Do these things cause dementia?

Caregivers, and healthcare professionals,here is some great information

Here is a great dementia resource for caregivers and healthcare professionals,

Follow alzheimersideas on twitter
The Dementia Caregiver's Little Book of Hope [Kindle Edition]

Your residents will love the Amazon Kindle Fire

Here is information on being the best caregiver you can be

Here is a way for nurses administrators, social workers and other health care  professionals to get an easyceu or two

Which of these cause Alzheimer's: 
1) Flu shots?
2) Aluminum?
3) Statin drugs?
See the latest research. 

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Video on Aluminum and Flu Shots

Statins

Researchers question whether there is substance to the US Food and Drug Agency's recent warning that statins could affect the memory, attention span and other cognitive abilities of people who take this drug to control high cholesterol. This follows a systematic review of 25 clinical trials incorporating nearly 47,000 people. It was led by Brian R. Ott, M.D., director of The Alzheimer's Disease & Memory Disorders Center at Rhode Island Hospital and professor at the Alpert Medical School of Brown University in the U.S. The review findings¹ appear in the Journal of General Internal Medicine², published by Springer. 

Since 2012, the FDA regulates that labels on statin packaging should warn that the drugs could change users' cognitive abilities. These cognitive changes could include attention span, problem solving, memory, and language or visuospatial abilities. The warning was based on surveillance and case reports, observational studies and randomized trials.

Subsequent reviews of available research have cast doubts on the cautionary stance taken by the FDA. Ott's team therefore set out to do a more comprehensive analysis using well-studied analysis methods. They scrutinized the data of 25 relevant randomized clinical trials that investigated a possible link between statin therapy and mental ability. Combined, these studies included the test results of 46,836 patients. Ott and his colleagues also contrasted and combined the results of 14 of these studies through a meta-analysis, which in total included 27,643 participants.

The review found no significant effect of statin use on the mental capacity of either people with normal brain functioning or even those with Alzheimers' disease. The results suggest that the FDA's statin warning should be re-evaluated. Ott also believes there is a need to investigate the reasons behind the differences in the review results and the initial reports on which the FDA warning was based. It could be that some of the mental changes that were reported in the case studies were the result of overdosing with statins.

The review findings are congruent with the 2013 safety statement made by the American College of Cardiology and the American Heart Association Cholesterol Guideline. It advises that patients on statins who seem to be confused or who might have memory problems should be evaluated for causes other than their cholesterol medication. This could include the use of other drugs or systemic and neuro-psychiatric causes.

The researchers believe that there is more benefit to be had by sticking to statin therapy to manage heart-related diseases and prevent strokes than worrying about the possible adverse mental effects of these drugs.

"We found no significant effects of statin treatment on cognition," concludes Ott. "Given these results, it is questionable whether the FDA class warning about potential cognitive adverse effects of statins is still warranted.."

How to pick the right gift for those with dementia for Mother's Day

Activities directors and other healthcare professionals here is a great dementia resource for caregivers and healthcare professionals.

Here is information on being the best caregiver you can be

Here is a way for nurses administrators, social workers and other health care  professionals to get an easyceu or two



Choosing the right present for someone with Alzheimer's disease or a related dementia is certain to give him/her joyful times independently or with a loved one. Here are some tips on how to pick a perfect gift. You can give a gift anytime, but Mother's Day is coming soon which is a perfect opportunity to give that special someone a special gift.

Over 5.4 million Americans are living with dementia. Is one of them someone you know or a client of yours? Get him/her or anyone with Alzheimer's disease or another dementia, a gift that will keep on giving
Of course, person appropriate offerings are the best. This means matching a gift to a person's interests and abilities, However, there are some presents that will make them smile no matter what.

One such gift is a book by Susan Berg called Adorable Photographs of Our Baby -- Meaningful, Mind-Stimulating Activities and More for the Memory Challenged, Their Loved Ones and Involved Professionals, This book features baby photographs that seniors with dementia love. This book shares a plethora of ideas and resources for you. Mothers especially love babies

Another gift dementia persons will fancy is a classic musical video or DVD especially a musical love story. A classic movie of this type is Rogers and Hammerstein's movie, Carousel (1945) or South Pacific (1949)


click here for the whole story

Is there a relation between Alzheimer's and sleep?

