Citizens For Health: Action Alerts Updates

[HoopsTer]

I am just going to use this thread to post news and action alerts from Citizens for Health. :)


Citizens for Health is the national nonprofit consumer advocacy group working to broaden health care options, create an integrative health system based on wellness, and advance the freedom to make health choices. We promote the fundamental policies needed to improve health choices and information in the U.S. and the world. We work with grassroots and education organizations and the private sector to insure consumer access to a wide range of therapies, a healthy environment, safe foods, and the dietary supplements of their choice. We foster active citizen leadership and organize natural health consumers to create political solutions that support these rights.

[HoopsTer]

Our thanks to Citizens For Health policy advisor Frank Herd for sharing this great news - You'll recall that a few months ago, many of you followed our Action Alert, demanding that General Mills discontinue the use of rBGH in its Yoplait yogurt. Through our Action Alert you joined with thousands of others from similar campaigns to prompt this important change to GM's policy. Refresh your memory about our campaign here. http://www.citizens.org/action-alerts/tell-yoplait-put-lid-rbgh

You succeeded! General Mills has just announced that as of August of this year it no longer will use milk from cows injected with recombinant bovine somatotropin (a/k/a rBST or rBGH). Read General Mills' press release here. http://www.generalmills.com/corporate/media_center/news_release_detail.aspx?itemID=36812&catID=227

This is a major victory for the natural health movement. It's a reminder about what the Voice of the People can do when our efforts are concerted. But we've now got to take the next step. Proponents of these artificial hormones have mounted an effort to convince General Mills (GM) to rescind its decision. AFACT, or American Farmers for the Advancement and Conservation of Technology, is urging its members to contact GM and tell them "why consumers, processors and the environment will lose with the loss of technologies used in agriculture." One comment already generated by this push asks GM to consider "the role technologies play in helping feed the world, not just cave into activist driven campaigns to push us to organic production practices." (Italics added for emphasis).

So, although we've succeeded to this point, we must support GM in its decision. Help GM stand strong against the pressures of disgruntled industrial milk producers who want to cut corners and artificially increase milk production by injecting their cows with rBST/rBGH.

Let's keep our momentum going! Cut and paste the following comment to GM via the GM website by clicking here: http://consumercontacts.generalmills.com/ConsolidatedContact.aspx?page=http://www.generalmills.com/corporate

As a Citizen For Health, I support GM's decision to remove rBGH from Yoplait. Don't back down in response to pressures from the industrial milk producers by rescinding your decision. Thank you for doing the right thing.

Or, you can write, phone or fax the company:

General Mills, Inc.
P.O. Box 9452
Minneapolis, MN 55440
Phone: 800-248-7310
Fax: 763-764-8330

Keep up the good work - you are making a difference! And as always, thanks for your support.

[irieday]

Cool! Thanks for the info Terra.

[HoopsTer]

We predicted late last year before, during and after the election that 2009 would begin a time of change and challenge for dietary supplements. It looks like the first shoe has dropped: The U.S. Government Accountability Office (GAO) presented a report to Congress last week, titled Dietary Supplements: FDA Should Take Further Action to Improve Oversight and Consumer Understanding.

A link to the full 70+ page report appears at the end of this article. Here are a few highlights:

1. The Players

The GAO is known as "the investigative arm of Congress." It's self-described mission is to improve the performance and ensure the accountability of the federal government. Typically, its work is performed at the direction of Congressional Committees. Its work "leads to laws and acts that improve government operations."

With regard to this particular report, the GAO's work was done at the request of Congressional Representatives Henry Waxman, John Dingell and Bart Stupak, and Senator Richard Durbin. Rep. Stupak has been one of the FDA's most vocal critics, as we reported some weeks ago. As we have also reported in the past, Reps. Waxman and Dingell, and Sen. Durbin have been skeptics - if not outright critics - of DSHEA and the dietary supplement industry for years.

