FDA issues new safety rules for vitamins

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WASHINGTON - For the first time, generic erectile dysfunction drugs of vitamins, herbal pills and other dietary supplements will have to test all of their products' ingredients. The Food and Drug Administration said Friday it is phasing in a new rule that is designed to address concerns that existing regulations allowed supplements onto the market that were contaminated or didn't contain ingredients claimed on the label.

Last year, the agency found that some supplements contained undeclared active ingredients used in prescription drugs for erectile dysfunction. In the past, regulators found supplements that didn't contain the levels of Vitamin C or Vitamin A that were claimed.

If, upon inspection, the FDA finds that supplements do not contain the ingredients they claim, the agency would consider the products adulterated or misbranded. In minor cases, the agency could ask the manufacturer to remove an ingredient or revise its label. In more serious cases, it could seize the product, file a lawsuit or even seek criminal charges.

Dietary supplements — pills, liquids or other products — are a $22 billion industry.

Most companies already test their raw ingredients, said Steve Mister, president and CEO for the Council for Responsible Nutrition, a trade association erectile dysfunction advices
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“This raises the bar so that all have to comply,” Mister said.

The new rule goes into effect Aug. 24 and will have a three-year phase-in that gives smaller manufacturers more time to comply. Even the largest of the generic viagra fast shipping
won't have to comply until June 2008.

The rule applies to all domestic and foreign companies that manufacture, package and label supplements for sale in the U.S. It requires them to analyze the identity, purity and strength of all the ingredients that go into their products before they are distributed.

It also includes requirements for record keeping and handling consumer complaints.

Dr. Sidney Wolfe, who has testified before Congress on problems with dietary supplements, said the new rule does not ease his concern that unsafe supplements are too easy to bring to market.

“You still don't have to show the product is safe. You don't have to prove it works,” said Wolfe, director of Public Citizen's Health Research Group.

Consumers Union, publisher of Consumer Reports, called the rule a good step toward improving consistency in the ingredients that go into supplements.

“However, consumers still have no idea if a given product works, or whether it is dangerous,” said Janell Mayo Duncan, senior counsel for Consumers Union, publisher of Consumer Reports.

Congress limited the Food and Drug Administration's oversight of vitamins and other dietary supplements in 1994. The new rule is a product of that law, meaning that the rule took nearly 13 years to develop.

Under the old regulations, supplements were governed by the same rules that applied to producing foods, such as cans of soup.

“The final rule will help ensure that dietary supplements are manufactured with controls that result in a consistent product free of contamination, with accurate labeling,” said Dr. Robert E. Brackett, director of FDA's Center for Food Safety and Applied Nutrition.

___

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No evidence magnets dull pain despite widespread use, researchers conclude

By Sheryl Ubelacker Health Reporter, The Canadian Press

TORONTO - They’re embedded in everything from mattresses to insoles for shoes to wrist bands - but there is no definitive scientific evidence that static magnets actually relieve chronic pain, researchers say.

Products that incorporate static magnets are a multibillion-dollar business worldwide and many chronic pain sufferers are drawn to the promise they hold for alleviating such nagging conditions as arthritis, fibromyalgia and low back discomfort.

The theory from proponents is that the device’s magnetic field increases blood flow, causing increased oxygen, nutrients, hormones and painkilling endorphins to be distributed to tissues in the affected area.

So researchers at the Complementary Medicine, Peninsula Medical School, at the Universities of Exeter and Plymouth decided to search the medical literature to determine whether there is any proof magnets can actually reduce pain.

In their analysis of nine randomized trials comparing products containing magnets with those containing either no magnet or very weak ones, the researchers found that the data did not support the use of the alternative therapy for pain control.

“There is no definite grounds of being absolutely sure that a magnet works or not,” lead author Dr. Max Pittler, a complementary medicine specialist, said Monday from Exeter, England.

“The evidence does not support the use of static magnets for pain relief and therefore magnets cannot be recommended as an effective treatment,” he said. The analysis is published in Tuesday’s Canadian Medical Association Journal.

However, Pittler acknowledged that the findings also mean that magnets could work - but the clinical trials weren’t able to prove that either. In part, that’s because pain measurements are subjective - subjects self-report pain levels - and individual studies in the analysis may have been too small to provide statistically relevant results.

Still, Pittler said the biggest concern is that people seeking to ease their pain may be buying into - and paying big bucks - for a therapy that may not be effective.

“It is important to realize that this is a situation where there is a huge market out there,” he said. “In a situation where you don’t have rigorous data . . . patients are putting their hopes into a magnet and spending a lot of money on it.”

He suggests many pain sufferers would be better off taking an over-the-counter painkiller such as ASA or generic say viagra wordpress
.

