Interesting article below about a company being fined because their cold flu product did not have any warning stickers about it containing more than one-half of a microgram of lead (i.e. as per the new California’s Proposition 65 tough new guidelines).

A dietary supplement distributor has agreed to pay $1.5 million in civil penalties and costs to settle a lawsuit filed by 10 California counties that accused it of engaging in false and misleading advertising, prosecutors said today.

The settlement with Iovate Health Sciences, a Canadian corporation based in Oakville, Ontario, and its American affiliate, Iovate Health Sciences USA, Inc., is the second largest dietary supplement settlement in California history, according to prosecutors.

The suit was brought by the district attorney’s offices in Alameda, Napa, Marin, Monterey, Orange, Santa Clara, Santa Cruz, Shasta, Solano and Sonoma counties and the settlement was signed in Napa County Superior Court.

The suit alleged that the company engaged in false and misleading advertising in connection with the marketing and sale of some of its dietary supplement products and violated Proposition 65, which requires a warning label on products that expose consumers to more than one-half microgram of lead a day.

The settlement calls on the Iovate companies to pay $1.2 million in civil penalties that will provide support for the future enforcement of California consumer protection laws as well as $300,000 for investigative costs.

Alameda County Deputy District Attorney Scott Patton, one of the prosecutors involved in the case, said state action against the companies was necessary because the federal government doesn’t regulate the dietary supplement market.

He said unlike prescription medication, dietary supplements do not need to be pre-approved by U.S. Food and Drug Administration before they can be sold to consumers and a dietary supplement can be sold without prior government approval or proof that it is either safe or effective for its intended use.

Patton said the suit alleged that the Iovate companies were making claims that their products could cure colds and diseases without any scientific proof to back up those claims.

For example, he said the companies said its Cold MD product could increase resistance to colds by 312 percent, reduce the duration of colds by 94 percent and prevent people from catching colds in crowded places such as airplanes and buses.

The products named in the settlement mainly were aimed at fighting colds and allergies and helping people lose weight, Patton said.

Prosecutors said their investigation also disclosed that Iovate was marketing and selling Cold MD in violation of California’s Proposition 65, which requires that all products containing more than one-half of a microgram of lead be marked with warning labels.

They said laboratory tests revealed that certain lots of Cold MD product contained significantly more than one-half microgram of lead in a single dose of the product. The company stopped selling the product in 2008, according to prosecutors.

Iovate officials couldn’t be reached for comment Wednesday.

Prosecutors said the Iovate companies did not admit fault or liability, but have agreed to abide by comprehensive court orders to prevent any future unfair or deceptive business practices.

Alameda County District Attorney Nancy O’Malley said her office participated in the case because it is “committed to protecting California consumers from deceptive advertising and potentially harmful products in the dietary supplement market place.”

—Bay City News

Almost 20 million individuals in the United States suffer from depression. Many of them are prescribed antidepressants to help them cope. Not uncommonly, a variety of medications are tried before results are seen; furthermore, the effect of some regimens decreases over time. In recent months, Deplin, a prescription form of folate, is being increasingly recommended for depressed patients. Folate and folic acid are forms of a water-soluble B vitamin. Folate occurs naturally in food; folic acid is the synthetic form of this vitamin. People with low folate levels are six times as likely to respond poorly to antidepressants as those with normal levels.

Although Deplin has been on the market since 2006, it has recently been found to be beneficial to individuals who do not improve after being placed on an antidepressant. Folate, which is present in green, leafy vegetables, legumes, nuts, and some fruits, is necessary for cell growth and brain function. Recent research has found that the body converts folate (the synthetic version, and folic acid) into an active form, known as L-methylfolate. This substance is necessary for the production of serotonin, dopamine and norepinephrine, which are neurotransmitters that are essential for mood regulation.

Many factors can reduce L-methylfolate levels; these included aging, genetics, illness, poor nutrition, excess alcohol consumption, and some medications. Many antidepressants slow the “reuptake” of serotonin or norepinephrine; thus, making them available longer to the brain; however, these antidepressants may be less effective or ineffective if the brain is not producing adequate quantities of the neurotransmitters in the first place.

