Daily Archives: April 29, 2023

FDA: SARMs not worth the health risk ‘for a few extra likes’ – NutraIngredients-usa.com

Posted: April 29, 2023 at 6:00 am

Targeting teenagers and young adults, videos on social media platforms tout SARMs as a quick or easy way to improve physical appearance, gain muscle mass, or increase athletic performance, the FDA warning reads. The reality isSARMs are potentially dangerous.

The concocted chemical substances, which mimic the effects of testosterone and anabolic steroids, are not FDA approved and are often marketed as dietary supplements or sold for research purposes only without warnings on the labels.

SARMs cannot be legally marketed as dietary supplements or drugs for human use, the FDA emphasized in a video accompanying the warning. These products are not worth risking your health for a few extra likes.

Among the potential side effects listed are increased risk of heart attack or stroke, psychosis and hallucinations, sleep disturbances, sexual dysfunction, liver injury and acute liver failure, infertility, pregnancy miscarriage, and not least testicular shrinkage.

SARMS are not legitimate dietary supplements; they are unapproved drugs,Steve Mister, president and CEO at the Council for Responsible Nutrition (CRN) told NutraIngredients-USA.While some SARM-containing products masquerade as being supplements, these products are patently illegal.

He added that in 2018, as the industry was seeing an increase in these products, CRN developedvoluntary guidelineswith its members against the distribution or marketing of dietary supplement products containing SARMs. This was accompanied by the launch of a#SARMsCanHarm campaignto raise awareness of the potential dangers among consumers.

Despite its clear stance, FDA said that it continues to receive adverse event reports associated with SARMs use and acknowledged that the real number of adverse events is likely higher due to underreporting by reluctant or uninformed consumers.

In the past, the FDA has issued warning letters to companies selling unapproved products marketed as SARMs, in addition to pursuing select criminal actions against distributors of these products.

Just this month,an Idaho man pled guiltyto a federal felony for selling over $4.4 million in product through his SARMTECH company website and faces a maximum penalty of three years in federal prison. Asearch of FDA recordsreturns over a dozen additional convictions tied to the smuggling, misbranding and distribution of SARMs. In one of the biggest cases, a federal court sentenced the founder of Blackstone Labs to 4.5 years in prison and ordered him to forfeit $2.9 million for conspiring to sell SARMs and other products as dietary supplements. He wasreleased just before Christmas last year after serving 11 months.

The latest consumer advisory follows a similarFDA letter issued in 2017against SARMs use in body building products, raising questions as to whether much has changed in the last six year.It was accompanied by three warning letters to companies that represented the best snapshot of the issue,an FDA spokesperson said at the time.

Surely, consumer warnings and advisories have their place but if the FDA is serious about eliminating the illicit SARMs market, it will need to be more consistent in its enforcement operations against the marketers, Rick Collins, founding partner at Collins Gann McCloskey & Barr, told NutraIngredients-USA. Perhaps enforcement administrators and field agents have bigger fish to fry.

Although he noted that there must be more dangerous drug product markets out there and that government resources are limited, he added that spotty and inconsistent enforcement actions tend to suggest to some in this market that the Government doesnt really care so much, despite the advisories every few years.

Companies who continue to market these ingredients as dietary supplements should face swift and strong enforcement actions by the FDA, CRNs Mister said.

In 2018, US Senators Orrin Hatch (R-UT) and Sheldon Whitehouse(D-RI) introduced a legislative solution called the SARMs Control Act. Although never passed, the bill would have added SARMs to the federal list of controlled substances and passed enforcement jurisdiction from FDA to the U.S. Drug Enforcement Agency (DEA).

Im poorly inclined toward any proposed law that expands the war on drugs into the fitness market and criminalizes not just marketers but otherwise law-abiding end users, Collins commented. For example, someone who walked into an independent health food store and bought a SARMs product for personal use could be arrested and prosecuted as a federal drug criminal for its possession immediately upon the law taking effect.

When the act was presented, the American Herbal Products Association, Consumer Healthcare Products Association, Council for Responsible Nutrition, United Natural Products Alliance and the US Anti-Doping Agency expressed their joint support for the initiative.

I think there are better ways to crack down on the market, one of which is simply to enforce the existing laws in a more consistent and expansive way, Collins added.

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Are Melatonin Gummies Safe? Here’s What (Kinda Scary) New Research Says – POPSUGAR

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As blissful as the idea of drifting off to sleep is, sometimes it can be really hard, especially for someone who deals with chronic insomnia, restless leg syndrome, or any number of other sleep-disrupting conditions. For many people, the go-to fix has been to pop a melatonin pill or chew on a melatonin gummy. A 2022 survey by the National Sleep Foundation found that 27.4 percent of adults take melatonin as a sleep aid and that more than five times as many US adults used melatonin in 2018 as in 2000.

However, if you're part of that 27 percent, you may want to take note of the most recent research on the popular supplement: a new research letter published in JAMA Network found that you can't exactly trust what's on the label of a melatonin supplement.

Specifically, 22 out of the 25 melatonin gummies examined contained different amounts of melatonin than what was listed on their labels, reports The New York Times. One gummy contained 74 percent of the amount of melatonin on the package label, another had 347 percent of the labeled amount, and finally, one product contained no melatonin at all, but did contain cannabidiol, or CBD. (It's "currently illegal to market CBD by adding it to a food or labeling it as a dietary supplement," per the Food and Drug Administration, but there are plenty of products on the market that currently do so.)

This isn't the first bit of research to suggest melatonin supplements can be wildly mislabeled. In a 2017 study published in the Journal of Clinical Sleep Medicine, researchers found that, of the 31 supplements they analyzed, the actual melatonin content ranged from -83 percent to +478 percent of the label amount. It also noted that a particular product varied by as much as 465 percent from bottle to bottle meaning you could buy the same exact supplement and get a different dose. Even more worryingly, this study found that eight of the supplements tested contained serotonin a naturally produced hormone, yes, but also a controlled substance used in the treatment of several neurological disorders.

This doesn't bode well for those who take and trust that melatonin gummies are a safe way to help get to sleep. But it's also a glaring reminder that supplements, overall, are kind of sketch. ICYDK, supplements are largely unregulated, meaning you can never be sure exactly what you're getting (but more on that below).