Caregivers, and healthcare professionals,here is some great information

Here is a great dementia resource for caregivers and healthcare professionals,

Follow alzheimersideas on twitter
The Dementia Caregiver's Little Book of Hope [Kindle Edition]

Your residents will love the Amazon Kindle Fire

Here is information on being the best caregiver you can be

Here is a way for nurses administrators, social workers and other health care  professionals to get an easyceu or two

• University of California - Berkeley

The link between sleep, beta-amyloid and Alzheimer's is increasingly clear. Beta-amyloid deposition leads to a vicious cycle - it disturbs sleep and impairs memory, which trigger further deposition. Learn what it means for lowering Alzheimer's risk and improving sleep habits. 

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Scientists at the University of California, Berkeley, have found compelling evidence that poor sleep -- particularly a deficit of the deep, restorative slumber needed to hit the save button on memories -- is a channel through which the beta-amyloid protein believed to trigger Alzheimer's disease attacks the brain's long-term memory. (Beta-amyloid is the protein that makes up the toxic plaque that is the most common suspect behind Alzheimer's.)

"Our findings reveal a new pathway through which Alzheimer's disease may cause memory decline later in life," said UC Berkeley neuroscience professor Matthew Walker, senior author of the study to be published in the journalNature Neuroscience.

Excessive deposits of beta-amyloid are key suspects in the pathology of Alzheimer's disease, a virulent form of dementia caused by the gradual death of brain cells. An unprecedented wave of aging baby boomers is expected to make Alzheimer's disease, which has been diagnosed in more than 40 million people, one of the world's fastest-growing and most debilitating public health concerns.

The Good News

The good news about the findings, Walker said, is that poor sleep is potentially treatable and can be enhanced through exercise, behavioral therapy and even electrical stimulation that amplifies brain waves during sleep, a technology that has been used successfully in young adults to increase their overnight memory.

"This discovery offers hope," he said. "Sleep could be a novel therapeutic target for fighting back against memory impairment in older adults and even those with dementia."

The study was co-led by UC Berkeley neuroscientists Bryce Mander and William Jagust, a leading expert on Alzheimer's disease. The team has received a major National Institutes of Health grant to conduct a longitudinal study to test their hypothesis that sleep is an early warning sign or biomarker of Alzheimer's disease.

Real People

While most research in this area has depended on animal subjects, this latest study has the advantage of human subjects recruited by Jagust, a professor with joint appointments at UC Berkeley's Helen Wills Neuroscience Institute, the School of Public Health and the Lawrence Berkeley National Laboratory.

"Over the past few years, the links between sleep, beta-amyloid, memory, and Alzheimer's disease have been growing stronger," Jagust said. "Our study shows that this beta-amyloid deposition may lead to a vicious cycle in which sleep is further disturbed and memory impaired."

Using a powerful combination of brain imaging and other diagnostic tools on 26 older adults who have not been diagnosed with dementia, researchers looked for the link between bad sleep, poor memory and the toxic accumulation of beta-amyloid proteins.

"The data we've collected are very suggestive that there's a causal link," said Mander, lead author of the study and a postdoctoral researcher in the Sleep and Neuroimaging Laboratory directed by Walker. "If we intervene to improve sleep, perhaps we can break that causal chain."

A buildup of beta-amyloid has been found in Alzheimer's patients and, independently, in people reporting sleep disorders. Moreover, a 2013 University of Rochester study found that the brain cells of mice would shrink during non-rapid-eye-movement (non-REM) sleep to make space for cerebrospinal fluids to wash out toxic metabolites such as beta-amyloid.

How It Works

"Sleep is helping wash away toxic proteins at night, preventing them from building up and from potentially destroying brain cells," Walker said. "It's providing a power cleanse for the brain."

Specifically, the researchers looked at how the quantity of beta-amyloid in the brain's medial frontal lobe impairs deep non-REM sleep, which we need to retain and consolidate fact-based memories.

In a previous study, Mander, Jagust and Walker found that the powerful brain waves generated during non-REM sleep play a key role in transferring memories from the hippocampus -- which supports short-term storage for information -- to longer-term storage in the frontal cortex. In elderly people, deterioration of this frontal region of the brain has been linked to poor-quality sleep.

For this latest study, researchers used positron emission tomography (PET) scans to measure the accumulation of beta-amyloid in the brain; functional Magnetic Resonance Imaging (fMRI) to measure activity in the brain during memory tasks; an electroencephalographic (EEG) machine to measure brain waves during sleep; and statistical models to analyze all the data.