“Or if patients are keen on trying complementary medicine for certain pain conditions, there is some data available that acupuncture might alleviate some of the pain they feel,” Pittler said. “Acupuncture might be one complementary therapy in certain pain conditions,” such as osteoarthritis.

Health Canada considers claims for specific therapeutic benefits of static magnets to be unfounded, a spokeswoman for the federal department said by e-mail Monday. “These claims include, but are not limited to: pain relief, increased blood circulation, increased oxygenation, reduction of high blood pressure, stimulation of the immune system and the treatment of sleep disorders, infections, depression, erectile dysfunction, rheumatoid disease and cancer.”

A static magnet promoted for any of these purposes is considered a violation of the Food and Drugs Act or Medical Devices Regulations.

Commenting on the analysis, naturopath Kieran Cooley agreed that magnets wouldn’t be high on the list of possible therapies to treat chronic pain.

“I don’t think naturopaths overall would be strong advocates of magnetic therapy if (patients) hadn’t already tried other modalities like acupuncture or other sildenafil citrate treatments for what they’re going through, whether it’s fibromyalgia, chronic fatigue syndrome or even acute back pain,” said Cooley, a researcher and assistant professor at the Canadian College of Naturopathic Medicine in Toronto.

“Acupuncture is probably the biggest one. Mild to moderate exercise has actually been shown to have the best effect on pain overall of any sort of therapy you can use, even conventional drugs or over-the-counter pain medications like Advil or Aspirin.”

Yet magnets can’t be written off completely until more definitive evidence on their effectiveness or lack of effectiveness is obtained, Cooley conceded. “There are clearly some people (in the British analysis) who are benefiting from the therapy. There are other people who are not benefiting very much and a few people who seem to be getting worse.”

“So in that respect, magnet therapy is definitely a buyer-beware or consumer-beware kind of industry.”

Read another articles about men’s health medicine.

Recalls

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The following recalls have been announced:

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• TWC Global of Mountain View, Calif., is recalling 200 boxes of its supplement products sold under the names Axcil and Desirin because the products contain potentially harmful, undeclared ingredients. No illnesses have been reported, according to the company. The products, manufactured in the U.S. and sold on the Internet nationwide, are sold as a 15-capsule erectile dysfunction pill
, packaged in a box.

The company said in a statement Wednesday that the Food and Drug Administration found samples of the products contained an active ingredient for an Erectile dysfunction medication
drug for erectile dysfunction. The undeclared chemicals pose a threat to consumers because they may interact with nitrates found in some prescription drugs and may lower blood pressure to dangerous levels, the company said.

Customers should stop using the products immediately and contact their doctor if they have experienced any problems that may be related to taking this product. Any reactions should be reported to the Food and Drug Administration’s MedWatch adverse event reporting program at http://www.fda.gov/medwatch/report.htm. For more information, consumers can call the company at 650-575-0828.

• Bravo! LCC is recalling tubes of frozen cat and dog food, because of a potential bacterial contamination. The recall includes erectile pill
tubes of Bravo Original Formula Chicken Blend frozen raw food and 2-pound tubes of Bravo Basic Formula Finely Ground Chicken frozen raw food, because they could be blindness causing citrate sildenafil with both salmonella and Listeria monocytogenes. The original formula chicken was manufactured on August 24 and the finely ground chicken was manufactured on August 14. The company is also recalling various-sized tubes of Bravo Original Formula Turkey Blend frozen raw food because they could be contaminated with listeria. This product was manufactured on August 24.

Both salmonella and listeria can cause serious infections in cats, dogs and — if there is cross-contamination — in young children, frail or elderly people and others with weakened immune systems. The company has received no reports of illness in people or animals. Details: by phone at 866-922-9222; by Web at http://www.bravorawdiet.com

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No evidence magnets dull pain despite widespread use, researchers conclude

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By Sheryl Ubelacker Health Reporter, The Canadian Press

ADVERTISEMENT

TORONTO - They’re embedded in everything from mattresses to insoles for shoes to wrist bands - but there is no definitive scientific evidence that static magnets actually relieve chronic pain, researchers say.

Products that incorporate static magnets are a medicine online viagra business worldwide and many chronic pain sufferers are drawn to the promise they hold for alleviating such nagging conditions as arthritis, fibromyalgia and low back discomfort.

The theory from proponents is that the device’s magnetic field increases blood flow, causing increased oxygen, nutrients, hormones and painkilling endorphins to be distributed to tissues in the affected area.

So researchers at the Complementary Medicine, Peninsula Medical School, at the Universities of Exeter and Plymouth decided to search the medical literature to determine whether there is any proof magnets can actually reduce pain.

