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| July 2, 2011 |
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Sneak Attack on Supplements: FDA and Senator Durbin Use Slow News Day to Launch
Today, both the FDA and Sen. Dick Durbin (D-IL) dropped policy “bombs” on those of us who use dietary supplements. It is no mere coincidence that both were released on the Friday before a holiday weekend. By timing the introduction of their anti-supplement legislation and regulatory guidance this way, the FDA and Sen. Durbin are both hoping to evade negative publicity. We think it is better to keep American citizens fully informed, and with your help, we will get the word out. Please send this communication far and wide.
First, the FDA has issued draft guidance for complying with the New Dietary Ingredient (NDI) notification protocols contained by the Dietary Supplement Health and Education Act (DSHEA). As you may recall, DSHEA said that supplements already on sale prior to the passage of the act were "grandfathered" in, and did not have to be reviewed by the FDA. New supplements developed after the Act have been in a kind of limbo waiting for the FDA to spell out the procedures to be followed.
These new supplements have always been at risk because of the uncertainly surrounding their regulatory status. And many of these new supplements are extremely important for our health. We won't name them, because to do would be to put a bull’s-eye on them for the FDA to shoot at, but you would recognize many of them and may be currently taking them.
DSHEA was passed in 1994. The FDA has thus taken seventeen years to provide regulatory guidance for these new supplements. Now a draft version of guidance is here, and it isn't good. It is just another effort by the FDA to suffocate the supplement industry so that everything—supplements and drugs alike—will go through the vastly expensive drug approval process, a process that pays for FDA salaries.
We have said it before and we will say it again. Supplements cannot usually be patented. No non-patentable substance can be taken through a drug approval process that on average costs a billion dollars. If supplements are treated like drugs, there simply won't be any supplements. The FDA knows this perfectly well.
The new draft guidance is written in the usual regulatory non-English, but buried within it are definitions of "new supplements" that will make more and more supplements subject to the new rules. The rules themselves are designed to make it harder and harder to market new supplements, all of which will need to submit notification to an agency that is fundamentally hostile to the supplement industry. Not only does each supplement require its own notification, a separate notification must be submitted by each company that offers it. Additionally, notification must be submitted again if the supplement is reformulated in any way or offered in combination with any other supplement or ingredient. Based on what the FDA has done in the past, many more applications will be rejected than accepted and the cost of the whole process will be high.
The FDA is required to give us 90 days to comment on their proposed guidance. Our experts are busy analyzing the proposal in all its detail and we will report on it again and provide an Action Alert in our next newsletter right after the holiday. We already know this needs to be stopped. With your help we will do everything we can to change it. Your ability to use supplements not already documented as having been on the market under the same exact name and formulation prior to 1994 will depend on it.
As we mentioned above, Sen. Durbin’s much-feared Dietary Supplement Labeling Act of 2011 (S.1310) has been formally introduced in Congress. The language is not available online yet, but the draft procured by ANH-USA yesterday reaffirmed the analysis we sent you earlier this week. Look for our in-depth article and Action Alert on S.1310 in our newsletter on Tuesday, July 5th!
T
he Alliance for Natural Health USA1350 Connecticut Ave NW, 5th Floor, Washington, DC 20036
www.anh-usa.org
Color of Change
Yesterday afternoon, Glenn Beck took to Fox News for the last time as a daily host. It’s a huge victory, and it was powered by more than 285,000 members of ColorOfChange, with the support of our allies.
Thanks to our actions, over 300 advertisers abandoned Beck. The effort has been credited by the Washington Post, New York Times, and others as having turned him into too much of a financial liability for Fox to keep on air.
This victory proves that everyday people working together can make change. But as we celebrate this moment, let's be clear — our work isn't finished. Roger Ailes and Rupert Murdoch — the men who truly call the shots at Fox News and Business networks — still permit race-baiting on their networks. It’s up to us to fight back.
