The Dangerous Durbin Anti-Supplement Bill

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dick durbin anti supplement billThe FDA can count on mainstream media to mislead the public. Let’s get the truth out and stop this bill. Action Alert!

Sen. Dick Durbin (D-IL)’s bill, S.1425, is meant to “improve the safety of dietary supplements by [requiring]manufacturers of dietary supplements to register dietary supplements with the Food and Drug Administration and to amend labeling requirements with respect to dietary supplements.” Sounds innocuous, doesn’t it? But as we reported in August, this is nothing but a smokescreen—a naked power grab for the FDA and an attempt to regulate safe dietary supplements as if they were dangerous FDA-approved prescription drugs.

A recent article in Newsday quotes “a top agency official” (probably FDA’s Division of Dietary Supplement Programs director Dan Fabricant, who is quoted extensively in the article) as saying that 70% of supplement companies have violated FDA’s manufacturing rules over the last five years—with the clear implication that such manufacturing violations somehow puts the American public at risk. There is no mention of the nature, context, or seriousness of these alleged violations, and no link to any official reports or documentation.

The article declares that the number of adverse events caused by supplements “outstrips” those triggered by prescriptions drugs. This is totally false. The Newsday article’s author, Delthia Ricks, tells us that approximately “6,300 people nationwide complained about adverse reactions to dietary supplements between 2008 and 2012, according to FDA statistics. But the actual number may be more than eight times higher, some experts say, because most people don’t believe health products can make them sick.” This “eight times higher” claim has no basis in fact, and no documented source. Even if it were true, this number is far less than for prescription drugs.

The 6,300 figure averages to 1,575 per year, which is extremely low considering that 157 million Americans—half the US population—take supplements. This is in comparison to 526,527 adverse events for prescription drugs, 275,421 of which had “serious outcomes,” including death.

Why would we want to let the agency regulate supplements as if they were drugs when the drugs they approve cause over 400 times the adverse events than supplements do? When the Government Accountability Office (GAO) looked at the number of adverse events for supplements at the request of Senator Durbin, it was unable to uncover anything alarming, as we reported back in March.

On the contrary, the GAO report showed that FDA-approved drugs caused 80% of Poison Control fatalities. More than 100,000 calls to Poison Control Centers, 56,000 emergency room visits, 2,600 hospitalizations, and nearly 500 deaths each year are attributed to acetaminophen (Tylenol) alone!

The Newsday article goes on to describe, in detail, the FDA’s authority to regulate the vitamin supplement industry, noting the agency’s inspection of supplement company facilities, and its ability to issue product warnings, recalls, and seizures and levy steep fines against companies that run afoul of FDA regulation. Inexplicably, the article then quotes Dan Fabricant as saying, “There is little the FDA can do to exercise more power over supplement safety without an act of Congress,” and concludes that FDA has “limited power” to regulate supplements. In what universe does that statement make sense?

The only way it makes sense is if mainstream media pieces like this Newsday article are viewed as propaganda: a concerted alliance between the media, the FDA, and legislators like Sen. Durbin to weaken the public’s determination to keep dietary supplements freely available. Lest this sound too conspiratorial, we need to remember that drug advertising is what keeps much of print media alive in these days of online competition.

The theme of adverse events is very much echoed in Durbin’s legislation. His bill requires that the FDA, together with the Institute of Medicine (IOM), compile a list of dietary ingredients (supplements) that might lead to adverse events, or are otherwise deemed risky in some way—based on completely arbitrary or nonexistent standards. Given the FDA’s profound bias against supplements, and the skewed, anti-science recommendations of the IOM’s vitamin D report, these are hardly trustworthy sources of guidance!

By the way, speaking of IOM and adverse events, why does the IOM absolutely refuse to study adverse events from vaccinations? In this case it holds that adverse events are meaningless because not studied, but then refuses to study them.

Returning to supplements, the FDA already has complete authority to keep them safe—it’s just a matter of enforcement, as the FDA’s Fabricant himself said when he worked for the Natural Products Association: “The barriers to enforcement are simple: [FDA] money, manpower, and will.” (You’ll note he doesn’t say “more regulation”!) He also made the distinction between the “legal, safe and healthy dietary supplement industry” and “the seedy, fly-by-night, unsafe world of illegal steroids,” and called on FDA, DEA, and other appropriate agencies to work together to enforce the laws that already exist. Most of the violations cited in the Newsday article are examples of bad manufacturing practices, which are already illegal and subject to FDA enforcement action. All the FDA has to do is enforce existing rules.

