Category Archives: Food Supplements

Pawan Kumar Agarwal, Chief Executive Officer of the Food Safety and Standards Authority of India (FSSAI) said Thursday that the FSSAI is committed to ensuring robust and unambiguous standards for food supplements with the help of industry.

Addressing a FICCI seminar on Nutraceuticals - Seizing Growth Opportunities under Changing Economic and Regulatory Landscape held here today, Agarwal urged food processing industry players to work with the FSSAI on developing good manufacturing practices, document and adoption of it for overcoming challenges of spurious and dubious products flooding Indian markets.

Agarwal also mentioned that FSSAI is working with the central drug regulator to make a clear distinction between drug and food, which will clear a lot of ambiguity present among the stakeholders.

The other speakers in the inaugural session included Dr. B. Sesikeran, Chairman, Scientific Panel on Functional Foods, Nutraceuticals, Dietetic products and other similar products, FSSAI, Dr. A K Sharma, Consultant, FSSAI; Mr. Sanjaya Mariwala, Chairman, FICCI Task Force on Nutraceuticals and Managing Director and CEO, OmniActive Health Technologies Ltd; Mr. Sandeep Ahuja, Chairman, FICCI ? Wellness Committee and Executive Director, VLCC Healthcare Ltd and Dr. A Didar Singh, Secretary General, FICCI.

Dr. A Didar Singh emphasized the need for having standards for food products and how FICCI can collaboratively work with FSSAI to further expand the scope of standards beyond the current standards.

Sanjaya Mariwala highlighted the growth opportunities in Nutraceuticals and its contribution to Make in India initiative. He also invite industry member to work collaboratively on matters related to GST.

The seminar was attended by about 100 participants from the nutraceuticals industry.

(This article has not been edited by DNA's editorial team and is auto-generated from an agency feed.)

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FSSAI committed to robust and unambiguous standards for food ... - Daily News & Analysis

There has always been money in testosterone, but especially now. The world is awash in ads for products that enhance and support testosterone levels. They promise health and virility. They are predicated on the contested assumption that there is a widespread dearth of testosteronethat more problems lie in scarcity than surplus.

Among these products is a potion known as Super Male Vitality. A single two-ounce vial costs $59.95. (The retail price on the sellers website is given as $69.95, but that price has been conspicuously crossed out.)

For buyers who are not convinced by the discount and the phallic applicator and the promise of some kind of superior maleness, there is the question of what this product is. Its seller claims: As men age, they may often experience a slow-down in vitality, energy, and overall wellness, so Super Male Vitality is specifically designed to assist the body in regulating proper balance to create superior vitality in males.

The liquid is a mix of widely available herbs. The reason many people seem to believe it creates superior vitality in males is that the liquid is sold at a store called Infowarswhich you may know as the media business owned by Alex Jones, who you may know as the man who takes his shirt off and yells a lot, and who believes that the massacre of children at Sandy Hook was a hoax, and who has said tap water is a gay bomb.

Jones was in the news this week regarding an interview with NBCs Megyn Kelly, which was diffusely criticized for the fact of even giving air time to Jones. He is often described as a media personality or commentator, and his radio show is widely syndicated, and his videos have been seen millions of times onlinethough he distances himself from the media in any sense. He might better be described as a provocateur, thena person in the business of getting attention.

At some point, of course, that attention needs to be turned into money. That seems to be where Super Male Vitality and the rest of Jones health business comes in. Buzzfeed reported last month that according to multiple former Infowars employees, the supplements were what really turned Infowars into a media empire that caters to conspiracy-minded consumers, estimating annual sales in the tens of millions of dollars. (Its not just Super Male Vitality: Infowars also sells a product called Brain Force Plus, and another called Caveman, which will invite users to rediscover the human blueprint, and experience the power of cutting edge science.) One former employee said Jones can sell 500 supplements in an hour.

These supplements seem to be more than a part of the business model, but the core of it. Infowars does not operate like a newspaper or magazine, by selling ad space to third parties.

Last month in New York magazine, Seth Brown detailed that Jones makes no money from selling ads on his radio show, which amounts to a widely syndicated four-hour infomercial for supplements. An examination of his business seems to indicate that the vast majority of Infowars revenue comes from sales of these dietary supplements. Infowars isnt a media empireits a snake-oil empire.