Here's what you need to know about the safety of melatonin gummies and any other supplements you might be taking or see come across your TikTok feed.

"In general, and for adults, I think the answer is yes, most of the time," says family physician Mark T. Loafman, MD. Melatonin is a naturally occurring hormone in the body and is therefore considered safe. Experts also don't believe that melatonin can be addictive or habit-forming.

As a supplement, "there's fairly good evidence that a 'small' supplement dose of oral melatonin shortens the time it takes to fall asleep by anywhere between 10 and 50 minutes," Dr. Loafman says. Specifically, it may be helpful if the time it takes to fall asleep after lights out is uncomfortably long and when other attempts to sleep are not working.

That said, the dosage recommendation for adults is small. Specifically, Cleveland Clinic recommends starting at one milligram and increasing that dose by one milligram (never exceeding 10 milligrams) if needed. But if your melatonin pill doesn't contain the dose it says it does (as the new research suggests may be the case), are you in danger of unintentionally taking too much? And what might happen if you do?

One of the biggest concerns presented by this new research (and the older research, for that matter) is the idea of getting too much melatonin. After all, if one of the tested gummies had 347 percent of the labeled amount, that's got to be one heck of a dose. But can you overdose on melatonin? And what side effects are there if you take too much?

TBH, we don't have all the answers. "Taking too much, or overdosing on melatonin, is also an area in need of formal research," Dr. Loafman says. But there's good news: "The limited studies available have not shown significant adverse effects, which is some reassurance," he says.

That said, there are a couple potential risks, in theory, he says. Higher doses of melatonin are thought to suppress the hormone secretion and regulation in your hypothalamus, pituitary gland, and gonadal glands, for example. So, "higher doses of melatonin over time may increase immune system reactivity," Dr. Loafman says, which could exacerbate immune-mediated conditions (those caused by abnormal activity of the immune system, such as multiple sclerosis or psoriasis. "Again, these are theoretical but are also based on good science," he notes.

In the short-term, taking a megadose of melatonin can cause nightmares or headaches, neurologist Alcibiades Rodriguez, MD, told POPSUGAR in September 2020. You could also experience nausea, dizziness, or daytime drowsiness, which Mayo Clinic describes as a "hangover effect." In one example cited by Poison Control, a 66-year-old man took too much melatonin and it resulted in lethargy and disorientation. He woke up feeling "drugged" and couldn't recall the events of the night before.

If you think you've taken too much melatonin, seek guidance from Poison Control via its online tool or by calling 1-800-222-1222. And if you find yourself experiencing any of those side effects frequently after taking a melatonin supplement, it could be to blame. In this instance, Dr. Rodriguez recommended scaling back on the dosage and speaking with your doctor. And since recent research is showing some brands contain much more melatonin than what's listed on the label, if taking less of one brand isn't alleviating symptoms, you may want to switch to a new one entirely.

Another area of concern around melatonin gummies, specifically, is kids' safety, as children can confuse the gummies for candy and consume too many. "There have been an increasing number of calls to Poison Control centers regarding children accessing and ingesting higher dose quantities of melatonin, for which short-term surveillance is provided, but no long-term studies that we can learn from," Dr. Loafman says.

Over time, it's possible that the effects high doses of melatonin have on hormones could "alter and accelerate the onset of puberty," Dr. Loafman warns, adding that no long-term studies have proven that's a risk.

Regardless, he advises against giving melatonin to any children under 5 and suggests speaking with your child's doctor before giving older kids the supplements.

The Food and Drug Administration regulates supplements as foods, not drugs. That means the organization does not need to test or approve dietary supplements for safety and effectiveness, nor do they need to approve the marketing or labeling. It's "the responsibility of dietary supplement companies to ensure their products meet the safety standards for dietary supplements and are not otherwise in violation of the law," per the FDA, which means it's a bit of an honor system.

"Supplements are largely unregulated, which leaves each manufacturer a wide range of flexibility on what their products contain and what health benefits they claim, so it's really a matter of buyer beware," Dr. Loafman explains. "Similarly, doing your own research on vitamins and supplements is limited to the research that is available, which is often based on small studies and subject to marketing goals."

It's important to keep that in mind when considering studies like the new one presented here. With so much money and marketing behind supplements but little actual oversight, it's difficult for consumers to know exactly what they're getting. (Add on celebrity backing of supplement brands and misinformation and hype spread by social media, and the whole industry seems a bit sus.)

One of the best things you can do is look for products that have been independently verified for quality and purity by the US Pharmacopeial Convention (USP), a nonprofit organization recognized by the FDA, Dr. Loafman says. Poison Control agrees. Look for its gold USP seal on supplement labels. "USP performs testing on vitamins and supplements to verify both the contents and the dosages the product contains. USP and other certifying bodies do not evaluate the purported health benefits or the overall safety, but they do provide peace of mind on contents," Dr. Loafman says.

It's also worth noting that supplements of any kind including melatonin can interfere with certain health conditions and some types of medicine, per Mayo Clinic. For that reason, Mayo Clinic recommends talking to your doctor before taking anything new or if you start to experience any side effects.

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New paper discusses the rationale for proprietary blends in … – Nutritional Outlook

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A recent paper published in The Journal of Nutrition, and co-authored by the The Consumer Healthcare Products Association's (CHPA; Washington, D.C.) senior vice president of dietary supplements, Duffy MacKay, summarizes the rationale for using proprietary blends in dietary supplements, how they are regulated and labeled, as well as the challenges this presents for researchers.

While proprietary blends of non-nutritive ingredients are permitted under current law, the issue is not without controversy, as manufacturers are not required to disclose the exact amounts of each ingredient used in the blend, explained MacKay, in a press release. This raises transparency issues and challenges for both researchers and consumers when it comes to understanding exposure levels. For example, researchers needing to calculate exposures in assessments of intakes or determine doses in clinical trials must use alternative ways to arrive at amounts. From a consumer standpoint, this creates obstacles to informed decision making, as its challenging to understand if the product will provide the intended benefits if they are unable to determine the amount of each ingredient included in the blend.

