Criticism grows over FDA supplement regulations

Criticism grows over FDA supplement regulationsIn recent days, critical voices have spoken out against the FDA’s approach to the regulation of dietary supplements which they say overburdens their producers and benefits big pharma.

Commentators have drawn attention to an FDA practice of classifying dietary supplements as drugs if they are an ingredient of newly approved medications, according to Examiner.com.

In January, the agency approved a petition by pharmaceutical company Biostratum to classify Pyridorin as a ‘new drug.’ Since the product contains pyridoxine, a form of vitamin B6, this will effectively prevent natural supplements companies from selling any product that contains it.

In response, food and supplements industry organizations have vowed to challenge the approval as setting a dangerous precedent.

This will mean that "we’re all violating that law each time we eat something with brewer’s yeast, or fish or chicken," because pyridoxine is a naturally occurring compound, says the Examiner.

It also suggests that the price of such supplements is likely to rise once they are only available by prescription, limiting access to them and preventing many consumers from enjoying their beneficial effects.

The FDA has recently met with much criticism from government oversight agencies. A report prepared by the Government Accountability Office and released on March 5 suggested that the FDA does not have the information and resources necessary to adequately regulate dietary supplements.
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Tax Payments for Them and the Rest of Us

“It’s important for this administration to send a message that there aren’t two sets of rules—you know, one for prominent people and one for ordinary folks who have to pay their taxes.”

That was President Barack Obama’s spin after the third of his cabinet nominees was found to have failed to pay federal taxes until just before he was nominated. Don’t be fooled by the smooth tongue of the man many have begun to mockingly call “The One.”

What this shows is that those in power know something most Americans don’t: that there is no law requiring Americans to pay income taxes. And there is indeed a set of rules for the elites and one for “ordinary folks.”

So Timothy Geithner, Tom Daschle and Nancy Killefer didn’t pay until their nominations became inevitable. And then they only did so to head off a public relations nightmare. Still, the issue torpedoed the nominations of Daschle and Killefer. But Geithner was confirmed by the Senate as Treasury Secretary, which means he’s the head of the IRS.

Geithner, when caught up to his elbows in the cookie jar, blamed tax software for his problem. But that argument is specious coming from someone supposedly as smart as he is.

This is what they know: In truth, there is no provision in the IRS code imposing an income tax on monies received by citizens, and residents are not required to file form 1040.

The so-called income tax is a cover operation for the regulation of the regime of paper money.

Paper money must be regulated (reduced) or it will sooner than later become worthless. Should the American people discover that the income tax is only a system of regulation, not taxation, they would understand the fraud. The paper money scam must be concealed.

The people must never find out that the government gets everything that it gets for nothing and without payment, including wars.

Rarely has any lawyer ever spoken out against this system of harassment and wealth extraction. This theft through deception of trillions of “dollars” of wealth from the American people is greater than that stolen from any nation at any time in the history of the world.

Any time a lawyer speaks out against the system he is speaking out against the thing that gives him his professional existence. All lawyers are “officers of the court” and are entrapped in their own deception. Anyone who is licensed by the system, the system owns.

Now there are tens of thousands of very intelligent and highly educated Americans who silently consent to this criminal payola without even a thought of rebellion. This has been going on for 100 years.

Tea may reduce the risk of stroke

Tea may reduce the risk of stroke Scientists have found that both green and black tea may be useful in preventing serious cardiovascular events.

The research conducted at UCLA suggests that drinking at least three cups of tea each day can reduce the risk of stroke by 21 percent. And three more cups reduce it by a further 21 percent.

"That’s why these findings are so exciting," says lead author Lenore Arab, a professor of medicine at the David Geffen School of Medicine at UCLA. "If we can find a way to prevent the stroke, or prevent the damage, that is simple and not toxic, that would be a great advance."

She adds that although scientists are not sure which compounds in tea are responsible for this effect, they suspect that either the antioxidant epigallocatechin gallate (EGCG) or the amino acid theanine may do that.

This effect was found in tea made from the plant Camellia sinensis, not from herbal teas.

