Category : Supplements

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Industry Self-Regulation and FDA Ensure Dietary Supplement Safety & Quality

Safety

By James Gormley via www.thegormleyfiles.blogspot.com

If retailers ask their customers about dietary supplement safety, they’re bound to get a variety of responses, especially considering that quality and safety often go hand-in-hand.

In terms of quality, Vitamin Retailer magazine’s 2007 Annual Retailer Survey showed that the percentage of retailers who identify “high quality” as the most important element of their store’s success nearly doubled from the previous year—from 13.9 percent to 27 percent.

While a 2008 survey sponsored by the Council for Responsible Nutrition (CRN) tells us that over 80 percent of American consumers are confident that they are buying high-quality and safe dietary supplements, bad press is likely to discourage potential, fence-sitting shoppers from hopping off that fence and going into their favorite health food store, especially if yet another scientific study has just been misrepresented by researchers or misreported by media.

What does Mel Gibson have to do with DSHEA?

By James Gormley via www.thegormleyfiles.blogspot.com

A public-service ad that first aired in December 1993 showed camouflaged Federal agents equipped in full Special Forces gear, including night vision and weapons converging on Mel Gibson, who says, in defense, as he holds up a supplement bottle: “Hey. Guys. Guys. It’s only vitamins.”

Before DSHEA

This call-to-action video warned consumers that the Federal government is “actually considering classifying most vitamins and other supplements as drugs. The FDA has already conducted raids on doctors’ offices and health food stores. Could raids on individuals be next?”

Near the end of the ad, as Mel Gibson’s character is being arrested, he says in desperation: “Vitamin C, you know, like in oranges?”

We Cared About Numbers, Not People: Former CIGNA PR Chief Comes Clean

By Alison Rose Levy via The Integrative Health Outlook

“When you’re in the executive offices… you don’t think about individual people. You think about the numbers and whether or not you’re going to meet Wall Street’s expectations… That enables you to stay there, if you don’t really think that you’re talking about and dealing with real human beings, ” Wendell Potter, former head of Corporate Communications for health insurance giant told Bill Moyers in his recently aired program.

Potter, who voluntarily left a life of corporate jets and managing media information, got a wakeup call when he attended a so-called health fair on a trip back home to the South.

“What I saw were doctors who were set up to provide care in animal stalls. Or they’d erected tents, to care for people. I mean, there was no privacy. In some cases — and I’ve got some pictures of people being treated on gurneys, on rain-soaked pavement.

And I saw people lined up, standing in line or sitting in these long, long lines, waiting to get care. People drove from South Carolina and Georgia and Kentucky, Tennessee — all over the region, because they knew that this was being done. A lot of them heard about it from word of mouth.

There could have been people and probably were people that I had grown up with. They could have been people who grew up at the house down the road, in the house down the road from me. And that made it real to me.”

In his conversation with Moyers, Potter also revealed how health insurance PR execs sought to marginalize Michael Moore’s film Sicko, dissuade Democratic legislators from addressing the concerns the film raised about the quality of American health care and the uninsured, and defeat health reform under Clinton.

Currently, these same insurance PR folks are “working relentlessly to kill off efforts to include a public insurance plan in the health care bill. Although three quarters of Americans polled support a public option, the industry is spending more than 1.4 million dollars a day to make sure it doesn’t happen,” said Moyers.

In the show Porter details the kinds of messages that that daily dose of $1.4 million will buy, recounting in the past how the industry sought to discredit Moore by characterizing him as a “radical” and “Hollywood film-maker.”

WENDELL POTTER: They don’t want you to think that it was a documentary that had some truth. They would want you to see this as just some fantasy that a Hollywood filmmaker had come up with. That’s part of the strategy.

BILL MOYERS: So you would actually hear politicians mouth the talking points that had been circulated by the industry to discredit Michael Moore.

WENDELL POTTER: Absolutely.

The insurance industry’s “war on Sicko” reveals the kinds of tactics and disinformation in use now to discredit a public option in health insurance reform — and to line up Congressional support to defeat it.

Moyers asked about how the industry acts to influence Congress.

WENDELL POTTER: By running ads, commercials in your home district when you’re running for reelection, not contributing to your campaigns again, or contributing to your competitor.

Potter also addressed the underlying PR goals:

WENDELL POTTER: The industry has always tried to make Americans think that government-run systems are the worst thing that could possibly happen to them, that if you even consider that, you’re heading down on the slippery slope towards socialism. So they have used scare tactics for years and years and years, to keep that from happening

Watch the show here.
Read the transcript here.