The lack of transparency also raises safety concerns, notes MacKay. While FDA does have access to the specific amounts of each ingredient in a proprietary blend through a Master Manufacturing Record, this is very much seen as reactive regulating, said MacKay. To that point, its equally important to consider the potential benefits of proactive regulating, especially considering the attention supplement modernization has received in Congress.

The paper's lead author is Leila G. Saldanha, PhD, RD, FAND, senior nutrition scientist at the National Institutes of Healths (NIH) Office of Dietary Supplements (ODS). Other co-authors included ODS Senior nutrition scientist Johanna T. Dwyer, DSc, RD and Constance J. Hardy, interdisciplinary scientist at FDAs Center for Food Safety and Applied Nutrition (CFSAN).

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The Best Brain Supplements For Cognitive Health Forbes Health – Forbes

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While experts agree a healthy diet and lifestyle are the most important components of supporting brain health, research suggests the supplements below can help fill important nutrient gaps in a persons dietand potentially support cognitive health and mood.

Of all the supplements recommended by experts for brain health, omega-3 fatty acids top the list. Omega-3 fatty acids, particularly the long-chain fatty acids DHA and EPA present in fatty fish, are essential for the development of the brain and the eyes and have a significant influence on mental health at all ages, notes Eva De Angelis, licensed dietitian nutritionist and chef based in Argentina.

These fatty acids help reduce inflammation in the body and the brain and are associated with a reduced risk of cognitive decline, Alzheimers disease and dementia, adds Delk.

Omega-3s play important roles in the membranes of nerve cells, and people with neurodegenerative disorders tend to have lower levels of EPA and DHA. Furthermore, research suggests omega-3s may help protect against neurodegeneration and reduce risk of cognitive decline.

The recommended daily intake of omega-3 fatty acids for all adults is between 1.1 and 1.6 grams. A typical fish oil supplement provides about 1,000 milligrams (or about 1 gram) of fish oil, with about 300 milligrams of omega-3s specifically. Dosage varies widely, so check product labels carefully before choosing a supplement.

Creatine supplementation is often used for building muscle and improving athletic performance, but recent research suggests creatine may help improve brain function as well.

According to a 2022 research review in the journal Nutrients, creatine may aid recovery from concussion and mild traumatic brain injury, ease symptoms of depression, improve cognition and help protect against neurodegenerative diseases. In one study referenced in the review, creatine supplementation helped improve memory in older adults.

Creatine is a naturally occurring amino acid found in muscle tissue and the brain. Its important for energy production, especially during times of increased metabolic demand, such as sleep deprivation.

According to the Internal Society of Sports Nutrition (ISSN), consuming up to 30 grams of creatine monohydrate daily for five years is safe for healthy individuals. If you choose to supplement with creatine, the ISSN recommends starting with a daily dose of around 0.3 grams of creatine per kilogram of body weight (for example, 20 grams of creatine for a 150-pound person) for five to seven days, followed by 3 to 5 grams daily thereafter. Its important to stick to the recommended dosages, as ingesting too much creatine at once can cause damage to the liver or kidneys.

Research confirms what coffee lovers around the world suspectcaffeine improves cognitive performance. A 2016 research review in the journal Practical Neurology suggests caffeine can increase alertness and feelings of well-being, improve concentration and mood and help alleviate depression symptoms. Its even associated with a reduced risk of cognitive decline and Alzheimers disease.

Caffeine is very popular for cognitive function, as it has demonstrated neuroprotective benefits, notes Susan Hewlings Ph.D., vice president of research affairs at Radicle Science.

Just dont overdo it. Experts recommend limiting caffeine intake to no more than 400 milligrams (about five cups of coffee, depending on the brew strength) a day and no more than 200 milligrams per sitting. Excessive caffeine consumption can be associated with restlessness, insomnia and heart palpitations.

L-theanine is an amino acid found naturally in some mushrooms, as well as green and black teas. Its linked to an improvement in mental performance and focus in numerous studies, notes Chicago-based registered dietitian Leah Johnston.

In one small study in the journal Neuropharmacology, participants who took 100 milligrams of L-theanine before a monitored two-hour task period made fewer errors during that time than those who received a placebo.

While there isnt an established dose recommendation or upper limit for L-theanine supplementation, studies examining its effects on cognitive function often use daily doses between 100 and 250 milligrams. A cup of green tea provides between 8 to 30 milligrams of L-theanine.

Though called the sunshine vitamin, vitamin D is actually a hormone, notes U.K.-based specialist dietitian Sascha Landskron. Vitamin D has hundreds of important functions [in the body] and is essential for good brain health, she adds.

Research shows vitamin D is important for early brain development, and deficiency is linked to conditions including dementia, depression, autism and schizophrenia. One 2017 study in Current Gerontology and Geriatrics Research suggests vitamin D helps maintain cognitive function in older adults.

While the best source of vitamin D is sun exposure, you may need a supplement during the winter months or if you work indoors, wear sunscreen, cover your skin, have darker skin or have obesity, advises Landskron. Good food sources of vitamin D include cod liver oil, fatty fish like salmon and trout, mushrooms and fortified cereals and milk.

For most adults, the ideal daily dose for vitamin D is 600 to 800 IU. However, people supplementing with vitamin D over the long term can experience adverse health effects over time, such as high calcium levels in the blood, which can block blood vessels or cause kidney stones. Consider getting your vitamin D levels checked and consulting with your health care provider to determine the correct vitamin D supplementation dose for your bodys needs.

Found naturally in eggs, choline is an essential nutrient that helps your brain make acetylcholine, which is a neurotransmitter needed for memory and general cognition, explains Jacques Jospitre, Jr., M.D., board-certified psychiatrist and co-founder of SohoMD in New York.

In one study of over 2,000 older adults, those who consumed high amounts of choline tended to have lower risk of cognitive decline. While more human clinical trials are needed, animal-based research shows some promise in regards to cholines role in reducing amyloid plaques and Alzheimers disease risk, adds Dr. Jospitre.

Resveratrol, an antioxidant polyphenol abundant in grapes and red wine, may help protect cells from damage, improve blood flow to the brain and slow cognitive decline. Taking resveratrol supplements could prevent the deterioration of the hippocampus, an important part of the brain associated with memory, notes Adash Bajaj, M.D., an anti-aging and longevity specialist in Los Angeles.

