My last post  Nutritional Supplements – Going Going GONE  contained a article by Byron Richards which sums up perfectly the shocking plans of the FDA to destroy the supplement industry.

I hope all Americans who read it let their voices be heard by using the link at the end of that article to visit the ‘Take Action’ page on the wellness resources site and follow the instruction there.

It’s important to keep all American supplement consumers informed and up to date with this story and keep encouraging more and more people to contact both the FDA and their senators and voice their strong disapproval.

Today I’m reprinting an article from the Mercola.com website which discusses this story in further detail and also contains a link to another ‘Take Action’ site put up by the Alliance for Natural Health

FDA Set To Ban Your Supplements

Tuesday, September 13, 2011  -  Dr. Mercola

The FDA has issued a proposed mandate that represents the greatest threat to dietary supplements since 1994. Back in the early 1990s, consumers were so alarmed by FDA bullying that they staged a massive revolt. The result was that Congress passed a law prohibiting the FDA from banning popular nutrients (as the agency had threatened to do).

There was, however, a loophole in the 1994 law. The FDA was given authority to regulate ingredients introduced after October 15, 1994.

It has been 17 years, but the FDA just issued draconian proposals as to how it intends to regulate what it now calls “new dietary ingredients”. You can find the FDA Draft Guidance on New Dietary Ingredients (NDI’s) here. If implemented, some of the most effective nutrients you are taking will be removed from the market. This includes many fish oil formulas and natural plant extracts. A detailed analysis of the FDA Draft Guidance is available here.

These oppressive rules are exactly what the 1994 law (DSHEA) sought to prevent. The FDA is using its authority in direct violation of Congressional intent.

In order for these ingredients you are using today to return to the market, the FDA will require manufacturers to conduct outrageously expensive studies using absurdly high doses, in some situations multiplied by a “safety factor” up to 2,000-times the recommended dosage on a per product basis.

The FDA defines dietary supplements as being “new” if they were introduced after October 15, 1994. That means that even certain nutrients that have been safely used over the course of three decades will be subject to the FDA’s oppressive policies that mandate costly animal testing.

The FDA Views Supplements in Same Light as Synthetic Food Preservatives

According to the new guidelines, the FDA believes that “new dietary supplements” must be regulated similarly to synthetic food preservatives. The FDA guidelines have modeled the outrageous safety thresholds after those in place for food additives. This appears to be in direct violation of DSHEA, the law enacted in 1994 to protect consumer access to dietary supplements, which classifies dietary supplements as foods, not food additives.

The FDA proposes that new dietary supplement ingredients should adhere to aggressive safety margins, which are typically reserved for chemical compounds known to be dangerous in all but the most miniscule concentrations.

Since food additives or preservatives such as aspartame, monosodium glutamate, and sodium nitrate are known to cause cancer or other severe health problems, the FDA has implemented safety guidelines which limit allowable concentrations of these food additives to levels that are supposed to be physiologically inert.

The fact that the FDA is trying to impose the same limits upon dietary supplements seems to be arbitrary and completely unfounded. In fact, when someone takes a dietary supplement, their intent is to positively affect the structure or function of their bodies in some way – limiting dosages of dietary supplements to physiologically inert levels defeats the entire purpose of supplementation with health-sustaining nutrients.

The FDA’s new guidelines are so flawed that even nutrients shown to be completely safe in hundreds of human clinical studies would fail to accommodate the unreasonable safety margins.

To give you an example, each manufacturer of certain fish oils would have to conduct a one year study where animals would have to consume the human equivalent of 240,000 milligrams each day of fish oil.

Another option under the FDA’s proposed mandates is to conduct a 90-day, 1,000 – fold safety margin study in which two species of animals, one being non-rodent – likely young beagle dogs, will theoretically consume the equivalent of 2.4 million milligrams of fish oil daily. We know of virtually no species can tolerate this high dose, so by default, FDA guidelines will make it impossible for certain omega-3 supplements to be sold. (Note typical dose of EPA/DHA people take each day is around 2,400 mg—100 times less than what the FDA proposes must be tested.)