Another element in Durbin’s legislation is a greater restriction of health claims: he has said his bill is designed to stop “mislabeling products and making health claims that have no scientific basis.” This is more nonsense.

The vast majority of supplement health claims have plenty of scientific basis—just not the random-controlled trials (RCT) that Durbin and the FDA want. And there’s a very good reason for this: most natural products companies cannot afford to spend up to a billion dollars on RCTs, because in most cases that natural product can’t be patented, so the companies could never hope to make back their investment. In addition, many supplements should be taken with co-factors and so should not be studied in isolation like a drug.

Durbin knows all this. The demand for RCTs is just a backdoor way to get rid of most supplements entirely.

In the past, Dan Fabricant did not support greater restrictions of health claims. In response to IOM’s recommendation that dietary supplement health claims should be subject to the same scrutiny as pharmaceuticals, Fabricant said, “Trying to see foods through the same lens as isolated pharmaceuticals is impractical from a policy standpoint.” He also noted that many widely used general claims about how nutrients work, such as “calcium builds strong bones,” can’t be subjected to the same clinical evaluation as pharmaceutical drugs.

In other words, the FDA’s Fabricant said exactly what we’ve been claiming all along—that supplements are safe and the FDA needs no expanded powers—before he changed employers!

Action Alert! Please write to your senators immediately and tell them to stop Sen. Durbin’s frontal attack on your right to use supplements dead in its tracks! We don’t need this new legislation—all we need is for existing laws to be fully enforced. We need our access to nutritional supplements to be protected. Please write your senators today!

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  • Dr. Robert B. Vincelette Jr.

    Why not regulate the destructive junk foods that make people fat and sick and why not regulate tobacco so that no smoker will ever be allowed to administer his or her tobacco smoke without medical authority to prescribe it to those who are forced to breath it?
    Are we to believe that vitamin pills or creatine in a protein shake enjoyed after lifting weights are akin to Pepsi Cola with all the additives that are designed to sabotage blood sugar, apatite, and make people overeat?

  • Judith Nicholls

    There are lots of problems in our country, and plenty of it related to drugs, but supplements are not a big problem. We want our supplements, which help keep us from needing to take dangerous prescription drugs. We do not want heavy handed regulation of our supplements.

    My understanding the FDA already has the authority to keep our supplements safe.

  • Michael Davidson

    Most companies are GMP And FDA Registered I Don’t see where the Problem is

  • Michael Davidson

    Most companies are GMP And FDA Registered I Don’t see where the Problem is

  • Michael Davidson

    Most companies are GMP And FDA Registered I Don’t see where the Problem is

  • Michael Davidson

    Most companies are GMP And FDA Registered I Don’t see where the Problem is

  • Michael Davidson

    Most companies are GMP And FDA Registered I Don’t see where the Problem is

  • Kris Mason

    Please tell Mr Durbin – to STOP interfering with our dietsry supplements. There are many of us that have been taking them for years – ie. – calcium-magnesium – vit. B – fish oil. And we are VERY healthy – and much the better for it. Not everyone wants to take drugs. The prescription drugs are the problem. Mr Durin is clearly in the pockets of the drug Companies. STOP IT NOW>

  • Wendy Swanson

    No one dies from natural nutrition supplements. Leave the supplements alone, please. We have a policing agency that watches over the supplements to make sure they are safe, and obviously, they are doing a great job. Take care of the medications that are so dangerous, and leave the GOD-GIVEN, natural supplements alone. God left them here for us to take care of the bodies He gave us. You have no right taking them over, or taking them away.

  • Nina C Riegler

    This is ridiculous. Supplements are no danger to the Pharma society. They just think they are. More for them, $$$ and less health for all of us.

  • The FDA uses user fees as its source of funding
    The drug companies have fewer new drug applications each year
    Are they looking to supplement manufacturers to make up their losses?

  • kiki

    This intent is so laughably transparent … this bill wants to address LABELING requirements for supplements … when that whole world which is trying to control supplements, and has been trying for years, is fighting tooth and nail (and $ millions) AGAINST LABELING GMOs???