For health science, information, and action, the get free Health Outlook at www.health-journalist.com

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Website that gives safety ratings for personal care products

Skin Deep

Through an interactive personal care product safety guide, “Skin Deep,” consumers can consult brand-by-brand safety ratings for more than 14,000 products. “Skin Deep” fills the information gap left by an industry that markets thousand of products with ingredients that have not been assessed for safety by either industry or government health experts. Those safety decisions are made behind closed doors, guided by an industry-funded panel, without the benefit of peer-reviewed pre-market testing. The industry’s own panel has screened only 11 percent of 10,500 ingredients for safety.

The searchable “Skin Deep” database features in-depth information on shampoos, lotions, deodorants, sunscreens and other products from almost 1,000 brands, built from a core of 37 toxicity and regulatory databases.

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Important Players in Congress

The following is list of congresspersons who have played a role in the regulation of natural health generally, and DSHEA in particular over the past few years. This list is certainly not exhaustive. We encourage you to research individual congresspersons and candidates at www.yourcadidatesyourhealth.org to see if particular candidates have taken clear positions on natural health issues.

House Reps:

Dan Burton

Rep. Burton (R-IN) is widely considered a strong supporter of dietary supplements and natural healthcare, generally. He is a member of Congress’ Dietary Supplement Caucus and the Complementary & Alternative Medicine Caucus. In 2001, he chaired a committee hearing titled “Six Years After DSHEA,” in which he stated, “My colleagues in Congress and I will continue to protect Americans’ rights to access dietary supplements.”

Peter DeFazio

Rep. DeFazio (D-OR) is a strong supporter of dietary supplements and natural healthcare. He is a member of Congress’ Dietary Supplement Caucus and the Complementary & Alternative Medicine Caucus. Along with Rep. Ron Paul, DeFazio submitted a joint statement to Rep. Burton’s “Six Years After DSHEA” committee in 2002, strongly supporting DSHEA and the rights of consumers to access dietary supplements without FDA interference. He was one of the prime sponsors of the original Access to Medical Treatment Act, which if passed, would have given consumers greater access to health care practitioners of their choice.

John Dingell

Rep. Dingell (D-MI) is no fan of DSHEA as presently written and implemented. He has sponsored unsuccessful legislation over the past several years that, if passed, would have repealed major pieces of DSHEA, and that would have granted the FDA greater authority over dietary supplements. He has been quoted in numerous sources as saying about DSHEA, “I would like to repeal the whole sorry mess.”

Dennis Kucinich

Rep. Kucinich (D-OH) is a member of the Dietary Supplement Caucus, and was prime sponsor of legislation that would require mandatory labeling of genetically modified foods.

Ron Paul

Rep. Paul (R-TX) is a well-known supporter of health freedom. He has been the prime sponsor of the Health Freedom Protection Bill (H.R. 2117), which would give dietary supplement manufacturers the ability to make broader claims about the helpful, curative effects of their products.

Edolphus Towns

Rep. Towns (D-NY) is a member of the Dietary Supplement Caucus, and the prime sponsor of H.R. 1107, which would allow certain dietary supplements to qualify for reimbursement under IRS rules pertaining to Health Spending Accounts and Flex Spending Accounts.

Henry Waxman

Rep. Waxman (D-CA) co-sponsored with Rep. Dingell legislation that, if passed, would have gutted major portions of DSHEA and given the FDA significantly greater authority over dietary supplements. He has been critical of the dietary supplement industry in sub-committee hearings on DSHEA.

Senators:

Richard Durbin

When it comes to natural health and DSHEA, there may be no one more important and controversial in Washington, D.C. than Sen. Durbin (D-IL). Durbin has co-sponsored a number of DSHEA-revisions, including the Adverse Event Reporting bill that became law in 2006. He has made critical remarks in perhaps every hearing on DSHEA that’s been held in the past 8 years. He is largely credited or blamed as one of the driving forces behind the Adverse Event Reporting law.

Some of the quotes attributed to Sen. Durbin about DSHEA include the following:

• “[The] FDA has fallen down on the job. [Regardless] increasing surveillance under the existing law is unlikely to occur.”

• “We need to make a couple of critical changes in DSHEA.” [referring to mandatory adverse event reporting and some form of pre-market approval].

In fairness to Sen. Durbin, the focus of his hostility toward dietary supplements has been largely on stimulants and steroids. In his comments leading up to the AER law, he said this: “[A]ll I would ask in my bill would be that supplements which cause an adverse effect would be reported to the government. We preserve the DSHEA assumption that supplements are safe, except for steroids and stimulants.”