Beck will now pursue his career squarely outside the mainstream. But Fox's handling of recent comments by Fox Business commentator Eric Bolling, who attacked President Obama using destructive racial stereotypes, is an indication that Murdoch and Ailes didn't learn the larger lesson from advertisers fleeing Beck's show. Fox's executives could have treated this moment as an opportunity to change course and opt for more civil discourse that doesn't rely on playing off of racial stereotypes and race-based fears. Instead, they've pretended not to see the problem and have lined up in support of Bolling.
This week, we ran a full page ad in the New York Daily News calling on Murdoch and Ailes to abandon race-baiting. It will take more than that first ad, and with your support, we will continue to push back and speak to Americans of all stripes who believe that political discourse and delivery of the news should come without the divisive race-baiting that has become a hallmark of Fox.
So this week, as we celebrate the end of Glenn Beck on Fox News and America's independence, please support ColorOfChange's efforts to strengthen our democracy. By ensuring that all of our voices are heard, we can hold those in power accountable for how they represent, portray and treat our communities.
We would like to thank CREDO, Media Matters, MoveOn.org, and the other organizations that jumped in to support our campaign, as well as StopBeck and Jewish Funds For Justice with whom we collaborated. The campaign and this result would not have been possible without them.
www.truth-out.org
The good news is that the more conscious you are of these techniques, the less likely they are to work on you. The bad news is that those reading this article are probably the least in need in of it.
So take a quick moment today to learn a bit more about Christine Lagarde, the IMF's new leader:
Thousands of ONE members from around the world asked the IMF to run a transparent, fair and open hiring process. While we don't think they delivered on the open or transparent piece, Christine Lagarde definitely has a wealth of experience.
We were happy to see that her candidacy won the support of several key African nations—and I'm particularly excited to have a woman hold this top job for the very first time.
She's also said some promising things over the past few weeks. As you know, the IMF sets key global economic policies that greatly impact the world's poor. And Lagarde has vowed to dedicate special attention to low-income countries—especially in Africa—and has made it known that the IMF should strive to be even more diverse. Now it's our job to make sure she keeps her word.
So we welcome Christine Lagarde to this new top job and we look forward to working together to make sure that the IMF truly works for the world's poorest people.
Dr. Sipho S. Moyo
Africa Director, ONE
Africa Director, ONE
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Center for Biological Diversity
A federal judge this morning rejected attempts by the state of Alaska, Safari Club International and others to strip Endangered Species Act protection from the polar bear. U.S. District Judge Emmet Sullivan shot down the groups' claim that there wasn't enough evidence that global warming is pushing polar bears toward extinction. In fact, scientists have made it clear that, left unchecked, warming could melt so much sea ice that two-thirds of the world's polar bears, including all in Alaska, will probably be gone in 40 years.Polar bears were listed as "threatened" under the Endangered Species Act in 2008 after a petition and legal action led by the Center for Biological Diversity. We returned to court last year to seek additional protections with an "endangered" designation and fight off efforts by Alaska and others to throw out all protections for the bear. In his ruling today, Sullivan left the polar bear listed as "threatened" but made it clear its protection under the Endangered Species Act is warranted and needed for the bear to survive. Our separate challenge over a Bush administration rule that exempted greenhouse gases from being addressed because of polar bears is still pending.
Read our press release and learn more about the polar bear.
More than 40 rare species that depend on large swaths of national forests in Southern California will get increased protection thanks to years of work by the Center for Biological Diversity and partners. A federal judge on Tuesday called for additional safeguards in response to our suit challenging insufficient management plans in the Angeles, Cleveland, Los Padres and San Bernardino national forests. The ruling is a big win for the California red-legged frog, Santa Ana sucker, California spotted owl and dozens of other federally protected animals and plants.Due to our suit, the court has now given the U.S Fish and Wildlife Service and National Marine Fisheries Service six months to put in place better safeguards for the 40-plus species. And while permanent protections are in development, the U.S. Forest Service must take interim conservation steps, including protecting sensitive habitat in the Angeles forest and counting steelhead trout in the Los Padres and Cleveland forests.