Since these are not patented drugs, no supplement maker will be able to afford these “safety” studies, which means that many of the nutrients you now purchase at low prices will convert into high-priced drugs.

Pharmaceutical Industry Profit Threatened By Low Cost Supplements

It appears that the FDA is claiming that dietary supplements are unsafe, and in order to “protect consumers” the agency must place a stranglehold on the dietary supplement industry by requesting exorbitant safety testing. These ludicrous safety thresholds are in excess of those required by pharmaceutical drugs despite studies showing supplements are far safer than drugs.

According to the 2001 report of the American Association of Poison Control Centers (AAPCC), of the substances implicated in fatal poisonings in 2001, 84.6 percent were pharmaceutical drugs, with analgesics being implicated as the primary cause of death in 32 percent of fatalities or 341 deaths. This compares with 0.8 percent for all dietary supplements combined, even including substances such as dinitrophenol, a dangerous (and illegal) substance banned in 1938, as well as the central nervous system stimulant Ma Huang (Ephedra). Interestingly, the anti-asthma drug theophylline alone was responsible for 15 deaths, 66 percent more than all the available dietary supplements combined.

There is, however, a massive economic benefit for the drug industry if the proposed guidelines are enforced by the FDA. Health conscious Americans who properly supplement slash their risk of degenerative disease. The FDA’s new rules, if enacted, will force the price of many supplements to surge upwards, while removing many effective ones altogether. That means that more aging people will have to rely on side effect laden prescription drugs to treat the degenerative diseases they will contract because they will be denied access to health-promoting nutrients.

What You Can Do to Stop this Impending Carnage!

No one can sit on the sidelines with an emergency of this magnitude about to befall everyone who depends on dietary supplements. As citizens, we have the constitutional right to petition the government to redress our grievances. In this case, the FDA proposals pose a direct threat to our health and longevity.

We therefore have to take extraordinary measures to defend our right to continue using supplements that our very lives depend on, and to gain access to new natural ingredients that demonstrate efficacy in scientific studies.

I ask each one of you contact your representatives by following this link:

Contact your local representative now!  (Please use this link)

Recall how Consumers revolted back in 1994 and the result was a glorious victory over FDA tyranny!

Let your voice be heard by exercising your right to petition the government against these serious violations of the law and scientific principle.   Please be sure to call, fax, or send a certified letter to your representative – emails can be easily dismissed.

Here is a set of talking points for your consideration:

• My name is [Name] and I am a constituent of [Congress Member’s name].

• I am very concerned about the new FDA draft guidance on dietary supplements and new dietary ingredients.

• I request that Congress hold hearings and take action to review the FDA’s draft guidance and stop their overreach of power.

• The FDA’s draft guidance flies in the face of the original congressional intent of the Dietary Supplement Health Education Act: The guidance turns what was meant to be a simple notification system for new dietary ingredients into a preapproval scheme that Congress did not intend to create.

• Congress recognized that dietary supplements are natural ingredients and therefore inherently safer than drugs and chemical food ingredients. It did not intend that the FDA would have the power to approve or reject dietary supplements.

• The FDA’s draft guidance creates unnecessary regulations that limit my access to dietary supplements I rely on. The expensive and burdensome process will force between 20,000 and 42,000 dietary supplements to be removed from the market and will increase the cost of those supplements that remain.

• The draft guidance hurts our economy. Expert analyses show that this guidance will cause a total economic loss of $21.2 billion to $39.8 billion annually.

• Thank you for your time.

Tips:

• Be courteous and respectful.

• Keep your comments brief and focused on the facts.

• Always thank the staff member for their time taking your call.

SAMPLE LETTER TO CONGRESS:

The Honorable _________________________  Washington, DC

In direct violation of the law, the FDA is threatening to ban my access to new dietary supplements.

