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elmerjfudd

FDA launches tougher oversight of supplements

7 years ago
last modified: 7 years ago

Heading and following comments quoted from Washington Post

" the sector’s explosive growth has resulted in risks to consumers — such as an increase in supplements “spiked” with unlisted drug ingredients, and false and misleading claims about health benefits "

" the industry has allowed “bad actors” to sell dangerous products or ones that carry unproven claims. "

I'm surprised but pleased that there's a bit of enlightened thinking in the current administration, in the face of so many other actions in agencies that have cancelled or removed critical programs and policies. Action on this problem is long overdue.


Here's the article:

FDA's new approach to supplements

Comments (13)

  • 7 years ago

    Your article is locked to all but those who subscribe to WaPo.

  • 7 years ago

    It's not locked for me ,although I have been before. You're right Mr.Fudd -- it's about time.

  • 7 years ago
    last modified: 7 years ago

    Try a different browser, rob, or clear the browser's saved cache, cookies and files. I'm not a subscriber and I access articles without difficulty. When it says you've reached your free limit, clearing the browser and then restarting it resets your usage to zero.

  • 7 years ago

    I could see it. Bravo! Some oversight is definitely needed, about time in deed.

  • 7 years ago

    I copied and pasted for those not able to get in.


    FDA launches tougher oversight of supplements


    Agency plans to overhaul 25-year-old rules to protect consumers and spur innovation.

    By Laurie McGinley February 11 at 11:02 AM

    The
    Food and Drug Administration said Monday it plans to beef up oversight
    of the sprawling, $50-billion-a-year dietary supplements industry,
    warning that the sector’s explosive growth has resulted in risks to
    consumers — such as an increase in supplements “spiked” with unlisted
    drug ingredients, and false and misleading claims about health benefits.

    The
    agency underscored the need for greater oversight by announcing it had
    sent 12 warning letters and five advisory letters earlier this month to
    companies the FDA said are selling dozens of products that contain
    unapproved drugs or make illegal claims for treating Alzheimer’s and
    other serious diseases.


    FDA Commissioner Scott Gottlieb saidthe agency is planning policy changes
    that could lead to the most important regulatory modernization since
    enactment of the 1994 Dietary Supplement Health and Education Act, which
    considers supplements safe until proved otherwise.


    Gottlieb said in an interview that while most
    supplement makers are responsible, the huge growth in the industry has
    allowed “bad actors” to sell dangerous products or ones that carry
    unproven claims. “I’m concerned that changes in the supplement market
    may have outpaced the evolution of our own policies and our capacity to
    manage emerging risks,” he said.

    Under the 1994
    law, dietary supplements are regulated as food and, therefore, are not
    subject to premarket approval or the kind of safety and effectiveness
    testing required for drugs. Since the law was enacted, the industry has
    grown from 4,000 products and $4 billion a year in sales to as many as
    80,000 products and $50 billion in sales, according to the FDA.

    While the FDA doesn’t clear the products ahead of time, it is charged with removing unsafe ones from the market.


    Three out of four Americans take a dietary
    supplement on a regular basis, and for older Americans, the proportion
    is four out of five, the agency said. One in three children also take
    supplements.

    Gottlieb said he plans a “balanced
    approach” to improve safety, reduce inaccurate claims and encourage
    industry innovation. For example, the agency plans to create a
    rapid-response tool to quickly alert the public if a supplement contains
    an illegal and potentially dangerous ingredient. It intends to
    streamline the handling of supplements containing prescription drugs
    such as the generic version of Viagra and to increase enforcement
    actions.

    In a nod to the industry, he said the
    agency would review its regulations on new dietary ingredients to make
    sure they are flexible enough to ensure product improvements. And he
    promised to call a public meeting to discuss that and other topics.


    Gottlieb also waded into an intense debate over whether there should be a
    mandatory FDA registry where supplement makers would be required to
    list their products and ingredients. He said mandatory listing “could
    provide significant benefits by improving transparency in the
    marketplace” and allowing the FDA to focus its enforcement efforts. But
    he acknowledged that such a major change likely would require
    legislation.