Read more in the Los Angeles Times.
In response to a petition from the Center for Biological Diversity, the U.S. Fish and Wildlife Service announced Tuesday that the eastern small-footed and northern long-eared bats may warrant protection under the Endangered Species Act. Both bats are seriously threatened by white-nose syndrome, a fast-spreading, fatal bat disease that has killed more than 1 million bats and been detected in 19 states and four Canadian provinces.The eastern small-footed bat, a silky, black-masked bat with a small population and slow reproduction rates, has long faced many threats besides white-nose -- from habitat loss to disturbance to random, population-devastating natural events. Similar threats affect the northern long-eared bat, a medium-sized, pointy-nosed bat whose long, sensitive ears help it detect insects even when they're sitting still.
Read more in The New York Times. Then take action for bats and check out -- and share -- our new Save Our Bats Facebook page.
The National Marine Fisheries Service has finally announced plans to address the recent rash of sea turtle deaths in the Gulf of Mexico due to the region's shrimp-trawl fishery. A record number of dead sea turtles -- nearly 400 individuals, all protected under the Endangered Species Act -- have turned up this year on Gulf beaches. The shrimp fishery is the likely culprit: Increasingly poor compliance with rules requiring shrimpers to use turtle-excluder devices or tow-time restrictions with their trawls have led to the entanglement and drowning of Kemp's ridley, loggerhead and other Gulf turtle species already weakened by the BP oil spill. The Center for Biological Diversity recently filed a notice of intent to sue over the government's inaction on the turtle deaths. Now the Fisheries Service has vowed to evaluate several measures to better protect the magnificent marine reptiles, including broader requirements for the use of turtle-excluder devices.
Read more in the Summit County Citizens' Voice.
A study released Tuesday shows that desert tortoises in California and the Southwest are two different species instead of one, meaning each species is even rarer than previously thought.Scientists discovered that desert tortoises living north and west of the Colorado River (the population now called Agassiz's desert tortoises, or Gopherus agassizii) are officially a different species from tortoises in Arizona and Mexico (previously called "the Sonoran population of desert tortoises" and newly dubbed Morafka's desert tortoises, or Gopherus morafkai). Both tortoises are seriously imperiled by development, off-road vehicles, habitat degradation and other threats, but only the Mojave tortoise (Agassiz's) now has Endangered Species Act protection. In 2010, the feds found that Sonoran desert tortoises warranted federal protection -- but they didn't grant it.
The Center for Biological Diversity's Lisa Belenky, who's been working to save desert tortoises for years, says the new distinction means that each special tortoise needs greater protections to conserve its dwindling habitat and ensure its survival.
Read more in the Las Vegas Review-Journal.
The Center for Biological Diversity and allies filed a challenge this week to the Environmental Protection Agency's decision to exempt a proposed power plant in California from air-pollution laws.According to an EPA decision this spring, the proposed Avenal Power Plant wouldn't be required to conform to current pollution controls required by the Clean Air Act that deal with nitrogen dioxide, sulfur dioxide and certain greenhouse gases. We filed our challenge with judges on the EPA's Environmental Appeals Board, which has final say over the agency's permitting decisions.
The plant is planned for the San Joaquin Valley, which already has some of the most polluted air in the country and can ill afford a new, uncontrolled air polluter.
Read more in our press release, learn about the Clean Air Act and take action to become a Clean Air Advocate now.
Mountaintop-removal coal mining has long been known to pollute Appalachian air and waterways; it has annihilated more than 500 mountaintops and polluted 2,000 miles of streams, releasing toxins like mercury, lead and arsenic. Now new research shows this pollution's startling human toll. According to a study published last month in Environmental Research, devastating birth defects -- from malformed hearts to club foot to spina bifida -- are more likely to occur in Appalachian counties with mountaintop removal than in other counties in the region. In fact, rates for defects in Appalachian counties were about 235 per 100,000 live births versus 144 per 100,000 live births in areas without mountaintop removal. Previous studies have documented the coal industry's terrible public-health impacts, like a higher rate of chronic heart, lung and kidney disease in mining communities.