In their analysis of nine randomized trials comparing products containing magnets with those containing either no magnet or very weak ones, the researchers found that the data did not support the use of the alternative therapy for pain control.

“There is no definite grounds of being absolutely sure that a magnet works or not,” lead author Dr. Max Pittler, a complementary medicine specialist, said Monday from Exeter, England.

“The evidence does not support the use of static magnets for pain relief and therefore magnets cannot be recommended as an effective treatment,” he said. The analysis is published in Tuesday’s Canadian Medical Association Journal.

However, Pittler acknowledged that the findings also mean that magnets could work - but the clinical trials weren’t able to prove that either. In part, that’s because pain measurements are subjective - subjects self-report pain levels - and individual studies in the analysis may have been too small to provide statistically relevant results.

Still, Pittler said the biggest concern is that people seeking to ease their pain may be buying into - and paying big bucks - for a therapy that may not be effective.

“It is important to realize that this is a situation where there is a huge market out there,” he said. “In a situation where you don’t have rigorous data . . . patients are putting their hopes into a magnet and spending a lot of money on it.”

He suggests many pain sufferers would be better off taking an over-the-counter painkiller such as ASA or acetaminophen.

“Or if patients are keen on trying complementary medicine for certain pain conditions, there is some data available that acupuncture might alleviate some of the pain they feel,” Pittler said. “Acupuncture might be one complementary therapy in certain pain conditions,” such as generic erectile dysfunction drugs
.

Health Canada considers claims for specific therapeutic benefits of static magnets to be unfounded, a spokeswoman for the federal department said by e-mail Monday. “These claims include, but are not limited to: pain relief, increased blood circulation, increased oxygenation, reduction of high blood pressure, stimulation of the immune system and the treatment of sleep disorders, infections, depression, erectile dysfunction, rheumatoid disease and cancer.”

A static magnet promoted for any of these purposes is considered a violation of the Food and Drugs Act or Medical Devices Regulations.

Commenting on the analysis, naturopath Kieran Cooley agreed that magnets wouldn’t be high on the list of possible therapies to treat chronic pain.

“I don’t think naturopaths overall would be strong advocates of magnetic therapy if (patients) hadn’t already tried other modalities like acupuncture or other pain-specific treatments for what they’re going through, whether it’s fibromyalgia, chronic fatigue syndrome or even acute back pain,” said Cooley, a researcher and assistant professor at the Canadian College of Erectile dysfunction tablets
Medicine in Toronto.

“Acupuncture is probably the biggest one. Mild to moderate exercise has actually been shown to have the best effect on pain overall of any sort of therapy you can use, even conventional drugs or over-the-counter pain medications like Advil or Aspirin.”

Yet magnets can’t be written off completely until more definitive evidence on their effectiveness or lack of effectiveness is obtained, Cooley conceded. “There are clearly some people (in the British analysis) who are benefiting from the therapy. There are other people who are not benefiting very much and a few people who seem to be getting worse.”

“So in that respect, magnet therapy is definitely a buyer-beware or consumer-beware kind of industry.”

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Alaskan man pleads guilty to sale of seal penises

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ANCHORAGE, Alaska (Reuters) - An Alaska man has pleaded guilty to selling more than 100 fur seal “oosiks” — or penises — to a local gift shop that intended to sell the items as an alternative drug viagra
.

Michael Richard Zacharof, an Aleut and former tribal president from the Bering Sea village of St. Paul, pleaded guilty this week to one count of violating the Marine Mammal Protection Act.

Federal law forbids the sale of any raw marine mammal parts unless they have been crafted into pieces of Alaska Native artwork.

In Zacharof's case, the former tribal leader sold the raw seal penises to a gift shop female use viagra
to link order viagra
from Asia. The shop then sold the items for about $100 each, according to the Justice Department.

Assistant U.S. Attorney Andrea Steward said seal penis bones, also known as seal sticks, are believed to have properties similar to erectile dysfunction drugs like Viagra.

Zacharof faces a possible one-year prison term and a $20,000 fine, the U.S. Attorney's office said.

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Product contains tadalafil

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Confidence Inc. is recalling about 1,500 boxes of Long Weekend dietary erectile dysfunction medicine
because representatives from the

Food and Drug Administration

Food and Drug Administration found the product contains undeclared tadalafil, which makes the product an cure dysfunction erectile drug. Tadalafil is a drug used to treat erectile dysfunction. Tadalafil can interact with nitrates found in some natural cure for erectile dysfunction drugs and could lower blood pressure to dangerous levels. People with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates, according to the FDA. No illnesses have been reported.

The product comes in three-capsule boxes. It was sold nationwide and in Puerto Rico, Canada, the United Kingdom, Russia and China. Details: by phone at 516-767-1870.

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