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Undisclosed Ingredients Cause U.K. Regulatory Agency to Take Action

Recent months have witnessed an increasing amount of skepticism begin to surround that of the dietary supplement industry. Of significant concern, however, is the influx of illegally adulterated products that contain potentially dangerous ingredients. According to the Medicines and Healthcare products Regulatory Agency (MHRA) in the U.K., a growing number of dietary supplements contain dangerous and undisclosed ingredients that are likely to cause adverse reactions like kidney failure, seizures and heart problems. Furthermore, the U.K. medicines regulator was recently forced to warn retailers and manufacturers to remove approximately 84 tainted products from the market.

The vast market, known collectively as the dietary supplement industry, contains a variety of products that are intended to enhance particular aspects of an individual’s life. The majority of these products are often promoted for weight loss, sexual enhancement and bodybuilding. In the United States, annual sales have averaged nearly $20 billion every year since 2004. Therefore, it is only safe to assume that millions of patients around the world rely on these products and their unique applications.

Unfortunately, however, federal regulators in countries all over the world have recently acknowledged an influx of dangerous products that are masquerading as dietary supplements. Most of the tainted products identified so far have contained hidden or deceptively labeled ingredients such as prescription drugs or unapproved and highly dangerous compounds such as synthetic steroids that do not qualify as dietary supplements under federal laws.

Officials at the MHRA recently identified 84 individual products, most of which were muscle-building and fat-burning supplements, that contained illegal and potentially dangerous undisclosed ingredients. The majority of these products contained undisclosed amounts of ephedrine, synephrine and yohimibine; each of which can cause adverse reactions like kidney failure, seizures and heart problems.

Officials at the MHRA acknowledged that, “it might seem like a high number, but this is just the earlier stages of a campaign and people will hear more from us.” The also stressed that they “are not trying to persecute the industry, but inform them.”

Complicating the already volatile situation, is the current investigation regarding the controversial stimulant DMAA (methylhexaneamine/ 1, 3- dimethylamylamine). Products containing DMAA have been marketed as a dietary supplements. When combined with caffeine and other ingredients, DMAA may be used as an over-the-counter thermogenic or general purpose stimulant intended to increase workout energy and efficiency. However, it is unclear as to whether or not DMAA is a natural derivative of geranium plants or the products of synthetic productions.

DMAA has been associated with several complications, the most notable of which are the deaths of 2 U.S. soldiers. Mr. Graves, an Army spokesman, announced that DMAA had been identified in the toxicology reports of the two soldiers who suffered fatal heart attacks during physical exercise. Last summer, a 22-year-old soldier collapsed at an Army base in the Southwest during a training run with his unit. The fallowing fall witnessed a 32-year-old soldier at the same base collapse after taking a physical fitness test.

In addition to the two deaths, Graves acknowledged a possible link between products with DMAA and an influx of kidney failure, seizures, loss of consciousness and rapid heartbeat in other military personnel. As a result, the Army is currently evaluating whether the potential link between DMAA and these adverse events warrant further action.

As is apparent by these transgressions, dietary supplement manufacturers have become the target of intensive criticism. “These products are masquerading as dietary supplements—they may look like dietary supplements but they are not legal dietary supplements,” says Michael Levy, director of FDA’s Division of New Drugs and Labeling Compliance. “Some of these products contain hidden prescription ingredients at levels much higher than those found in an approved drug product and are dangerous.”

In an ongoing effort to keep dietary supplements free of undisclosed and potentially dangerous ingredients, regulatory officials around the world are cracking down.

Do I Have a Dietary Supplement Lawsuit?

The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in dietary supplement lawsuits. We are currently accepting new cases in all 50 states.

If you or a loved one has been injured by a dietary supplement, you may be entitled to financial compensation. For a free case review, please click the link below or call toll free 24 hrs/day 1-800-773-0849.

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