The Food and Drug Administration (FDA) categorizes Deplin as a “medical food,” which is held to less-rigid standards by the agency. Medical foods are intended to provide dietary management for a disease or condition; all ingredients must be “generally recognized as safe” (GRAS) and physician supervision is required. Two recent randomized, placebo-controlled trials have evaluated Deplin, with a total of 223 subjects. Both studies were subsidized by the product’s manufacturer: Pamlab LLC (Covington, LA). One study, which was presented at the American Psychiatric Association’s meeting last May, 75 depressed patients were randomly assigned to take either 15 milligrams of Deplin or a placebo along with an antidepressant. After 30 days, 32% of subjects on Deplin had responded, compared with 15% on the placebo. However, an earlier study using a lower dose of Deplin found no difference with a placebo. In both trials, the subjects reported no more side effects with Deplin than with the placebo.

Facts about depression:

• 11% of Americans over age 12 take antidepressants.
• Nearly 20 million individuals in the U.S. suffer depression during their lifetime.
• Only 30% improve well on the first antidepressant alone.
• Almost 50% of depressed patients never improve significantly.
• Individuals with low folate levels are six times as likely to fail to respond to antidepressants as those with normal levels.

Take Home Message: Folate is present in cereals, baked goods, leafy vegetables (i.e., spinach, broccoli, and lettuce), okra, asparagus, fruits (i.e., bananas, melons, and lemons), legumes, yeast, mushrooms, organ meat (i.e., liver and kidney), orange juice, and tomato juice. These substances are components of a healthy diet; thus, including them in one’s diet is sensible. Pregnant women are advised to ingest folate or folic acid to reduce the risk of neural tube defects in their developing fetus. Although Devlin is likely to be effective as an adjunct medication for patients on depression, fresh food sources of the folate could not only add nutrition but also save the cost of a prescription medication. In fact, some individuals suffering from depression might find that that they can discontinue their antidepressants; thus, avoiding their cost and potential side-effects. An activity that can reduce depression is an exercise program. When one exercises, endorphins are produced in the brain. These substances improve one’s mood in a natural manner.

via emaxhealth

Making some simple changes to your diet could help keep dementia at bay, a new study suggests.

U.S. researchers found that elderly people with high levels of omega 3 found in oily fish and vitamins common in fruit and vegetables did better in memory tests than those with a less healthy diet.

Brain scans confirmed those with the highest levels of vitamin D and omega 3 and vitamins B, C and E, also had a significantly larger brain volume.

Conversely people whose blood had higher levels of trans fats – found in cakes and fried foods, as well as red meat – had the worst scores and less brain tissue.

This is thought to be the first study to investigate nutrient levels through blood tests rather than looking at food diaries or questionnaires.

The scientists, from Oregon Health & Science University, say this gives a more accurate picture because it does not rely on memory or honesty, and because in old age some people’s blood absorbs more of the nutrients they eat than others.

Study author Dr Gene Bowman said: ‘These results need to be confirmed, but obviously it is very exciting to think that people could potentially stop their brains from shrinking and keep them sharp by adjusting their diet.’

As the research was carried out on healthy patients, rather than those with the degenerative disease, it suggests the effect of fish oils could be preventative, rather than a cure for age-related memory loss.

Dr Bowman said nutrient levels in the blood accounted for 37 per cent of the variations seen in brain volume. In memory tests, it accounted for a ‘significant’ 17 per cent -  other factors being age, years of education and blood pressure.

The authors noted that very few studies have assessed the risk of effect of trans fats on Alzheimer’s, and the fact that they ‘may aggravate cognitive decline’.

Children in low and middle income countries should be given vitamin A supplements to prevent death and illness, say the authors of a study published in the British Medical Journal. The researchers argue that the effectiveness of vitamin A supplementation is now so well-established that further trials would be unethical, and they urge policymakers to provide supplements for all children at risk of deficiency.

Vitamin A is an essential nutrient that must be obtained through diet. Vitamin A deficiency in children increases vulnerability to infections like diarrhoea and measles and may also lead to blindness. Globally, the World Health Organisation estimates that 190 million children under the age of 5 may be vitamin A deficient. But, despite widespread efforts, vitamin A programmes do not reach all children who could benefit.

So a team of researchers based in the UK and Pakistan analysed the results of 43 trials of vitamin A supplementation involving over 200,000 children aged 6 months to 5 years. Differences in study design and quality were taken into account to minimise bias. They found vitamin A supplements reduced child mortality by 24% in low and middle income countries. It may also reduce mortality and disability by preventing measles, diarrhoea and vision problems, including night blindness.

via bmj

A report from the Commonwealth Auditor-General has found up to 90 per cent of alternative medicine products do not comply with regulations.

The report found many products had quality issues and not enough evidence to substantiate claims about their benefits.

It says the Therapeutic Goods Administration (TGA) does not bother prosecuting companies for failing to comply because the fines are too small to justify the expense of investigating.

The TGA agrees it is toothless.

