Act now: Oppose the FDA’s NDI!!!

Why You Need to Actively Oppose the FDA’s NDI (New Dietary Ingredient) Draft Guidance

By Dr. Jen Morganti / NEEDS Education Director

Your access to dietary supplements is at risk! The FDA is proposing changes that could significantly limit the availability of many herbs and vitamins, and potentially increase the cost associated with manufacturing, thus putting supplements out of financial reach for the average American. We need YOU to take action and help stop this unnecessary and unjust regulatory devastation. Please see the link to the petition below and take 2 minutes to help make a difference!

In 1994, the FDA instituted guidelines for marketing and manufacturing dietary supplements called the Dietary Supplement Health and Education Act, otherwise known as “DSHEA”. Within DSHEA, there is a requirement that every “new” dietary ingredient brought to market after 1994 must file as a “New Dietary Ingredient” or NDI to prove their safety. Up until now, every ingredient that was already on the market prior to 1994 was grandfathered in and did not require any additional documentation to be sold in the US.

The NDI guidelines have been quite vague ever since DSHEA was instituted, so the FDA is finally attempting to “clarify” the NDI requirements in a document now known as NDI (New Dietary Ingredient) Draft Guidance. Unfortunately, this supposed “clarification” of the NDI sounds much more like a total revision. It significantly raises the requirements to bring a new ingredient to market, and more importantly it disqualifies many of the grandfathered ingredients that are currently being sold and used by consumers. The likely results, if this is passed, is that  many dietary supplement ingredients and formulas will be pulled off the market, many small manufacturers will go out of business because they can’t meet the stringent, expensive, time consuming new requirements, and that innovation for new ingredients will virtually cease due to the excessive expense.

Required Testing

The safety testing requirements for NDIs have been raised to a level well above what was suggested originally in DSHEA. The new NDI will require the manufacturer to submit extensive information about “new” ingredients, including expensive research on safety in humans and animals. It will require toxicology studies, human studies, and other safety studies in order to allow an ingredient to be brought to market. This will apply to many ingredients that are already on the market, which have already proven to be safe by extensive human use for many years. In addition, the current list of “grandfathered” ingredients that was created by dietary supplement industry associations and referred to by manufacturers will no longer be acceptable, thus putting the burden on each manufacturer to provide evidence that their ingredients were sold and used prior to 1994, in that exact form, using exactly the same technology. These requirements will be harder for manufacturers to meet, inevitably leading to fewer new products in the marketplace.

Redundancy in NDI Documentation Process

Beyond the fact that the FDA will require manufacturers to conduct practically drug-level research studies on perfectly safe ingredients, they will also require EVERY manufacturer to provide documentation on every ingredient in every product, even if those exact ingredients have already been approved through the NDI procedure by another manufacturer. And every time an ingredient is added to a different formulation, or used in a different dosage, it will need a new NDI to prove its safety in combination with other ingredients, i.e.: different forms of minerals will each need their own NDI, and a change in the ratio of EPA to DHA in a fish oil would require an NDI. This level of documentation is redundant and wasteful of the manufacturers’ resources and the FDA resources required to review each NDI. NDIs must be submitted 75 days prior to releasing a product to the market. The 75-day wait period can be suspended indefinitely if the FDA deems the application is not adequate, thus causing additional financial stress on the manufacturer. Furthermore, it is clear that the FDA doesn’t have adequate resources to handle the expected influx of NDI applications and it is inconceivable how this process could be managed without a significant and costly increase in FDA resources.

The Potential Downfall of the Dietary Supplement Industry

In the spectrum of food regulation to pharmaceutical regulation, dietary supplements are currently viewed more like foods rather than under the category of drugs. This proposed legislation will slide dietary supplements much closer to the category of drugs. The enormous expense of this procedure will put many nutrition companies out of business, and for those that can afford the process, they will have to increase prices closer to drug prices, without the benefit of being covered by health insurance to help absorb the cost (as drugs are). If this guidance document went into effect, it is expected to significantly cripple the dietary supplement industry to the detriment of consumers who rely on supplements to maintain their health and wellbeing.

Our current call to action is to sign the petition sponsored by Citizens for Health, “calling for Congress to withhold FDA appropriations until this unaccountable agency is held accountable: by adjuring the FDA to withdraw the supplement-killing NDI Guidance and to cease and desist from reviewing and enforcing against dietary supplements and nutritional ingredients according to its willfully adversarial reinterpretation of the laws governing dietary supplements.”

This link will direct you to the petition, and can be found on www.natur-tyme.com:

http://salsa.democracyinaction.org/o/750/p/dia/action/public/?action_KEY=8806

Three Supplements to Prevent Insulin Resistance

By Dr. Jen Morganti

November is “National Diabetes Month”, but as a Naturopathic Doctor, I would prefer to rename it “National Insulin Resistance Month.” Focusing on this condition is the most effective way to reduce the incidence of diabetes. Insulin resistance tends to lead to Type 2 diabetes, which is primarily developed in adulthood and accounts for over 90% of diabetic cases. Bad habits, such as fast food, sedentary lifestyle, and smoking are all contributors. The good news is that it is largely avoidable or correctable through basic diet and lifestyle modifications. Type 1 diabetes, typically diagnosed at a younger age, tends to be related to genetics or autoimmune disease. In both cases, there is not enough insulin being produced by the pancreas to handle glucose in the blood.

