FDA Pre-Approval of Dietary Supplements Debated

A research paper, revealing that a number of dietary supplements have been spiked with pharmaceutical ingredients, has ignited a debate over whether the $20 billion industry should be subject to more rigorous regulations.

Sidney Wolfe, M.D., the founder of the Public Citizens Health Research Group, said on a radio program that dietary supplements should have to be pre-approved like prescription drugs before they enter the market.

Most people dont realize dietary supplements dont have to be shown to be effective or safe," he said Wednesday, April 17 during an episode of AirTalk" on Southern California Public Radio. The dietary supplement industry, he added, thrives on the fact it doesnt have to spend money on research."

Marc Ullman, a New York-based attorney who specializes in dietary supplement law, vigorously challenged Wolfes implication that pre-approval of the products would solve the problem called out by the authors of the research paper: that some supplements are spiked with pharmaceutical ingredients, endangering consumers health.

The companies guilty of this behavior are "criminals" located outside the United States and selling products that are not actually supplements, but adulterated drugs, through the Internet, Ullman said on the radio broadcast.

What may change their behavior is if FDA uses their authority and can convince a U.S. attorney to prosecute these people in the chain of supply who put these products on the market," the lawyer said.

The live broadcast aired two days after a research letter was published online in the Journal of American Medical Association Internal Medicine. In that letter, researchers disclosed that slightly more than half (237) of the drugs that were subject to a class 1 recall" were dietary supplements from Jan. 1, 2004 through Dec. 19, 2012.

Class 1 recalls are those for which there is a reasonably probability that the use of or exposure to a product will cause serious adverse health consequences or death," the researchers stated.

Muhammad Mamdani, a research scientist at Toronto, Ontario, Canada-based St. Michaels Hospital who contributed to the paper, didn't seem convinced that supplements should require pre-approval. However, he advocated for further government regulation.

Because they can potentially cause serious harm, I think there should be some level of oversight," he said on the radio program. "How do you regulate a market that is not regulated right now? It becomes very difficult."

That kind of observation is maddening to trade associations, lawyers and supplement firms who are familiar with FDAs dietary- supplement regulations. Although the agency does not pre-approve a supplement before it is stocked on shelves, it has the authority to withdraw the product from the market for a number of reasons, including if it finds a supplement is adulterated" with an illegal substance such as a pharmaceutical drug.

Less than two weeks ago, Ullman observed, a supplement manufacturing facility in New York was shut down. Kabco Pharmaceuticals was found to be out of compliance with FDA regulations that govern the manufacturing of supplements, known more formally as cGMPs (current good manufacturing practices).

Requiring pre-approval of supplements would fundamentally impact companies' bottom line. During the radio program, a caller from Santa Monica, CA said the average cost to approve a drug is $150 million. Ullman, the lawyer, noted the figure is closer to $1 billion.

The notion of adding pre-approval would do nothing other than increase costs to consumers, drive companies out of business, create a structure where people wont be able to afford these products they want," he said.

"Don", who is one of the 150 million Americans who are said to take dietary supplements, wrote that he wanted to verify the products he was taking were what they purported to be but his doctor wouldn't comment on supplements. I'd rather have the FDA tell me about it efficacy and take the chance of a price rise," he stated in the comments section of the radio program.

Another commentator, blasting the federal government, indicated it wouldn't matter whether FDA pre-approved supplements.

"Come on FDA approved medication kills or harms people all the time," "ListenerOfFontana" wrote. "No one trusts FDA approval anymore."