The study results were published in the online edition of Stroke: Journal of the American Heart Association. They were also presented at the American Heart Association’s annual International Stroke Conference in San Diego on February 19.
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ISSA offers tips for healthy heart

International Sports Sciences Association has offered tips for a healthy heartThe American Heart Month may have ended last week, but a sports association’s healthy heart tips continue to inform and educate about beneficial lifestyle choices.

The International Sports Sciences Association, the only nationally accredited fitness organization that educates and certifies personal trainers, has set out to contribute to raising awareness about heart disease and listed some simple steps that can prevent it.

They include getting 30-60 minutes of exercise each day, healthy diet rich in fruit, vegetables and oily fish, limited consumption of saturated fats, salt and alcohol, as well as quitting smoking.

Furthermore, people should have regular medical check-ups to get necessary feedback from their physicians that can help them stay on the right track, according to Dr. Sal Arria, CEO of ISSA.

He adds that a supervised cardiovascular fitness program can also be of great benefit.

According to the Centers for Disease Control and Prevention, heart disease is the leading cause of death in both women and men in the United States.

In 2009, it is estimated that 785,000 Americans will have a new heart-related coronary attack, and about half a million will have a recurrent attack.
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Organization blasts administration on conscience protections

Family Research Council has blasted administration on conscience protections A Christian organization promoting traditional family values has criticized President Obama for plans to relax the enforcement of the amendments that protect healthcare providers’ right of conscience.

The Family Research Council (FRC) has said that a move against the enforcement of the Church, Coats and Weldon Amendments would be a huge blow to religious freedom and First Amendment rights.

"[For the president to do so would] open the door to discrimination against the choice of healthcare workers who do not want to be complicit in abortion or other controversial practices," Tony Perkins, president of Family Research Council wrote in a statement.

He added that relaxing the conscience protection regulation would "result in the government becoming the conscience and not the individual."

This is not the first interest group that has expressed criticism of the new administration’s moves on civil liberties.

In recent days, the National Shooting Sports Foundation responded to a statement by Attorney General Eric Holder that the administration would consider banning semi-automatic rifles by saying that it would have no effect on reducing crime, but would violate gun owners’ constitutional right to own the firearm of their choice.

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The RDA Hoax (Recommended Daily Allowance)

One way to suppress nutrition and its health benefits is the establishment of a nebulous, arbitrary and meaningless standard of measurement such as the RDA or “Recommended Daily Allowance.”

The purpose of the RDA hoax is to get the public to accept it as the gold standard. This is what has happened.

A prime example is in the case of vitamin D. The RDA for vitamin D has indeed practically wiped out rickets in the United States. But this is a camouflage for the need of much higher amounts of vitamin D—1,000 to 3,000 units daily even up to 10,000 in the case of tuberculosis (TB)—as proven therapy for patients with cancer, heart disease, dementia, autoimmune disease, influenza A, chronic pain, depression, gingivitis, the common cold and dozens of other diseases associated with vitamin D deficiency.

Laboratory evidence shows that TB can be prevented with vitamin D. Then straight off the press, a controlled clinical study showing vitamin D resulted in a 100 percent cure rate for TB patients, but they treated TB patients with 10,000 units of vitamin D a day—not the RDA 400.

Of course “orthodox medicine” screams toxicity. If you can experience natural healing therapy, you don’t need drugs. As Royal Lee, M.D., said, “One of the greatest deceptions is the treatment of symptoms with drugs instead of nutrition.” Starvation is being treated with drugs instead of nutrition.

As in the case with vitamin D, a certain amount of nutrition is required to get a therapeutic result—many times a large amount. This is not supposed to be known to the public.

Iodine

The RDA for iodine is outright deception. The medical establishment, Institute of Medicine, says 150 micrograms per day for adults and less for children.

Guy Abraham, M.D., at UCLA School of Medicine and researcher of iodine says that 12.5 milligrams per day (that’s 12,500 micrograms) is the optimal dose, and that’s 83 times more than the RDA. Chances are very high that most of us are not getting nearly enough iodine.

We think in terms of overdose but the risk of underdose may be the highest risk when taking nutritional supplements. The big exception to this would be taking mega doses of synthetic vitamins. When we use synthetic instead of natural or organic, we go from food to pharmacology. Pharmacology is chemicals made in the laboratory. It is not food or nutrition.

The high risk of public fixation on the RDA is that we underdose on vital nutrition as in vitamin D and iodine.

