Tag: FDA

Making the Lawsuits More Tasty

The Washington Post’s story Tuesday breaking the news about the FDA’s scheme to reduce salt content in food through regulation quoted one of the most radical we-know-better-than-you groups out there, the Center for Science in the Public Interest.

Michael Jacobson of the Center for Science in the Public Interest, which first petitioned the FDA to regulate sodium in 1978, said voluntary efforts by industry are laudable, “but they could change their minds tomorrow. . . . Limiting sodium might be the single most important thing the FDA can to do to promote health.”

This context would have been helpful to the reader. From a Center for Science in the Public Interest news release, July 23, 2009, “Unsafe Sodium Levels at Denny’s Prompt Class Action Lawsuit“:

WASHINGTON—Most Denny’s meals are dangerously high in sodium, putting the restaurant chain’s customers at greater risk of high blood pressure, heart attack and stroke, according to a class action lawsuit filed today by a New Jersey man with the support of the Center for Science in the Public Interest.

The lawsuit was filed in Superior Court of New Jersey in Middlesex County, and seeks to compel Denny’s to disclose on menus the amount of sodium in each of its meals and to place a notice on its menus warning about high sodium levels. CSPI is working with the New Jersey firms of Galex Wolf, LLC and Williams Cuker Berezofsky. 

Big surprise. Trial lawyers are trolling for cash.

Galex Wolf’s website is here. Williams Cuker Berezofsky’s site is here.

Here’s a good report of the Center for Science in the Public Interest’s activities over the years from ActivistCash.com.

With the war on salt gaining in activity, expect to see many news reports cite the Center for Science in the Public Interest as some sort of disinterested observer, “scientists” working on important issues. Reporters who do so are misleading the public about the group’s agenda, which correlates closely to the agenda of the trial lawyers.

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The Consumption Protection Salt Intake Act

The Washington Post reports, “Fast action to limit salt in processed foods pushed by Sen. Harkin, Rep. DeLauro“:

Two members of Congress urged the Food and Drug Administration on Tuesday to move quickly to limit the amount of salt in processed foods, calling the matter a “public health crisis” that demanded a swift response from government.

“I understand they want to do it in a phased kind of a deal, but I don’t want it to be too long,” said Sen. Tom Harkin (D-Iowa), chairman of the Health, Education, Labor and Pensions Committee. “This is crying out for change that’s long overdue.”

Rep. Rosa DeLauro (D-Conn.) agreed, saying in a conference call with Harkin and reporters: “I don’t want this to take 10 years. . . . This is a public health crisis.”

Millions of American of Americans work in the food industry, and it’s disheartening to see members of Congress immediately jump on a regulatory scheme that could have a huge impact on those jobs.

And just because you call it a crisis, doesn’t make it one.

Frankly, we’re surprised the members of Congress didn’t vow tough legislation to crack down on those nefarious salt merchants. Maybe one of the lawmakers who want to control more of Americans’ lives will introduce the bill, the Consumption Protection Salt Intake Act. We know how well the last CPSIA worked out.

Earlier: “From the Latin: We’re Going to Regulate Every Aspect of Life

UPDATE (3:40 p.m.): Ramesh Ponnuru comments at WashingtonPost.com, Right Matters:

This strikes me as outrageous. Leave aside the irresponsibility of demanding immediate action when the FDA has not yet solved the many practical problems its ambitions require it to solve. The deeper problem is one of principle. There may be things that government can reasonably do to reduce the number of people who suffer from hypertension. Trying to force changes to every American’s diet isn’t one of them. Congress should change the law to block the FDA.

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From the Latin: We’re Going to Regulate Every Aspect of Life

Washington Post, “FDA plans to limit amount of salt allowed in processed foods for health reasons“:

The Food and Drug Administration is planning an unprecedented effort to gradually reduce the salt consumed each day by Americans, saying that less sodium in everything from soup to nuts would prevent thousands of deaths from hypertension and heart disease. The initiative, to be launched this year, would eventually lead to the first legal limits on the amount of salt allowed in food products.

Food manufacturers are undertaking serious, voluntary efforts to reduce the salt content in their products.

Voluntary? Hah!

“We can’t just rely on the individual to do something,” says Cheryl Anderson, an epidemiologist at the Johns Hopkins Bloomberg School of Public Health.

Here’s an idea. Salt is one of the most important commodities and even currencies in the history of man. The word “salary” comes from the Latin “salarium,” meaning money paid to soldiers to buy salt.

So, why not just wrap salt regulation in under the financial regulation bill in the Senate? As John Berlau of the Competitive Enterprise Institute argues, the financial regulation bill defines large (non-banking) sectors of the economy as banks in order to regulate them. If you sell salt or use it in your products, you’re a bank!

In other salt-related news, Mark Kurlansky, author of Salt, has a new book out, “Eastern Stars,” about the great baseball players from San Pedro, the Dominican Republic. He speaks Wednesday evening at the DC bookstore, Politics & Prose. Salt is a very entertaining, commodity-oriented history of the world. We were hoping Zinc was next.

UPDATE (10:10 a.m.): Walter Olson comments at Overlawyered.com:

We’ve been warning of such developments for a while, and they come as little surprise given President Obama’s pick of hyper-regulator Margaret Hamburg as FDA commissioner.

