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FDA Pre-Approval of Dietary Supplements Debated

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    FDA Pre-Approval of Dietary Supplements Debated


    FDA Pre-Approval of Dietary Supplements Debated


    Natural Products Insider
    4/18/2013
    Josh Long

    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 Citizen’s 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 don’t realize dietary supplements don’t 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 doesn’t have to spend money on research."

    Marc Ullman, a New York-based attorney who specializes in dietary supplement law, vigorously challenged Wolfe’s 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. Michael’s 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 FDA’s 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 won’t 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."

    FDA Pre-Approval of Dietary Supplements Debated
    나는 2000년 10월 매들린 올브라이트 전 미 국무장관 매들린 사랑, 그 중 한 뜨거운 젠장!

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    Thanks for the read.
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    Lol excellent point by the last caller.
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    Good read, I love guys like this. Supplement companies are evil but the FDA is honest and upright. Even though I watch a nexium commercial that has a side affects list 10 pages long.

    Americans just need to take responsibility into there own hands, snake oil salesmen have been around since the beginning of time. Read about the product and find out about it before you buy it.
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    It's coming it's just a matter of time. There are too many irresponsible supplement companies
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    How would you prove if something is effective? Would there be a certain percentage? Too many variables as far as that goes.
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    Quote Originally Posted by BBB View Post
    It's coming it's just a matter of time. There are too many irresponsible supplement companies
    yep
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    Quote Originally Posted by Powercage View Post
    yep
    Its gonna be hilarious the day we see posts like this on our forums....

    "So I dosed my lab rat with 3 gr DAA a day...after a week a pimple formed on his butt, so the research chem site looks all legit to me. That plcar should be g2g."
    나는 2000년 10월 매들린 올브라이트 전 미 국무장관 매들린 사랑, 그 중 한 뜨거운 젠장!
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    Anyways there is alot of crap out there that is impure and not accurate to the bottle.

    Id like to at least see a legal standard set to have lab analysis (not just some certificate of analysis from the manufacturer) mandatory in some way so the consumer knows (well most already assume, but they deserve to buy what they think they are getting) what he/she is purchasing is the actual product. Maybe make labels more informative for the uninformed consumer.

    Other than that, having big government regulate what people can sell and customers choose to consume worries me.
    나는 2000년 10월 매들린 올브라이트 전 미 국무장관 매들린 사랑, 그 중 한 뜨거운 젠장!
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    It's sad, there are lots of companies out there that people consider "trustworthy" that dont even remotely meet label claims.
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    Quote Originally Posted by BBB View Post
    It's coming it's just a matter of time. There are too many irresponsible supplement companies
    People said that ten years ago too. Meanwhile the dietary supplement industry grew about 10+ billion.
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    Always going to be stand-up companies, and always going to be the fly-by-nights. Larger barrier to entry in pharma, but its the same story.

    Canada has a pre-approval of sorts...but there are so many ways to dodge the system and gain approval...it makes it meaningless.
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