The research was performed on 26 older adults, between the ages of 65 and 81, who showed no existing evidence of dementia or other neurodegenerative, sleep or psychiatric disorders. First, they each received PET scans to measure levels of beta-amyloid in the brain, after which they were tasked with memorizing 120 word pairs, and then tested on how well they remembered a portion of them.

The study participants then slept for eight hours, during which EEG measured their brain waves. The following morning, their brains were scanned using fMRI as they recalled the remaining word pairs. At this point, researchers tracked activity in the hippocampus, where memories are temporarily stored before they are transferred to the prefrontal cortex.

Memory & Sleep

"The more you remember following a good night of sleep, the less you depend on the hippocampus and the more you use the cortex," Walker said. "It's the equivalent of retrieving files from the safe storage site of your computer's hard drive, rather than the temporary storage of a USB stick."

Overall, the results showed that the study participants with the highest levels of beta-amyloid in the medial frontal cortex had the poorest quality of sleep and, consequently, performed worst on the memory test the following morning, with some forgetting more than half of the information they had memorized the previous day.

"The more beta-amyloid you have in certain parts of your brain, the less deep sleep you get and, consequently, the worse your memory," Walker said. "Additionally, the less deep sleep you have, the less effective you are at clearing out this bad protein. It's a vicious cycle.

"But we don't yet know which of these two factors -- the bad sleep or the bad protein -- initially begins this cycle. Which one is the finger that flicks the first domino, triggering the cascade?" Walker added.

And that's what the researchers will determine as they track a new set of older adults over the next five years. 
"This is a new pathway linking Alzheimer's disease to memory loss, and it's an important one because we can do something about it," Mander said.

Source:

• University of California - Berkeley

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Journal Reference:

1. Matthew P Walker et al. β-amyloid disrupts human NREM slow waves and related hippocampus-dependent memory consolidation. Nature Neuroscience, June 2015 DOI: 10.1038/nn.4035

Can psuedodementia be cured?

Caregivers, and healthcare professionals,here is some great information

Here is a great dementia resource for caregivers and healthcare professionals,

Follow alzheimersideas on twitter
The Dementia Caregiver's Little Book of Hope [Kindle Edition]

Your residents will love the Amazon Kindle Fire

Here is information on being the best caregiver you can be

Here is a way for nurses administrators, social workers and other health care  professionals to get an easyceu or two

• Psychological Masquerade: distinguishing Psychological from Organic Disorders
  By Dr. Robert L. Taylor, MD, Published by Springer Publishing Company, 2007
• Clinical Concerns: Dementia, Depression, or Both? Differentiating in Older Patients The Canadian Journal of Diagnosis. October 2012.

Pseudodementia walks and talks like dementia, but it often responds positively, with treatment permanently improving cognition. Learn how recognizing the difference can change one's life.

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Pseudodementia was first coined in 1961 by psychiatrist Leslie Kiloh. Dr. Kiloh noticed patients with cognitive symptoms consistent with dementia who improved with treatment, a pattern inconsistent with the progressive neurodegenerative nature of dementia.

Diagnosis

Pseudodementia can be caused by a large variety of underlying disorders, but most commonly, it is depression masquerading as dementia. 

Depressed elderly patients may exhibit substantial cognitive deficits. To further complicate the clinician's task, people with dementia are often depressed. For example, 20% to 40% of Alzheimer's patients have major depression (Brown, 2005). This makes the relationship between depression and dementia very complicated. So the question is how to differentiate the two. 

In unusual cases, pseudodementia may be misdiagnosed based on causes that are “not real” and even “fake”. This is worth noting because it occurs often enough that professionals, caregivers and patients can benefit from being aware of it. 

Pseudodementia can be the result of psychological tension that is not caused by a physical illness. 

Notwithstanding, it is more likely that it is caused by a real brain pathology.

Telling Depression & Dementia Apart

In contrast to the gradual onset of dementia, pseudodemented depression comes on rapidly. Furthermore, whereas the pseudodemented patient appears distressed and may express fear of losing his mind, the person with true dementia often seems relatively unconcerned and tends to minimize his problem.

Continued below table... 
Source: Clinical Concerns 

The truly demented patient is usually inattentive and has greater impairment of recent than remote memory. In contrast, the depressed patient, though attentive, will complain of both kinds of memory loss and then test better than what he describes. He is also more likely to have had previous similar episodes.

While a demented person may cooperate and try to bluff his way through the testing, the pseudodemented person is often uncooperative, insisting that he cannot do it. This should not be confused with malingering but seen more as a reflection of the feeling of inadequacy that goes along with serious depression.