According to the National Institutes of Health (NIH), supplementing with up to 1,500 milligrams of resveratrol daily for up to three months is considered safe. Higher doses up to 3,000 milligrams are also safe but more likely to cause stomach upset. Resveratrol can also slow blood clotting, so it should be avoided in people preparing for surgery or who take blood thinner medications.

Lions mane mushrooms (Hericium erinaceus) are tied to a host of health benefits, including reducing inflammation, treating anxiety or depression and enhancing cognitive function, notes Johnston.

According to New York-based prebiotic and gut health expert Kara Landau, lions mane mushrooms support oxygen flow to the brain and can enhance memory, focus and concentration. I find incorporating [lions mane mushrooms] on a daily basis helps one have a clearer mind and be able to take on the day without the negative side effects of increasing caffeine [intake], she says.

Landau recommends starting with 250 to 500 milligrams of lions mane mushrooms daily to gauge your bodys tolerance, working up to around 1 gram daily. Note that, similar to resveratrol, lions mane mushrooms can interfere with the bodys blood clotting abilities. It can also cause a rash for some people.

The eight B vitamins play essential roles in brain health. The vitamin B complex is crucial for supporting healthy brain function and may protect against memory loss, cognitive decline and neurodegenerative diseases, says De Angelis.

Vitamins B6, B9 (folate) and B12 specifically are necessary for the metabolism of homocysteine, a molecule created in methionine metabolism, notes De Angelis. Chances of neurodegeneration and cognitive decline increase with high blood homocysteine levels because it can cause oxidative stress and DNA damage, she explains.

Most people can meet their B vitamin needs through a nutritious, well-balanced diet. However, older adults, people who follow plant-based diets and those with certain medical conditions may need a supplement to meet their needs. The recommended dietary allowance (RDA) for vitamin B6 for adults is between 1.2 and 2 milligrams daily, the RDA for folate for adults is between 400 and 600 micrograms daily, and the RDA for vitamin B12 for adults is between 2.4 and 2.8 micrograms daily. Most B vitamins are safe, but consuming excessive amounts of vitamin B6 can lead to nerve damage.

Theobromine is a natural stimulant found in chocolate that helps people feel more alert without the jittery feeling often associated with caffeine-containing foods and beverages, explains Landau. While animal and in vitro studies suggest theobromine may be effective at enhancing cognitive performance by improving blood flow to the brain, more studies in humans are needed.

Landau recommends a daily cup of brewed cacao as a delicious, rich source of theobromine.

Gut health is another important factor for optimal cognitive function, according to Hewlings. Probiotics can benefit cognition via the gut-brain axis, she says, which connects the gastrointestinal tract and the central nervous system through bidirectional neural, hormonal and immune signaling pathways.

In a 2021 study in the Journals of Gerontology Series A: Biological Sciences and Medical Sciences, 12 weeks of supplementation with a probiotic combination of Bifidobacterium bifidum BGN4 and Bifidobacterium longum BORI specifically appeared to improve brain function and decrease perceived stress in healthy older adults.

Prebioticsnon-digestible fibers in fruits, vegetables and grainsalso support gut health by providing food for healthy gut bacteria. Landau recommends prebiotics called galacto-oligosaccharides (GOS) for both gut health and mood support. GOS is a specific prebiotic thats proven to support mental health, she says. According to Landau, as little as 5.5 grams of GOS daily may help relieve anxiety.

In addition to probiotic and prebiotic supplements, you can support healthy gut flora by eating a wide range of fruits, vegetables and grains rich in prebiotic fiber, as well as fermented foods like kimchi, yogurt and sauerkraut that naturally contain probiotic bacteria.

While magnesium has many important physiological functions, its effect on brain health and cognition is only starting to come into focus. Magnesium supports normal neural function by protecting brain and nervous system cells from degeneration. Multiple studies suggest low magnesium consumption is associated with higher risk of cognitive impairment and dementia.

A 2022 study of over 2,500 people ages 60 and older found those who consumed the highest amounts of magnesium through food and supplements had higher scores on cognitive tests compared to those who consumed the least amounts of magnesium. Another long-term study found low magnesium levels during middle age to be associated with increased risk of dementia but not cognitive decline. However, in both studies, its unclear whether low levels of magnesium increase the risk of dementia or if people with dementia have low levels of magnesium for some other reason.

Magnesium is widely available in many plant- and animal-based foods, including leafy green vegetables like spinach, legumes, nuts, seeds and whole grains. The RDA for magnesium is between 310 and 420 milligrams for adult men and women.

Healthy people dont need to worry about getting too much magnesium from foodthe kidneys filter out magnesium the body doesnt need. But high doses of magnesium supplements can lead to gastrointestinal issues like nausea and diarrhea or even toxicity when taken in excess.

Ashwagandha is a shrub used in the traditional Ayurvedic system of medicine to help enhance memory and reduce stress. Emerging research suggests ashwagandha may help improve cognitive function.

In one small but well-designed 2017 study in the Journal of Dietary Supplements, 50 adults with mild cognitive impairment received either 300 milligrams of ashwagandha root extract twice daily or a placebo for eight weeks. Those taking ashwagandha experienced significant improvements in memory, executive function, attention and information-processing speed compared to those who took a placebo.

In another 2021 study in Evidence-Based Complementary Alternative Medicine, healthy but stressed adults who took 300 milligrams of sustained-release ashwagandha extract daily for 90 days experienced significantly improved memory and focus, as well as psychological well-being, sleep quality and reduced stress compared to those who took a placebo.

Ashwagandha is commonly used in doses up to 1,000 milligrams daily for up to 12 weeks. While ashwagandha may be used safely in the short term, its long-term safety isnt known, and large doses may lead to gastrointestinal upset or, rarely, liver problems.

According to the NIH, ashwagandha may interact with certain prescription medications, including antidiabetes drugs, antihypertensive drugs, immunosuppressants, benzodiazepines, certain sedative medications and thyroid hormones.

Consult your health care provider before taking ashwagandha to determine a proper dose for your needs and ensure its safe for you and medications you take. People who are pregnant or breastfeeding should avoid taking ashwagandha.

Phosphatidylserine (PS) is a class of phospholipids naturally found in brain tissue membranes. PS plays a critical role in communication throughout the nervous system by activating important signaling pathways and affecting the release of chemical messengers known as neurotransmitters. Studies suggest supplementing with PS can help protect brain health, lower risk of central nervous system diseases like Alzheimers and Parkinsons disease, and improve cognitive function by reducing inflammation in the brain.

Observing the effect of phosphatidylserine on cognitive function in older adults, a 2022 review and meta-analysis in the Korean Journal of Food Science and Technology found PS supplementation at a level of 300 milligrams daily may improve cognitive function and memory without side effects.

However, many of the available studies on PS are dated, small and of relatively short duration. While more studies are needed to know whether supplementing with PS can improve brain health and cognition, the existing research seems promising.

Theres currently no recommended dose of PS, but studies suggest doses between 300 and 500 milligrams per day are safe and free of side effects.

One of the simplest ways to support brain health is to stay hydrated. About 73% of the brain and central nervous system is composed of water.

Hydration is key for allowing nutrients into the brain and for toxins to get out of the brain, explains Dr. Jospitre. It sounds simple, but ensuring adequate water intake is very important to ideal brain health, and most people typically dont get enough.

The Institute of Medicine of the National Academies recommends adult women consume about 11 cups and men about 15 cups of water daily, including fluid from fruits, vegetables and other water-rich foods you eat.

However, even water can be toxic in very large quantities. If you drink excessive amounts of water faster than your kidneys can process it, it can deplete the sodium levels in your blood to dangerously low levels, resulting in psychosis, coma and potentially death.

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Protein powders: Are they bad for your health? – BBC

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When I go into my local health food store, theres one corner that's always been a bit of a mystery to me the shelves packed with dozens of white plastic tubs filled with powdered protein supplements. In the changing room at the gym, however, there are plenty who sing their praises, explaining that they simply add a scoop of powder to milk or to a smoothie, work out and then build extra muscle.

With their popularity reaching way beyond bodybuilders and professional athletes, now seems like a good time to look at the evidence around protein powders.

Some people use a protein drink as a snack between meals or even use it instead of a meal if they've not got time to eat. People eating a vegan diet sometimes use the supplements to up their protein intake if they feel they're not getting enough. And there are hundreds of new food products in supermarkets from cereal bars to ice cream and chocolate which signal their protein-containing credentials in bold letters.

There's a range of strengths available, with the highest doses aimed at bodybuilders. The powder might come from an animal source such as eggs or milk, or from plants. For example, protein from peas, potatoes, rice and soybeans can all be extracted and powdered, sometimes with added flavourings to make them taste good.

Protein is big business. But how many of us really need any extra?

Theres no doubt that protein is an essential part of the diet. We need it to build and repair muscles, to help our bones stay strong, to maintain the immune system and to keep our brains, hearts and skin doing what we need them do.

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Foods such as eggs, milk, yoghurt, fish, lentils, meat, soya, nuts and seeds are all rich in protein and the majority of adults in high-income countries do get at least the daily amount of protein recommended by health authorities.

In a meta-analysis of 49 studies, the average protein intake from people's diets at the start of the research was more than 75% greater than the US and Canadian recommendations, for example. There are some scientists in the field such as Stuart Phillips from McMaster University in Canada who argue that the recommended levels might not be high enough for everyone.

One of the difficulties is knowing how much you as an individual might need. The answer depends on your age, health and exercise routine, so the standard recommendation may not apply to you. Some older people, for example, find they don't have much appetite which can lead them to eat so little that they don't get enough protein from their diet. And if you're a professional endurance athlete you more need more protein than the average adult.

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New Regulation on Turkish Food Codex Nutrition Claims Has Just … – Lexology

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In accordance with the Regulation on Turkish Food Codex Nutrition Claims ("Regulation") published in the Official Gazette dated 20.04.2023 and numbered 32169, the issues regarding nutrition claims have been re-regulated.

Moreover, the Regulation on the Use of Health Claims in Foods and Food Supplements prepared by the Turkish Medicines and Medical Devices Agency, which sets out the rules on health claims, entered into force on the same day as this Regulation prepared by the Ministry of Agriculture and Forestry. With the entry into force of these new regulations, the Regulation of Turkish Food Codex Nutrition and Health Claims dated 2017 ("Repealed Regulation") which contained provisions on the subject was repealed. Therefore, it is aimed to provide ease of implementation by regulating the health and nutrition claims with two different regulations. Thus, the Regulation does not directly refer a definition of health claims unlike the Repealed Regulation.

This article targets the Regulation on Turkish Food Codex Nutrition Claims and the regulation regarding the Use of Health Claims in Foods and Food Supplements will be discussed in a separate article.

1. General Provisions

The Regulation stipulates that nutrition claims can be used in the labelling, promotion and advertisement of foods placed on the market and the basic principles during this use. Are regulated. Accordingly, the use of nutrition claims cannot be: (i) ambiguous, inaccurate or misleading (ii) in a way that cause doubt about the nutritional adequacy or reliability of other foods; (iii) in a way that support or encourage excessive consumption of a certain food (iv) in a way that state, assert or imply that a varied and balanced diet cannot provide adequate amounts of nutrients in general and may cause concern in the consumer, and (v) in a way that refers to changes in bodily functions through written, pictorial, graphic or symbolic representations.

Furthermore, a trademark or proper name is included in the labelling, presentation or advertisement of food and may be interpreted as a nutrition claim, it may be used provided that the relevant nutrition claim conditions in the Regulation are met and the relevant claim is also made. However, the Ministry determines the use of equivalent claims that do not change or strengthen the meaning of the nutrition claim expressions included in the labelling, presentation or advertisement of food.

2. General Conditions

The Regulation also lists the conditions for the use of nutrition claims. However, it should be noted that these general conditions are the same as the Repealed Regulation and have only been repeated specifically for nutrition claims.

3. Scientific Verification

As in the Repealed Regulation, the Regulation also includes scientific verification and nutritional claims for declarations. According to these provisions, nutrition claims must be based on and verified by generally accepted scientific evidence. Within this scope, the food business operator who makes a nutritional claim must prove that the claim complies with the provisions of the Regulation, and the Ministry of Agriculture and Forestry may request the food operator supplying the product to the market to submit all relevant information and documents showing that the claims comply with the Regulation.

4. Nutrition Claims

Lastly, the Regulation also includes comparative nutrition claims as in the Repealed Regulation. Accordingly, comparative nutrition claims, subject to the provisions of the Law on Protection of the Consumer, can only be made between foods with the same product name in the same category, taking into account product variety. This claim must be made for the same amount of food and the difference in the amount of a nutrient in the food and/or the energy value of the food must be specified.

The Regulation, which includes provisions that are similar to the Repealed Regulation regarding nutrition claims, aims to prevent problems arising in practice by separating the regulations on nutrition and health claims in a way to be specific to each other.

You can access the Regulation from this link.

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Selenium: Benefits, Side Effects, and More – Verywell Health

Posted: at 6:00 am

Selenium is a trace mineral commonly found in the soil of most regions of the world.

Because it is a trace mineral, your body only needs it in small amounts. However, consuming too much or too little selenium can cause serious side effects and health conditions.

Once consumed and metabolized, selenium is inserted into various selenoproteins. These selenoproteins play essential roles in many processes in the human body, including immunity, metabolism, and the synthesis of hormones.

In food, selenium is found in both organic and inorganic forms. Organic selenium, or selenomethionine, is more readily absorbed than inorganic forms, like selenate or selenite. Dietary supplements typically contain selenomethionine.

Regarding human health, selenium is thought to act mostly as an antioxidant that may be useful in preventing conditions like type 2 diabetes, heart disease, and other metabolic disorders.

This article will provide an overview of common uses of selenium. It will also discuss selenium deficiency, toxicity, dosage, side effects, and more.

Dietary supplements are not regulated the way drugs are in the United States, meaning the Food and Drug Administration (FDA) does not approve them for safety and effectiveness before products are marketed. When possible, choose a supplement tested by a trusted third party, such as U.S. Pharmacopeia (USP), ConsumerLab.com, or NSF International.

However, even if supplements are third-party tested, they are not necessarily safe for all or effective in general. Therefore, it is important to talk to your healthcare provider about any supplements you plan to take and check in about potential interactions with other supplements or medications.

Supplement use should be individualized and vetted by a healthcare professional, such as a registered dietitian, pharmacist, or healthcare provider. No supplement is intended to treat, cure, or prevent disease.

Selenium is needed for basic human health. Although some people use selenium with the desire to improve certain health conditions, research results confirming any additional benefits of the mineral are mixed.

The use of selenium supplements is typically only necessary when recommended by a healthcare provider to treat a deficiency. Most people can obtain all the selenium they need through a normal diet.

Below is a look at some research surrounding common uses of selenium.

In the human body, selenium can be found in the highest concentrations in the thyroid gland.

Selenium also plays a vital role in the synthesis of various enzymes that act as antioxidants and regulate thyroid hormones. A deficiency in selenium has been linked to hypothyroidism (underactive thyroid) and other thyroid diseases, like Graves' disease and Hashimoto's disease.

As healthy levels of selenium appear to be vital for thyroid health, several studies have looked at how selenium supplements may prevent thyroid disease.

According to one review, selenium supplementation may be especially beneficial for people with autoimmune thyroiditis, which affects the production of thyroid hormones essential to normal metabolism. Researchers also found that maintaining normal selenium levels helps prevent thyroid disease. However, selenium intake or supplementation should be closely monitored, as high selenium levels may be harmful.

Selenium's role as an antioxidant has led some researchers to hypothesize that it may reduce the risk of heart disease. However, the scientific evidence is inconsistent.

According to one meta-analysis of various studies, taking selenium supplements does not affect the risk of cardiovascular (heart) disease. It's worth noting, though, that normal selenium blood levels were associated with a lower heart disease risk.

Another review found that, while selenium supplements alone didn't affect heart disease risk, adding selenium to other antioxidants did. Researchers found that when selenium was part of an antioxidant supplement, the risk for heart disease and all-cause mortality (death fro all sources) was lower than when selenium or antioxidants were taken separately. This led the researchers to believe that selenium is an essential part of any antioxidant supplement.

A third review examined how selenium status (how much selenium you have in your body) affects both the incidence and mortality of heart disease. It was concluded that high levels of selenium in the body are associated with a decreased risk of heart disease. However, researchers cautioned that excessive selenium intake may be harmful.

Clearly, more research is needed to support the role of selenium in heart disease.

Some evidence suggests that selenium may help prevent and treat type 2 diabetes.

One small selenium study was performed on adult males and females with type 2 diabetes. In the study, participants followed a Mediterranean diet (an eating plan high in plant-based foods and healthy fats and low in red meat and processed foods) and took 200 micrograms of selenium per day on an empty stomach. By the end of the six-month trial, participants had significant reductions in fasting blood sugar, A1C, total cholesterol, and low density lipoprotein (LDL) cholesterol (considered "bad" cholesterol).

It should be noted, though, that we do not know for certain if these study results were due to selenium supplementation, adherence to the Mediterranean diet, or a combination of both.

Alternatively, some research has found a possible causal relationship between high selenium status and type 2 diabetes. Yet, the 20132018 National Health and Nutrition Examination Survey (NHANES) found no association between selenium status and the prevalence of diabetes.

In the end, there is not enough strong evidence that confirms the role of selenium in either the development or prevention of type 2 diabetes. More research is needed.

There is some belief that selenium levels may factor into COVID-19 infection and infection severity.

Selenium has been found to have antioxidant and anti-inflammatory effects, as well as an influence on immune function. This may explain why one study found that regions of China with higher levels of selenium in the soil had decreased rates of COVID-19 infections.

A systematic review noted that various studies have correlated a deficiency in selenium to more severe infections from COVID-19. One study included in the review found that high levels of selenium in the urine were found in fatal cases. However, other studies have found no link between selenium levels and COVID-19 infections.

Research should continue in this area with the hope of finding more consistent results.

WLADIMIR BULGAR/SCIENCE PHOTO LIBRARY

Although rare in the United States, a selenium deficiency may lead to serious health issues.

