Good Question: How Are Herbal Supplements Regulated?
MINNEAPOLIS (WCCO) -- Lamar Odom was found unconscious at a brothel in Nevada on Tuesday. Investigators say the former L.A. Laker had abused cocaine and taken ten tablets of so-called "herbal Viagra" in recent days. The FDA had previously warned against using those sexual enhancement pills.
But drugs and herbal supplements are not regulated in the same way by the federal government. Why not? Good Question.
"I think the most important thing for people to understand is that they are regulated, they're just regulated differently than drugs," Dr. Rick Kingston, President of Regulatory and Scientific Affairs for SafetyCall, a company affiliated with the University of Minnesota that helps drug and herbal supplement companies monitor the safety of their products.
With prescription and over-the-counter drugs, the Federal Drug Administration must approve the product before it hits the market. Dietary supplements don't require that same pre-market FDA approval as long the product doesn't include any new vitamins, minerals, herbs, amino acids or substances not previously approved. According to FDA, it's the responsibility of the dietary supplement's manufacturer to ensure its products are safe and its claims are not misleading.
"They're more like food than a drug," said Dr. Kingston. "You can't make claims the dietary supplements will treat, prevent, cure, mitigate any diseases, so the health claims are different."
In 1994, President Clinton signed the Dietary Supplement Health and Education Act (DSHEA) into law. It gave the FDA more oversight and authority regarding dietary supplements.
Now, the FDA can inspect the facilities and test the supplements once they're being sold and take action if they're found to be unsafe. Dietary supplement manufacturers are also required to report and document serious adverse events, just like it's done for over-the-counter drugs.
DSHEA puts dietary supplements in a special category under foods, not drugs, and requires the supplements be labelled as dietary supplements.
"It has more to do with the nature of the ingredients. They're not synthesized," said Dr. Kingston. "Just because they're natural doesn't mean they're safe, but the reality is that if you look at the raw ingredients of these products, they've been extensively studied."
Dr. Kingston says dietary supplement manufacturers gather information about their product from event reports, medical literature and healthcare professionals.
In the case of "herbal Viagra" reportedly used by Odom, FDA officials had warned people against using the product. The FDA says its makers had tainted
DA laboratory analysis confirmed that Herb Viagra contains sildenafil, the active ingredient in the FDA approved prescription drug Viagra,
In the case of "herbal Viagra" reportedly used by Odom, the FDA did previously warn against using it. The FDA said laboratory analysis confirmed the "Herb Viagra" had been tainted with hidden ingredients, including sildenafil, the active ingredient in Viagra.
Dr. Kingston says that situation exposes a big problem about limited resources within the FDA.