It is likely that Sen. Durbin’s influence will increase in an Obama administration.

Tom Harkin

Sen. Harkin (D-IA) has been a long-time proponent of natural health, dietary supplements and DSHEA. He is a member of the Dietary Supplement Caucus, and is credited with resurrecting DSHEA from possible repeal and other emasculating revisions. He was co-sponsor of S. 770, which would allow dietary supplements to be purchased with food stamps.

Orin Hatch

Sen. Hatch (R-UT) has been a long-time proponent of natural health, dietary supplements and DSHEA. He is a member of the Dietary Supplement Caucus. Along with Sen. Harkin, he is credited with resurrecting DSHEA from possible repeal and other emasculating revisions. Also along with Sen. Harkin, he has co-sponsored S. 770, which would allow dietary supplements to be purchased with food stamps.

To the extent that Sen. Hatch has been concerned about implementation of DSHEA, he has been focused on the FDA’s failure to properly implement the law, rather than any failure of the law itself.

Ted Kennedy

Sen. Kennedy (D-MA) was the prime sponsor of S. 1082, which passed the Senate in 2007, but has yet to make its way to the House. This bill represents one of the most sweeping pieces of legislation to affect the FDA in years. It includes provisions that would relax restrictions on the importation of drugs from overseas. The bill as passed by the Senate should not affect DSHEA; however, it would give the FDA significantly greater authority over foods and drugs generally.

Sen. Kennedy is also the Chair of the Health, Education, Labor and Pension (HELP) Committee. It’s been reported that just a month ago, he chaired a videoconference in which he called for an overhaul of the nation’s healthcare system. His health may also be an issue to watch. If he’s unable to continue as Chair of HELP, we will want to take note of who his replacement will be.

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GAO Report on Supplements

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:

Protecting Your Individual Health Freedoms Radio Broadcast

Statue of Liberty

In this increasingly complex world of regulations, environmental contamination, and special interests vying for control of your medical privacy and access to complementary/alternative healthcare practices, fortunes are in play and your basic human right to health is being challenged. Advocates have described the wellness arena as follows, “Medicine is a science, healing is an art, and healthcare is a business”. Today, hosts Dr. Meg Jordan and Terry Moore will discuss exactly what’s at stake here in the United States, and how alarming regulatory trends around the world and special interests are jeopardizing your Constitutional rights and your ability to live a long and healthy life. Today’s guests will be James Turner, a renowned regulatory, environmental and product safety attorney who has appeared before every major consumer regulatory agency, including the Food and Drug Administration, Environmental Protection Agency, Consumer Product Safety Commission and Federal Trade Commission, as well as the Department of Agriculture and the National Institutes of Health. Jim will be joined by Michael McCormack, the President of Citizens For Health and an accomplished litigation attorney and counselor focusing on emerging health law matters, including regulation and advocacy.

Click here to listen to radio broadcast.

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Petition the FDA for more health information labeling

Currently, food manufacturers are prohibited from labeling their products with accurate health-related information without being subjected to a lengthy and expensive FDA review. In a recent court case, the judiciary agreed with natural health consumers and ruled that the FDA’s approval process is unconstitutional on First Amendment grounds. In response, the FDA has announced the opening of a comment period to guage public opinion on the subject of qualified health claims. This is our opportunity to help expand public knowledge and wisdom regarding natural health products like foods, vitamins, herbs, and minerals. Don’t delay, click here to register your comment today.

Congressional Dietary Supplement Caucus Update

WASHINGTON—The Congressional Dietary Supplement Caucus, in cooperation with the two the Council for Responsible Nutrition (CRN) and the Natural Products Association (NPA), hosted the third of a series of lunch briefings since the Congressional Dietary Supplement Caucus was founded. The briefings were aimed at educating Congressional staffers on important issues related to the dietary supplement industry.

William Cooper, M.D., medical director of cardiovascular surgery, Wellstar-Kennestone Hospital in Marietta, Ga., and assistant professor of Cardiothoracic Surgery, Emory University School of Medicine, spoke to more than 90 attendees about the importance of using dietary supplements as part of an overall healthy lifestyle. Dr. Cooper also offered advice for how supplements can play an important role in prevention and healthcare reform.

“When you get to me, you really don’t want to buy what I’m selling,” said Dr. Cooper, referring to his heart surgery specialty. He encouraged the individuals in the audience to focus on preventative health, rather than the current sick-care health system that is in place. “As a nation, we are consistently inconsistent. But there are simple things that all of us can do every day to better our health—and that includes taking dietary supplements.”