We have to think of iodine in the United States as a dietary supplement because there is little in the soil that would translate into food production. The Japanese consume more iodine mostly from seaweed and they have much lower breast cancer. In fact, they have much lower rates of all cancer including prostate cancer.

Thyroid Health

Forty percent of the U.S. population has hypothyroidism, which is low thyroid function leading to a multitude of illnesses including heart disease and cancer.

So many people are on thyroid medication (hopefully on Armour natural thyroid), but all these people should also be taking iodine. The reason is that unless we get enough iodine with our thyroid supplement, we may be raising the risk of breast cancer and prostate cancer. The fact is if we had enough diet iodine, we wouldn’t have low thyroid function and wouldn’t need medication.

Hypothyroidism is a nutritional deficiency of the vital mineral iodine. It is extremely fundamental to health.

You can check your own thyroid function. It’s simply a matter of body temperature. The normal body temperature is 98.6º F.

Take your underarm temperature in the morning before you get out of bed and as you wake up, preferably with a shake down mercury thermometer. Leave the thermometer on the nightstand or table by your bed at night. Take your morning temperature at rest, underarm temperature for five days in sequence and record your average—which you get by adding them up and dividing by five.

If you are as much as one degree under 98.6, you are hypothyroid and you at least need daily iodine supplementation. I can’t go into it here, but conventional blood tests in a doctor’s clinic do not accurately show your thyroid function. Tens of thousands of people are struggling daily with low energy and obesity just because a blood test showed “normal” thyroid function. Do the body temperature test on yourself and your family.

If your thyroid is two to four degrees low, you need thyroid hormone by prescription from your doctor. Ask for the Armour natural. You should also take daily iodine supplement (see below for sources and amount).

Iodine displaces or flushes chlorine, bromine, fluorine, lead, cadmium, arsenic, aluminum and mercury with safety. In today’s world this is huge!

Sources and Amounts

I have never read of any injury because of iodine but don’t take more than 12 to 14 milligrams daily. Japanese researchers say that they have found cases of hypothyroidism caused by excess iodine, 20 mgs daily or more.

Lugol’s iodine is an old favorite. Two to four drops in water for an adult would be okay.

Iodoral from compounding pharmacies and some health food stores—one tablet daily.

Another choice is Prolamine Iodine. This is an all-natural, vegetarian source.

All three can be purchased from Amazon.com.

Iodine is powerful and can be used in many ways. It’s an excellent water purifier. It can cure infection.

From The Cure for All Cancers by Hulda Clark, Ph.D.: “Salmonella and Shigella are two stomach and digestive tract bacteria. Six drops of Lugol’s solution can end it all for Salmonella and Shigella. If you have gas and bloating, pour yourself ½ glass of water. Add six drops of Lugol’s exactly, stir with wood or plastic and drink at once. The action is noticeable in an hour. Take this dose four times a day, after meals and at bedtime for three days in a row, then as needed.

“Notice how calming six drops of Lugol’s can be, soothing a manic stage and bringing a peaceful state where anxiety ruled before. Lugol’s is perfectly safe (if not allergic) to take day after day when needed because of its peculiar attaching property. It arrives in the stomach and then reattaches to everything in proximity. Doomed are Salmonella and Shigella; doomed also are eggs (cysts) of parasites that might be in the stomach.”

Unless we read a lot (which I recommend), we go by the RDA hoax. As you can see in just two examples of vitamin D and iodine, the RDA leads us into, or keeps us in, a deficiency state and disease.

References:

Wright, Jonathan V. Nutrition and Healing newsletter, www.wrightnewsletter.com.

Brownstein, David, M.D. Iodine, Why You Need it, Why You Can’t Live Without It. Bloomfield, MI: Medical Alternative Press.

Derry, David, M.D., Ph.D. Breast Cancer and Iodine. Trafford Publishing.

Barnes, Broda O., M.D., Ph.D., and Charlotte W. Barnes. Solved: The Riddle of Heart Attacks.

Acta Med Indones, 2006 Jan-Mar, 38(1):3-5, Vitamin D Newsletter, 2/24/06.