Sales of complementary medicines, including vitamins, minerals, herbal, aromatherapy and homeopathic products, amounted to $1.2 billion last year, and they are becoming more popular every year.

La Trobe University senior lecturer in public health, Dr Ken Harvey, says the industry has exploited Australia’s lack of regulation.

“This light-touch regulation has actually led to an explosion of products and it’s very easy to get a product to market so you can make a lot of money by advertising it for claims that sound good but in fact aren’t based on practical evidence,” he said.

Dr Harvey says Australia’s trust-based system of regulation has failed.

“The major problems seem to be the matter of claims and the fact that people say things work when they don’t and they put statements on the label and in advertising that are not true,” he said.

“The TGA, I think, deserves criticism. There’s a lot of it in the Auditor-General’s report.

“Consultations that go on and on for years, papers on guidance that never come to fruition or never – never come to a final version.

“The TGA has certainly procrastinated in trying to deal with these issues, and I think they deserve censures of that.”

The Complementary Healthcare Council of Australia head, Dr Wendy Morrow, agrees there should be better regulation of the industry.

“Industry has long been supportive of tougher penalties and sanctions for ongoing non-compliance with advertising regulations,” she said.

But Dr Morrow says caution is needed when it comes to the figures mentioned – particularly that 90 per cent of alternative medicines do not comply with the rules.

“[90 per cent] should be alarming, but I think that the use of the 90 per cent statistic does require an abundance of caution,” she said.

“The statistic is driven by a very small sample size and includes a large number of minor non-compliances.”

A statement from the Therapeutic Goods Administration says it agrees with the recommendations of the audit.

It says the TGA has been working with the industry to improve compliance.

Via abc

Vitamin C is magical stuff. It not only staves off snotty noses and sore throats, but it’s also good for the skin.

Being a powerful antioxidant, vitamin C helps protect the skin from wrinkle-inducing sun rays, pollution and stress.

It also neutralises free radicals, which are tiny molecules that skin pharmacists think are evil.

The folk at The Body Shop must be scared of the little blighters too, because they’ve just put out an entire vitamin-C skincare range.

The range contains a very serious-looking small bottle. It’s a Facial Radiance Powder Mix and requires a very fiddly but fun process of dropping powder into liquid and making your own mix.

I felt like a mad scientist making my own skincare, but they didn’t do it like this just for fun.

The solution, once mixed together, lasts for only 10 days. It’s designed to give your skin a super boost of radiance-enhancing vitamins – perfect for the leadup to a special event. After 10 days, my skin didn’t look particularly luminous, but it felt wonderfully soft and rejuvenated.

- The Body Shop Facial Radiance Powder Mix, $60

Consumer advocates are warning shoppers to be careful about taking over-the-counter diet pills after many were found to contain harmful ingredients.

A survey by Choice examined 10 over-the-counter supplements and found two of the pills contained bitter orange and panax ginseng which, when combined, can increase the risk of heart problems.

Two other pills had very high doses of caffeine which could cause heart palpitations and high blood pressure.

Diet supplements have to be listed with the Therapeutic Goods Administration (TGA).

Choice spokesperson Ingrid Just says only 20 per cent of listed drugs are audited by the TGA to verify their effectiveness.

“If the majority of these pills and potions are not tested by the TGA for efficacy, how can someone be confident that they work?” she said.

Two other weight loss products, Leptin Weight loss chocolate bars and Latin Seed products, have been removed from sale because they contain potentially harmful ingredients.

Choice says consumers need to be wary of “happy customer testimonials” that are part of the marketing of the supplements.

It says people should talk to their doctor before taking the supplements.

via abconline

The Therapeutic Goods Administration said although Natural Vigra VIAGRA tablets were marketed as being “100 per cent herbal”, they contained the prescription-only drug, sildenafil.

In a statement posted on its website, the TGA said sildenafil may be harmful if taken without the supervision of a doctor, particularly in people with a history of cardiovascular disease.

It advised anyone using them to stop taking them and to discard the remaining tablets.

Sildenafil is the active ingredient in the approved impotency drug Viagra, manufactured by pharmaceutical company Pfizer and available in Australia on prescription.

But the TGA said the supply of Natural Vigra VIAGRA in Australia was illegal.

It said the tablets had not been assessed by the TGA for quality, safety or effectiveness as required under Australian law.

Consumers are … advised to exercise extreme caution about purchasing medicines from unknown overseas internet sites,” the TGA said.

