Sunday, September 5, 2010 4:23

FDA Alert – Slim-30 Herb Weight Loss Supplement Contains Undeclared Drug

Posted by Paul Young on Wednesday, July 28, 2010, 10:38
This item was posted in Health and has 1 Comment

This product poses a threat to consumers because Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.


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This fact sheet provides basic information about the herb hoodia—common names, uses, potential side effects, and resources for more information. Hoodia is a flowering, cactus-like plant native to the Kalahari Desert in southern Africa. Its harvest is protected by conservation laws.

How Hoodia Is Used

  • Dried extracts of hoodia stems and roots are used to make capsules, powders, and chewable tablets. Hoodia can also be used in liquid extracts and teas.
  • Hoodia products often contain other herbs or minerals, such as green tea or chromium picolinate.

This fact sheet provides basic information about hawthorn—common names, uses, potential side effects, and resources for more information. Hawthorn is a spiny, flowering shrub or small tree of the rose family. The species of hawthorn discussed here are native to northern European regions and grow throughout the world.

What Hawthorn Is Used For

  • Hawthorn fruit has been used for heart disease since the first century. It has also been used for digestive and kidney problems.
  • More recently, hawthorn leaf and flower have been used for heart failure, a weakness of the heart muscle that prevents the heart from pumping enough blood to the rest of the body, which can lead to fatigue and limit physical activities.
  • Hawthorn is also used for other heart conditions, including symptoms of coronary artery disease (such as angina).

Studies of the safety, effectiveness, and biological action of botanical products are major focuses for the five dietary supplement research centers selected to be jointly funded by the Office of Dietary Supplements and the National Center for Complementary and Alternative Medicine, two components of the National Institutes of Health (NIH). The NIH’s National Cancer Institute is co-supporting two of the five centers.

Throughout the year-long strategic planning process, NCCAM is seeking input from its stakeholders through many different channels, including both in-person and Web-based meetings and workshops and through other online vehicles. We particularly encourage input from the public and will be offering several opportunities for people to contribute their thoughts and feedback.

The draft Strategic Plan has be posted for comment. Comments will be accepted between August 30 and September 30, 2010.

Creatine is a naturally occurring compound in the body made from amino acids that supplies energy to muscles. Creatine is also found in meat and fish. The use of creatine supplements by athletes became popular in the 1990s as a way to reportedly enhance athletic performance and build lean muscle mass. Today, creatine remains one of the more widely used supplements by athletes, particularly among adolescents.

Recently, there have been reports of contaminated creatine supplements. Side effects of creatine and interactions with other medications also have been reported. People who are using or are considering using dietary supplements, including creatine, should discuss this decision with their health care provider.

A recent study in the New England Journal of Medicine (NEJM) showed a positive outcome for tai chi in the management of the troubling symptoms of fibromyalgia—a condition with which many patients struggle and for which conventional medicine has little to offer. That is why this study is so provocative—can a CAM modality really affect this condition?

Tai chi is one CAM practice that clearly illustrates the challenge of conducting clinical research in CAM. As an accompanying editorial in NEJM notes, it is a complex intervention involving multiple components: exercise, breathing, meditation, relaxation, and a practitioner. How do you control for all of these variables when designing a study? Some CAM proponents will say that it is the combination that makes the intervention work; many conventional researchers will say you must isolate the components to identify the active "ingredient." Critics will say it all just the placebo effect—you expect the intervention to work, and so it does.

FDA notified healthcare professionals, their patients, and consumers not to consume Vita Breath, a dietary supplement manufactured by American Herbal Lab and marketed at health fairs and on the Internet, because the product may contain hazardous levels of lead. The New York City Department of Health and Mental Hygiene analyzed a sample of Vita Breath and reported it contained 1,100 parts per million of lead. This level is more than 10,000 times higher than FDAs maximum recommended level for lead in candy.

People with fibromyalgia may benefit from practicing tai chi, according to a study published in the New England Journal of Medicine. Fibromyalgia is a disorder characterized by muscle pain, fatigue, and other symptoms. People with fibromyalgia have chronic widespread pain, as well as "tender points" on areas of the body, which hurt when slight pressure is applied. Although exercise appears to be an important part of fibromyalgia treatment, many people with fibromyalgia need medication to control symptoms and are unable to maintain muscle strength, flexibility, and overall fitness.

Lab analysis has found Prolatis’ to contain Sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug used as treatment for male Erectile Dysfunction (ED), making Prolatis’ an unapproved drug. The active drug ingredient is not listed on the product label. The analogue may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance

At the request of the Federal Trade Commission, a U.S. district court has ordered the marketers of acai berry supplements, “colon cleansers,” and other products to temporarily halt an Internet sales scheme that allegedly scammed consumers out of $30 million or more in 2009 alone through deceptive advertising and unfair billing practices. The FTC will seek a permanent prohibition. Since 2007, victimized consumers have flooded law enforcement agencies and the Better Business Bureau with more than 2,800 complaints about the company.

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