Treating Pseudodementia

When treated (as depression), in contrast to true dementia, pseudodementia often responds positively. While the depression may be treatable, treatment rarely achieves a full reversal of the cognitive impairment that made the doctor suspect dementia.

Risk Factors

Unfortunately, recent studies suggest pseudodementia carries an increased risk for the subsequent development of true dementia (Brown, 2005). It may turn out that depression in the elderly, at least in some cases, is an early signal of dementia. Still, if at the initial presentation the problem is mainly depression, it is important that it be recognized and treated accordingly.

Clinical Suspicion is Essential

In summary, psychiatric symptoms that bring on dementia-like deficits in the elderly result from a host of conditions. Many of them are readily treatable, if properly recognized. The term "pseudodementia" provides a "starting" language that offers a useful step in getting to a more accurate diagnosis and treatment. A high index of clinical suspicion is essential.
SOURCES:

• Psychological Masquerade: Ddistinguishing Psychological from Organic Disorders
  By Dr. Robert L. Taylor, MD, Published by Springer Publishing Company, 2007
• Clinical Concerns: Dementia, Depression, or Both? Differentiating in Older Patients The Canadian Journal of Diagnosis. October 2012.

Dangerous dementia supplements

Caregivers, and healthcare professionals,here is some great information

Here is a great dementia resource for caregivers and healthcare professionals,

Follow alzheimersideas on twitter
The Dementia Caregiver's Little Book of Hope [Kindle Edition]

Your residents will love the Amazon Kindle Fire

Here is information on being the best caregiver you can be

Here is a way for nurses administrators, social workers and other health care  professionals to get an easyceu or two

• FDA: U.S. Food & Drug Administration
  The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
• FDA 2019 Warning Letters

17 Alzheimer's supplement manufacturers just received FDA warnings about 58 illegal below-standard products. 

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The U.S. Food and Drug Administration today posted 12 warning letters and 5 online advisory letters issued to foreign and domestic companies that are illegally selling more than 58 products, many that are sold as dietary supplements, which are unapproved new drugs and/or misbranded drugs that claim to prevent, treat or cure Alzheimer’s disease and a number of other serious diseases and health conditions. 

These products, which are often sold on websites and social media platforms, have not been reviewed by the FDA and are not proven safe and effective to treat the diseases and health conditions they claim to treat. These products may be ineffective, unsafe and could prevent a person from seeking an appropriate diagnosis and treatment. 

Protect Against Alzheimer's Scams

“Science and evidence are the cornerstone of the FDA’s review process and are imperative to demonstrating medical benefit, especially when a product is marketed to treat serious and complex diseases like Alzheimer’s. 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. Simply put, health fraud scams prey on vulnerable populations, waste money and often delay proper medical care – and we will continue to take action to protect patients and caregivers from misleading, unproven products,” said FDA Commissioner Scott Gottlieb, M.D. 

“Today’s actions are part of the FDA’s larger effort to address the booming growth of the dietary supplement industry through the implementation of modern regulatory initiatives that will enable the agency to preserve the balanced vision of the Dietary Supplement Health and Education Act (DSHEA), enacted by Congress 25 years ago. That law sought to achieve the right balance between preserving consumers’ access to lawful supplements, promoting innovation in these products, while upholding our obligation to protect the public from unsafe and unlawful products and holding accountable those actors who are unable or unwilling to comply with the requirements of the law. Our newest policy efforts will seize the game-changing opportunity to further strengthen the regulatory framework overseeing dietary supplements and will hone in on important steps to both promote industry innovation while upholding the safety of these products as part of our overall commitment to protecting public health.” 

In a statement issued today, FDA Commissioner Gottlieb also outlined several important new actions and policy priorities the agency will take in the coming months to improve the safety of dietary supplements and purported dietary supplements, including efforts to more rapidly communicate potential safety issues with dietary supplement products with the public, establishing a flexible regulatory framework that promotes innovation and upholds product safety and other, new steps the FDA could consider taking to better ensure product safety and integrity.

Unapproved or Misbranded Alzheimer's Drugs

The products cited in the warning and online advisory letters posted today are unapproved new drugs and/or misbranded drugs that claim to prevent, treat or cure Alzheimer’s disease and a number of other serious diseases and health conditions, and have been sold in violation of the Federal Food, Drug, and Cosmetic Act. The products include a variety of product types, such as tablets, capsules and oils. The companies have been asked to respond to the FDA within 15 days of receipt of the letters, stating how the violations outlined in the agency’s letters will be corrected. Failure to correct the violations promptly may result in legal action, including product seizure and/or injunction.