Add these human impacts to the environmental devastation of mountaintop removal -- which irreversibly deforms natural landmarks and obliterates habitat for rare species -- and the next stop is obvious: End this destructive practice now.
Read more in the Lexington Herald-Leader and get the latest on the Center's work to end mountaintop-removal mining.
A decade ago, a team of independent scientists gathered to examine the future of Mexican gray wolves in the Southwest. Their study found that, in order for the population to survive and thrive, the recovery program needed immediate, dramatic improvements. For the past 10 years this "Paquet Report" has been gathering dust, its recommendations largely ignored.The U.S. Fish and Wildlife Service this week commemorated the decade-old study by bringing together the scientists that published it, but the agency has yet to significantly reform management of the small, severely endangered wild canine. As a result, the study's warning that "the wolf population will fall short of predictions for upcoming years" has been fulfilled -- and then some. At last count the population in the wild included only about 50 total animals and two breeding pairs. That's a stark contrast to the 100 animals and 18 breeding pairs previously called for by 2006. The Center for Biological Diversity is using the report's anniversary to renew our call to save these ecologically critical Southwest carnivores from extinction.
Read more in our press release and learn about the Center's decades-long campaign to save the Mexican wolf.
In the first-ever study of cumulative impacts of multiple stresses on the world's oceans, an international panel of expert scientists has come to a deeply alarming conclusion: Our marine life is in even worse trouble than previously thought. In fact, the International Program on the State of the Ocean says that overfishing, pollution, ocean acidification and global warming threaten to unravel entire marine ecosystems within a single generation.The report adds to the urgency of the Center for Biological Diversity's work to protect oceans. If we don't act soon to curb greenhouse gas emissions, stop overfishing and save the seas, marine life across the globe could face the worst spate of extinctions in 65 million years.
What do chapped lips have to do with saving polar bears, whales, pikas, seals, jaguars and green sturgeon? A new line of lip balms launched today by Endangered Wildlife Lip Balm is donating 25 percent of its profits straight to Center for Biological Diversity programs to save those species (and hundreds more). The balms come in flavors like vanilla, lavender orange and spearmint, and they're 100 percent organic, handcrafted and cruelty-free. Organic lip therapy for a worthy cause? We like it.Learn more about new Endangered Wildlife Lip Balms and then order some of your own. If you know of any museums, nature centers or aquariums that might be interested in carrying the balm -- and expanding support for the Center's work -- click here.
SpongeBob SquarePants stars in his own TV show and has a wild following among kids (and some adults). Now he's getting extra love from mycologists. A just-discovered mushroom in Borneo, and also the star of a new study, has been christened Spongiforma squarepantsi. Spongiforma squarepantsi has a few things in common with its animated namesake: It's yellowish (well, more like orange), resembles a sea sponge (though SpongeBob looks more like the kitchen variety) and, most of all, is delightfully unique -- one of only two species in its genus and among just 5 percent of fungi that have been formally named (however oddly). The stem-less, cap-less mushroom also has a vaguely fruity smell; no word yet on whether its preferred habitat is a submarine pineapple.
Read more in Science Daily.
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National Iranian American Council
June 30, 2011
Mujahedin-e Khalq: Washington's Favorite Terrorists
By Trita Parsi - AnalysisFeatured in The Huffington PostIn the 10 years that I have lived in Washington, I have never seen lobbyists for al-Qaeda parade through the halls of Congress. I have not seen any events on Capitol Hill organized by Hamas. And I have not seen any American politicians take campaign contributions from the Islamic Jihad. But the Mujahedin-e Khalq (MEK), an organization with the blood of Americans and Iranians alike on its hands, freely does all of these things, despite being a designated foreign terrorist organization by the U.S. government.
