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The Relative Safety of Natural Products

By Neil E. Levin, CCN, DANLA via www.honestnutrition.com
Mortar Pestle

1. Some have stated that the dietary supplement industry is largely “unregulated”.

My response: This is not really a fair statement considering that recent regulatory efforts – supported by that same industry – have clamped down on the industry’s freedom to operate outside the regulatory system. Drug and dietary supplement regulation are becoming more and more similar, though the safety records of the two types of products are remarkably distinct. The dietary supplement industry is now largely regulated, with more and more regulations closing the gaps. Indeed, the industry strongly supported the law to ban steroid precursors from being sold as dietary supplements, making all such products illegal drugs. And the 2006 passage of a law to require all serious adverse events to be reported to MedWatch within 3 weeks – now in effect – is an appropriate method of monitoring safety and determining problem areas needing increased monitoring or official action; though we should not confuse raw AERs with actual evidence of causes-and-effects. The implementation of the long-delayed current good manufacturing practices (cGMP) regulations (that were actually authorized by the oft-maligned DSHEA law in 1994) now requires all supplement manufacturers to be cGMP compliant over the next two years, but with the largest manufacturers required to follow that standard no later than this coming June (2008). cGMP regulations are forcing manufacturers to have quality controls on raw materials and finished goods throughout the manufacturing process, including identity and safety testing. The FDA already prohibits all adulterated products, and has in fact used its authority to act against known offenders, as noted by the agency itself.

2. There are claims that “the Institute of Medicine and the Food and Drug Administration have found that supplement health claims are largely unsupported”.

My response: The FDA clearly regulates supplement label claims and requires manufacturers to submit all label claims and maintain proper documentation. The agency apparently does not review this information unless there is a problem; meanwhile making manufacturers submit such information to it while requiring a contradictory label disclaimer that the FDA has not reviewed the claims. I guess that’s what’s called “plausible deniability”. However, the vast majority of responsible manufacturers are careful to present adequate documentation to the FDA, and the cGMP regulations require well-documented justification of all processes, including the writing of label claims. DSHEA requires preapproval of all new dietary supplement ingredients with an eye to proving safety, though manufacturers are allowed to use existing ingredients if they first submit their new label claims to the agency. All new drugs need pre-approval, as do all new supplement ingredients, but drugs are approved for specific uses (though often used for other unapproved “off label” conditions) while supplements are not allowed to make any disease claims, with very few exceptions for FDA-approved health claims. www.cfsan.fda.gov/~dms/supplmnt.html

Bias Against Natural Products

By Neil E. Levin, CCN, DANLA via www.honestnutrition.com

Supps

Once again, a widely distributed article has savagely attacked the safety and efficacy of natural products; including vitamins, minerals, and herbs. That this article may be more commentary than journalism is immediately revealed by the author inexplicably linking energy medicine (with admitted health benefits for patients) with a concocted image of “shooing evil spirits”, even when performed by technicians in a top trauma hospital. The ignorance of journalists and medical experts is exposed when they claim that natural products are intended as cures and treatments. These products are actually prohibited by law from claiming this; allowed only documented claims to support healthy body structures and functions. Ironically, this is the same law – the Dietary Supplement Health and Education Act, DSHEA – that is falsely mischaracterized as “deregulation” of the industry. In fact, this law prohibits new ingredients without FDA pre-approval; empowers the agency to regulate manufacturing, advertising, and label claims; prohibits unsafe, adulterated, and mislabeled products; and even allows banning a product based on only theoretical risks. A recent companion law requires all serious adverse events be reported to the FDA; generating far fewer reports than expected.

The erroneous assumption that dietary supplements should be considered as potential treatments or cures has resulted in many negative reports. One problem is that some medical researchers, perhaps too used to drug studies using novel substances, sometimes base reports mainly on supplementation levels but fail to properly understand or explain other relevant variables such as dietary intake and relationships to other nutrients that affect body levels and functions of the targeted nutrient. The synergies of natural substances in the diet are complex and interactive, but many researchers design simplistic studies that generate incomplete or misleading data; often leading to dramatic conclusions that the pharmaceutical advertising-dependent press eats up. A press that fails to investigate and present all of the relevant facts and perspectives in a sensational negative report may be accused of laziness, if not bias. Rigorous studies refuting negative reports about the safety of vitamin E, beta-carotene, herbs, the use of supplements with cancer treatments, and drug-nutrient interactions have been noticeably absent from the same media that eagerly broadcasts reports attacking nature’s own nourishing substances. Sadly, there is no matching eagerness to set the record straight.

Let’s keep this in perspective. We have all seen drugs pulled from the market because of unforeseen safety issues, medical schools and authors of articles published in peer-reviewed journals accused of being on the take from pharmaceutical companies, contaminated drugs as well as hundreds of thousands of deaths and millions of hospitalizations caused by pharmaceutical side effects each year. Foods cause hundreds of deaths and millions of illnesses annually. Compare this to dietary supplement safety, where proven deaths are extremely rare. Supplement users believe in the healing power of nature, at odds with the often unproven treatments of conventional medicine. The goal of Integrative Medicine is putting aside traditional institutional medical bias to allow science to dictate the comprehensive treatment of an individual patient, including quality of life issues. Many millions of Americans choose to use natural products in order to protect and improve their own health and vitality. Reasonable people will reject these sensational assaults on natural health (including dietary supplements), recognizing that conventional medicine sometimes fails without a little help from Mother Nature.