40 Alzheimer's Warning Letters on 80 Products

As part of the FDA’s effort to protect consumers from Alzheimer’s disease health fraud, the FDA has issued more than 40 warning letters in the past five years to companies illegally marketing over 80 products making Alzheimer’s disease claims on websites, social media and in stores. We’ve also taken action in recent years against companies and dietary supplements making similar claims for the treatment of serious conditions such as cancer and opioid addiction. Although these companies may have stopped selling the products or making unproven claims, numerous unsafe and unapproved products continue to be sold directly to consumers due in part to the ease with which companies can move their marketing operations to new websites. 

The FDA continues to encourage consumers to remain vigilant whether online or in a store in order to avoid purchasing products that claim to prevent, treat or cure diseases without any proof they will work. Health care professionals and consumers are also advised to report adverse reactions associated with these or similar products to the agency’s MedWatch program.

Supplements Statement by FDA Commissioner Scott Gottlieb, M.D.

SILVER SPRING, Md. -- The use of dietary supplements, such as vitamins, minerals or herbs, has become a routine part of the American lifestyle. Three out of every four American consumers take a dietary supplement on a regular basis. For older Americans, the rate rises to four in five. And one in three children take supplements, either given to them by their parents or, commonly in teens, taking them on their own. 

That's why today we are announcing a new plan for policy advancements with the goal of implementing one of the most significant modernizations of dietary supplement regulation and oversight in more than 25 years.

Benefits of Safe, High-Quality Supplements

I've personally benefited from the use of dietary supplements and, as a physician, recognize the benefits of certain supplements as a part of a comprehensive care plan. It's clear to me that dietary supplements play an important role in our lives as we strive to stay healthy. It's also clear that the U.S. Food and Drug Administration plays an important role in helping consumers make use of safe, high-quality dietary supplements while also protecting Americans from the potential dangers of products that don't meet the agency's standards for marketing. 

In the 25 years since Congress passed the Dietary Supplement Health and Education Act (DSHEA), the law that transformed the FDA's authority to regulate dietary supplements, the dietary supplement market has grown significantly. What was once a $4 billion industry comprised of about 4,000 unique products, is now an industry worth more than $40 billion, with more than 50,000 – and possibly as many as 80,000 or even more – different products available to consumers.

Dangerous, Unproven or Misleading Supplements

DSHEA imposes a number of requirements around the manufacture and labeling of dietary supplements. We know that most players in this industry act responsibly. But there are opportunities for bad actors to exploit the halo created by quality work of legitimate manufacturers to instead distribute and sell dangerous products that put consumers at risk. As the popularity of supplements has grown, so have the number of entities marketing potentially dangerous products or making unproven or misleading claims about the health benefits they may deliver. 

Making healthy choices about diets can have a significant and positive impact on Americans' health. To be able to make those choices with respect to dietary supplements, consumers need to have access to safe, well-manufactured, and appropriately labeled products. One of my top goals is ensuring that we achieve the right balance between preserving consumers' access to lawful supplements, while still upholding our solemn obligation to protect the public from unsafe and unlawful products, and holding accountable those actors who are unable or unwilling to comply with the requirements of the law.

Announcing New, Confidence Inspiring Steps

Today, we're announcing new steps we intend to advance to achieve these twin goals. These steps include communicating to the public as soon as possible when there is a concern about a dietary supplement on the market, ensuring that our regulatory framework is flexible enough to adequately evaluate product safety while also promoting innovation, continuing to work closely with our industry partners, developing new enforcement strategies and continuing to engage in a public dialogue to get valuable feedback from dietary supplement stakeholders. 

The opportunity to strengthen the framework that governs dietary supplements couldn't come at a more pivotal time. On the one hand, advances in science and the growth and development in the dietary supplement industry carries with it many new opportunities for consumers to improve their health. At the same time, the growth in the number of adulterated and misbranded products – including those spiked with drug ingredients not declared on their labels, misleading claims, and other risks – creates new potential dangers. 

Legitimate industry benefits from a framework that inspires the confidence of consumers and providers. Patients benefit from products that meet high standards for quality.

Dietary Supplement Health and Education Act (DSHEA)

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. To continue to fulfill our public health obligations we need to modernize and strengthen our overall approach to these products. Toward these goals, the FDA is committing to new priorities when it comes to our oversight of dietary supplements at the same time that we carefully evaluate what more we can do to meet the challenge of effectively overseeing the dietary supplement market while still preserving the balance struck by DSHEA.