The FDA defines dietary supplements as being “new” if they were introduced after October 15, 1994. That means that nutrients that I have been safely using over the course of three decades will be subject to FDA’s oppressive policies that mandate costly animal testing, which translates into forced withdrawal from the market, and higher prices for me if the supplement is ever allowed to be sold again.

The Dietary Supplement Health and Education Act of 1994 states that:

“The Federal Government should not take any actions to impose unreasonable regulatory barriers limiting or slowing the flow of safe products and accurate information to consumers.”

It says that Congress finds that:

“dietary supplements are safe within a broad range of intake, and safety problems with the supplements are relatively rare.”

And it says that:

“legislative action that protects the right of access of consumers to safe dietary supplements is necessary in order to promote wellness.”

 

This draft guidance does the exact opposite of what Congress intended. It imposes unreasonable barriers that limit and slow the flow of safe products and accurate information to consumers. I call upon Congress to:

1. Uphold the landmark legislation it passed seventeen years ago, and to direct the FDA to revise its New Dietary Ingredient draft guidelines to reflect DSHEA’s (and Congress’s) stated values and goals.

2. Vote against the newly introduced Dietary Supplement Labeling Act as this would give the FDA even greater arbitrary powers to remove safe dietary supplements from the market, and will profoundly impact this nation’s health in a negative way.

All of these proposals result in wasteful federal spending, while at the same time impose a massive new “regulatory tax” on consumers and the vitamin industry.

Kindly let me know what actions you are taking in response to the urgent issues raised in this letter.

Sincerely,
Name________________________________________
Address______________________________________
City______________________ST____ Zip___________

I’m new to your site and trying to examine a product I purchased for my fibromyalgia. It is Source Natural’s ‘Fibro-Response’ with Malic Acid and MSM.

I usually never buy before researching but guess I had a “stupid” moment and did so—-but I want to know more about its contents before I start taking it.

It is so difficult to ascertain whether a vitamin/herb/supplement is a quality product.

I have used vitamins/supplements for many of my 62 years and I sure do need a product for my fibromyalgia and my arthritis.

Thank you in advance for your assistance.

Hello Maggie,

Thanks for contacting me with your question. With respect to your Fibromyalgia firstly let me congratulate you on your desire to include an all natural (non-pharmaceutical) approach to your treatment. I’m assuming from this that chronic pain/tender points are not a major symptom for you and I certainly hope that this is the case.

Since you haven’t supplied any details about the exact nature and severity of your symptoms, my initial advice would be to take a more comprehensive multi faceted approach aimed at addressing the (suspected) root causes rather than just trying to suppress/manage the symptoms. Fibromyalgia, as you would know, is a complex chronic syndrome for which the exact causes are simply not known or understood at this point. Medical researchers however tend to have a general ‘genetic’ predisposition that it is likely caused and triggered (made worse) by several factors acting together rather than one isolated underlying factor.

Non pharmaceutical treatment options for FM encompass nutrition, relaxation techniques, and exercise. Looking at your nutritional intake is a great place to start and this is where the nutritional health supplements come in. It is always recommended that FM patients have an optimal dietary regime, fluid intake, and whatever exercise is within their means. Also, to strictly limit the amount of sugar, caffeine, and alcohol they use (as these have been shown to irritate muscles and stress body systems).

You asked about the ‘supplement quality issue’ and I can tell you that although Source Naturals Supplements are of very high quality, I would not recommend their ‘Fibro-Response’ supplement you bought , very simply because the formula is nowhere near comprehensive enough. In order to address the root causes of FM (whatever they may be) you need a much broader spectrum of general and specialized nutrients on a daily basis which overall target every single organ and system in your body including your brain.

The supplement which I do want to recommend to you is called ‘Total Balance’ (in your case the Women’s ‘Premium’ version). This supplement formula contains 91 ingredients, many of which are highly specialized nutrients not found in any other health/vitamin supplements (due to their cost and need to be protected by an enteric coating on the tablet to bypass the stomach and release them in the upper intestine). SAMe (S-Adenosylmethionine), L -Carnosine and L-Glutathione (low molecular weight) are good examples of these highly specialized/highly effective nutrients.