Infowars didnt reply to my request to discuss some products health claims and sales. Though a representative did tell me that in the future I should address questions about the supplement business to an account called whistleblower@infowars.com, the existence of which seems like an admission of something.

The store itself is heavily fortified with legal caveats for its health claims, like The information contained in the Website is provided for informational purposes only, and is not meant to substitute for the advice provided by your doctor or other health care professional.

So to be clear: The information is for informational purposes only.

Though even this is not quite true. The fine print actually says that the act of reading the information absolves Infowars and Alex Jones of any responsibility for conveying that information. (By using this site for any purpose whatsoever, including reading, browsing, studying you are agreeing to indemnify Infowars from any claims or responsibility for anything which may result there from, and you accept sole responsibility for any legal, medical, or financial liability which may occur as a result of your usage of the pages on this site.)

The company is not responsible for the information, or for the act of selling products that make unsubstantiated health claims. You the reader are responsible for the act of using the page. This is the sort of setup for which consumer protection exists. Of course, Jones rants against all sorts of consumer-protection measures, entities, and ideas. He has a vested interest in it remaining that way.

It was in fact because of an expensive campaign of fear-of-government-mongering by the supplement industry that Jones and others are able to sell these medicinal concoctions without the government getting in their way. The 1994 Dietary Supplements Health and Education Act effectively lets anyone sell medicineso long as its not explicitly medicines, but ingestible non-food products that claim to improve health. More specifically, a product cant be sold to treat or cure a specific disease, as pharmaceuticals are, but a supplement can claim to provide health, vitality, cardiovascular support, joint functionality, brain wellness, et cetera.

The law has led to much consumer confusion and piles of money wasted on products that may or may not be offering support or vitality or enhancement. But it has been a boon for industry. Instead of paying hundreds of millions of dollars to bring a product to market as a vetted pharmaceutical, anyone can go to market with a potion or pill or whatnot. This is acknowledged in a dark grey font on a black background on Infowars: These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

Meanwhile much more visibly, right next to the product, buyers are assured: As always, we offer what we have researched and believe to be the highest quality selection of products for you and your family that have been developed along with the advisory of top doctors and experts.

Only one doctor and/or expert is named on the site. He is referred to as Dr. Edward Group, and he is the person credited with inventing the Infowars supplement concoctions. It was he who created the most powerful herbal male hormonal support product on the market, Super Male Vitality. And it was Group who explained in an Infowars Youtube video called The B12 Conspiracy that everyone is deficient in B12 because of all the pesticides and everything else that's been sprayed on the soil. Infowars also sells vitamin B12 (as most pharmacies do for a few dollars). Though the Infowars product is called Secret 12, and it costs $29.99.

I find no leading expert who agrees that all people are deficient in B12or even that many people are. In particular cases, a B12 supplement may be beneficialbut this is a discussion for a particular patient with their particular doctor who knows their particular case. Apart from certain few other casesvitamin D in certain people, folic acid in pregnant females, vitamin C in 18th-century transoceanic seamensupplements do not help us.

Group is a chiropractor. He is pictured on his web site in a white coat and scrubs, signifying to clients some belonging in the medical profession. His website lists multiple media appearances, the recurring theme being opposition to Western medicine. For example, he told The New York Times in 2009, Western medicine is treating the symptoms instead of addressing the root cause.

This is a mantra of alternative and naturopathic healers. Its, of course, true. Like Joness conspiracy theories, its based in truth and plausibility. But it can be true that the U.S. health-care system is built around a fee-for-service model that ignores the causes of diseaseand it can simultaneously be true that the answer to the problem is not to spend your money on Super Male Vitality or other dietary supplement pills, powders, and potions. They risk providing a false security and distract from addressing the root cause of disease. And it is not a discussion to be had with a doctor who also sells supplementsmuch less at exorbitant markups.

Yet worse than all this is that these sales tactics are predicated on sowing distrust in what is actually known. The near consensus of actual leading experts is that eating mostly minimally processed plant-based foods is the best way to keep a body nourished. If there are indeed effects of certain herbs on human testosterone levelsa plausible conceptit is not likely necessary to pay exorbitantly for ultra-concentrated vials. In addition to lack of evidence, the products validity is undermined by the fact that Infowars also sells a potion called Super Female Vitality. It does not mention testosterone. The list of ingredients is almost identical.

Though it ends in ellipses.