Products purchased in this way may … contain undisclosed and potentially harmful ingredients.”

via couiermail

Scientists may have discovered hope for people suffering from brain and spinal tumors, in the form of an herb. Researchers at the Department of Neurosurgery at the University of Southern California found that hypericin—a compound found in St. John’s Wort—not only reduced tumor size in people suffering from cancerous brain or spinal tumors, it also increased the rate of survival from this tragic disease.

Consider the seriousness of this form of cancer: approximately 10,000 Americans are diagnosed with a malignant glioma every year and the survival rate one year after diagnosis is only 50 percent.

Typically, treatment involves a combination of surgery, chemotherapy, and radiation. While the study group was small, hypericin showed superior results as a treatment for this serious condition. Additionally, the St. John’s Wort compound was well-tolerated by the cancer patients, something that cannot be said for chemotherapy and radiation.

On its own, this study, published March 31 in the journal, Cancer, would be exciting; however, it is particularly interesting to note that St. John’s Wort is perhaps the most maligned herb by the media. St. John’s Wort is notorious for its interaction with some drugs, causing it to be viciously attacked by the media. However, it interacts with many medications because it tends to be effective in the treatment of numerous conditions, including mild to moderate depression. If drugs interact with herbs, the herbs are frequently given a bad rap for working at all.

While the results are early and obviously more research is necessary, perhaps this study will help restore St. John’s Wort to its rightful place in herbal apothecaries—as a powerful and effective healing botanical medicine.

The European Union’s half a billion people can rest assured that traditional herbal medicines on sale on the shelves are safe and effective, the European Commission said Friday.

May 1 is the deadline for the expiry of a seven-year transition period set by the European Union to register and authorise traditional herbal medicines.

“Patients can now be confident about the traditional herbal medicinal products they buy in the EU,” said the commissioner for health John Dalli.

“We have now reached the end of a long transition period which has given producers and importers of traditional herbal medicinal products the necessary time to show that their products have an acceptable level of safety and efficiency.”

Under EU rules set in place in 2004, products had to be registered to be authorised for sale, with applicants asked to provide documentation showing products were not harmful.

They also had to show products had a “proven track record” – that they were used safely for at least 30 years, including half of that period in the EU.

In a closely watched case that could test the reach of U.S. antitrust law, four Chinese companies face powerful evidence that they colluded to limit production and fix prices of vitamin C in the United States. The evidence is so convincing, in fact, that the defendants have not contested the allegations.

But they still have a potentially solid legal defense: the Chinese government made them do it. It’s a position that has been bolstered by the Chinese government itself, which made an official appearance in the case — believed to be its first ever in a U.S. court — to file briefs in support of the defendants. After more than six years of litigation, a Brooklyn federal judge is expected to decide soon whether the case can be decided without a trial.

The legal theory underpinning the defendants’ argument is known as the foreign sovereign compulsion doctrine, which protects foreign companies that were compelled by their own government to break U.S. law. As Chinese companies increasingly become the target of antitrust lawsuits in the United States, the doctrine is expected to undergo more legal scrutiny. In addition to the vitamin C case, Chinese companies have raised the sovereign compulsion defense in two other price-fixing cases.

The outcomes of those cases are not expected to have an immediate impact on U.S. trade relations with China, the largest supplier of goods imported into the United States. As China’s economic power continues to grow, however, the disputes could be a sign of more trade fights ahead.

Shanker Singham, a partner at Squire, Sanders & Dempsey and the chairman of the International Roundtable on Trade and Competition Policy, said that a ruling for the defendants would undermine global competition. “It would be a declaration of war on the market system where business competition on the merits is the organizing economic principle,” Singham said.

PACT LIMITS EXPORT VOLUMES

Until recently, Chinese companies have been known for low production costs that have benefited consumers worldwide, and only in the last five years have they been accused of coordinating production in an effort to raise prices. “The appearance of Chinese cartels that are hiding behind the state is a disturbing trend,” said John Connor, a professor at Purdue University specializing in antitrust law enforcement.

Among the documents in the vitamin C case is a 2001 written production and price agreement among the four Chinese manufacturers, which together controlled around 60 percent of the world’s vitamin C market. The pact explicitly limited each company to a specific volume for export. According to the plaintiffs, after the agreement was made, spot prices for vitamin C shot to as high as $7 per kilogram in December 2002 from $2.50 per kilogram in December 2001.

In an amicus brief filed in support of the defendants, China’s Ministry of Commerce argued that the vitamin C manufacturers were compelled by Chinese law to coordinate their production and pricing. It also argued that a ruling against the manufactures would “improperly penalize” them for “the sovereign acts of their government and would adversely affect implementations of China’s trade policy.”