Supplement Warnings and Advisories

As part of our comprehensive efforts, today we sent 12 warning letters and five online advisory letters to companies whose products, many of which are marketed as dietary supplements, are being illegally marketed as unapproved new drugs because the products bear unproven claims to prevent, treat or cure Alzheimer's disease, as well as a number of other serious diseases and health conditions, including diabetes and cancer. Products intended to treat Alzheimer's disease must gain FDA approval before they are sold in order to help ensure they are safe and effective for their intended medical use. Dietary supplements can, when substantiated, claim a number of potential benefits to consumer health, but they cannot claim to prevent, treat or cure diseases like Alzheimer's. Such claims can harm patients by discouraging them from seeking FDA-approved medical products that have been demonstrated to be safe and effective for these medical conditions. In recent years, we've also taken action against companies and dietary supplements making similar claims regarding treatment of serious conditions such as cancer and opioid addiction. These enforcement actions are just one part of our overall efforts to update our policy framework governing dietary supplements. 

At the FDA, we have an obligation to ensure that we're using the resources that we have as efficiently and effectively as we can, and as we engage in discussions about whether our existing resource levels are adequate, I take that obligation very seriously. That's why I recently directed the establishment of a Dietary Supplement Working Group at the FDA, led out of my office and comprised of representatives from multiple centers and offices across the agency. I've tasked this group with taking a close look at our organizational structures, processes, procedures and practices in order to identify opportunities to modernize our oversight of dietary supplements.

Office of Dietary Supplement Programs (ODSP)

Additionally, when the FDA created the Office of Dietary Supplement Programs (ODSP) three years ago, the agency recognized that keeping up with the evolving marketplace meant giving dietary supplement regulation more attention and making it a higher priority. One of the things that this office has done is to articulate the FDA's strategic priorities on dietary supplements to ensure that we're focusing our attention and using our resources in ways that make sense. 

Our first priority for dietary supplements is ensuring safety. Above all else, the FDA's duty is to protect consumers from harmful products. Our second priority is maintaining product integrity: we want to ensure that dietary supplements contain the ingredients that they're labeled to contain, and nothing else, and that those products are consistently manufactured according to quality standards. Our third priority is informed decision-making. We want to foster an environment where consumers and health care professionals are able to make informed decisions before recommending, purchasing or using dietary supplements. 

In the coming months, we'll be providing additional details on the steps we are taking to continue moving our dietary supplement program forward to implement these priorities. Our new approach benefits consumers by balancing new policies to promote innovation and efficiency in the marketplace for dietary supplements with increased steps to protect the public from potential safety issues.

FIRST OF FIVE IMPORTANT STEPS

Today, I'm also announcing the first of several important steps to help advance our important policy goals. Among the steps that we're considering or actively formulating, first are new ways to communicate more quickly when we have concerns that an ingredient is unlawful and potentially dangerous and should not be marketed in dietary supplements. We're developing a new rapid-response tool to alert the public so consumers can avoid buying or using products with that ingredient, and to notify responsible industry participants to avoid making or selling them.

SECOND

Second, we also need to ensure that our regulatory framework is flexible enough to adequately evaluate product safety while promoting innovation. The key to this effort will be important steps to foster the submission of new dietary ingredient (NDI) notifications. An effective NDI notification process represents the FDA's only opportunity to evaluate the safety of a new ingredient before it becomes available to consumers and helps promote transparency and risk-based allocation of resources. We're continuing to develop guidance for preparing NDI notifications to ensure FDA can thoroughly review the safety of these ingredients. In conjunction with this effort, we're planning to update our compliance policy regarding NDIs. 

We know these are important and timely issues and we're also planning a public meeting this spring on the topic of responsible innovation in the dietary supplement industry. I expect the feedback received during this meeting will be essential as we move to modernize our approach toward NDIs. We'll look to address other challenges that may act as barriers to dietary supplement innovation and safety including issues such as what the right incentives might be for establishing dietary supplement exclusivity, and the scope of permitted dietary ingredients. We invite all our stakeholders to share their views on how the FDA should strengthen the dietary supplement program for the future. So, please stay tuned for more information regarding registration and logistics.