Maggie, this Total Balance supplement I’m recommending to you is an elite grade specialty supplement for very health conscious people who want superior nutritional support to protect the health of their DNA, normalize their aging process and avoid all those 21st century influenced (and preventable) degenerative diseases which are effecting people at younger and younger ages these days. Most Importantly this formula contains ingredients from ALL the various nutrients classes (which is important in your case). It covers these nutrients categories:-

If you can afford a full daily dose of the Total Balance Women’s Premium version then this is what I recommend. If not then use whatever your budget allows.

Now, because FM affects the nervous system, I recommend that in conjunction with the Total Balance you also use another supplement called ‘Neuro Natural’. The ‘General’ version is the one to get (unless you’re having severe bouts in which case the Neuro Natural ‘Memory’ version would be better).

Omega 3 fish oil is also a key part of a highly efficious nutritional intake so if your budget allows please add in 1000mg of Omega 3 oil each day.
Maggie – just to let you know, Total Balance is the only supplement I trust for my own health and I have been using it as the foundation of my own personal supplement regime for the past 10 years. My entire family, including my mother and father, use it.

You also mentioned having Arthritis (unfortunately, a common condition with FM patients). So I’d like to tell you about a supplement called ‘Arthrit-Eze’ (also from the Xtend-Life company in New Zealand). It is, in my opinion, the most advanced all natural arthritis formula in the market (31 ingredients). This supplement was formulated to specifically treat the ROOT CAUSES of Arthritis and this is why I recommend to people with Arthritis.

The truth is that virtually all Arthritis formulas in the supplement industry only aim at suppressing symptoms, simply because they do not have enough specialized ingredients to go after the root causes of the condition.

My father had arthritis in his fingers and so I got him onto Arthrit-Eze. After 3 months he was able to stop using it as his pain and stiffness had gone. This was a fast and excellent result for him.

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MAGGIE, I’ve prepared these links for you and they will take you to the product pages for the supplements I’ve recommended (and to some pages on my website where more product info can be found):

Total Balance product info

Detailed Review of Total Balance

Neuro Natural “General’ version

Omega 3 DHA Fish Oil

Omega 3 DHA Fish Oil – what to look for in the best oils

Arthrit-Eze Product Info

I’ve been taking Total Balance Men’s version from Xtend-Life for two months along with Cardio-Klenz.
One side effect I noticed was constipation… I do not take any other medication (never did in my life) and I am 72.

My wife ordered Total Balance for women a month ago, along with Viral-Protec. A few days after starting using the products, she had constipation too (she is 66)… Like me, she avoids all type of medication.

This is a strange coincidence, isn’t it? Constipation has never been a concern to us before!
Searching reviews about Total Balance, I found your nutritional-supplement-truths.com website.
I did not find any side effect such as constipation.

My wife and I do not understand what is going on and worry about this problem. Any idea or suggestion?

Response From Brett:

Hello Jack

I know that this isn’t a usual problem with Total Balance or Cardio-Klenz but I have heard about others experiencing it on occasion – including my mother a few years back.

What I tend to find is that constipation occurs when people’s systems are adjusting if their diet and fluid intake isn’t usually optimal. Total Balance is formulated to be used ‘ in addition to an improved dietary regime, increased pure fluid intake, and regular exercise daily”. This all helps the digestive system to adjust.

Total Balance also helps to eliminate some toxins initially that may have laid dormant in the system for some time. This is another cause and what is known as the toxin release or commonly “detox”. This could also be a part of what is happening here with you and your wife.

So here is what I recommend you do. Stop the supplement(s) for a day or two, until problems disappear, at the same time concentrate diligently on a good dietary regime – based on raw/steamed vegetables, fruits, nuts, seeds, fish, whole grains (in moderation), etc; increase your pure fluid intake (water, vegetable juicing, greens and others: 2+ liters per day, or as near as possible, daily), and whatever daily exercise you can regularly do to keep oxygenated. Then, restart the supplements again at a one tablet of each after a few days, and gradually increase this one by one until you’ve reached full dose (or the dose you want) again without any adverse effects.

