Food & Nutrition: 'FDA Targets Tainted Dietary Supplements, Issues a warning to Supplement Industry and Launches New System to Notify Consumers"

Food & Nutrition: 'FDA Targets Tainted Dietary Supplements, Issues a

warning to Supplement Industry and Launches New System to Notify Consumers" 

By Kathleen Doheny

WebMD Health News

Reviewed by Louise Chang, MD

December 15, 2010

The vast advertising campaigns over the benefits of supplementation to make up for our inadequate modern diet has lead to the creation of a multi-billion dollar vitamin and supplement industry a lot of companies want to be a part of. Less honorable companies have taken advantage of this 'health' craze to distribute harmful substances they label as healthful supplements.  The FDA is stepping up to put an end to these disloyal practices and help consumers make sense of what is beneficial for them as opposed to what isn't.  For more details, read the WebMD Health News article below.

The FDA today announced new steps to target harmful products marketed as dietary supplements, including the possibility of launching criminal investigations against companies endangering public health.

''The FDA is stepping up our efforts," Joshua Sharfstein, MD, principal deputy commissioner of the FDA, said during a news conference announcing the new steps. At issue are products marketed as dietary supplements that contain hidden or deceptively labeled ingredients, such as the active ingredients in FDA-approved drugs or closely related drugs, as well as other compounds, such as synthetic steroids that don't qualify as dietary supplement ingredients.

Since December 2007, Sharfstein says, the FDA has alerted consumers to about 300 products marketed as dietary supplements that were tainted in some way. Serious adverse reports associated with the products include strokes, artery blockage in the lungs, kidney failure, acute liver injury, and death, although the FDA couldn't provide exact numbers of adverse events or deaths.

Most commonly, Sharfstein says, the tainted products marketed as dietary supplements are for weight loss, sexual enhancement, or body building.

Dietary supplements are regulated by the FDA under a different set of regulations than are foods and drugs. Dietary supplement manufacturers are responsible for ensuring that their products are safe before marketing them, and the FDA is responsible for taking action against any unsafe dietary supplement on the market.

Tainted Dietary Supplements: New Targeting Efforts

The new steps taken by the FDA include:

A letter from FDA Commissioner Margaret A. Hamburg to the dietary supplement industry, stressing its legal obligation to prevent tainted products from reaching the market. Hamburg emphasizes in the letter the possibility of criminal investigations against those who endanger public health by their involvement in tainted products.

A new, rapid notification system for the public on the FDA web site to alert the public quickly to tainted products marketed as dietary supplements.

A mechanism for industry to alert the FDA about the tainted products and the firms involved. 

Industry Support for New Effort

At the conference, representatives of five dietary supplement industry organizations pledged to give their support to the new effort. Among the speakers was Loren Israelsen, executive director of the United Natural Products Alliance. "We are committed to joining the FDA to find them," he said of the tainted product makers, "and drive them out of our industry and out of the U.S." Another industry representative, Anthony Young, general counsel for the American Herbal Products Association, pledged support and commented on the commissioner's letter. "It is the strongest letter I've seen in 35 years of law practice," he says.

Also appearing were representatives from the Council for Responsible Nutrition, the Natural Products Association, and the Consumer Healthcare Products Association.

Recent FDA Actions Against Tainted Dietary Supplements

Among the warnings and alerts recently issued, the FDA today warned people to stop using Man Up Now, a product marketed for sexual enhancement, as it contains a variation of a drug ingredient found in Viagra that can lower blood pressure to a dangerous level. In October, the FDA warned people not to use Slimming Beauty Bitter Orange Slimming Capsules, as they contain sibutramine, the active ingredient in a weight loss drug no longer available in the U.S. because of increased risk of heart attack and stroke.

In 2009, the FDA warned consumers against dietary supplements promoted as body-building products that contain synthetic steroids or other harmful ingredients, such as Tren Xtreme and Mass Xtreme. The products could cause serious liver injury, stroke, and other problems.

More Advice for Consumers

"We want consumers to be aware there are products masquerading as dietary supplements that can pose significant dangers," Sharfstein says.

Among the tip-offs that a product may be tainted, he said, are claims of being an alternative to FDA-approved drugs or of being legal alternatives to anabolic steroids. Products that promise fast or long-lasting sexual enhancement results are also suspect, he said, as are products marketed via mass email.

Consumers should also be wary of products that give warnings about testing positive in performance-enhancing drug tests, he says.

