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

Postby Julie G » Wed Feb 13, 2019 11:57 am

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

At this point, just sellers making unsubstantiated claims. Their list of "unsubstantiated" claims includes those that are supported with evidence. From memory:

-CoQ10 can support those taking statins
-B vitamins can help prevent AD
-L-Carnitine can help fight cognitive decline
-Curcumin can benefit those with Alzheimer's

This has a real "Big Brother" feel. Follow all of the links in this thread. The warning letters jumble false and supported claims together. The FDA is now deciding the level of evidence necessary to make a claim. (FWIW, I like to use the Alzheimer's Drug Development site Cognitive Vitality for a succinct place to find substantiating evidence for specific supps.)

I'm concerned that this may be a pre-cursor to broader crackdowns and Pharma controlled supps. :shock:

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

Postby bladedmind » Sun Mar 17, 2019 12:20 am

They’re back!

https://www.alzforum.org/news/community ... ement-hype

The campaign against Alzheimer’s supplements continues to roll out, now at Alzforum in much more detailed and passionate form, backed by more authorities, and urging the FDA to crack down. There are comments from credentialed researchers urging that only products proven in clinical trials should be allowed on the market.

I recognize that there is an unacceptable degree of charlatanry in the supplement industry, especially content fraud, and also exaggerated claims. Sophisticated consumers can avoid being taken in, but not everyone is sophisticated. However, official medicine can be harmfully doctrinaire and can be corrupt in some quarters (I accidentally stumbled into a pharmaceutical-sponsored and paid “medical conference” for physicians at an ocean resort that reeked of corruption and the provision of sexual favors - it felt like an ancient Roman banquet). We do live in a democracy and compromise is inevitable between elite providers wanting to outlaw anything not subject to strict trials and ailing citizens who want the freedom to choose the unproven and the risky. Freedom is the freedom to do wrong if it harms only yourself (John Stuart Mill, On Liberty).

Here is the shocking truth:

The FDA flagged multiple products from each company (see table). They span a wide range, from vitamins (particularly B, C, D, and E) and minerals such as selenium, to various herbal extracts such as echinacea root and milk thistle. The list also includes physiological compounds like melatonin and colostrum, antioxidants like glutathione, and non-essential amino acids such as L-carnitine and L-theanine, which is found in plants. Some of the products have been investigated in AD studies, including curcumin, green tea, ginkgo biloba, omega-3 fatty acids, and coenzyme Q (CoQ10).

https://www.alzforum.org/file/0308tablefortomjpg

Wouldn't want anyone taking a nonessential amino acid.

There are two things I find baffling about the Alzheimer’s campaign. First, to the extent that there are abuses in the supplement industry, they afflict the entire range of health issues, and there are implicit claims at less than the gold standard of evidence for thousands of products, from simple vitamins and minerals, or, picking arbitrarily, things like berberine for blood sugar or red yeast rice for cholesterol. Why single out Alzheimer’s, a minuscule portion of that market, especially when there is no effective official treatment for Alzheimer’s and greater risks are justified for people in later life who want to avoid the burdens of dementia for themselves and their families?

Second, the FDA action was the lightest possible sanction - a warning letter - sent to a handful of laughably marginal suppliers, among them a third-tier Alzheimer’s medical supply company that sells things like twiddle activity muffs for the demented, sanctioned because they offered an Alzheimer’s aromatherapy kit, and a herbalist (This Wonderful Life New Age Shop) in Malaysia for selling on an English-language website vegetable oils with claimed medicinal value. That’s like taking on Exxon by sending letters of inquiry to a few of its gas stations. I can’t make sense of it.

The FDA Commissioner had announced that he was going to modernize supplement regulation, but my impression from journalistic accounts (not knowing the policy debates in this field) is that he wanted to be more aggressive about content fraud and acting quickly on clearly harmful products. He is an interesting conservative and a qualified regulator who was leading a crackdown on vaping and its use among teens. He suddenly gave notice of resignation on March 5, news reports suggesting that he was forced out by Chamber of Commerce front groups who complained to the White House about the menace of “overregulation” of teen vaping.