In addition to this, upon rising in the morning, before doing anything else, drink 2 large glasses of room temp water, with added lemon juice to taste: STRAIGHT DOWN ( before anything else). This in itself is helpful for relieving constipation as well as cleansing the liver and digestive process before it has to begin for the day!

Jack this is the same advice I give to anyone who experiences gastric complaints after starting on Total Balance. It is a very sophisticated supplement which provides your body with a full spectrum of highly effective nutrients – targeting all organs and systems in the body (including the brain). This protocol has worked for everyone who I recommended it to – including my mother.

Here’s to great health Jack!

And here’s some links to anyone interested in reading up on Total Balance:

Men’s Premium Version   (the one I take)

Women’s Premium Version   (my mum and sister use this version)

Men’s standard Version   (my uncle)

Women’s Standard Version   (my Aunt)

Children’s Version   (my niece and nephew use this one)

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]]> http://blog.nutritional-supplement-truths.com/nutritional-supplement-side-effects/feed/ 9 http://blog.nutritional-supplement-truths.com/grape-seed-extract-and-ibs/ http://blog.nutritional-supplement-truths.com/grape-seed-extract-and-ibs/#comments Sun, 02 Aug 2009 22:24:47 +0000 Brett http://blog.nutritional-supplement-truths.com/?p=68 Question: From Bernice

I have severe bacterial dysbiosis  in my small intestine. I’ve had to use natural anti-microbials because the bad bacteria is antibiotic-resistant. I’ve been using grapefruit seed extract and berberine for 2+ weeks.

However, because the grapefruit seed extract hurts my stomach I’ve had to have it enteric-coated by a compounding pharmacist, and it costs LOTS! And because I haven’t had any “die-off” I’m worried that the enteric coating is somehow keeping the GSE from getting to the bad guys, if they are high up in my duodenum. I know that this enteric coating disintegrates within 20 minutes of hitting an active alkaline environment however, I’m not getting any “die-off,” at all. (Maybe GSE doesn’t create die-off?)

I have a couple of questions:

1)  Do you know if small intestinal fermentation dysbiosis occurs high-up in the duodenum, or in the jejunum? Because I want my enteric-coated GSE to be disintegrating wherever the bacteria is located. On one of your web pages, you said that certain ingredients including some herbal extracts “should” be enteric-coated, but I’m worried that mine isn’t getting into where it should be.

2)  Do you know of any better natural anti-microbials for bad bacteria (including Pseudomonas aeruginosa and Klebsiella, plus more)? I can’t take garlic, because it’s a thiol and chelates Hg.

Thank you very much, Brett.

Response From Brett:

Hi Bernice

First of all, please understand that grape seed extract isn’t a sole cure on its own for IBS or anything related to this type of digestive condition. It is helpful as an aid, but shouldn’t just be relied on solely for cure. It’s also important to know that die-off isn’t always experienced outwardly, depending on the severity of the condition.

The condition can effect any part of the small or large intestine, but even enteric coated products would disintegrate accordingly and via the bloodstream would get to the appropriate place, so I don’t think this is a concern.

The best course of action which I recommend is to consider taking a cutting edge broad spectrum nutritional health supplement such as  Total Balance Women’s Premium version (which contains 50 mg of standardized Grape Seed Extract amongst it’s 90 + ingredients).

In addition take xtend-life’s Omega 3/DHA supplement (high DHA content!!) at 4-5 caps per day – as a good start to help balance your digestive system fully.

Additionally, taking Aloe Vera (orally) twice a day could help further. And intermittent courses of acidophilus and bifidus probiotics to help balance out the bacterial levels. Along with this start, ensure that your diet is optimal and your fluid intake is high. This all helps.

Bernice, monitor your levels and stages and I can help adjust any regimes as they progress if you wish to update me, in case anything else can be added, depending on the severity and stubbornness of the condition.

I hope this helps initially.

Brett