P.S. Perhaps we should invite comment from the New York Times journalist who sternly admonished an interview subject recently: “You shouldn’t trivialize issues of health and safety by calling them nanny issues.”

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The Encompassing Tax on Medical Devices, 2.9 Percent

Subtitle E, Section 1405 in the House substitute amendment to the health care legislation is “Excise tax on medical device manufacturers”

The section states:

SEC. 4191. MEDICAL DEVICES.
(a) IN GENERAL.-There is hereby imposed on the
sale of any taxable medical device by the manufacturer,
producer, or importer a tax equal to 2.9 percent of the
price for which so sold. 

There are exemptions for eyeglasses, contact lens, hearing aids and items purchased by the general public at retail stores, things like tongue depressors. Even with the exemptions, there’s much covered under the bill’s definiion of “taxable medical device,” which “means any device (as defined in section 201(h) of the Federal Food, Drug, and CosmeticAct) intended for humans.”

From the FDA, “Is The Product a Medical Device?”

Medical Device Definition

Medical devices range from simple tongue depressors and bedpans [presumably exempt as noted above] to complex programmable pacemakers with micro-chip technology and laser surgical devices. In addition, medical devices include in vitro diagnostic products, such as general purpose lab equipment, reagents, and test kits, which may include monoclonal antibody technology. Certain electronic radiation emitting products3 with medical application and claims meet the definition of medical device. Examples include diagnostic ultrasound products, x-ray machines and medical lasers. If a product is labeled, promoted or used in a manner that meets the following definition in section 201(h) of the Federal Food Drug & Cosmetic (FD&C) Act it will be regulated by the Food and Drug Administration (FDA)4 as a medical device and is subject to premarketing and postmarketing regulatory controls. A device is:

  • “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
     

    • recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
    • intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
  • intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of it’s primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.
  •  Funny how health care “cost controls” so easily morph into tax increases.

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    A Modest Solution to Health Care Financing

    Washington Post, “What Would a Health Overhaul Cost? All Eyes on the CBO“:

    [CBO Director Doug] Elmendorf, 47, faces the toughest task of his brief tenure: attaching a price to a monumental overhaul of the nation’s health-care system, which holds out the promise of delivering care to millions of uninsured Americans, cutting costs for an overburdened federal government and sealing the political legacy of a popular new president.

    Washington Post, “Senate Passes Bill to Let FDA Regulate Tobacco“:

    The legislation creates a new tobacco center within the FDA that will be funded by fees from the industry. Those fees are estimated to reach more than $500 million annually by 2013, according to the Congressional Budget Office.

    Forbes.com, “Health Organizations Cheer Senate Vote on Tobacco Control“:

    “While we celebrate this notable victory, we recognized that we have yet to win the war,” added Charles D. Connor, the lung association president and CEO. “As the FDA tobacco legislation continues its way to the President’s desk for signature, we will also continue our work for higher tobacco taxes, smoke-free laws and funding of tobacco control and prevention programs at the state level to reduce tobacco use and save lives.”

    From Americans for Tax Reform, “Louisiana Tobacco Tax Hike Passes Committee”:

    HB 889 would cause Pelican State tobacco consumers to see taxes to rise 50% on cigars, 50% on smokeless tobacco, and the price of a pack of cigarettes rise by 50 cents per pack – a whopping 138% tax increase. This adds insult to injury for taxpayers as it will be levied on top of a new 61-cent hike in the federal cigarette tax passed in Congress earlier this year.

    Etc.

    Why not just raise the tax on cigarettes to $1 billion a pack? Sell a thousand packs, financing problem solved!

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    CPSC Legislation: Let a Million Lawsuits Bloom

    It looks like the final version of H.R. 4040, the Consumer Product Safety Modernization Act, could come to the House and Senate floors as early as this week.

    Conferees met on July 17, getting down to the more disputed issues, and convene again on Tuesday, the National Whistleblowers Center reports in a news release decrying the possible of “sham reforms.”

    Consumer Affairs summarizes the agreed-upon provisions in this online report. Included is state attorneys general authority to enforce existing consumer protection laws (not as sweeping, and therefore as lawsuit friendly, as the Senate version).

    For business, a significant problem remains the provisions establishing a national database for complaints. Again, from Consumer Affairs, “Establishment of a public consumer product safety database:” Within 2 years, the CPSC would establish a searchable database to include any reports of injuries, illness, death or risk related to consumer products submitted by consumers and other agencies. Upon receiving a complaint, the CPSC has five days to submit the complaint to the manufacturer. The manufacturer then has 10 days to respond. The complaint and manufacturer’s response, if available, would then be posted on the database. The CPSC would have the authority to remove a complaint if it is found to be inaccurate.”

    So it’s not quite the invitation for the free-for-all chumming of the lawsuit waters as originally proposed. Think of it more as targeted trap baiting.

    Apparently there’s also continued disagreement on phthlates, i.e., whether a federal ban is warranted. It’s not, scientifically or economically.  We direct the reader again to this excellent Fortune report, “Wal-Mart: The new FDA” about the activist/lawyer/politician combine against chemicals.

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