McConnell to Congress: Take caution before spending taxpayers’ money

Congress has promised a quick stimulus packageSenate Minority Leader Mitch McConnell has warned Congress not to rush plans for an early 2009 stimulus package, in order to avoid "wasting" taxpayers’ money.

His comments come after one of President-elect Barack Obama’s advisers said that the total cost of an economic stimulus plan could reach $775 billion.

McConnell suggested that instead of immediate consideration, any proposals should be considered for at least a week by Congress and the public due to its enormous price tag.

"As a result, it will require tough scrutiny and oversight. Taxpayers, already stretched to the limit, deserve nothing less," he said.

Meanwhile, Representative John Boehner has also urged Democrats to be cautious about pork-barrel spending during these challenging times.

As an alternative to Obama’s plan to spend on infrastructure, Boehner has suggested increasing the child tax credit for families and cutting the capital gains, small business and corporate taxes.

Democrats said that a stimulus package will be a priority during Obama’s first 100 days in office.
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MRSA found to be common among ER workers

Nurses have one of the highest rates of MRSA infectionTwo recent reports reveal that the rate of MRSA positivity among emergency room workers is more common than previously thought.

The findings, published in the Annals of Emergency Medicine, indicate that the proportion of ER workers testing positive as MRSA carriers is higher than that of the general population, Reuters Health reports.

In one study, researchers at Advocate Christ Medical Center in Illinois collected nasal swabs from ER personnel and found that 15 percent tested positive.

The other research study, at the University of Pittsburgh Department of Emergency Medicine, discovered that 31.8 percent of nasal cultures were positive for the bug Staphylococcus aureus, while MRSA was present in 4.3 percent of those tested.

Nurses, nursing assistants, and radiology and respiratory technicians were most likely to test positive.

"The varying prevalence among the different healthcare workers was unexpected," lead researcher Dr. Brian P. Suffoletto told the news provider.

Figures from the Centers for Disease Control and Prevention estimate that as many as 2 million people contract an infection in a hospital each year, with around 90,000 dying as a result.
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Could we be facing another Great Depression?

The economy needs to turn around fastInternational economists are warning that unless the U.S. economy sees signs of a turnaround in the near future, the country could be headed for a deeper recession – or even a depression.

The IMF’s top economist, Olivier Blanchard, told French newspaper Le Monde that the next few months are likely to be "very bad."

"It is imperative to stifle this loss of confidence, to restart household consumption, if we want to prevent this recession developing into a Great Depression," he said, according to Agence France Presse.

His comments come after the U.S. government announced that the country’s economy contracted by 0.5 percent in the third quarter.

If the GDP contracts during the fourth quarter as well, it will embody the traditional definition of a recession – two consecutive quarters of negative growth. There is little doubt that this criteria will be met.

During the third quarter of 2008, personal consumption fell by 3.8 percent, while exports and imports stalled and the construction industry suffered losses.

Gross domestic purchases, which reflect purchases made by Americans for all goods and services regardless of where they were made, also decreased by 1.5 percent, according to the US Bureau of Economic Analysis.
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Melamine found in cocoa products

Melamine has been uncovered in some cocoa productsThe FDA may have stated that melamine is safe in small doses, but food manufacturers seem to be playing it safe and recalling tainted products.

Melamine, a toxic chemical that has been linked to kidney problems, was discovered in G&J Gourmet Market cocoa products, according to parent company Dorsey Marketing Inc.

The items, which are sold in the U.S. at Big Lots and Shopko, have not caused any known injuries, the firm stated in a news release on the FDA’s website.

"No injuries have been reported and only a few samples have, in fact, been found to include melamine," the statement reads.

The products in question include G&J Hot Cocoa Stuffer, G&J His and Hers Hot Cocoa Set and certain flavors of G&J Cocoa.

Earlier this year, melamine was responsible for sickening and killing babies in China who were consuming the chemical through their baby formula.

There have also been trace amounts found in U.S. baby formula, but the FDA insists that doses are too low to cause any harm to infants.
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Greenspan: Banks need capital for recovery

Alan Greenspan thinks the economy could turn around next yearAlan Greenspan may be currently taking some heat as the man whose policies enabled financial institutions to lend irresponsibly, but he has faith in the U.S. market to recover within the next year – as long as banks receive the capital they need.