Selenium deficiency has been linked to such conditions as heart disease, cancer, male infertility, cognitive decline, and inflammation. Selenium is also known to be important for normal development, immunity, and delaying the progression of AIDS in patients with human immunodeficiency virus (HIV).

You may develop a selenium deficiency for various reasons.

A selenium deficiency may occur due to diet, where you live, or other factors.

Possible causes of selenium deficiency include:

A deficiency in selenium may lead to certain illnesses, including:

Additionally, selenium deficiency may be associated with male infertility. Some research also suggests that a deficiency in selenium may negatively impact the nervous system and lead to increased anxiety or the development of depression or Alzheimer's disease.

A healthcare provider can properly identify a selenium deficiency through an exam and lab tests.

Taking selenium supplements or consuming too much selenium in food may lead to side effects. Side effects of selenium can be mild or severe.

You are more likely to experience side effects if you ingest too much selenium, either acutely or chronically.

Common side effects of selenium include:

If you experience side effects while taking selenium supplements, stop use and speak with a healthcare provider. Mild side effects should resolve on their own with time and treatment.

Selenium in amounts commonly found in foods is not thought to cause side effects.

However, taking extremely high doses of selenium may cause severe side effects, such as:

You should seek immediate medical attention if you experience these or other severe side effects after using selenium.

Selenium is an essential nutrient throughout the life cycle. This means you must consume enough selenium through food or supplements for health. However, precautions should be taken when using selenium supplements.

How you take selenium supplements affects their safety. If you take a high dose of selenium or take selenium for too long, you may experience various side effects.

Talk with a healthcare provider before using selenium supplements, especially if you have a preexisting medical condition or are taking any medications.

Always speak with a healthcare provider before taking a supplement to ensure that the supplement and dosage are appropriate for your individual needs.

There are guidelines called Dietary Reference Intakes (DRIs) for taking selenium daily. DRIs provide dosage information for people of all ages and genders based on scientific evidence. Essential nutrients, like selenium, have DRIs.

The Recommended Daily Allowances (RDAs) for selenium are as follows:

An Adequate Intake (AI) (an average nutrient intake for adequate needs) has been established for infants. From birth to 6 months old, infants need 15 micrograms/day of selenium, while older babies ages 7 to 12 months need 20 micrograms/day.

Selenium supplements tend to come in doses much larger than these RDAs. Work with a healthcare provider before taking selenium supplements to determine the proper dose. Typically, you can get all the selenium you need through your diet.

Selenium supplements can be toxic if you take too much.

Mild cases of selenium toxicity may result in:

In severe cases, taking too much selenium may lead to:

Because selenium can become toxic, tolerable upper limit levels (ULs) have been established. The UL pertains to all food, drinks, and supplements containing selenium. Do not exceed the following ULs for selenium:

To prevent toxicity, never exceed dose recommendations for selenium supplements, and keep these ULs in mind.

Selenium may interact with certain medications, supplements, or nutrients. These interactions may alter the way selenium or your medications work.

There is a possible interaction between selenium and cisplatin, a type of chemotherapy used to treat cancer. Cisplatin may reduce the amount of selenium in your body. But there is also some evidence that selenium may decrease the toxic side effects of cisplatin.

Evidence supporting other selenium interactions is weak or nonexistent. Despite this, additional interactions may exist for selenium. Tell a healthcare provider what medications and supplements you take before starting selenium.

Also, it is essential to carefully read the ingredients list and nutrition facts panel of a new supplement to know which ingredients and how much of each ingredient is included. Please review supplement labels with a healthcare provider to discuss any potential interactions with foods, other supplements, and medications.

Keep selenium supplements out of direct sunlight and store them in a cool, dry place. It's important that supplements do not overheat.

It's also important to keep selenium supplements out of sight and reach of children and pets who may accidentally ingest them.

Discard any remaining selenium supplements once they reach their expiration date or as indicated on the packaging.

Does selenium have any health benefits?

Selenium is an essential mineral, which means your body needs it for certain processes.

Selenium is also an antioxidant and may have additional health benefits. Some research shows that selenium may be beneficial for heart health, diabetes, fertility, inflammation, cognitive decline, and viral infections.

It's best to get selenium from your diet rather than supplements if possible. Too much selenium in your system can cause side effects and toxicity.

Who should not take selenium?

Typically, selenium supplements are only necessary if you are deficient in the mineral. Taking selenium without a deficiency present may result in selenosis, or selenium toxicity.

Selenium may interact with various medications and may not be appropriate for all health conditions. Talk with a healthcare provider before taking selenium supplements.

Can you get selenium from food?

Many foods contain selenium. Foods are preferred over supplements for obtaining selenium.

Selenium can be found in foods like seafood, meat, poultry, eggs, dairy, grains, Brazil nuts, and vegetables.

How do I know if I have a selenium deficiency?

A selenium deficiency is rare, especially in the United States.

People who are deficient in selenium may develop various diseases. These include Keshan disease, Kashin-Beck disease, and cretinism.

A selenium deficiency may also impact the nervous system, which could result in anxiety, depression, or cognitive impairment.

The best way to get selenium is through your diet. Selenium supplements may contain higher levels of the mineral than you need. Getting selenium through food rather than supplements is thought to be safer and more effective.

Selenium is found in both plant and animal foods. The amount of selenium in plant-based foods may depend on how much selenium was in the soil in which they were grown. This means that selenium levels may vary depending on your country or region.

Animal-based foods tend to contain more selenium than vegetables, cereals, and fruits. Food sources of selenium include:

Remember that you only need selenium in small amounts. Many of these and other selenium-containing foods can provide your daily selenium needs in just one serving.

If a healthcare provider has recommended that you use selenium, there are a few things to keep in mind when looking for the right supplement.

Selenium supplements are mostly available as capsules, tablets, and liquid extracts. Some supplements may contain other nutrients or ingredients, so read the nutrition label and ingredient list to know what you're getting.

You can find selenium supplements that are organic, vegan, and/or gluten-free.

Selenium is often added to daily multivitamins. It may be present as selenomethionine, sodium selenate, or other forms in dietary supplements.

