Dietary Supplements

Dietary Supplements are sold as part of a multi-billion dollar industry in the U.S. The ads promise that consumers will get "ripped", lose weight, or promote health. But, just what are these products? How safe are these supplements? And, what can you do if your health has been compromised by using them?

What is a Dietary Supplement?

The Dietary Supplement Health and Education Act of 1994 (“DSHEA”) was enacted by Congress and amended the Food, Drug and Cosmetic Act. It defines a dietary supplement as a product taken by mouth that contains a “dietary ingredient” intended to supplement the diet. The “dietary ingredients” include vitamins, minerals, herbs or other botanicals, amino acids, enzymes, organ tissues, glandulars and metabolites.

How are Dietary Supplements Regulated?

Under DSHEA, the US Food and Drug Administration (“FDA”) has no pre-market oversight or approval authority. Dietary supplement products may be sold unless that supplement, or an ingredient in the supplement, is shown to present significant or unreasonable risk of illness or injury. There is no pre-market requirement for testing for safety or efficacy. Effectively, the public is used just like lab rats. The FDA acts only after there are reports of deaths and injuries.

Do Manufacturers Have to Show Evidence of Safety?

No. There is no provision under any law or regulation that requires a manufacturer to prove, through testing or otherwise, that a dietary supplement is safe for the consuming public before the product is sold. There is virtually no safety testing in the dietary supplement industry.

Do Manufacturers Have to Show Evidence to Substantiate Claims of the Purported Benefits of Their Product?

No. As with safety, there is no provision under any law or regulation that a manufacturer must prove that a dietary supplement works before the product is marketed to the consuming public. Efficacy studies are almost non-existent in the dietary supplement industry.

Can Dietary Supplements be Marketed as a Treatment or Cure for a Disease?

No. Under DSHEA, dietary supplements cannot be promoted to treat, prevent or cure any specific disease or condition. If these types of claims are made, the product is then considered to be an unapproved, illegal drug.

Safety Concerns with Dietary Supplements

Potential for Contamination

Botanicals are also subject to contamination. Many botanical ingredients in dietary supplements come from foreign countries. The environmental, food, and drug laws of those countries are, for the most part, less stringent than in the United States. Human, animal and industrial waste contaminate water and soil, and then is absorbed by the plants. The California Department of Health conducted tests on some botanical products and found high levels of lead, mercury, arsenic and other heavy metals. Further, pesticides that have been banned for use in the United States are still in use in other countries. These, too, are absorbed by botanicals and not washed off before the plants are harvested, dried and shipped to the manufacturer of botanical products. In the process of harvesting, drying and shipping, botanicals are also subject to mold, fungus and insect contamination.

In October, 2006, Health Canada issued an Advisory warning consumers of heavy metal contamination in two natural health products, Emperor’s Tea Pill (Tian Huang Bu Xin Wan) and Hepatico Extract (Shu Gan Wan), which were found to contain high levels of lead and mercury.

Adulteration of Dietary Supplements

Investigators have identified some “all-natural” dietary supplements that were actually adulterated with prescription drugs. A research letter published I the Journal of the American Medical Association (“JAMA”) reported the chemical analysis of a dietary supplement promoted for enhancing sexual performance for men. Actra-RX was found to contain presecription-strength amounts of sildenafil (Viagra). These chemical analyses were confirmed by the FDA. Even recently, the FDA has found that some herbal male sexual enhancement products (Zimaxx, LIbidus, Neophase, Nasutra, Vigor-25, Actra-RX, 4EVERON) contain sildenafil or vardenafil (Levitra).

One product that was removed from the U.S. market in 2002, had been marketed as an “all-natural” treatment for prostate cancer. It was found to contain the prescription drugs warfarin (a blood thinner), indomethacin (an anti-inflammatory drug) and/or diethylstilbestrol (DES, a synthetic estrogen hormone).

Variation in Dosage Amounts of Active Ingredients

ConsumerLab.com, an independent testing lab, ran extensive tests on several herbal products, including gingko biloba, saw palmetto, and SAMe. Their testing found that one-quarter to one-third of the products do not meet the claims made on the labels for dosage of active ingredients. For example, ConsumerLab.com tested 13 different SAMe products. In over half of those products, the dosage levels of SAMe were less than one-half of that claimed on the label, and in one, the SAMe content was below detectable levels.

Herb/Drug Interactions

What many consumers don’t know is that using some herbal supplements at the same time as prescription or over-the-counter drugs can have serious and potentially life-threatening consequences. For example, if Echinacea is taken with Valium, it can cause liver damage. Combining a garlic supplement or ginko biloba with blood thinners such as warfarin or aspirin may cause excessive bleeding. And St. John’s Wort weakens the effectiveness of antibiotics and birth control pills.

If you or a family member has been seriously injured because of a dangerous dietary supplement or other herbal product, contact the professionals at Tiedt & Hurd.

Related to our Dietary Supplement practice is our handling of Pharmacy malpractice cases. If you or a family member has been seriously injured because of a mistake in your drug prescription, click on the following link for more information. Pharmacy Malpractice