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Testosterone Wars: Infowars and the Promise of Power in a Vial ... - The Atlantic

Uganda is so poor that few can afford medical care, giving it one of the lowest life-expectancies on the planet -- this toxic combination made the country ripe for infiltration by Tiens, a Chinese Multi-Level-Marketing "nutritional supplements" cult whose members set up fake medical clinics that diagnose fake ailments and proscribe fake medicines, then rope patients into becoming cult recruiters who convince their friends to sign up for the cult.

Al Jazeera outfitted an investigator with a hidden camera, and recorded her "diagnosis" and prescription by a fake doctor at a Tiens "clinic," then followed her through her induction into the cult at a series of high-pressure indoctrination sessions.

So we asked Halima to go to the weekly "training sessions" with her hidden camera.

This, we knew, was risky. I'd spoken to people who had been investigating MLM practices for years and they thought Halima, who would be attending training sessions over several weeks, might actually be in danger of being convinced and recruited.

She was going to be subjected to a barrage by the Tiens motivational speakers. We couldn't be with her the whole time, so we agreed to monitor her with regular phone discussions to check that she was not suddenly having unrealistic dreams of becoming rich through selling food supplements.

Luckily she isn't so easily fooled, and was able to document how Tiens convinces people to stay loyal through reinforcement of the idea that distributors are starting a new life and by its unrelenting "blame and shame" rhetoric about personal failure and not selling enough products. Only their inadequacies and doubts - and those of sceptical family and friends who should, of course, be dropped - were barriers to the recruits achieving great wealth.

When we met up with Michael Halangu, a former Tiens distributor, he confirmed these were the same techniques that had kept him in the business for years. In our interviews he was open about how they fooled him and how much money he lost, but the psychological impact had gone deeper; although he could see all the aspects of the scam, he still blamed himself for not having made a success of it.

But while it is clear that the poor, weak and vulnerable are particularly susceptible to such schemes, even strong people can succumb under enough pressure. Michael is an intelligent and determined man with a college degree, and we even met a university professor among the distributors at one Tiens event we attended.

Eventually, as you will see, we were able to put some of the points raised in this film to a Tiens representative. The company told us about its 5,000 distributors in Uganda and its operations across the African continent and how if people worked hard enough they too could enjoy the cars and yachts and millionaire lifestyles that their top distributors enjoyed. The company was less illuminating about those who hadn't been so lucky - or those of its distributors who, after carrying out bogus medical diagnoses, were happy to con gullible members of the public into buying Tiens products.

Uganda's Health Pyramid [Priya Biring/Al Jazeera]

(via Super Punch)

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A Chinese vitamin MLM cult is replacing healthcare for poor Ugandans - Boing Boing

Pawan Kumar Agarwal, Chief Executive Officer of the Food Safety and Standards Authority of India (FSSAI) said on 23 June 2017 that the FSSAI is committed to ensuring robust and unambiguous standards for food supplements with the help of industry.

Addressing a FICCI seminar on Nutraceuticals - Seizing Growth Opportunities under Changing Economic and Regulatory Landscape held here today, Agarwal urged food processing industry players to work with the FSSAI on developing good manufacturing practices, document and adoption of it for overcoming challenges of spurious and dubious products flooding Indian markets.

Agarwal also mentioned that FSSAI is working with the central drug regulator to make a clear distinction between drug and food, which will clear a lot of ambiguity present among the stakeholders.

The other speakers in the inaugural session included Dr. B. Sesikeran, Chairman, Scientific Panel on Functional Foods, Nutraceuticals, Dietetic products and other similar products, FSSAI, Dr. A K Sharma, Consultant, FSSAI; Mr. Sanjaya Mariwala, Chairman, FICCI Task Force on Nutraceuticals and Managing Director and CEO, OmniActive Health Technologies Ltd; Mr. Sandeep Ahuja, Chairman, FICCI - Wellness Committee and Executive Director, VLCC Healthcare Ltd and Dr. A Didar Singh, Secretary General, FICCI.

Dr. A Didar Singh emphasized the need for having standards for food products and how FICCI can collaboratively work with FSSAI to further expand the scope of standards beyond the current standards.

Sanjaya Mariwala highlighted the growth opportunities in Nutraceuticals and its contribution to Make in India initiative. He also invite industry member to work collaboratively on matters related to GST.

The seminar was attended by about 100 participants from the nutraceuticals industry.