  • Jack R

    If you live in Illinois beware of Senator Durbin. He knows how to grandstand at the opportune moments. He’s been in the game of politics for a long time and knows how to portray himself to the lower and middle class. Watch him carefully. I am not voting for him in the next election. Like many others sitting on the high thrones in government, he is an incumbent who we can well do without.

  • Trish summers

    When will progressive and liberals learn that the current democratic party is no longer the party of the people for the people or of their parents, they are a socialist / communist / Marxist party. They will move towards controlling your health care, your religious beliefs, your income through their redistribution of your wealth while the elitists will take their share before they redistribute! Your healthcare will become the determination of a socialist government clerk. Wake up this is the work of 40 Plus years of planning.. Remember many of you voted for this! I was a socialist. So it takes one to know one.

  • Maggie Rose

    I can’t believe this! People are begging for genetically modified foods to be labeled. That used to be illegal (in the George (the father)Bush years) but our politicians want to have supplements registered with the FDA!! We’ve been using supplements for many years without any regulations. I wonder how many people have been hospitalized for a vitamin C overdose.

  • Alan Bradbury

    Nothing is being mentioned about Chemtrails in your writings. I know this issue is a seriouse health issue. What can we do to stop this spraying of our sky’s?

    Thank you,
    Alan Bradbury

  • Grover Syck

    Do not support Sen. Dick Durbin’s bill to let the FDA regulate dietary supplements.

    This is nothing but a power grab by the FDA.

  • Jan Lindner

    Mr. Durbin should stop selling his soul to the pharmaceutical industry and pay attention to educating people on the safe use of herbal remedies, which are FAR less dangerous than most over-the-counter drugs. But plants aren’t patented, so no billionaire fat-cats can get richer off them.

    Keep your paws off my vitamins!

  • Senator Durbin,
    Regarding your Bill S. 1424:
    Supplements are NOT drugs. We don’t need to give the FDA more power over the American peoples decisions. LESS government control. We don’t want a socialist country!
    Sincerely,
    Marjune Iooss

  • Charles Barnard

    The FDA’s job with supplements is to ensure that they contain exactly what they are labeled to contain. Unfortunately many supplement manufacturers add actual pharmaceuticals to their supplements and more commonly lie about the ingredients.

    Since all ‘incident’ numbers only report reported incidents, and few supplements list possible adverse reactions, the numbers are undoubtedly higher than reported, though how much is unknown. It is likely higher than with prescription drugs because people are warned to watch for side-effects. But far more people take prescription drugs in the first place.

    But herbal supplements are often as strong as prescription drugs with unknown dosages (varying from zero on up,) due to the high number of opportunists using supplements as a fast track to profits.

    Over-regulation or under-regulation are both dangerous.

    • mrhjdez

      Have any drugs have a safety history of hundreds, even thousands of years.

      Get real! Profits of drug companies run in the billions. Drug companies spend more money on lies, than can be made selling supplements.

  • Dear Alliance for Natural Health. You have made many clear points regarding the political drive to regulate natural products and supplements. The number of fatal and debilitating adverse events associated with medical drugs speaks loudly for further regulation, safety and testing. I wish the legislators could take the energy and funds that have gone towards their campaign to deter health freedom and direct it toward examining the pharmaceutical production, manufacture, safety and efficacy of drugs before they go to market, so they would not have to be recalled. We need a strong voice from the public so we can maintain our ability to choose non-patentable natural remedies. We’re in a mess right now with the Affordable Care Act because a preliminary testing period within one state did not work out all the problems before opening it up to the entire country. Many generations of populations and cultures have been using natural supplements and remedies to reduce symptoms from illness. More people would benefit in the long run if we were able to hand down our traditions that help build our immune system and recover from illness.

  • Katy beauchamp

    Stop Senator Durbins frontal attack on my right to use supplements!

  • Renee Villani

    Leave my supplements ALONE! I am healthy because of them. Get rid of the damned pharmaceuticals that create so many problems! Sheesh… common sense man–did you lose it?

  • Julie Bennett

    Stop Sen. Durbin’s frontal attack on my right to use supplements, PLEASE. Do not take away this health freedom.

  • Rick Baldwin

    Sen Durbin is a lackey for Big Pharma & should be impeached.