The Two Sides of Oregano

By Brenda Hyde and Lucinda Jenkins via www.fabulousfoods.com

Like most herbs, there are two sides to oregano: the culinary and the medicinal. For centuries people have used plants and herbs of all sorts for their apparent health giving qualities. How convenient that something so healthy can also add so much flavor to our daily diets.

To explore the two sides of oregano, we’ve enlisted the help of Brenda Hyde, editor of SeedsOfKnowledge.com, a website dedicated to creating and sharing family memories, and Lucinda Jenkins, editor of GlenbrookFarm.com, a comprehensive herbal website.

We’ve filled this article out with some recipes from right here at FabulousFoods.com, so you can experiment with the distinctive flavor of oregano yourself.  Find them in the related recipes section below.

The Culinary Side of Oregano
By Brenda Hyde

Oregano is an herb everyone is familiar with in some form or another. It’s an easy to grow perennial with some controversy surrounding it.

I was told long ago that true oregano has white flowers, but many times we end up with a plant that has pinkish flowers. This is actually wild marjoram. I have two large oregano plants that are probably not true oregano but sure do work well in all recipes, vinegars and the flowers are wonderful dried and used on wreaths. To be sure of what you are getting talk to someone at your garden center that understands the difference.

Oregano can be used fresh with sautéed zucchini and onions, or is a welcome addition along with cilantro to black beans.

For a simple elegant appetizer, carefully grill thick slices of provolone cheese that have been sprinkled with oregano. When the cheese is warmed and starts to melt spread on crusty fresh bread with a butter knife.

Add oregano to your fresh salsa recipes, or any Mexican dishes as well as Italian recipes.

The leaves can be dried on the stem and crumbled into jars, or frozen in individual bags, then used as fresh.

One oregano plant that is put in full sun, fairly dry soil and harvested frequently will supply all that you need. It does grow quickly and spread, but that will allow you to pot up some oregano for your windowsill and for your friends!

The Medicinal Side of Oregano
By Lucinda Jenkins

Oregano: origanum vulgare

Heard the spicy news about oregano? There is a lot of research going on right now with this common kitchen cupboard herb. It seems to be able to land a knock punch to free radicals those awful compounds in our body that cause us to age and get sick.

In a recent study sited by James Duke in his book the Green Pharmacy, Oregano a member of the mint family out ranked over 100 mint family herbs in delivering rosmarinic acid.

Action and uses:
Rosmarinic acid is a compound in oregano that is

  • antibacterial: will kill bacteria
  • anti-imflammatory: will ease swelling
  • antioxidant: means anti-aging
  • anti-viral: it will kill a virus

So not only is oregano tea good for helping to heal from a cold ,it is helpful with arthritis.

I read a comment on the internet that Oregano essential oil is strong enough to treat sewage, meaning it could kills all the nasty bacteria in sewage. I can’t back that up but thought it was an “interesting” claim.

Oregano is currently being studied by the Delaware State Univerisity with federally funded dollars, which means there is something to the powerful claims made by Scientist W H Martindale in 1910, documented that the essential oil of oregano is the most powerful plant-derived antiseptic known. He showed it was 26 times more active as an antiseptic than phenol (a powerful disinfectant).

Walmart’s $4 Drugs Coming From Indian Company Whose Products Have Been Banned In US and Canada

Not So Smiley

A New Report from WakeUpWalMart.com

WakeupWalmart.com supports the use of generic prescription drugs as a safe alternative to expensive, name-brand medications. Walmart’s use of a corporate bad actor to cut costs, however, deserves significant scrutiny.

Walmart is heavily promoting a program of 30-day supplies of generic drugs for $4, pointing to the program as an indicator of the company’s leadership on making healthcare more affordable. To profit on $4 dollar prescriptions, Walmart is importing drugs from foreign countries, including India. Walmart competitor Costco went a different direction in late 2006, when it ended its $4 dollar prescription drug plan because it was losing money selling prescription drugs at such a low price. Costco switched to selling 100 pills for $10.

One of Walmart’s Indian drug suppliers, Ranbaxy Laboratories, LTD, has been repeatedly investigated by the Food and Drug Administration and the Department of Justice for “inadequate” safeguards against contamination, falsification of records and submitting false information to the FDA. Eight months before the FDA inspected Ranbaxy’s Paonta Sahib plant and found significant violations, Walmart awarded the company a “Supplier Award” for improving shipping times and performance.

In 2008, the FDA banned importation of drugs manufactured at two of Ranbaxy’s plants, and in 2009, the FDA halted review of applications to import drugs manufactured at the Paonta Sahib plant. Soon thereafter, Canada followed suit and banned importation of drugs manufactured at that facility.

Yet Walmart still imports generic drugs made by Ranbaxy at its other Indian facilities.

Read whole story at www.WakeUpWalMart.com/feature/ranbaxy/

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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: