Supplement Safety

Supplement manufacturers do not have to prove that their products are safe! In the past, supplement manufacturers had to prove to the Food and Drug Administration (FDA) that their products were safe. Under current law, however, it has become the responsibility of the FDA to prove that a supplement is unsafe. With the high number of new supplements coming onto the market and the limited resources of the FDA, it is very likely that a product could cause harm before the FDA can take action. In addition, even after the FDA has declared a supplement unsafe, they then have to prove that the supplement is unsafe in the court of law.

Although FDA officials insist the agency monitors medical emergencies linked to dietary supplements, only three staff members are currently assigned to evaluate adverse reactions in the $12 billion dietary supplement industry. It would be pretty hard for only three FDA staff members to monitor the supplement industry when the Harris Poll in 2002 reported that seven out of ten U.S. adults take supplements. The monitoring system was established to record adverse reactions including heart attacks, strokes, seizures, kidney damage, bleeding and deaths associated with more than 3,000 products.

Critics charge that the agency's limited monitoring program poses a significant public health risk, making it difficult for consumers and scientists to get early warnings about possible medical problems linked to dietary supplements.

Case Studies

In the year 2002, a 28-year-old California woman purchased a weight loss dietary supplement over the internet. Not knowing that she had purchased the supplements from a tee-shirt salesman who was just trying to make some extra money, she began to take the supplements. Instead of losing weight, she experienced severe liver damage and fell into a coma after only taking half of the recommended dose for three weeks. The liver damage was caused by an ingredient in the supplement called usnic acid. Surgeons performed an immediate liver transplant and luckily saved her life. However, she now has to take 47 pills a day to prevent her body from rejecting the new liver.

A woman from Anchorage, Alaska also taking weight loss supplements, experienced a stroke while at a company picnic back in 1995. The supplements contained caffeine and ephedra, and she reported taking the supplements intermittently for three years. After six months of recuperation and missing work due to her stroke, she still experienced hand tremors. She took the ephedra company to court and was awarded $13.3 million for her sufferings.

In 2001, a woman in her mid forties took kava supplements for about two months to help with stress and anxiety. A week later she ended up in the hospital suffering from severe jaundice and hepatitis due to a failing liver. Out of Europe and the United States, she became the 11th liver transplant due to kava supplementation.

Source: Schardt D. Are you supplements safe? Nutrition Action Health Letter. 2003;30:2-7.

For more information on safety of supplements, visit the additional resources list, or go to Supplement Watch.

8 Supplements to Stay Away From

Aristolochic acid -- toxic to kidneys

Chaparral -- causes hepatitis

Comfrey -- causes chronic liver disease

Ephedra -- may cause high blood pressure, stroke, and heart attack. Has been shown to be 200 times more likely to cause adverse health effects than all of the other herbs together!

Kava -- linked to liver damage

PC SPES and SPES -- do not help fight the battle against prostate cancer as was proposed

Tiratricol -- can cause heart attack and stroke and is an ingredient in some weight-loss supplements

Usnic acid -- toxic to liver

Source: Schardt, D. (2003) Are Your Supplements Safe? Nutrition Action Healthletter. 30(9):1,3-7.