    Manufacturers are supposed to register their
    facilities with the FDA — but are not required to list their products or
    ingredients. It’s not clear how many are complying with the minimal
    requirement. The result is that the agency doesn’t have a clear idea of
    who is making what.

    Sandra Eskin, who directs
    the food safety project at Pew Trusts, welcomed Gottlieb’s comments and
    stressed the need for mandatory listing. “FDA needs to know what
    supplement products each company makes, as well as the ingredients and
    copies of the product labels,” she said. “This information is the
    cornerstone of an effective oversight and enforcement system, and
    Congress should require that supplement companies provide it to the
    agency.”


    Steve Mister, president and chief executive of the
    Council for Responsible Nutrition, which represents supplement makers,
    said in a statement that the FDA “shares our vision to further develop
    the thriving, innovative and safe marketplace for dietary supplements.”

    Increasingly,
    officials and public health experts have become concerned about unsafe
    ingredients — such as the active ingredients in drugs, often from
    overseas — showing up in supplements. An analysis published in October,
    written by a team from the California Department of Public Health, found
    unapproved and sometimes dangerous drugs in 746 dietary supplements,
    almost all of them marketed for sexual enhancement, weight loss or
    muscle growth. The drugs included sildenafil — the active ingredient in
    Viagra — and steroids in muscle-building products.


    In the fall, the FDA warned consumers to avoid Rhino male enhancement products that contained sildenafil.
    It said it had received reports of people experiencing chest pain,
    severe headaches and prolonged erections after taking a Rhino product.
    The agency also warned companies marketing supplements for opioid addiction that contained an unapproved antidepressant called tianeptine.


    Dietary supplement makers are allowed to make what are called
    “structure/function claims” on how a nutrient or dietary ingredient
    affects the body — for example, “calcium builds strong bones.” But they
    aren’t permitted to say their products treat or cure specific diseases
    such as osteoporosis. Such claims would mean the product would be
    regulated as a drug and subject to premarket approval requirements.

  • 7 years ago
    last modified: 7 years ago

    Thank you solcalgal, that helps. Not only is the article available to anyone, it's the facts with no spin. I am encouraged that they've already taken specific action in sending letters to quacks.

  • 7 years ago

    Great news. Its surprising that this action has taken this long,given the rampant fraud in that industry.

  • 7 years ago
    last modified: 7 years ago

    Spin? The Washington Post article is mostly quotes from the FDA boss (same as in the press release). Then a short blip from a rep of the Pew Trusts, presumably a public interest org, followed by a short blip from a representative of an industry group, members of which are supplement manufacturers. So the article has the source and then a short comment from each of two sides of the issues.

    It seems to be as balanced as balanced could be. Did I miss something?

  • 7 years ago

    Long overdue. So happy to see that there will oversight regarding the quackery and the modern snake oil sales people.

  • 7 years ago

    Thank goodness. I hope they can put an end to the TV commercials and their fake promises. I hate to think how much money they make off of pepole's false hopes.

  • 7 years ago

    This is very good news, and thanks for posting. It is much needed, not only because of the false claims but because of the harvesting of endangered animals for some of these ingredients.

  • 7 years ago
    last modified: 7 years ago

    Despite the years of `warnings and incidents of dangerous and/or undisclosed ingredients, cautions from the medical community, the complete absence of testing or proven effectiveness for so many of the products, etc, etc., there are still people who are devoted to taking one or more products in the unregulated supplement market. And who are ready to tout the benefits they've experienced. We've all heard such comments from supplement users.

    It's too many people and too many products to attribute imagined benefits solely to the placebo effect. Is it instead attitudes of "maybe wishing will make it so", blind faith, or maybe it's ignoring better informed advice suggesting caution or avoidance that devoted users don't want to hear?

    Many smokers take the same approach and decide to ignore or tune out the conclusively accepted and proven findings of the adverse health effects of smoking they don't want to hear. With supplements, not all the press is about warnings but the other info is concerning ineffectiveness.

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