Texas Dietary Supplement LawyerAugust 2, 2012 — In the September issue of Consumer Reports, investigators have identified ten hazards of dietary supplements, and warns: “Don’t assume they’re safe because they’re ‘all natural.’” More than half of Americans take a vitamin, herb, mineral, or other supplement, believing that the product is safe and natural. In fact, supplements are not risk-free, and they may cause life-threatening side effects.

The researchers analyzed adverse event reports submitted to the U.S. Food and Drug Administration (FDA) between 2007 and April 2012, obtained under the Freedom of Information Act. There were more than 6,300 reports which described 10,300 serious outcomes, including:

  • 115 deaths
  • More than 2,100 hospitalizations
  • 1,000 serious injuries
  • 900 emergency-room visits
  • 4,000 other serious medical events

These reports are voluntarily submitted and they do not prove that the supplement caused the injury. However, the large number of reports linked to supplements is a cause for concern.

One of the biggest risks with dietary supplements is that the ingredients may not always be safe. Many “supplements” actually contain prescription drugs, although this is against the law. Some supplements also have mega-doses of certain vitamins, which could interact with prescription drugs. Even supplements with “normal” doses of vitamins or minerals could be harmful, especially for patients who take blood-thinners or have digestive problems.

Furthermore, the labels and warnings on supplements are often unreliable. One example is DMAA, a stimulant that was often listed on ingredient labels as “geranium oil” or “geranium extract” — despite the fact that the FDA determined DMAA was a synthetic drug, and most experts believe it has no link to the geranium plant. Consumer Reports also found that warning labels were inconsistent. The FDA only requires supplement manufacturers to warn if their product contains iron.

Many people take supplements to improve their health. The FDA prohibits supplement manufacturers from claiming their product can treat, cure, or prevent a specific disease. Although many people believe antioxidants reduce the risk of cancer, a study published in May in the Journal of the National Cancer Institute found that vitamins A, C, E, selenium, and beta-carotene do not reduce the risk of cancer. Another study found that daily vitamin E could increase the risk of prostate cancer.

Omega-3 (fish oil) supplements are also widely-believed to be beneficial, but a study published in June in the New England Journal of Medicine found the pills did not reduce the risk of heart disease in people who had a high risk of cardiovascular problems.

Calcium supplements are also very popular, because people believe they can help bone health. However, they may increase the risk of heart attack. A study found people who take calcium supplements are 86% more likely to have a heart attack compared to people who do not take the supplements. The researchers recommended getting enough calcium from food sources — people who had adequate calcium intake from foods were 30% less likely to have a heart attack.

Despite the risks, the FDA does not ban supplements very often. The last time the FDA banned a drug was ephedra. Despite the fact that another supplement, DMAA (sometimes listed as geranium oil, methylhexanamine, 1,3-dimethylamylamine etc.) has been linked to dozens of adverse event reports and several deaths, the FDA has not officially banned the ingredient. The FDA has sent warning letters to several manufacturers of DMAA products, but stores like GNC and Vitamin Shoppe continue to stock these supplements.

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