FDA launches tougher oversight of supplements

Elmer J Fudd

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

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rob333 (zone 7a)

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

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Toomuchglass

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

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Elmer J Fudd

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.

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share_oh

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

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OklaMoni

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.

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socalgal_gw Zone USDA 10b Sunset 24
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rob333 (zone 7a)

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.

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amylou321

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

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Elmer J Fudd

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?

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watchmelol

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

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Elizabeth

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.

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OutsidePlaying

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.

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Elmer J Fudd

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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