2. The Issues

The GAO organized its comments according to four themes:

• The FDA has insufficient information from the industry about dietary supplements and manufacturing operations to be effective.

• The FDA has applied insufficient resources to properly oversee dietary supplements.

• The FDA has insufficient authority to remove products from the market.

• The FDA needs to do more to educate the public about dietary supplements.

3. GAO Comments of Concern

Within the GAO Report, we find these comments:

"According to several experts we spoke with, [the FDA's] regulatory approach [to supplements under DSHEA] has fallen short in protecting U.S. consumers in the past."

Among other things about this statement, we would like to know who these purported experts are, and the methods they used to arrive at their conclusion. We would also like clarification: is it the FDA or the law itself that has failed the public?

"[Even though reported adverse events average about 500 per year], the FDA recently estimated that the actual number of total adverse events . . . related to dietary supplements per year is over 50,000 . . ."

We would very much like to know how the FDA arrived at this estimate, including how the FDA evaluates whether an adverse event was actually caused by supplements as opposed to other potential causes. We also point out that the average adverse events reported for pharmaceuticals each year for the past 5 years is over 300,000.

4. GAO Recommendations

The GAO made four recommendations

• Dietary supplement companies should be required to identify themselves as a dietary supplement company as part of the existing registration requirements, and they should be required to update this information annually; they should be required to provide a list of the products they sell and a copy of the labels, updated annually; and they should be required to report all adverse events related to dietary supplements, not just major events.

• The FDA should issue guidance to clarify when an ingredient is considered a new dietary ingredient, the evidence needed to document the safety of new dietary ingredients, and appropriate methods for establishing ingredient identity.

• The FDA should provide guidance to industry to clarify when products should be marketed as either dietary supplements or conventional foods formulated with added dietary ingredients.

• The FDA should work better to educate consumers about the safety, efficacy, and labeling of dietary supplements.

Note that the GAO made no specific recommendations about changing outright the regulation of dietary supplements under DSHEA. But you can bet this report isn't the last shoe to land.

We'll have more in the coming days about the GAO report and the recommendations. In the meantime, you can read the report for yourself here.

Thanks for your support.

To view our privacy policy, click here: http://www.gao.gov/new.items/d09250.pdf

[HoopsTer]

President Obama has nominated Dr. Margaret Hamburg to become the new Commissioner of the FDA and Dr. Joshua Sharfstein as the Deputy Commissioner. Both nominees are subject to confirmation by the Senate in the coming weeks. The internet is already full of information about these two nominees since the President announced their candidacy just days ago. And you're sure to hear more about them in the days to come.

In the meantime, this article in the New York Times has some interesting information about the significance of these nominations beyond the credentials of the nominees themselves. The Times notes that "some legislators [are] advocating that the FDA be split in two." The article then quotes former FDA associate commissioner Peter J. Pitts (now president of the Center for Medicine in the Public Interest) as suggesting that the Obama administration supports this split:

"I think Dr. Hamburg will become the commissioner of food, since she's a safety and security person," Mr. Pitts said, "and then Dr. Sharfstein would slide into the F.D.A., which would become the Federal Drug Administration."

This information is both preliminary and speculative, but it's not unreasonable to think it could happen. Such a split could bode well for some aspects of food and drug safety. Nevertheless, thought of such a split begs this question: On which side of this split will dietary supplements be regulated?

This is an issue to watch. More on this soon.

[HoopsTer]

We're hearing more and more news out of Washington, D.C. that there is an effort underway to divide the FDA into two separate agencies - one for food and one for drugs. Evidence for this move lies in House Bill 875, which if passed will establish a new Food Safety Administration (FSA), and which will turn the existing FDA into the Federal Drug Administration. Pros and cons are circulating about this move, and we'll be reporting on all of it in the coming weeks.

We hasten to remind you, as we suggested last week, that the status of dietary supplements under H. 875 remains in grave doubt. That is, will supplements be regulated as food under the new FSA, or as drugs under the coming FDA? This is only one of many questions that have to be answered before this legislation should get anywhere near a vote.