THIRD

Third, as with other commodities that the agency regulates, it's critical that the FDA continue to work closely with our partners in industry to achieve our primary goal of protecting public health and safety. As the dietary supplement industry develops new products and ingredients, advances new delivery systems and innovates in other ways, the FDA must do more to leverage its existing resources and authorities to evaluate these products. This requires collaborative research and a shared understanding. I'm pleased to announce that we've recently created the Botanical Safety Consortium, a public-private partnership that will gather leading scientific minds from industry, academia and government to promote scientific advances in evaluating the safety of botanical ingredients and mixtures in dietary supplements. This group will look at novel ways to use cutting-edge toxicology tools, including alternatives to animal testing, to promote the goals of safety and effectiveness we share with consumers and other stakeholders.

FOURTH

Fourth, we'll continue to take actions to protect public health – like those we took today for illegal Alzheimer's disease products – and develop new enforcement strategies, as a key element of our approach to protecting consumers as the risks evolve. We're already making our internal processes more efficient for taking enforcement action when products claiming to be supplements contain unlawful ingredients, including drug ingredients. For example, last April we took strong action to protect consumers from the dangers of dietary supplement products marketed in bulk and containing pure and highly concentrated caffeine. We warned consumers in November to not purchase Rhino male enhancement products because they were unapproved new drugs that contained sildenafil and/or tadalafil, which are among active ingredients in the FDA-approved prescription drugs Viagra and Cialis. During the same month, we issued warnings to companies for unlawfully marketing as dietary supplement products that contained a compound called tianeptine; these products were unapproved new drugs that bore unproven claims that the products could be used to treat opioid addiction. We've also been active with compliance and enforcement efforts against firms that have shown persistent inability to comply with the current good manufacturing practice requirements for dietary supplements, and taking action to protect the public against unsafe imports and recalled products.

FIFTH

Finally, we'll engage a public dialogue around whether additional steps to modernize DSHEA are necessary. We've heard from stakeholders who want to open such a dialogue. While the FDA is committed to leveraging its existing resources and authorities to the fullest extent possible, we believe there may be value in a broader public conversation about whether certain changes to the law might be helpful. We believe there may be opportunities to modernize DSHEA for the future, while preserving the law's essential balance. For example, some stakeholders have suggested that the statute should be amended to establish avenues for dietary supplement exclusivity and add a product listing requirement. A mandatory listing requirement could provide significant benefits by improving transparency in the marketplace and promoting risk-based regulation. It could also help facilitate efficient enforcement of the law and establish new mechanisms to identify bad actors who put the public at risk and undermine consumer confidence in the entire industry. 

We're interested in hearing other ideas our stakeholders may have, and not just those limited to changes to the law, so we can go about the task of regulating this space in a way that reflects where the industry is today, and continue to safeguard consumers' ability to access safe, compliant dietary supplements for the next 25 years. For example, is it possible to design a product listing regime that helps us protect consumers and level the playing field for responsible industry participants by making it easier for us to take swift action against illegitimate and dangerous products, such as products that are tainted with drug ingredients? And is it possible to do this without disrupting the balance struck by DSHEA, and without imposing any significant new burdens on responsible firms? The answer to these questions may very well be yes. And if that's the case, these are absolutely things that we should be talking about. 

I'm confident that the efforts we're announcing today, and the ones that we'll continue to advance in the months and years to come, will help us achieve these goals on behalf of consumers. The steps outlined today highlight both where we are currently and where we look forward to moving toward. We are eager to continue our work with both our industry partners and dietary supplement consumers and will announce more upcoming ideas that we hope to roll out in the near future.

