Just in: FDA clamping down on supplements purported to influence AD

Alzheimer's, cardiovascular, and other chronic diseases; biomarkers, lifestyle, supplements, drugs, and health care.
circular
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Just in: FDA clamping down on supplements purported to influence AD

Postby circular » Mon Feb 11, 2019 10:08 am

FDA targets illegally marketed dietary supplements
The US Food and Drug Administration is taking new action against dietary supplements, sending warning letters to companies who claim, without proof, that their products can prevent or treat Alzheimer's, diabetes and cancer, the agency announced Monday.

The FDA vowed to update its policies on dietary supplements, promising "one of the most significant modernizations of dietary supplement regulation and oversight in more than 25 years," according to a statement by FDA commissioner Dr. Scott Gottlieb...

On Monday, the FDA sent 12 warning letters and five online advisory letters to companies marketing their products illegally as Alzheimer's treatments...

In his statement Monday, Gottlieb said plans were underway to enhance the agency's policies when it comes to dietary supplements -- including "new enforcement strategies" and "a new rapid-response tool to alert the public" of unsafe products. He said more details will be available "in the coming months."

I actually agree that supplement companies shouldn't be making inflated claims, in many case not any claims wrt their supplement products, but as many of us feel, there's a lot more to the story.
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Re: Just in: FDA clamping down on supplements purported to influence AD

Postby circular » Mon Feb 11, 2019 10:16 am

Wondering if the FDA, the Alzheimer's Association, and JAMA are in cahoots. In case anyone missed it, JAMA very recently published an editorial wrt this issue. Is the timing coincidence? Establishment Hostility to Alzheimer's Remediation

That said, the supplement industry is a mess, but so is conventional medicine.
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Re: Just in: FDA clamping down on supplements purported to influence AD

Postby circular » Mon Feb 11, 2019 10:19 am

Here are the latest warnings wrt AD supplements. I don't recognize any of the companies. It would be good if they really are unreliable and should be reigned in. IDK
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Re: Just in: FDA clamping down on supplements purported to influence AD

Postby circular » Mon Feb 11, 2019 10:41 am

Apparently there is a recent study out by the CDC, collaborating with the FDC, reporting on research into emergency room admissions due to supplements. The shallow journalism short take also interviews a naturopath to represent that perspective. It's in the video at the link in the OP.

I see the CDC has taken to using testimonials to make its points (at least wrt raw milk) :lol:
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Re: Just in: FDA clamping down on supplements purported to influence AD

Postby Josiah » Mon Feb 11, 2019 11:46 am

The pharmaceutical industry isn't very interested in any therapies that don't line their pockets and they're very good about putting their finger on the scale. Thanks for sharing this somewhat upsetting news.
E3/E3 male age 84

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Re: Just in: FDA clamping down on supplements purported to influence AD

Postby Julie G » Mon Feb 11, 2019 2:08 pm

Hmm, at first glance, this looks like a non-story. By all means, get Prevagen off the market. After following some of Circ's links, however, I'm not so sure. :shock: They're targeting Omega-3s, choline, and CoQ10. Seriously? I understand if manufacturers are making unsubstantiated claims but if they're simply selling supplements such as those above, will they also be taken down? Could this be a play for transitioning towards all Pharma-branded supps like Lovaza vs. Nordic Naturals, etc?

We're the wrong target audience given the lack of any effective treatment for Alzheimer's. This could be huge.

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Re: Just in: FDA clamping down on supplements purported to influence AD

Postby bladedmind » Mon Feb 11, 2019 2:53 pm

There are many cranks and charlatans marketing supplements. These warning letters do not have to do with fraud or purity, however, but with the sellers making health claims. The targeted companies are accused of selling “supplements” as “drugs.” Notice that many sellers plaster their website and their products with “Attention: These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.” https://www.cancer.org/treatment/treatm ... abels.html

I thought maybe FDA was cracking down on those who fail to include that boilerplate. In a quick check, one of the companies does repeat that FDA statement. However, it was selling dodgy multi-ingredient remedies with bold health claims for the ingredients and the products.

Items singled out that are relevant to Alzheimer’s include Vitamin D3, Alpha GPC, bacopa, rhodiola, ubiquinol, melatonin, zinc, alpha-lipoic acid, coQ10, curcumin, carnitine, vinpocetine, B complex, Vitamin C, omega 3s, glutathione, n-acetyl-cysteine, lion’s mane, gingko, citicoline, coconut oil, avocado oil, green tea extract, etc.

It’s odd that the FDA news release was titled FDA takes action against 17 companies for illegally selling products claiming to treat Alzheimer’s disease, because none of the podunk outfits selected specialized in such and Alzheimer’s products seemed to be less than half of the product claims busted (I didn't count).
https://www.fda.gov/NewsEvents/Newsroom ... 631064.htm
Are they picking on small companies because they are less sophisticated about compliance, or are less able to pay for lawyers, or is the FDA choking the chicken to scare the monkey?
Alzheimer’s is a challenging disease that, unfortunately, has no cure. Any products making unproven drug claims could mislead consumers to believe that such therapies exist and keep them from accessing therapies that are known to help support the symptoms of the disease, or worse as some fraudulent treatments can cause serious or even fatal injuries.
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The threat of supplements diverting patients way from doctor-prescribed treatments for Alzheimer’s was also a main point in the JAMA/UCSF manifesto. When you see identical points in the news on an obscure topic that's a sign of organized public-relations activity by someone.

The news release and the resulting CNN story went on a good bit about impurity and fraud - but that’s misleading because none of the 17 companies was accused of either. That seems to me like a propagandistic maneuver: If there's impurity or fraud, prosecute them and provide the facts; rather than loosely implying that the 17 were guilty of such.

We citizens can discuss health claims with no hazard, as long as we're not selling something purported to treat disease.



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Re: Just in: FDA clamping down on supplements purported to influence AD

Postby bladedmind » Tue Feb 12, 2019 12:08 pm

Here are mugshots of the supplement culprits, courtesy of FDA.
https://www.flickr.com/photos/fdaphotos ... 056065697/
I feel sorry for the little essential-oils Alzheimer’s remedies from the New Age shop in Malaysia being displayed for public shaming.

More FDA links here:
https://www.fda.gov/ForConsumers/Protec ... 622714.htm

The FDA can be annoying, but I think a world without it would be worse. The FDA action seems to be extremely mild, mere warnings or compliance inquiries to small sellers and even resellers making unqualified health claims. Intended to make the larger supplement industry more careful about Alzheimer's health claims?

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Re: Just in: FDA clamping down on supplements purported to influence AD

Postby Julie G » Tue Feb 12, 2019 6:03 pm

The threat of supplements diverting patients way from doctor-prescribed treatments for Alzheimer’s was also a main point in the JAMA/UCSF manifesto. When you see identical points in the news on an obscure topic that's a sign of organized public-relations activity by someone.

Agree. This feels organized. I understand going after manufacturers who make false claims but following up on some of these FDA warning letters is a bit scary. They're going mainstream supps like B vitamins, D3, Omega-3s, Co-Q10, etc. I wonder if this is a trial run hitting fringe manufacturers to see if there's consumer pushback before going broader?

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Re: Just in: FDA clamping down on supplements purported to influence AD

Postby mike » Wed Feb 13, 2019 9:09 am

Julie G wrote:They're going mainstream supps like B vitamins, D3, Omega-3s, Co-Q10, etc. I wonder if this is a trial run hitting fringe manufacturers to see if there's consumer pushback before going broader?

Are they going after these particular supplements wholesale, or are they going after companies claiming unsupported benefits from these supplements?
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