Consumers Union, the publisher of Consumer Reports magazine, issued a statement, applauding the FDA actions. "Tainted dietary supplements can send you to the hospital or kill you," Ellen Bloom, a spokeswoman, says in the statement. ''The FDA should be commended for prioritizing this issue and alerting consumers about dangerous supplements.

Unfortunately, the challenge is that more dangerous products keep popping up." Consumers Union is urging the FDA to go further and vigorously oversee the dietary supplements marketplace through random spot checks and testing of products in the high-risk categories, Bloom says.

THE CONTROVERSY AROUND VITAMINS & MINERALS SUPPLEMENTATION

VITAMINS & MINERALS SUPPLEMENTATION

Extra Calcium and Vitamin maybe Harmful says 

New York Times - November 30, 2010

There is no substitute for nature.  This applies to everything, including vitamin and mineral supplementation.  If you want to receive the appropriate level of vitamins and minerals, you need to follow a healthy and varied diet that provides your body with all the natural nutrients and supplements it requires for optimal functioning.  Absorption of synthetic supplements is always less efficient and most likely second-rate when compared to natural absorption received directly through the consumption of vegetables and fruit.  Medical authorities are starting to question supplementation as totally unnecessary and consider it as a potential health risk factor.  For more, read below.

The very high levels of vitamin D that are often recommended by doctors and testing laboratories — and can be achieved only by taking supplements — are unnecessary and could be harmful, an expert committee says. It also concludes that calcium supplements are not needed. The group said most people have adequate amounts of vitamin D in their blood supplied by their diets and natural sources like sunshine, the committee says in a report that is to be released on Tuesday. “For most people, taking extra calcium and vitamin D supplements is not indicated,” said Dr. Clifford J. Rosen, a member of the panel and an osteoporosis expert at the Maine Medical Center Research Institute. Dr. J. Christopher Gallagher, director of the bone metabolism unit at the Creighton University School of Medicine in Omaha, Neb., agreed, adding, “The onus is on the people who propose extra calcium and vitamin D to show it is safe before they push it on people.” Over the past few years, the idea that nearly everyone needs extra calcium and vitamin D — especially vitamin D — has swept the nation. With calcium, adolescent girls may be the only group that is getting too little, the panel found. Older women, on the other hand, may take too much, putting themselves at risk for kidney stones. And there is evidence that excess calcium can increase the risk of heart disease, the group wrote. As for vitamin D, some prominent doctors have said that most people need supplements or they will be at increased risk for a wide variety of illnesses, including heart disease, cancer and autoimmune diseases. And these days more and more people know their vitamin D levels because they are being tested for it as part of routine physical exams. “The number of vitamin D tests has exploded,” said Dennis Black, a reviewer of the report who is a professor of epidemiology and biostatistics at the University of California, San Francisco. At the same time, vitamin D sales have soared, growing faster than those of any supplement, according to The Nutrition Business Journal. Sales rose 82 percent from 2008 to 2009, reaching $430 million. “Everyone was hoping vitamin D would be kind of a panacea,” Dr. Black said. The report, he added, might quell the craze. “I think this will have an impact on a lot of primary care providers,” he said. The 14-member expert committee was convened by the Institute of Medicine, an independent nonprofit scientific body, at the request of the United States and Canadian governments. It was asked to examine the available data — nearly 1,000 publications — to determine how much vitamin D and calcium people were getting, how much was needed for optimal health and how much was too much. The two nutrients work together for bone health. Bone health, though, is only one of the benefits that have been attributed to vitamin D, and there is not enough good evidence to support most other claims, the committee said.

'Fish Oils and Omega-3 fatty acids: A cure for psychotic mental illnesses?'

BBC News - February 17, 2010

The essential fatty acid Omega-3 has tremendous effects on the brain when received in ample quantities, improving brain functioning significantly.  While Omega-3 oils are present in fish, a much healthier alternative - in a time when most fish is contaminated by human pollution and contains poisonous mercury levels - is to turn to organic vegetable sources of Omega-3 such as botanical blue-green algae (which is the source of the Omega-3 for fish) and flax seeds.  For more on the findings related to fish oil, read below. 

The BBC reported that 'taking a daily fish oil capsule can save off mental illness in those at highest risk'.  A three-month course of the supplement appeared to be as effective as drugs, cutting a rate of psychotic illness like

schizophrenia by a quarter. The researchers believe it is the Omega 3 in fish oil already held for promoting healthy hearts that has beneficial effects in the brain.