Company Name (Click name for FDA Warning)	Alzheimer's Disease Product Name1	Image2 (Click Image to Enlarge)
Blue Ridge Silver	Collodial Silver
BR Naturals	Avocado Oil Unrefined Coconut Oil
DK Vitamins	Cognispark Gammadyn Mn-Co Melatonin Ubiquinol CoQ10 Vinpurazine Zinc Picolinate Formula
Earth Turns, LLC	Cogni-Flex Fundamental Omega-3 Green Tea Extract
Gold Crown Natural Products	New Ultra Colostrum Melatonin with Valerian
Emmbros Overseas Lifestyle PVT LTD.	Morpheme Remedies Memocare Plus Morpheme Remedies Mind Plus
John Gray's Mars Venus LLC	L-Glutathione Liposomal DHA – Ultimate Omega-3 Brain Support Liposomal Methyl B12/Folate NAC N-Acetyl-L-Cysteine
Nutrition Coalition Inc	Alpha Lipoic Acid, CoQ10, Curcumin, Liva-Vite, Milk Thistle, Selenium, Vinpocetine, Vitamin B Complex, Vitamin C, Vitamin D3, and Vitamin E
Peak Nootropics LLC	Bacopa Monnieri, L-Theanine, Noopept, Piracetam, and Uridine
Pure Nootropics	Alpha GPC Piracetam Vitamin D3 5000 IU
Sovereign Laboratories, LLC	Colostrum-LD® and Curcumin-LD®
TEK Naturals	Mind Ignite TestoTEK
Online Advisory Letters
Alzheimer's Corporation (ALZcorp)	Memory Revitalizer Cerebara GPC (L-Alpha glycerophosphocholine) Life Imagined
Alzheimer's Organization	Mind and Memory Support
Dr. Fitt Intelligent Designs, LLC	DHEA Capsules Robenyzme Capsules
Healthcare Products, LLC d/b/a/ The Alzheimer's Store d/b/a MindCare Store	Aromatherapy for Dementia Memory Kit Premier Aromatherapy for Dementia Memory Kit 2nd Edition Attention Aromatherapy Patch Calming Aromatherapy Patch Lavender Aromatherapy Patch Perk Up Aromatherapy Patch Refresh Aromatherapy Patch Rested Aromatherapy Patch Aromatherapy Patch Sample Pack
This Wonderful Life New Age Shop	Dementia/Alzheimer's (Day) Synergy Oil Dementia/Alzheimer's (Night) Synergy Oil

NOTES FROM CHART:

1. The other products cited in the warning letters are not listed here.
2. Product name linked to Flickr image when available.

REFERENCE:

• 
  

Company Name (Click name for FDA Warning)	Alzheimer's Disease Product Name1	Image2 (Click Image to Enlarge)
Blue Ridge Silver	Collodial Silver
BR Naturals	Avocado Oil Unrefined Coconut Oil
DK Vitamins	Cognispark Gammadyn Mn-Co Melatonin Ubiquinol CoQ10 Vinpurazine Zinc Picolinate Formula
Earth Turns, LLC	Cogni-Flex Fundamental Omega-3 Green Tea Extract
Gold Crown Natural Products	New Ultra Colostrum Melatonin with Valerian
Emmbros Overseas Lifestyle PVT LTD.	Morpheme Remedies Memocare Plus Morpheme Remedies Mind Plus
John Gray's Mars Venus LLC	L-Glutathione Liposomal DHA – Ultimate Omega-3 Brain Support Liposomal Methyl B12/Folate NAC N-Acetyl-L-Cysteine
Nutrition Coalition Inc	Alpha Lipoic Acid, CoQ10, Curcumin, Liva-Vite, Milk Thistle, Selenium, Vinpocetine, Vitamin B Complex, Vitamin C, Vitamin D3, and Vitamin E
Peak Nootropics LLC	Bacopa Monnieri, L-Theanine, Noopept, Piracetam, and Uridine
Pure Nootropics	Alpha GPC Piracetam Vitamin D3 5000 IU
Sovereign Laboratories, LLC	Colostrum-LD® and Curcumin-LD®
TEK Naturals	Mind Ignite TestoTEK
Online Advisory Letters
Alzheimer's Corporation (ALZcorp)	Memory Revitalizer Cerebara GPC (L-Alpha glycerophosphocholine) Life Imagined
Alzheimer's Organization	Mind and Memory Support
Dr. Fitt Intelligent Designs, LLC	DHEA Capsules Robenyzme Capsules
Healthcare Products, LLC d/b/a/ The Alzheimer's Store d/b/a MindCare Store	Aromatherapy for Dementia Memory Kit Premier Aromatherapy for Dementia Memory Kit 2nd Edition Attention Aromatherapy Patch Calming Aromatherapy Patch Lavender Aromatherapy Patch Perk Up Aromatherapy Patch Refresh Aromatherapy Patch Rested Aromatherapy Patch Aromatherapy Patch Sample Pack
This Wonderful Life New Age Shop	Dementia/Alzheimer's (Day) Synergy Oil Dementia/Alzheimer's (Night) Synergy Oil

NOTES FROM CHART:

1. The other products cited in the warning letters are not listed here.
2. Product name linked to Flickr image when available.

REFERENCE:

• FDA: 12 Warning Letters
• FDA: 5 Online Advisory Letters

SOURCES:

• FDA: U.S. Food & Drug Administration
  The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
• FDA 2019 Warning Letters