The foreign sovereign compulsion defense has rarely been litigated and it has only been successful once, according to antitrust law experts. But the presence of the Chinese government in the vitamin C case could cause Judge Brian Cogan to look for a way to dismiss the case. “You can see why a judge would be reluctant to keep the case when it’s about foreign affairs and trade policy,” said Spencer Waller, director of the Institute for Consumer Antitrust Studies at Loyola University Chicago School of Law.

NO U.S. ACTION

The Chinese government’s participation may explain why neither the U.S. Department of Justice nor the Federal Trade Commission has taken any action against the Chinese companies. According to enforcement guidelines that the government issued in 1995, the DOJ and FTC will not take action against a company if a foreign government makes a sufficiently detailed presentation that a specific law compelled the defendant’s actions. William Isaacson, a partner at Boies, Schiller & Flexner and the co-lead counsel for the plaintiffs, said that neither the Chinese government nor the defendants have been able to point to such a law.

Isaacson and his law firm have a unique perspective on the vitamin C market. In the late 1990s, they investigated a vitamin C cartel among European and Japanese companies. Their probe led to U.S. prosecutions that resulted in more than $900 million in corporate fines and several guilty pleas. Isaacson said he is bewildered that the U.S. government has not contacted him for more information about his case against the Chinese companies. “I’ve never understood why they don’t want to find out what’s been happening.” The Department of Justice’s antitrust division and the FTC declined to comment.

The plaintiffs, two U.S. buyers of vitamin C, alleged in one of their briefs that the defendants fixed prices without any help from the government. It was only after the defendants were accused of price fixing that they invoked their government’s involvement, according to the plaintiffs.

For their part, the Chinese manufacturers say that China’s Ministry of Commerce directed an entity called the Chamber of Commerce of Medicines and Health Products Importers and Exporters to coordinate production. According to the brief submitted by the Ministry of Commerce, the action was taken in order to mitigate the exposure Chinese companies faced in potential antidumping investigations from other countries and to ensure China’s orderly transition to a market-driven economy.

via reuter

A new study says women who enjoy a diet rich in vitamin B, have less risk of premenstrual syndrome (PMS).

Researchers found that women who consumed foods like spinach and fortified cereal had about a 25 percent lower risk of PMS. However, they said the same was not true for women who got their vitamin B from supplements.

But researchers cautioned that it’s not just taking in B vitamins that does the trick. Rather, it’s that women who eat more of the vitamins also have other health habits that have an effect on their PMS.

The study was published in the American Journal of Clinical Nutrition.

Essential Fatty Acids (EFAs) are the basic building blocks of which fats and oils are composed. Contrary to popular myth, the body truly needs fat. It must be the right kind, however, the fatty acids that are necessary for health and that cannot be made by the body are called essential fatty acids or EFAs. They must be supplied through proper diet.

There are two basic categories of essential fatty acids, designated Omega-3 and Omega-6, based on their chemical structures. In order to supply essential fatty acids, these oils must be consumed in pure liquid or supplement form and must not be subjected to heat, either in processing or cooking. Omega-3 EFAs, including alpha-linolenic and eicosapentaenoic acid, EPA, and docosahexaenoic acid, DHA, are found in fresh deepwater fish, fish oil, and certain vegetable oils, among them canola oil, flaxseed oil, and walnut oil. Omega-6 EFAs, which include linoleic and gamma-linolenic acids, are found primarily in raw nuts, seeds, legumes, and unsaturated vegetable oils, such as borage oil, grape seed oil, primrose oil, sesame oil, and soybean oil. Heat and light destroy essential fatty acids. Worse, heat and light result in the creation of dangerous free radicals. If oils are hydrogenated, processed to make the oil more solid, as is done in the production of margarine, the linoleic acid is converted into trans-fatty acids, which are not beneficial to the body.

Essential Fatty Acids have desirable effects on many disorders. They are beneficial for candidiasis, cardiovascular disease, eczema, and psoriasis. Found in high concentrations in the brain, EFAs aid in the transmission of nerve impulses and are needed for normal development and functioning of the brain. A deficiency of essential fatty acids can lead to an impaired ability to learn and recall information. Every living cell in the body needs essential fatty acids. They are essential for rebuilding and producing new cells. Essential fatty acids are also consumed by the body for the production of prostaglandins, hormone-like substances that act as chemical messengers and regulators of various body processes. They improve the skin and hair, reduce blood pressure, aid in the prevention of arthritis, lower cholesterol and triglyceride levels, and reduce the risk of blood clot formation.