And in a matter of weeks, this terrorist group may succeed in getting removed from the terrorist list -- not as a result of any change of heart -- but as a result of an unprecedented mutli-million dollar media and lobbying blitz.
Read More >>
Iranian Students in U.S. Organize to Turn Visa Nightmare into Dream Come True
By NIAC Staff - ProfileFor Ali Moslemi and other Iranian students, the single-entry visa policy was a nightmare. The policy required them to go through the expensive and often excruciatingly slow process of getting a new visa and undergoing yet another background check if they ever left the country. Fear of losing fellowships, missing entire semesters, or even not being able to finish their studies prevented many students from ever returning home to see their loved ones. “After four years, I decided to visit my family in Iran and got stuck because of the long administrative processing of my re-entry visa,” said Moslemi, who described the nine month wait and error-filled process of getting a new visa as a bureaucratic nightmare.
Read More >>
Iran: The Next Generation
By Reza Marashi and Jason Rezaian - AnalysisFeatured in The National Interest
For several weeks now, observers and analysts of Iran have been referring to an emerging rift between the Iranian president Mahmoud Ahmadinejad and the country’s Supreme Leader, Ayatollah Ali Khamenei. The recent back-and-forth between Ahmadinejad and Khamenei reflects a deeper generational shift. After three decades of Iran’s clerical network dominating the political scene, the emergence of the Islamic Republic’s next generation of leaders—nonclerical, war-veteran technocrats—may well portend larger ramifications for Iran’s inward and outward orientation. Read More >>
Ambassador Profile: Shawn Amoei - An Activist in the Making
By Sarah Ravani - Profile
“As Americans of Iranian origin, we have a lot to offer to the diverse tapestry of the United States. Although, we are a relatively new community, we have accomplished a lot,” said Shawn Amoei, NIAC Ambassador.
Shawn first began his activism work as a high school student in Texas when a friend of his who had grown up in the United States was deported to Mexico because he was undocumented.
Read More >>
Former Ambassador to Iran Briefs Congress on Engagement and Democracy Opportunities
By Jayhon Ghassem-Zadeh - NewsOn Monday, NIAC hosted former Italian Ambassador to Iran Roberto Toscano for a Congressional briefing entitled, “Iran: New Opportunities for Engagement and Democracy?” Toscano, who is completing his term as a Woodrow Wilson Public Policy Scholar focusing on prospects for democratic change in Iran, discussed his recent LA Times op-ed published with five other former European ambassadors to Iran. The piece called for a new diplomatic initiative on Iran based around establishing transparency and safeguard measures regarding Iran’s nuclear enrichment program.
Read More >>
( Iran has a little problem with 'diplomatic initiatives' that do not take into account that it already has a voluntary arrangement which it has signed to ensure transparency : an international treaty which has had the drawback that it is - improperly - all take and no give. Should it then violate those ineffective limitations so as to be really 'rogue' ?
Rather Iran has continued to press for nuclear disarmament in trying circumstances.
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)
“Viva Madame Rajavi!”
– Patrick Kennedy, speaking to an MEK rally in Paris, France. The MEK is a designated foreign terrorist organization.
- Oppose Congress's Iran War & Oil Embargo Legislation
- Stop Congress from Targeting Iranian Passenger Planes!
| The New International Focus on Human Rights in Iran The establishment of a UN human rights monitor on Iran represents hard-won leverage by the international community to press for change. |
| The world can only watch as Iran implodes from within Two years after the disputed reelection of the Iranian president, Mahmoud Ahmadinejad, the Tehran streets that seethed with protest for months are quiet. But the silence belies the increasingly chaotic and rowdy struggle for control within the corridors of power. |
| Iran's Power Struggle Lacks a Good Guy The Mark speaks with NIAC's Trita Parsi about the power struggle between Ayatollah Khamenei and Mahmoud Ahmadinejad that has revealed deep cracks in Iran's power structure. |
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