-ANI

Original post:

FSSAI committed to robust and unambiguous standards for food supplements - Catch News

Nearly one-third of the advertisements for memory-boosting supplements reviewed by a government watchdog may be illegally claiming to cure or prevent diseases like Parkinsons or Alzheimers, according to a recent report. The report suggests that government regulation is failing to keep up with the growing supplement industry, but regulators arent prepared to actually fix the problem at its root.

Don't take your supplements lightly.

Over two months, investigators from the Government Accountability Office (GAO) sorted through memory supplement marketing online, in print, on TV, and in stores. After analyzing 91 advertisements and labels in depth, they discovered 28 ads for 34 supplements that claimed a product could protect against or treat dementia, Parkinsons disease, or Alzheimers disease. Thats illegal; claims that a pill or concoction can treat, cure, or prevent diseases have to be approved by the US Food and Drug Administration.

The dietary supplement industry is massive, raking in an estimated $39 billion in sales in 2015. The portion catering to customers who want to improve their memories is growing nearly doubling from $353 million in 2006 to $643 million in 2015. Most of the advertising for these drugs is online, the GAO found. And the supplement makers are minimally regulated. Products can hit the shelves without being tested for safety or efficacy, and, often, without their labels being vetted for accuracy. "Its a challenge to take on an industry that's this large, says FDA spokesperson Lyndsay Meyer.

"Its a challenge to take on an industry that's this large.

The Senate Committee on Aging was concerned that aging consumers might be especially vulnerable to claims that one weird trick could stave off senior moments, so it asked the GAO to check in. The GAO shared the 28 examples it found with the FDA, which agreed 27 of them may have violated the law that generally bars supplement manufacturers from making disease claims.

But the agency has only taken action against a couple of the companies. It sent a warning letter to Utah-based Lifevantage Corp, and two online advisory letters to companies making similar statements: Healinginabottle.com for the product Immuno Boost Eximius, and Life Decoders, LLC, for Sheep Placenta Advanced Capsules marketed on stemcelltherapyplus.com. The FDA is monitoring the rest.

Healinginabottle.com has expired; an email to the account the FDA used to contact the company bounced, and the company didn't reply to a Facebook message. Stem Cell Therapy Plus' website still mentions Alzheimer's and Parkinson's disease; spokesman Joe Cruz says the company has addressed the FDA's concerns.

Ryan Nadeau, a spokesperson for Lifevantage, noted that the website the FDA discussed in its warning letter, nrf2science.com, is not selling a Lifevantage product its discussing the protein that this product is purported to target. We definitely agree with the need for transparent advertising and making sure that you stay within the guidelines, Nadeau says. I mean youre talking about diseases its not something you want to con your way into.

The problem with deceptive marketing is that it could lead people to, at best, waste their money, and at worst, make dangerous health decisions. Most people believe when they go to the store and they're able to just pick it up off the shelf that this is something that the agency has reviewed for safety and efficacy. Or safety, at a minimum, the FDAs Meyer told The Verge. The way that the framework is set up for supplements in this country that's just not true.

Obviously its not ideal or optimal by any means for consumer protection.

Despite its latest findings, the GAO doesnt have any big regulatory or enforcement recommendations for the FDA, which oversees supplement labeling, or the Federal Trade Commission, which oversees advertising. Instead, the GAO recommended that the FDA and FTC clarify to consumers which agency to report concerns to involving Internet marketing. If this seems like an anemic response, thats because it is.

Obviously its not ideal or optimal by any means for consumer protection and other issues. But those were the cards we were dealt, says Seto Bagdoyan, a director of forensic audits and investigations for the GAO. And that's why we focused on our market research and also on the consumer awareness of these regulators respective roles.

The problems with supplement oversight go back to a 1994 law called the Dietary Supplement Health and Education Act, or DSHEA. Under this law, supplements are regulated as food, not drugs. That means that supplement makers arent required to prove their products are safe or effective before selling them. And while manufacturers are typically legally barred from making disease claims on product labels, the FDA generally doesnt approve labels before supplements hit the shelves.

So the agency can only reprimand companies that it catches breaking the rules. And catching wrongdoers is challenging, because the FDA doesnt have a comprehensive list of the supplements on the market. You can have concerns over products and then the products get renamed, says Joshua Sharfstein, a professor at Johns Hopkins University and former FDA deputy commissioner. There are so many aspects of this that are out of control at the same time.