  • Raz

    Shills in Congress have tried this before. The FDA fails to ensure the safety of food, e.g. eColi outbreaks, and we know Pig Pharma wants to eliminate competition from products that actually improve health as opposed to treating symptoms rather than causes.

    We have had enough of representatives supposed to be representing their constituents, but instead shill for corps who will provide the bribe to contribute to their campaigns.

    Durbin is just showing his true colors.

  • Bruce Stewart

    Oh yeah, people are dropping like flies from their B complex. No one ever gets a little queasy from eating any kind of food do they? Maybe we need double blind studies on the safety of corn or bananas. The most dangerous supplement is iron and it is one of the few supplements mainstream doctors prescribe.

    Maybe it’s supplement takers like me that are the problem. I’m 64 and have never been on a prescription drug. No profits for big pharma there.

  • felicia kandel

    Outrageous & must be stopped dead in its tracks!

  • Don

    They get me sick, legalize hemp, it never hurt anybody but the wood and petroleum industries. Leave my supplements alone and clean up your prescription mess.

  • BRUCE

    As a pharmacist and over the years all the time so-called safe supplements have turned out to be unsafe. I truly believe it is in the best interest of the public to make these FDA controlled.A perfect example is the supplement drink craze that has turned out to have a compound close to meth.

    • Dwight

      If I have read this correctly the FDA already has the power and responsibility to oversea unsafe concoctions like the crazy energy drinks you refer to. They don’t need more power. They just need to do their job. Maybe they should start by clamping down on the many dangerous prescription medicines out there that have already proven to be harmful and not wait until thousands more die just to prolong the profiteering of some pharmaceutical giants…

    • Bruce, are you confusing Vitamin C with Vioxx or Celebrexx? I think maybe you should be more concerned about that than Vitamins. I have a degree in physical education and sports science and I am an ex Olympic Athlete. As such I have taken supplements my whole life with zero side effects. Whilst it’s true that some supplement makers make over the top claims, this can be addressed with current laws. We don’t need your pharmaceutical industry friends charging us $300 a month for vitamin C thank you very much. Stick to what you don’t really know all that much about, the dangerous drugs you help peddle.

    • mrhjdez

      Expected comment by a seller of drugs

    • Steve

      Obviously you haven’t read the article. Adverse events for drugs outnumber those for supplements by well over a 400 to 1 ratio. Furthermore, the FDA already has all the regulatory authority it needs to go after unsafe supplements or manufacturers that make unjustified claims. In fact, the FDA already has too much power; you can’t even sell water with the claim that it cures dehydration because by their reasoning that magically transmutes it into a drug that would require billions of dollars in testing and studies before it may be sold.

      The FDA needs to focus on where the problems are: drugs. 500 deaths a year from Tylenol! Don’t you think that’s a problem? How many deaths from vitamin C? Zero! But since there may have been a tummy ache or two from taking too much vitamin C at one time, let’s go crack down on that dangerous product, while we ignore the body count from Tylenol.

  • Senator Durbin’s bill S.1424requiring dietary suupplements to register with the Food and Drug Administration is simply a pathway for drug companies to either stop their production, or cause them to be available only by prescription so they can take the profit for themselves. It is the pharmaceutical companies that have lobbied for this change, and the media who have joined them, because of the vast amount of money that helps support them. It is the Food and Drug Administrations job to eliminate the bad or illegal supplements, not to join the drug companies in getting rid of their competition. We have the right to use the low priced supplements – many of them prescribed by our own doctors, and we highly resent underhanded power grab by the drug industry.

  • Jo Dotson

    I am writing to ask you to stop Sen. Durbin’s frontal attack on my right to use supplements dead in its tracks! We don’t need this new legislation–all we need is for existing laws to be fully enforced. We need our access to nutritional supplements to be protected.
    Thank You
    Jo Dotson

  • Mindano Iha

    What’s happening? The way things are going we won’t even be permitted to grow parsley in our own gardens!

  • Rusty Wilson

    I’m surprised that this failed to mention that the real purpose is to eventually make supplements only available by doctor prescription, as in Europe, so people can be gouged for their supplements as they are for medicines. Will the crooks that run our nation eventually prevail?

    • Rusty, I now live in Europe, specifically France, and I can tell you that my local bio (health food store) has just about every vitamin that you can buy in the states. Wherever did the myth of needing a prescription come from? I have had vitamins prescribed by my GP, which were filled at the pharmacy (which also carries a full line of homeopathic preparations), but most everything you have access to in the states is readily available here, over the counter, albeit at higher prices. But then, just about everything but wine is more expensive here.