If possible, look for selenium supplements that have been approved by a third party like USP, ConsumerLab.com, or NSF. Dietary supplements are not well-regulated in the United States, and these third parties ensure that supplements actually contain what is listed on the label.

Selenium is an essential mineral that you need in small amounts. It's important to many aspects of your health, including metabolism and the synthesis of hormones.

It's important to get the right amount of daily selenium, as either too much or too little can cause health issues. Food is the best source of selenium.

If you're thinking of using selenium supplements, talk with a healthcare provider first to learn how to use them safely.

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Selenium: Benefits, Side Effects, and More - Verywell Health

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FDA Warns of Use of Selective Androgen Receptor Modulators … – FDA.gov

Posted: at 6:00 am

Espaol

The U.S. Food and Drug Administration is warning consumers that the agency continues to receive adverse event reports related to selective androgen receptor modulators, commonly called SARMs. Social media posts by influencers and sellers of SARMs contribute to the availability and promotion of these dangerous products.

Targeting teenagers and young adults, videos on social media platforms tout SARMs as a quick or easy way to improve physical appearance, gain muscle mass, or increase athletic performance.

SARMs, which are chemical substances that mimic the effects of testosterone and anabolic steroids, are not FDA approved. Online vendors and social media influencers are using social media to make SARMs seem safe and effective.

The reality is SARMs are potentially dangerous. The FDA continues to receive adverse event reports associated with SARMS use. The real number of consumers experiencing adverse events is likely higher due to underreporting. Because these are not approved drugs, consumers may be reluctant to report adverse events or may not be aware that they can report adverse events that they experience. In addition, they might not know that their symptoms are being caused by the product.

Studies and reports show SARMs are associated with serious or life-threatening health problems, such as:

Although SARMs are often marketed as dietary supplements or sold for research use only, they are considered unapproved drugs. SARMs cannot be legally marketed in the U.S. as a dietary supplement or drug at this time. These products are often sold with no warnings on the labels, potentially leading consumers to believe the products are safe.

The FDA recommends consumers talk to a health care professional about the use of any products for increasing muscle mass or enhancing athletic performance.

The FDA has issued warning letters to companies selling unapproved products marketed as SARMs over the years. The FDA has also pursued criminal actions for distributors of these products.

Because these are unapproved drug products with potentially dangerous side effects, and they have not been reviewed by the FDA for safety or efficacy, consumers should be advised against using SARMs. Consumers should consult a health care professional if they are experiencing any side effect they believe may be associated with the use of a SARMs product.

The FDA encourages health care professionals and consumers to report any adverse event related to the use of SARMs products to the FDAs MedWatch Adverse Event Reporting program. To file a report, use the MedWatch Online Voluntary Reporting Form. The completed form can be submitted online or via fax to 1-800-FDA-0178.

Additional guidance on how to report issues with products can be found at the FDA 101: How to Use the Consumer Complaint System and MedWatch.

Additionally, you can reach out to your local consumer complaint coordinator: Consumer Complaint Coordinators.

04/26/2023

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What is the issue of gubernatorial inaction in the legislative process … – Insights IAS

Posted: at 5:59 am

Topic: Structure, organization and functioning of the Executive and the JudiciaryMinistries and Departments of the Government;

2. What is the issue of gubernatorial inaction in the legislative process and how does it affect federalism and democracy in India? Discuss the measures that can be taken to ensure greater accountability and transparency in the functioning of governors. (250 words)

Difficulty level: Moderate

Reference: The Hindu ,Insights on India

Why the question:

The article discusses the issue of pending bills and the role of governors in the legislative process. The author argues that governors in some Indian states have been delaying or refusing to give their assent to bills passed by the state legislature, thereby impeding the legislative process.

Key Demand of the question:

To write about role of governor in giving/withholding assent to bills passed by state legislature and measures needed to resolve them.

Directive word:

Discuss This is an all-encompassing directive you must debate on paper by going through the details of the issues concerned by examining each one of them. You must give reasons for both for and against arguments.

Structure of the answer:

Introduction:

Begin by giving context about gubernatorial inaction and article 200.

Body:

First, write in detail about the various options with the Governor with respect to a bill passed by the state legislature.

Next, write about the drawbacks on indefinitely sitting on the bill (pocket veto) and issues arising from such action.

Next, write about the possible solutions to the above issue.

Conclusion:

Conclude by writing a way forward.

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World Bank Approves $100 Million to Strengthen Nepal’s Healthcare … – ReliefWeb

Posted: at 5:59 am

WASHINGTON, April 28, 2023 The World Banks Board of Executive Directors today approved $100 million in financing for the Nepal Quality Health Systems Program operation.

The Program will improve the quality of healthcare services and increase the coverage of health insurance and enhance the capacity of the healthcare system to prepare for and respond to health emergencies in Koshi and Gandaki provinces.

By prioritizing and investing in health, Nepal can reap multiple benefits including improved health outcomes, increased productivity, and economic growth, said Faris Hadad-Zervos, World Bank Country Director for Maldives, Nepal, and Sri Lanka. The World Bank supports Nepals goal to put quality at the core of health system policy and planning and service delivery.

The Program will be implemented by the Ministry of Health and Population with the coordination of the Health Insurance Board at the federal level, and provincial and local governments in Koshi and Gandaki provinces to help achieve the strategic objectives of Nepals Health Sector Strategic Plan, 2022-2030. These include enhancing efficiency and responsiveness of the health system, promoting sustainable financing and social protection in health, and promoting equitable access to quality health services.

The Program supports the implementation of federalism and builds on Nepals first Program for Results in the health sector to address the challenges of access and quality and to build a resilient public health sector, said Dr. Feng Zhao, Practice Manager for Health, Nutrition and Population, South Asia Region. The results achieved under this Program have the potential for scale-up to other provinces.

The financing for the Program is complemented by a $3.84 million grant from the Health Emergency Preparedness and Response (HEPR) Trust Fund. The HEPR Trust Fund supports eligible countries and territories to improve their capacities to prepare, prevent, respond, and mitigate the impact of epidemics on populations.

Contacts

KathmanduAkash Shresthaashrestha9@worldbank.org

Washington, DCDiana Chungdchung1@worldbank.org

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