The current health and wellness trend has led to an influx of new dietary supplements entering the markets. Dietary supplements are a billion-dollar industry that, in many ways, impacts the day-to-day lives of many people. Given the volume of these products and their increasing popularity, it is incumbent on manufacturers to ensure their products are safe for consumers. Unfortunately, many dietary supplements are not as safe for consumers as manufacturers purport them to be.
According to the US Food and Drug Administration (FDA), dietary supplements are defined as “products taken by mouth that contain a dietary ingredient intended to supplement the diet; these ingredients may include vitamins, minerals, herbs, or other botanical products, amino acids, and substances such as metabolites.” Unlike pharmaceutical products, federal law does not require manufacturers of dietary supplements to undergo stringent review by the FDA prior to being placed on the market. However, federal law does mandate that dietary supplements are reasonably safe for consumers, which includes ensuring good manufacturing practices throughout the manufacturing, packaging, labeling, and storing of these products.
Dietary Supplements are subject to the Dietary Supplement Health and Education Act of 1994 (DSHEA). Although FDA approval is not needed before these products are marketed, this Act requires that companies be responsible for determining whether the dietary supplements that are manufactured and distributed are safe, and that any representations or claims made about them are substantiated by adequate evidence to show that they are not false or misleading.
More concerning, however, is the fact that the FDA does not require a manufacturer to disclose to the FDA, or consumers, the information they have about the safety or purported benefits of their dietary supplements. The validity of claims for dietary supplements is the responsibility of the manufacturer, the FDA, and the Federal Trade Commission (for advertising). Claims are often made in regards to the structure/function of the supplements, general health claims, and nutritional-content claims. If the manufacturer makes a structure/function claim on a dietary supplement label, which usually describes the role of a nutrient or dietary ingredient and how it intends to affect the structure or function of the body, then DSHEA requires that the manufacturer ensure the accuracy and truthfulness of these claims, and include a statement that the products are not approved by the FDA. In addition, the FDA has banned manufacturers from claiming their products can treat, cure, or prevent any medical condition.
Although many safeguards have been put in place, dietary supplements are often adulterated with pharmaceutical compounds when they enter the marketplace, many of which are harmful to consumers. According to FDA Enforcement Reports, studies have determined that dietary supplements accounted for more than 50% of the FDA’s Class I drug recalls between 2004 and 2012. Class I drugs are considered those that contain a reasonable probability of causing seriously adverse health consequences, or death. Most of the recalls concerned drugs marketed as sexual enhancement supplement products, followed by body-building and weight-loss products—all of which contained unapproved medicinal ingredients, and roughly one-quarter of which were manufactured outside the United States.
Harmful health risks that result from the use of dietary supplements can include the following:
- Heart Attack
- Lung Disease
- Kidney Damage
- Liver Damage
- Rectal Bleeding
- High Blood Pressure
- Neurological Problems
- Cardiovascular Problems
- Gastrointestinal Problems
Personal injury from dietary supplements may be the basis for a lawsuit, and may entitle you to compensation. Injuries related to the use of dietary supplements will be brought under a theory of products liability. This means that the manufacturer of the dietary supplement created a product that had a defective design, failed to provide adequate instructions, or was defectively manufactured. A dietary supplement may be defective if it contains unapproved ingredients that are harmful to consumers. Further, manufacturers have a legal obligation to inform consumers of how to use their products effectively—including the dosages, warning signs, and instruction on when/how to take the supplement. Absent adequate instructions, a manufacturer may be open to liability if a consumer is injured. In some cases, the supplement may have been defective in the manufacturing process. When a product is not manufactured as the company intended, and the defect causes injuries to a consumer, the manufacturer may liable despite establishing proof of negligence.
If you think that you have suffered a serious harmful effect or illness from a dietary supplement, you should first contact your health care provider immediately. Your health care provider can help you submit a report through the FDA Safety Reporting Portal. Even if you are unsure that the product caused the problem, anyone can report a serious adverse illness or event related to a dietary supplement directly to the FDA.
At the safe and appropriate time, we urge you to contact the experienced attorneys here at Rosensteel Fleishman, PLLC. We have years of experience dealing with personal injury claims and we are here to help you or a loved one seek the compensation you may be entitled to. Injuries of this type may entitle you to the following:
- Past and Future Medical Expenses
- Pain and Suffering
- Past and Future Loss of Income
Contact us today, the initial consultation is free of charge.