In an editorial on the Economist website, the former Federal Reserve chairman blamed the market depression on "fear not experienced since the early 20th century."

To help rebuild the market, Greenspan suggested that "temporary public capital injections" into financial institutions are needed and would be far more effective than "conventional fiscal stimulus."

As investors see more capital on banks’ books, their fear will subside and they will feel confident enough to begin lending to them again, he suggests.

Greenspan also predicted that over the next year, home prices will stabilize, helping banks to accurately judge the relative value of their toxic assets, which will in turn aid economic recovery.

"Human nature being what it is, we can count on a market reversal hopefully within six months to a year," he concludes.

Other economists have not been so hopeful in their forecasts for the U.S. economy, suggesting it could be years before it picks up again.
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Natural remedy offers relief of common cold

Natural remedy offers relief of common cold In a climate where pharmaceutical drugs and traditional OTC medications can cause side effects and dangerous interactions, consumers are increasingly looking to alternative and natural products for relief of flu symptoms.

One such product, which is based on a pelargonium extract, has just been made available in the U.S.
Pelargonium sidoides is a medicinal plant native to South Africa that has a proven track record in treating upper respiratory tract infections.

The new product called Zucol is thus naturally safe and clinically proven to shorten the duration and reduce the severity of symptoms associated with the common cold.

Dr. David Riley, a clinical professor at the University of New Mexico Medical School and founder of the Integrative Medical Institute, says that given recent warnings about conventional cough and cold medications, the product provides an attractive alternative.

Side effects associated with some OTC cold remedies include rash, swelling, difficulties breathing, sleep disturbances, stomach bleeding and many other.

In recent months scientists have also issued a warning against using such medications in children under 6 years of age because they may cause dangerous reactions including hallucinations.

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Obama budget unrealistic, says RNC

Obama budget unrealistic, says RNCThe Republican National Committee has blasted the Democratic administration’s $3.6 trillion budget proposal as too lavish and based on unrealistic economic expectations.

Reminding Americans that President Obama promised to produce a budget that honestly accounted for the money the government would spend and would be free of gimmicks and deception, the RNC has set out to warn that the bill does not offer an accurate picture of the country’s financial situation.

Citing a wealth of research, the RNC claims that the economic forecasts in the budget are much higher than private forecasts.

In particular, it emphasizes that in order for the government to reduce the deficit to $600 million by 2012 the economy would have to grow by more than 4 percent a year.

However, most economists believe that it will fall by 2 percent this year and grow by between 2-3 percent during subsequent years.

The RNC also questions Obama’s predictions regarding the future direction of unemployment. While his administration assumes that it will stabilize at 7.9 percent in 2010, the committee cites expert opinions which suggest that it will far exceed 8 percent.

The Republicans have also expressed their dismay at the fact that the budget proposal will increase taxes on businesses and on individuals who make more than $250,000 a year.
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FDA approves drug from genetically engineered material

FDA approves a drug derived from genetically engineered animal milkThe Food and Drug Administration has issued its first approval for a medication that is produced using material from genetically engineered (GE) animals.

ATryn, as the drug is known, is an anticoagulant used for the prevention of blood clots in patients with a rare disease known as hereditary antithrombin (AT) deficiency.

It is formulated as a protein derived from the milk of goats whose genes have been manipulated by introducing a segment of DNA (called a recombinant DNA or rDNA) with instructions to produce human antithrombin in its milk.

Antithrombin naturally occurs in healthy people and prevents blood from clotting.

To preempt the expected criticism from the natural products industry, the FDA quoted scientists from the Center for Veterinary Medicine who said that based on their observations of seven generations of the GE goats they have not discovered any adverse effects from the rDNA or its expression.

According to the National Alliance for Trombosis and Trombophilia, about 1 in 5,000 Americans has AT deficiency, and these patients are at high risk for clotting during surgery and childbirth.

Until now, the only AT drug available in the U.S. was derived from human blood donors.

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Herbal supplement may lower risk of prostate cancer

Scientists investigate the potentially beneficial role of isoflavones in lowering the risk of prostate cancer Scientists suspect that isoflavones may be able to reverse the androgenic effects of a steroid synthesized in the human body and play a role in prostate cancer prevention.

