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’.