Lack of Dietary Supplement Regulation Causes Concern Among Consumers

The majority of dietary supplements, including those of the weight loss and fitness variety, are marketed as shortcuts for those looking to enhance certain aspects of their body. However, recent years have witnessed an exponential increase in the transgressions committed by dietary supplement manufacturers. Of significant concern, is the onslaught of unsubstantiated claims made by these companies that are saturating the market. Furthermore, federal regulators are seeing an increase in the amount of dietary supplements that contain undisclosed and potentially dangerous active pharmaceutical ingredients (APIs).

Congress defined the term “dietary supplement” in the Dietary Supplement Health and Education Act (DSHEA) of 1994. Therefore, according to the DSHEA, a dietary supplement is a product taken by mouth that contains a “dietary ingredient” intended to supplement one’s diet. The “dietary ingredients” in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites.

The majority of dietary supplements combine these ingredients in a way that will benefit the user with respect to its indicated purpose. The most popular dietary supplements are those that are promoted for weight loss, sexual enhancement and body building. The development of these supplements has translated into a more than $62-billion-a-year industry, compared with about $38 billion 10 years ago, estimates Market Data.

As the data suggests, dietary supplements are growing at an alarming rate. Of significant concern, however, is a distinct lack of regulation upon their release. Most dietary supplements haven’t been approved by the U.S. Food and Drug Administration (FDA), and products often make unsubstantiated scientific claims, consumer experts say. Subsequently, dietary supplements do not need to register with the FDA, nor do they need to receive approval upon being released into interstate commerce; the agency only takes action if the product later proves to be unsafe.

The FDA tries to warn consumers against dangerous products by updating its list of “tainted” dietary supplements, meaning they have identified hidden active ingredients. In addition to FDA warnings, the Federal Trade Commission (FTC) looks for misleading and false advertising. However, with the number of new products that are introduced each year, officials have a difficult time keeping up.

“These products don’t require any pre-approval, and the government lacks the resources to look at more than a handful of them,” said the FTC’s Richard Cleland. “One of the problems is consumers assume these products wouldn’t be out in the marketplace unless the FDA or FTC had approved the product, and that’s just not the case.”

The FDA’s lack of regulation has lead to an increase of tainted products. More often than one would expect, undisclosed ingredients have been added to products that are promoted for weight loss, sexual enhancement, and bodybuilding. Subsequently, these tainted products contain “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.

“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.” Complicating the already volatile situation, are reports received by the FDA that acknowledge these products may be associated with an increased risk of stroke, liver injury, kidney failure, heart palpitations, and death.

Countless dietary supplement lawsuits have been filed on behalf of plaintiffs who have been injured by these products. Accordingly, the number of pending lawsuits may be directly correlated to the number of tainted products that are allowed onto the market.

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-(949) 557-5800.