Something negative has to happen before they take action.

In the past, the GAO has suggested that the FDA should come up with guidelines that spell out the scientific evidence companies need to back up claims like "calcium builds strong bones" on a products label. The GAO also said that the agency should ask Congress for the power to demand that supplement companies hand over that scientific evidence. Neither of these suggestions were implemented. They explained to us, once again, that they really are hamstrung in terms of their authorities, Bagdoyan says. The focus of their work is at the back end where something negative has to happen before they take action.

Thats why the GAOs recommendation is so unhelpful, especially since most consumers are unlikely to know whether a supplements advertising is illegal. Even if it were clearer where consumers should report concerns to, its hard to imagine that would make much of a difference. Adverse health events are already massively underreported (consumers and clinicians can report them here). Scientists with the CDC and FDA estimate that dietary supplements are associated with more than 23,000 emergency room visits annually. The FDA estimates that there are over 50,000 supplement-related health incidents each year. And yet only somewhere between 2 and 3 percent of these incidents are reported, according to a 2008 GAO report.

Until regulation of dietary supplements changes, Meyer sums up the bottom line for health-conscious consumers: Don't take your supplements lightly.

Original post:

Scammers selling fake cures for Parkinson's and Alzheimer's are ... - The Verge

The FSSAI on Thursday said presence of doping substances in food supplements posed a major challenge and efforts were needed to save the reputation of the supplements industry.

Pointing out that India stands at third position in doping cases, the FSSAI cautioned food supplements manufacturing and processing industry to be aware of the threat of doping substances in supplements.

The National Anti-Doping Agency (NADA) had circulated a list of banned drugs to the Food Safety Commissioners and Maharashtra had started enforcement against anti-doping practices, Food Safety and Standards Authority on India (FSSAI) CEO Pawan Kumar Agarwal said.

"Major enforcement exercise is going on in Maharashtra against anti-doping substances. You do need all these efforts to be taken up on an ongoing basis. It is to save the reputation of food supplements," he said at a seminar on nutraceuticals organised by FICCI here.

There have been reports that some supplement manufacturers add performance-enhancing and banned drugs in food supplements.

"In case of food supplements, major challenge we face is all kinds of spurious, dubious products in the market. There is growing instances of doping substances that are seen and being noticed in some of the food supplements," Agarwal said.

See the article here:

Banned drugs in food supplement major challenge: FSSAI - The Statesman

Alibaba's (BABA) data on its 500 million users in China will be invaluable to U.S. sellers looking to break into the $4.89 trillion China retail market.

Alibaba invited certain U.S. small businesses to its conference on Tuesday and Wednesday in Detroit to teach them more about breaking into the China market. The invite list was focused on fashion, apparel and everyday goods, including cosmetics, bicycles, fresh food, supplements, baby products and running shoes, Alibaba president Michael Evans told TheStreet.

Alibaba CEO Jack Ma and other company executives used the Gateway '17 conference to convince the selected U.S. businesses that they can no longer ignore the opportunity to sell goods to China's population of 1.4 billion. Ma noted China has 300 million in the middle class that wants to buy higher quality products from the U.S. He expects the middle class in China to double to 600 million in the next 15 to 20 years.

The company wants to reach 2 billion users in the next decade, meaning it needs more sellers to sign up for its platform.

Here's a look at two specific items Alibaba highlighted at the conference for their popularity in the current China retail market.

1. Sneakers

Demand for running shoesis surging in China and New York-based sneaker consignment shop Stadium Goods is benefiting big time.

Stadium Goods CEO John McPheters spoke on Wednesday at Gateway '17 and said he knew he wanted to sell in China after a customer came into his New York store and bought $10,000 worth of Nike Air Jordans to resell back in China. "That opened our eyes to the opportunity," he said.

More here:

Alibaba Says Chinese Consumers Are Obsessed With Sneakers and Supplements - TheStreet.com

At some point in the past decade, screening blood for vitamin D levels became a routine part of medical care. Feeling a little low this winter? Get a vitamin D test. Think you didn't get enough sun last summer? Check your vitamin D levels.

Between 2000 and 2010, the amount Medicare spent on vitamin D testing rose 83-fold, making the test Medicares fifth most popular after cholesterol. All that screening also led to an explosion in vitamin D supplement use, and millions of Americans now pop daily vitamin D pills.

