Dietary Supplement Safety and Quality Concerns

Insufficient oversight, unscrupulous manufacturers, and contaminated ingredients can spell problems for consumers

Unscrupulous manufacturers sometimes hide dangerous compounds

While the majority of dietary supplement manufacturers are honest and responsible, the industry also has a number of unscrupulous manufacturers whose products are problematic or even dangerous. Their supplements might contain stimulants, pro-hormones or other anabolic agents not listed on the ingredients list that can trigger positive doping tests and cause serious health problems.

Raw materials can be contaminated

The raw materials that make up the ingredients in a dietary supplement can present additional problems. For even honest manufacturers are not always aware of the exact contents of all of the raw materials in their products. Sometimes these raw materials are inexpensive and come from local sources, often they are shipped from other countries where quality control standards might not be as rigorous as those found in the United States. Contaminants can and do make their way into the raw materials found in supplement products being sold legally.

Unsettling high numbers of problematic supplements

A comprehensive study commissioned by the International Olympic Committee in 2001 analyzed 634 non-hormonal nutritional supplements bought from 215 different suppliers in 13 different countries and found that a whopping 14.8% contained at least one anabolic agent. Many of those originated in the United States.

DSHEA created barriers for regulation

The Dietary Supplement Health and Education Act of 1994 is a vital piece of legislation governing dietary supplement sales in the United States. Regrettably, DSHEA places the burden of proof on the Food and Drug Administration to show that a product intended to supplement the diet creates an unreasonable risk of illness or injury, and should therefore be prohibited. As was demonstrated in 2004 when the FDA attempted to ban ephedra only to have the ban subsequently overturned by a federal court, this is often a difficult burden for the FDA to meet.

FDA can only test a small fraction of products

Though the FDA is the federal body charged with regulating dietary supplements and protecting the public’s health, it only has the resources needed to test a small fraction of dietary supplements that could be problematic. As the FDA currently warns on its website, “Remember, (the) FDA cannot test all products on the market that contain potentially harmful hidden ingredients. Enforcement actions and consumer advisories for tainted products only cover a small fraction of the tainted over-the-counter products on the market.”

Anabolic Steroid Control Act of 2004 has limited impact

Responding to criticism that arose after it was revealed that some athletes (most notably baseball players) were using pro-hormones that were available over-the-counter in the United States, Congress enacted the Anabolic Steroid Control Act of 2004. This law, which took effect in January 2005, bans the sale of most steroid precursors such as androstenedione. Unfortunately, the act has had limited impact as it still puts the burden of proof on the authorities to demonstrate that a compound is a concern. Weaknesses in the act have allowed prohormones and designer steroids to remain widely available and unregulated in the online marketplace. The new Designer Anabolic Control Act of 2014 seeks to strengthen its effectiveness, which we support.

BSCG supplement certification offers effective solutions

BSCG’s Certified Drug Free® supplement certification programs fill a significant gap in dietary supplement quality control and aim to help average consumers and elite athletes alike differentiate safe products from those products that present unnecessary risks. BSCG is pleased never to have certified a product that went on to cause a positive drug test. We use the most up-to-date science to provide manufacturers and consumers with the best protection available against these risks.