      This is not to say that the EU pharma lackeys in Brussels aren’t working hard to limit supplement access in Europe. The public seems much more mobilized and ready to take it to the streets here, which remains why Codex Alimentarius has not been taken to its most draconian levels. The EU owes much to the work of Dr. Mathias Rath, who organized a million member resistance effort to combat Codex in Europe a few decades ago. The ANH-USA is fulfilling that role in the states. Best regards to them.

  • suzanne obrien

    Respectfully, I do not support this bill. I want the freedom to have affordable supplements of my own choosing. I’d prefer that my representatives chase down real dangers like GMO foods.

  • Roberta Becker

    Dear Senator Durbin,

    Please leave non prescritption supplements the way they are. We don’t need the government getting into regulating that too!

  • nan stevenson

    We need suppliments!

  • Eloise Hepokoski

    Leave our nutritional supplements alone, they are food and have not ever hurt anyone! Drugs kill and injure people, quit supporting the drug companies!! Do you think the American people are so ignorant?

    • deborah

      Your comments will not get to your senators here. Use the “TAKE ACTION’ button. The only people who read this section are members.

  • Alan8

    Dick Durbin is no good!

    Not only does he want us to be gouged for buying supplements (like we’re gouged for buying prescription drugs) he ALSO supports cutting Social Security, with the LIE that it’s going to be “broke” in 20 years.

    Link: http://crooksandliars.com/john-amato/sen-dick-durbin-social-security-will-be

    He’s bought and owned by the 1%. I hope any Illinois voters that read this vote this polyp out of office in the next election!

  • Steve Helgeson

    According to reports received by the FDA’s Adverse Event Reporting System (MedWatch) there were 266,418 cases of adverse reactions to FDA-approved psychiatric drugs between 2008 and 2012 – including 6,197 suicides – where the reporter (Medical Doctor, Pharmacist, Other Healthcare Professional, Lawyer or Consumer) deemed the drug’s role in the reported adverse event(s) to be Primary Suspect Drug. This is just the reports submitted on psychiatric drugs.

    And in accordance with the “under-reported” claim in the Newsday article, a USA Today article of May 2, 2006 entitled “New antipsychotic drugs carry risks for children” stated: “Studies suggest the FDA’s Adverse Events Reporting System database captures only 1% to 10% of drug induced side effects and deaths, “maybe even less than 1%,” says clinical pharmacologist Alastair J.J. Wood, an associate dean at Vanderbilt Medical School in Nashville. So the real number of cases is almost certainly much higher.”

    • Matt purvis

      The reason they want to regulate supplements is of course for public safety but also because the supplement industry needs to be regulated. They offer a completely unfounded and often highly embellished result from using their products and advertise as if they were a prescribed medication, fooling uninformed people and stealing their hard earned money. What we have is a supplement industry that has run amuck and is nothing more then a modern day version of a snake oil salesmen.

  • Sharilyn Wood Stalling

    Obviously Sinator Durbin is owned by Big Pharma. (Yes, I intentionally wrote “Sinator.”)This is another power grab for Big Pharma to be the only source for supplements because only they have the millions of to spend to “Prove” how wonderful supplements are. Someone like myself who rarely gets even a cold, let alone the flu, when everyone in the community is sneezing and coughing, is a living example of the benefits of supplements. And no one has ever died from the use of supplements. We all know the lie behind this bill has nothing to do with keeping anyone well.

  • Greg

    Here is the truth:

    (OMNS, May 22, 2006) An independent panel of university faculty, medical
    researchers, and physicians experienced in nutritional therapeutics says that
    vitamin supplements are exceptionally safe for the public. A new report by
    the expert Vitamin Safety Review Panel rebuts a recent US National
    Institutes of Health report that attempted to cast doubt on food supplement
    safety.
    “Over half of all Americans take vitamins every day,” said Andrew Saul,
    Assistant Editor of the Journal of Orthomolecular Medicine. “One cannot
    help but ask, where are the bodies? The NIH panel ignored pharmaceutical
    drug dangers, while concentrating on unfounded concerns over your daily
    multivitamins. This indicates bias.”