They mightve been encouraged by media reports over the past few years about the perils of getting too little of the sunshine vitamin. The supplements also seemed to be a cure-all: Many of us are confined to our computers, spending little time outdoors, and may feel we arent eating enough of the foods, like fish, that deliver vitamin D.

But as the interest in and testing for vitamin D has exploded, researchers have been wondering why so many people bother. Most of us actually get enough vitamin D without even trying. No high-quality study has found a benefit to screening asymptomatic adults, and putting people on treatment with supplements has also failed to demonstrably improve health outcomes.

That means when people seek out vitamin D tests and pop the supplement to alleviate the winter blues or prevent cancer, theres no evidence suggesting itll help them.

It would be great if you said the reason we screen is that we find out if a patient is low on vitamin D and we do something about it, we can prevent disease, says Dr. Clifford Rosen, one of the country's foremost experts on the health impact of vitamin D screening. Right now doctors can't confidently make that case.

Vitamin D is an essential vitamin that you get from food, including fatty fish such as salmon and tuna, beef liver, cheese, and egg yolks. Of course, it's also found in fortified foods, such as milk, orange juice, and cereal, and you get it from exposure to UV light.

You need vitamin D to regulate the absorption of calcium and phosphorous in your body, which keeps your bones strong and protects against osteoporosis and rickets.

In recent years, researchers have found associations between low levels of vitamin D and increased risk for a range of health problems, including fractures and falls, cardiovascular disease, diabetes, colorectal cancer, depressed moods, and even cognitive decline. As awareness about the importance of vitamin D for health has spread, so has the demand for testing.

So how much do you need? Less than 10 nanograms per milliliter of vitamin D in the blood is considered much too little, a vitamin deficiency. When your levels hover around there, you might experience symptoms such as muscle weakness, bone pain, and fractures.

Most experts agree that you want your vitamin D blood level to be at least 20 nanograms per milliliter.

The good news: Most of us have this much in our bodies without even trying.

In 2010, the Institute of Medicine brought together an expert committee to review the evidence on the vitamin and figure out whether there was a widespread deficiency problem in North America. According to the 14-member panel, 97.5 percent of the population got an adequate amount of vitamin D from diet and the sun.

The panel did, however, identify a few key populations that seemed to have higher levels of deficiency: people with dark pigmentation (such as African Americans), older folks who live in nursing homes, melanoma patients, and people who cant absorb the vitamin as a result of diseases of the liver or bowel.

The controversies about the benefits of vitamin D reflect how science evolves, said Dr. Barry Kramer, director of the cancer prevention division at the National Cancer Institute.

Early research on the benefits of vitamin D was mostly observational large-scale, population-level studies and did not look at endpoints that are important for long-term health, like whether a high vitamin D intake reduces one's risk for particular diseases or death.

Researchers found associations between higher levels of vitamin D intake and a range of health benefits. "But with the observational studies especially when you're dealing with dietary supplements and diet taking supplements is also associated with many other confounding factors that predict the outcome: being wealthier, being health-conscious, having health insurance and access to the health care system, low smoking prevalence, increased physical exercise," said Kramer.

In other words, the people who were taking these vitamins were doing many other things that might have caused them to have better health outcomes. Still, this early science encouraged people to hop on the vitamin D bandwagon.

Since then, randomized trials that introduce vitamin D to one group and compare that group with a control group have been disappointing, showing little or unclear benefit for vitamin D testing and supplementation in healthy people. That Institute of Medicine report noted that randomized trials had uncovered no health benefit for healthy people with vitamin D blood levels that were higher than 20 nanograms per milliliter.

There are also well-documented costs associated with overtesting and getting too much vitamin D: the cost to the health system for all those tests, and the potential harms from high vitamin D levels, such as kidney stones and high calcium which can cause nausea, vomiting, and loss of appetite.

So until we have more and better studies on vitamin D, related testing and treatment are clouded with uncertainty and a lack of evidence for any benefit.

There's also the issue of defining vitamin D levels that are problematic. Experts agree that anything less than levels of 10 ng/mL of blood is worrisome or a deficiency, but when is someone insufficient? Is 20 ng/mL really enough? Should the minimum cutoff be 30 ng/mL?

According to the US Preventive Services Task Force whose recommendations set the tone for medical practice in this country this uncertainty led to a lot of inconsistency around how vitamin D insufficiency was defined in studies. Different professional bodies also back different minimum blood levels, usually ranging from 20 to 30 ng/mL.

