplements undermines the statutory framework for regulating such supplements, as outlined in a bill crafted by the two Senators. If the outcry in the supplement industry and consumer advocates hasn't got the attention of FDA Commissioner Margaret Hamburg, perhaps the Senators' letter will.

In 2011, Congress passed the Food Safety Modernization Act (FSMA), which among other things, required the FDA to provide clarification on when supplement manufacturers must file New Dietary Ingredient notifications (NDI) and what information they must provide to the agency. The NDI filing system was meant to be a streamlined way for makers of new supplements to notify the FDA of the proper dosage and uses for the product, as well as why it is reasonably expected to be safe. As noted in the Senators' letter, the guidance required by the FSMA was meant to clarify the NDI filing process and work in conjunction with legislation already on the books - namely, the Dietary Supplement Health and Education Act of 1994 (DSHEA), which Hatch and Harkin wrote and which created the regulatory framework for the dietary supplements market.

DSHEA was created to, among other things, differentiate dietary supplements - minerals, herbs, and other natural substances - from drugs - chemical compounds meant to alter the structure of function of the human body. DSHEA was considered necessary for the U.S. to maintain vibrant supplement market. Supplements, unlike drugs, are generally non-patentable, so do not need to go through the same costly and time consuming process of pre-approval as drugs.

However, the NDI draft guidelines released by the FDA this summer would create a de facto pre-approval process on virtually all supplements on
the market, thus giving the agency carte blanche to pull any supplement off the shelf without the need to prove that it is unsafe. Naturally, Harkin and Hatch are not happy, nor are the many thousands of vitamin and supplement users and the employees of companies that manufacture them.

Despite what many critics have claimed, the market for supplements is not unregulated. Prior to the FDA's draft guidance, a "new" dietary ingredient was one that had not been marketed or widely used prior to 1994. Manufacturers had to provide evidence of why they believed the ingredient to be safe and wait 75 days before putting the product on the market. The FDA has full authority to pull supplements off the market if it finds they are unsafe. And manufacturers must comply with other laws regarding safety, such as the Nutrition Labeling and Education Act, the
Fair Packaging and Labeling Act, and Good Manufacturing Practices guidelines.

The FDA's proposed changes would force nearly all supplements currently on the market to apply for retroactive approval - even those that were around before 1994. The new draft guidance requires any supplement containing new ingredients, or ingredients that have been chemically altered or manufactured in a new way, to file for approval. Because the FDA defines these terms broadly, it is likely that almost all supplements on the market would meet this requirement and be forced to file an NDI. As a result, many supplements would disappear from shelves for good and those that return will likely cost consumers much more.

The documentation required by the guidance is so extensive that it seems impossible for many or most of the supplement makers to obtain the required evidence of safety. Even if companies could document 25 years of safe use, toxicology studies on animals and humans, two-year carcinogenesis studies, and the like, it's very unlikely that FDA, with its ever increasing backlog, would ever get around to approving any of the NDIs. By the agency's own admission, there are more than 55,000 NDIs that should be filed but haven't been.

So, what would happen to all of those supplements? Well, if the FDA does not officially approve the NDI, the manufacturer may market the product.
However, doing so gives the FDA an open door to pull those supplements off the shelves, not because they pose any threat to public safety, but simply because the agency considers them to be "adulterated."

If the FDA's proposed NDI guidance is adopted, supplement manufacturers will be left with a choice: either submit their products to similarly rigorous pre-approval trials as drugs, or give the FDA the power to ban product without justification and with full impunity. Senators Hatch and Harkin are right when they insist that the FDA's guidelines undermine the very heart of the supplement regulation they authored and Congress
passed.

If the FDA continues on this rogue effort to unilaterally expand its authority, the Senate Health, Education, Labor, and Pensions Committee, which Senator Harkin chairs, should be ready to ask the agency some tough questions.

Michelle Minton

Tue, 2012-01-31

Citation Source:

The Hill

http://thehill.com/blogs/congress-blog/campaign/207695-michelle-minton-fellow-competitive-enterprise-institute

Ryan Radia: SOPA could change the way the internet works

Ryan Radia — Thu, 19 Jan 2012 16:00:14 +0000

Image:

Experts:

Ryan Radia

Date:

Tue, 2012-01-17

OnDemandUrl:

http://ceiondemand.org/2012/01/19/ryan-radia-sopa-could-change-the-way-the-internet-works/