Researchers at the National Center for Complementary and Alternative Medicine (NCCAM) at the National Institutes of Health are looking into the role of isoflavones in countering the effects of DHEA, a steroid compound which stimulates the production of testosterone.

High testosterone levels are known to be adversely associated with prognosis in men with prostate cancer.

During a NCCAM laboratory study, cell cultures were subjected to DHEA and an increase in testosterone production was noted. However, when they were treated with red clover isoflavones, the androgenic effects of DHEA were reversed.

"Something is happening in the prostate tissue microenvironment that is illustrating a potential cancer prevention effect from this supplement," says Dr. Julia Arnold, a staff scientist at NCCAM.

However, she cautions that more research needs to be conducted before the effects of compounds and their interaction with DHEA are fully understood.
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Association responds to GAO supplement guidelines

Council for Responsible Nutrition has issued a statement in response to GAO supplement guidelinesA recent Government Accountability Office report on the supplement market regulation has met with a mixed response from a leading industry association.

The GAO’s January 2009 report acknowledged the progress that has been made in the area of regulation of dietary supplements, but stressed that the FDA should take further steps to improve oversight and consumer understanding.

In response, the Council for Responsible Nutrition (CRN) has praised the agency for highlighting the positive developments such as the adoption of the FDA Good Manufacturing Practices (GMPs) which the industry itself advocated and promoted.

"These kinds of improvements in industry regulation are the cornerstone of producing safe, high-quality dietary supplements used by more than 150 million Americans each year," said Steve Mister, president and CEO of CRN.

However, the association has criticized the report for its recommendations to submit all adverse event reports, and not just serious adverse effects under the current regulations, for FDA review.

"The agency is already overburdened and understaffed, and we are opposed to creating more bureaucratic paperwork that would not result in true benefits for consumer safety," added Mister.

He concluded by saying that the FDA should concentrate its limited resources on tighter enforcement with a view of ensuring that all companies live up to their commitments to protecting consumers and producing beneficial supplement products.
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CIA destroyed interrogation evidence, say government lawyers

Government lawyers have revealed that the CIA destroyed interrogation evidenceAs civil rights advocates fight for the release of the Bush administration documents related to the war on terrorism, a group of government lawyers has revealed the CIA has destroyed videotapes of interrogation proceedings.

They made the revelations in a letter to U.S. District Judge Alvin Hellerstein from New York who issued an order in 2004 to preserve the material.

A lawyer for the ACLU was quoted by Bloomberg as saying that this demonstrates a "systematic attempt" to cover up the mistreatment of suspects.

In responding to the news, President Obama’s spokesman Robert Gibbs said that under the new leadership the agency will have "the tools they need to keep us safe, but do so in a way that also protects our values."

Meanwhile, the ACLU has scored a victory in its attempt to obtain the release of records documenting the Bush administration’s policies regarding detainees in the so-called "war on terror."

The group filed a petition to that effect with the Justice Department last January.

On Monday, the department released nine secret memos written by the Office of Legal Counsel (OLC) that authorized some of the former administration’s national security policies. One of the memos was written by OLC lawyer John Yoo and argued the Fourth Amendment does not apply to military activities inside the United States, according to ACLU.

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Do You Have Seborrhea?

Seborrhea. Half the people have some form of it. Seborrhea is a common skin problem. It causes a red, itchy rash and white scales. When it affects the scalp, it is called “dandruff.” It can be on parts of the face as well, including the folds around the nose and behind the ears, the forehead, and the eyebrows and eyelids. On the body, seborrhea often occurs in the middle part of the chest, around the navel and in the skin folds under the arm, below the breasts and in the groin and buttocks area.

Who gets seborrhea? Infants may get seborrhea and it is known as “cradle cap.” Cradle cap goes away after about six months. It may also affect the diaper area and look like a diaper rash.

Seborrhea also affects adults and elderly people, and is more common in men than in women. It occurs more frequently in people with oily skin and is also common in patients with Parkinson’s disease or AIDS.

The cause of seborrheic dermatitis is not fully understood. It is likely that a number of factors such as hormones and stress can cause it. A yeast-like organism plays an important role.

Treatment will help keep seborrhea under control. It’s important to keep your body clean. The best treatment I have found is Neutrogena®T/Gel®, (which was passed on to us by a reader.) It kills the itch.