  • Ed

    I have just recently gotten involved in the use of supplements and I am not quite sure of all that has happened in the past that has prompted all this uproar about the regulation of them. One thing I have noticed is that some of the claims being made about all the wonderful benefits derived from their use seems a bit more than casual boasting or advertising. Maybe if some of the ads are toned down just a little they might not be attracting so much attention. Like I said before, I’m still very new at this but some of the things being said about the results from taking the supplements is a little hard to believe. Now that I’ve said all that, even with my limited experience, I still think it’s not a very good idea to get the FDA involved any more than is necessary. Just taking a look at what they have done, or not done, with prescription medications, gives you some idea of just how bad of a job they are capable of doing. That’s all that I have to say for now.

  • Laura Ames

    I have gone into anaphalactic shock five times requiring emergency medical attention, twice during surgery from the anesthetic, three times from prescribed antibiotics (penicillins and cephalosporins). Fortunately, I was aware of anaphalaxis and always kept bottles of Benedryl in my medicine cabinet at home (thanks to advice from a very smart physician) and was able to stabliize slightly and make it to the hospital emergency room before totally “whiting” out. I have taken supplements (again thanks to the advice of a very caring physician) for the past 20+ years due to a chronic condition and have never, ever sufferend any negative reaction but have gained better health.. If the FDA is so concerned about what works for many of us (supplements), they need to apply the same rigor to those drugs released for approval. Yesterday I was prescribed a new drug for my asthma. After reading the negative side affects of the drug (one of which was possibly death), I opted to not use. Instead I will search the supplements to help me obtain better health–with no side affects.

  • Cynthia Gallo Callan

    ENOUGH IS ENOUGH! When making informed decisions about my personal well-care, prescriptions drugs are not on my list!

    Farmers have depleted the soil of nutrients and trace minerals here in the United States by the overuse of chemicals. Depleting the soil accounts for depleting adequate nutrition in harvested food. I have the right to choose non-GMO foods, along with the right to pay out of pocket — not with insurance — my supplements as an informed consumer. And trust me, it takes creative accounting to live the healthy lifestyle we do!

    Perhaps Mr. Durbin, if you and your contemporaries stopped lining the pockets of the drug companies, America would be a healthier country. You don’t see TV commercials advertising supplements — you see pharmaceutical companies advertising OTC and prescription drugs with side effect warnings in the bottom of the screen! WAKE UP America. A healthier country based on promoting wellness instead of illness would perhaps be the first step in solving the “healthcare” crisis.

  • mrhjdez

    Samuel Clemons Quote… ‘Durbin’???

    …I never can think of Judas Iscariot without losing my temper. To my mind Judas Iscariot was nothing but a low, mean, premature, Congressman.
    – “Foster’s Case,” New York Tribune, 10 March 1873

  • Z54

    First things first. Check and see how much money Durbin has raked in from big Pharma recently. Second, check out how heavily invested Durbin is in big Pharma. Third, check and see how many Pharma lobbyists have called on Durbin recently. Fourth, hope that a big piece of space junk falls on Durbin!

  • Zoe Willet

    Instead of all this confrontational negative rabble-rousing, why don’t you try to sit down with Durbin and those who are promoting this legislation and look for common ground?

  • While I appreciate the energy of your furor, the simple truth is that supplements of herbs and vitamins in pill form do nothing good for the body. The recent mislabeling scandal that found that herbal supplements don’t even contain any of the herb they are sold as is just the tipping point.

    Whole foods, plants and organic is very important to nourishing health. Supplements in pill form are wasteful, ineffective and sometimes harmful.

    The body rejects herbs and supplements in pill form with an immune response designed to remove the invaders as quickly as possible. This is hard on the liver, kidneys and digestive system.

    Eat whole foods, consume herbs as nourishing herbal infusions, or fresh plant as tincture. These are ways to get benefits from herbs. Not like baby birds, mouths wide, wanting a quick fix pill. It just doesn’t work that way.

    Use your energy and resources to support organic and local farming and humane pasture-raised meat production. That’s where the real power lies.

  • Scott Long

    Let’s ban salt while we are at it. It is dangerous, causes high blood pressure, makes fatty foods taste good. Salt is bad too

  • Anonomyous

    The minute I see the words “FDA Approved” I question if the item is safe. It almost means it could very well be toxic.

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