In the meantime, here's a fundamental issue to consider as we brace for the possible creation of a new federal agency:


1946 was a watershed year for the U.S. government, and the way it's been run for the past 63 years. That was the year that the U.S. Congress passed the Administrative Procedures Act (APA). The APA was passed in the aftermath of the Depression and WWII to consolidate and standardize the expansion of government power as exercised through federal agencies .

In short, the APA is an extensive, complex and often confusing set of federal statutes that govern how administrative agencies operate. Under the APA, agencies possess powers similar to those possessed by all three branches of government rolled into one. Agencies have the power to legislate through rulemaking; the power to adjudicate through quasi-judicial courts; and the power to prosecute and enforce, like the executive branch.

The APA is like the operating program, if you will, that dictates the relationship between the American people on the one hand and administrative agencies on the other hand, including these agencies among others:

The Treasury Department
The Federal Reserve
The Federal Home Loan Bank Board
The Securities and Exchange Commission
The Department of Agriculture
The Federal Trade Commission
The Food and Drug Administration

Now, here are a few historical anecdotes about administrative law and the APA.


The accumulation of power within these agencies via the APA was largely a response to the crises of the Depression and WWII.
President Franklin Roosevelt - himself an architect of many administrative entities - is said to have worried that the establishment of agencies would create "a fourth branch of government for which there is no sanction in the U.S. Constitution,"
Indeed, a 1936 government report about administrative agencies described them as a "headless" branch of government.
By many accounts, the single most-cited U.S Supreme Court case is Chevron v. Nat'l Resources Defense Council, in which the 1984 Court held that decisions of administrative agencies are entitled to substantial judicial deference. In other words, there's not much legal leverage with which to hold these administrative agencies accountable - and this legal mantra from the highest court in the land is being embedded in our culture more often than any other.

As we consider these points, let's do so mindful of the prospects for a new agency that will control our food, the future of dietary supplements and much of our health care at large. Let's also be mindful of the performance of the existing agencies that appear at the top of that list above, especially what that performance has wrought over the past several months. Consider whether a new agency under the old system of accountability is really what we need, as opposed to a new system of accountability altogether.

And one more thing - remember George Orwell's book 1984, and the Ministry of Peace (that perpetuated war), the Ministry of Plenty (that ration food), the Ministry of Truth (to control information) and the Ministry of Love (where enemies of the State were interrogated and punished)? Those Ministries were administrative agencies.

Of course, that was just fiction.

[HoopsTer]

The symptoms of illness in the Body Politic these days seem almost too numerous to address. It's a challenge to stay on task and keep our discussion to healthcare. The urge is to respond to everything that's going on. But we are Citizens For Health. And healthcare is a fundamental element of the Body Politic and a model for other issues.

To prove our point, we offer here the first of a five part series about an important topic that often gets lost in the shuffle when we talk about healthcare reform. It's a topic that could apply to any of the symptoms afflicting us. It's especially acute in healthcare. That topic is information.

When we think about healthcare, we usually think about products and practices - their safety, efficacy, access and cost. Healthcare regulation typically addresses these elements. We tend to overlook that information is also regulated. In fact, that's the most fundamental purpose of healthcare regulation. The way in which information flow is structured shapes how questions of safety and efficacy get asked and answered.

Mindful of our past and present theme about the Body Politic - a phrase coined to mean the collective structures and functions of our society - consider that information is to the Body Politic as hormones are to the body. The word hormone has Greek origins meaning "to set in motion" or "to spur on." Healthcare professionals tell us that hormones are the means by which chemical messengers are transported among cells for the purpose of growth, development and energy. The flow of information, like hormones in the body, has an awful lot to do with the growth, development and energy of the Body Politic.

It's not farfetched to suggest that we're experiencing a hormonal imbalance or major hormonal changes in the Body Politic. Something in our cultural growth, development and energy is out of sync. Is there a dynamic about information flow in the Body Politic that we need to reconsider?