Finally, there's some question of whether healthy (asymptomatic) adults who undergo routine screening for vitamin D actually see any health benefit as a result. The task force points out that there were no studies on the benefit of screening otherwise healthy adults, but it did find that putting them on treatment with supplements did not improve health outcomes for a range of issues, including cancer, Type 2 diabetes, and fractures.

"Although the evidence is adequate for a few limited outcomes, the overall evidence on the early treatment of asymptomatic, screen-detected vitamin D deficiency in adults to improve overall health outcomes is inadequate," the task force authors write in their latest guidance.

To clear up some of the uncertainty, the NIH has funded one of the largest randomized trials on vitamin D, with the results expected to be ready next year. Maybe then we'll have a better sense of what, if any, benefit this vitamin holds.

One of the authors on that study, Dr. JoAnn E. Manson, recently told the New York Times, A lot of clinicians are acting like there is a pandemic, of vitamin D deficiency. That gives them justification to screen everyone and get everyone well above what the Institute of Medicine recommends.

It's important to be clear that the task force is highlighting uncertainty around screening and treating asymptomatic people who don't have real signs of illness, such as broken bones, or other illnesses that can cause vitamin deficiencies, like liver disease or multiple sclerosis.

"For healthy individuals, if youre tired and weak, but its nondescript, this is a really tempting thing to do: measure vitamin D and then treat," Dr. Rosen, who is based at the Maine Medical Center Research Institute, warned. "But there just isn't enough evidence it does anything."

So, for example, if you were feeling a little low this winter and you ask for a vitamin D test, then find out your levels are hovering around 20 or 30 ng/mL, you can go on supplements. And there's no doubt that those supplements will raise your vitamin D levels, since researchers have found they are absorbed by the body very efficiently. Doctors just don't know whether that change actually has any health benefit.

Rosen also cautioned that the biggest misconception about vitamin D is the association between low vitamin D levels and disease risk. "There's this idea, if we treat you, not only will some of your symptoms get better but also your long-term health benefit will be enhanced," he said. Again, there's no good evidence that that's the case.

"Unless you really are truly symptomatic," Rosen summed up, "it might not be worthwhile to measure vitamin D, and tag you with the diagnosis of deficiency, when its not clear those levels make you deficient and youre not at risk for disease." In other words, beware of the vitamin D test.

Read the original here:

Your vitamin D tests and supplements are probably a waste of money - Vox

The Natural Products Association (NPA; Washington, DC) has filed a formal petition asking FDA to shelve the agencys proposed final rule that would enact changes to both the Nutrition Facts and Supplement Facts labels. In its petition, NPA claims that these changes overly burden the food and dietary supplement industries and run counter to the Trump administrations goal of reducing unnecessary regulations.

The association focused heavily on two changes under the proposed final rule. The first is FDAs proposal to list added sugars on the label. NPA says that adding an added-sugars listing is unnecessary because a listing for total sugar is already required on labels today. Given the Trump Administrations stated goal to eradicate overly onerous regulations, NPA says it is now pushing back on what it considers unnecessary and overly burdensome regulations like these.

Daniel Fabricant, PhD, president and CEO, NPA, commented in a press release: We are heartened by the Administrations pledge to weed out bad regulations that only end up costing consumers more money, and this one is exhibit A. This rule was poorly written, rushed, unnecessary, and should be shelved immediately. Labeling is extremely important, but labeling changes posed by FDA must be material and based on scientific evidence or consumer empirical studies and not based on whim or the way the wind happens to be blowing.

The petition notes that data from FDAs own consumer studies do not seem to support the need to add an added-sugars listing to the nutrition label. According to the petition, FDA relied upon consumer studies to support their reasoning for including a new declaration for added sugars but found in these studies that consumers were largely confused about the difference between sugars and added sugarsregardless of whether added-sugar distinctions appeared on the label.

Further, NPA claims that FDAs own eye-tracking studies do not seem to support its decision to include added sugars to the nutrition label, either. FDAs eye-tracking study, which was conducted between January and March of 2015, analyzed the ways that consumers read various nutrition label elements. NPA says that the eye-tracking study sample size was too small and too regionally homogenous to obtain meaningful data. NPA used FDAs raw eye-tracking data in its own independent study on the dwell time of eye fixation (how long consumers looked at individual components of the nutrition label) to determine whether there was difference in how long consumers examined carbohydrates versus added sugars. NPA found that consumers dwell time was lower when consumers were looking at added sugars compared to carbohydrate information, which the association said suggests that the added sugars line does not provide any added benefit.