Another wrinkle is that Sen. Orrin Hatch, the supplement industry’s champion, retired last year, and thus the industry is more vulnerable. https://www.latimes.com/business/hiltzi ... story.html

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

Postby circular » Wed Mar 20, 2019 8:49 am

Ugh, depressing. Looking for my spaceship in shining armor ...
ApoE 3/4 > Thanks in advance for any responses made to my posts.

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

Postby daarmr » Mon Mar 25, 2019 12:52 pm

This is refreshing to see. I am new here so bear with me.
My 87 year old mother is e3/e4 and I am e4/e4. I watched her all my life take supplements, eat well and exercise. In the last 8+ years I have watched her slowly melt away with AD despite doing all the things everyone says to do. I am 65 years old and basically I am scared that I am next and frantically looking to stack the odds in favor of not contracting it. Watching my mom and being an avid amateur researcher I am so confused. I already take 6 pills for cardiovascular, depression and thyroid in the morning and then I take 10 pills at night. If I follow Stavia in the great tutorial on this web site I will be taking about 6 more pills! Are our bodies lacking that much that we have to take all this everyday? Isn't every other day or every third day enough? I am glad to see the FDA finally taking a stance on corporations and all the others who prey on this very vulnerable group of people (including me). The End of Alzheimer's book was a refreshing change in the narrative surrounding this disease. I can't wait for more.

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

Postby dscoachRN » Mon Mar 25, 2019 6:11 pm

Welcome to the ApoE4 community!
Yes, know that the way you feel is true of how most of us came to this site. I'm so glad you've found the Primer and have chosen to start a conversation! It is very hard to see a parent decline in spite of healthy habits... I applaud the steps you've taken toward understanding how to become more empowered within this community. We have a chapter in our wiki that may help you access info of interest that's been posted: How to get the most out of ApoE4 info. We'd love to hear more in Our Stories. Are you considering working with a practitioner in the Bredesen program? We look forward to continuing the conversation with you!
dscoachRN

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

Postby Lucy5 » Mon Mar 25, 2019 10:50 pm

daamr wrote: This is refreshing to see. I am new here so bear with me.
My 87 year old mother is e3/e4 and I am e4/e4. I watched her all my life take supplements, eat well and exercise. In the last 8+ years I have watched her slowly melt away with AD despite doing all the things everyone says to do. I am 65 years old and basically I am scared that I am next and frantically looking to stack the odds in favor of not contracting it. Watching my mom and being an avid amateur researcher I am so confused. I already take 6 pills for cardiovascular, depression and thyroid in the morning and then I take 10 pills at night. If I follow Stavia in the great tutorial on this web site I will be taking about 6 more pills! Are our bodies lacking that much that we have to take all this everyday? Isn't every other day or every third day enough? I am glad to see the FDA finally taking a stance on corporations and all the others who prey on this very vulnerable group of people (including me). The End of Alzheimer's book was a refreshing change in the narrative surrounding this disease. I can't wait for more.

Welcome daarmr!
I am so sorry to hear about your mother's struggle with this disease. Please know that there is a shared purpose and passion in this wonderful community of ours to find strategies to delay and prevent cognitive decline. Following the growing body of research while sharing and learning from one another, many of us believe very strongly that there is so much we can do to impact our health going forward.

I believe you'll continue to find some very helpful, targeted guidance in our site Primer written by Stavia, a practicing physician and also E4/4. We understand absorbing all this information can be overwhelming initially (we've all been there!), so take your time and feel free to ask questions as they come up. Your questions regarding how to approach supplements are good ones that probably most of us have struggled with and likely continue to! There's considrable debate on this topic with, of course, the understanding that despite our common gene we are all unique and may respond differently to any intervention. That is why many of us test frequently along the way to see how our lifestyle changes (diet, sleep, stress reduction, excercise, supplements, etc) are impacting our results. It's also so important to pay attention to how you are feeling as you make these changes.

You may also want to browse through our Wiki for more in-depth discussions on topics of interest to our members. And to easily search through our forums for specific areas of interest to you (ie:supplements), just click on the magnifying glass along the upper right of this page.

daarmr, please don't hesitate to share with us how you're doing. This is a supportive community and we're here for you.
warmly, Lucy


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