NPA also questioned FDAs approach to dietary fibers, stating that the agencys decision not to include isolated or synthetic dietary fibers within its new, official fiber definitionwhich was promulgated as part of the proposed label changesare not backed up by scientific or empirical studies. NPA challenged the new fiber definition in its petition, saying that it is selective and inconsistent and does not include isolated or synthetic dietary fibers such as inulin. FDA does not treat dietary fiber consistently as it does most other nutrients, the petition states. FDA has chosen to define dietary fiber in accordance with a showing of its beneficial physiological effect, rather than on the basis of its chemical definition and characteristics. All other nutrients and food components are defined based upon a chemical definition or some quantitative measurement.

Furthermore, the petition notes, NPA does not support FDAs current treatment of dietary fiber in the Food Labeling Final Rule, which requires industry to demonstrate at least one beneficial physiological effect in humans.

Finally, NPA criticizes FDAs failure to submit an economic impact analysis of the economic impact of this rule to the food and supplement industries when the final rule was announced. As NPAs press release states, FDA failed to submit a cost-benefit analysis to the Office of Management and Budget during promulgation of the rule, a clear violation of longstanding Executive Orders, the Regulatory Flexibility Act and the Unfunded Mandates Reform Act of 1995.

In 2014, the FDA proposed new requirements for Nutrition Facts Labels, originally mandated in 1994 and virtually unchanged in the years since. The most notable new requirements included a new way to list serving sizes, listing of added sugars, inclusion of vitamin D and potassium content, and voluntary inclusion of vitamin A and C content. For 90 days following the proposed changes, the FDA accepted public comments, and in May 2016, the new requirements were finalized and implemented. The requirements necessarily extended beyond food products to the supplements industry, and were to be implemented by July 26, 2018; however, the FDA recently revised its compliance deadline, now July 26, 2019, giving the industry more time to complete compliance documents.

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NPA Petitions FDA to Stop Changes to Nutrition Facts Label, Supplement Facts Label - Nutritional Outlook

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FDA urges caution about bodybuilding supplements

Its beach season and, while some might turn to bodybuilding supplements to get their body sand-and-sun-ready, experts said not all of these products are safe.

According to a consumer safety release from U.S. Food and Drug Administration, bodybuilding products that contain steroids or steroid-like substances are associated with potentially serious health risks, including liver injury. Some of the liver injuries were life-threatening, said Mark S. Miller, FDA regulatory review officer, in the statement.

In addition to liver injury, anabolic steroids have been associated with serious reactions such as severe acne, hair loss, altered mood, irritability, increased aggression, and depression. They have also been associated with life-threatening reactions such as kidney damage, heart attack, stroke, pulmonary embolism (blood clots in the lungs), and deep vein thrombosis (blood clots that occur in veins deep in the body).

These bodybuilding products are promoted as hormone products and/or as alternatives to anabolic steroids for increasing muscle mass and strength. Many of these products make claims about the ability of the active ingredients to enhance or diminish androgen, estrogen, or progestin-like effects in the body, but actually contain anabolic steroids or steroid-like substances, synthetic hormones related to the male hormone testosterone.

Some who use bodybuilding products engage in stacking, using multiple products (including stimulants or products providing false assurances of liver protection) to enhance results or gains. These combinations may put consumers at greater risk for serious and life-threatening reactions.

If youre taking any body building products that claim to contain steroids or steroid-like substances, the FDA recommends that you stop taking them immediately because of the potentially serious health risks associated with using them. The agency also recommends that you talk to your health care professional about any body building products and/or ingredients you have taken or are planning to take, particularly if you are uncertain about those ingredients. You should also talk to your health care professional if you are experiencing symptoms possibly associated with these products, particularly nausea, weakness or fatigue, fever, abdominal pain, chest pain, shortness of breath, jaundice (yellowing of the skin or whites of the eyes), or brown or discolored urine.

The FDA encourages consumers and health care professionals to report adverse events or serious side effects related to the use of these products to the FDAs MedWatch Safety Information and Adverse Event Reporting Program.

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FDA urges caution about bodybuilding supplements - CT Post