The role of insulin, produced by the pancreas, is to shuttle glucose (sugar) to tissue cells to store for use as energy. When cells’ insulin receptors are resistant to insulin, they ignore the glucose delivery, so blood levels increase. The pancreas is programmed to respond by producing more insulin. Eventually both insulin and glucose levels become elevated and the pancreas exhausts itself, yet cells aren’t getting the energy that they require. The excess glucose in the blood must be reduced by whatever means necessary; if it can’t be delivered to cells, it ultimately converts into fatty acids and stores in tissues as fat. Insulin resistance ultimately leads to weight gain, manifesting as a “spare tire” around the waist.

To put the brakes on the insulin/glucose culmination, let’s take one step back and ask what causes cells to stop responding to insulin in the first place? One of the key culprits is excessive inflammation, which has been created by fat cells, especially when there are a lot of them. Fat secretes inflammatory chemicals (called cytokines) that cause cells to become resistant to insulin. Insulin resistance in turn triggers sugar to be converted to more fat. The cycle perpetuates itself; fat cells cause insulin resistance, and insulin resistance contributes to fat cells and weight gain.

To break the vicious cycle, we need to question where the extra fat cells came from because they are responsible for producing inflammatory chemicals. The simple answer is the Standard American Diet (SAD). Those fast, convenient, processed meals are full of saturated fat and sugar, which increase the size and number of pro-inflammatory fat cells. So the unavoidable first step towards diabetes prevention requires switching to a nutrition-packed, moderate-calorie, anti-inflammatory, whole foods diet. The result will surely be weight loss and diminished inflammation, with cells regaining the ability to respond to insulin appropriately.

After establishing a solid foundation of healthy foods, add some herbs and nutrients that act to diminish inflammation and potentially improve insulin sensitivity. The herbal extract curcumin, derived from the tasty Indian spice turmeric, has been the subject of thousands of studies. One of the known super powers possessed by curcumin is it’s antiinflammatory activity, which, among other things, may effectively improve cells’ sensitivity to insulin and lower blood sugar levels.

A second delicious spice that helps prevent insulin resistance is cinnamon extract. There have been some conflicting studies about cinnamon’s role, but on a positive note, certain cinnamon extracts have been shown to reduce secretion of inflammatory cytokines from fat cells. By decreasing overall inflammation, cells become more sensitive to insulin. Cinnamon has also been shown in studies to reduce the amount of insulin released after eating, and helps keep blood sugar levels balanced. You can benefit from adding cinnamon to food on a daily basis, and take a standardized extract in pill form.

The recent plethora of vitamin D research has helped establish its potent anti-inflammatory actions, so it comes as no surprise to find that vitamin D deficiency is related to increased risk of developing Type 2 diabetes. A few studies have suggested that supplementing with vitamin D may improve insulin resistance. Anyone struggling to fend off diabetes should take a simple vitamin D blood test, setting a goal of over 50 dl/ml. That goal becomes more achievable when supplementing with 2,000- 5,000 IU of vitamin D a day.

Ultimately, inflammation is at the root of insulin resistance and diabetes. The key to prevention is dietary modification and supplementation to aid in weight loss and decreased inflammation. Under these conditions, insulin resistance can be reversed and blood sugar levels normalized.

References:
J Clin Invest. 2006;116 (7):1793–1801
Eur J Nutr. 2011 Apr; 50 (3):151-61
Diabetes Metab Syndr Obes. 2011; 4:205-12
Eur J Clin Nutr. 2011 Sep; 65(9):1005-15

Congratulations to our Contest Winner!

Congrats to L.P. from central New York! She won a free copy of the Whole Life Nutririon Cookbook and a free consultation with Tom Malterre, CN. Here was her submission, and as she replied when asked for permission to publish her story; “This is my soapbox” .

“I have been gluten free for six years.  My first challenge was accepting the diagnosis because I had not been sick.  My doctor found it looking for an answer to another problem. To begin one has to understand that we are a society whose food is wheat based and the majority of gatherings include food.  Therefore, I am constantly explaining why I cannot eat something. It is hard to convince people that “just a little” won’t hurt. Even my own mother still says, “I can’t believe that you can’t have a little bit”.  When you don’t appear sick, then you must be OK, right?  Going along with this is finding suitable substitutions for the things that one has loved.  I like to cook and have a good sense of taste so I have done a lot of experimenting.  Lately, however many, many new items have come to market which are good but you never know until you try them. Some of the products available are not great.  I feel like a super sleuth detecting all the hidden sources of gluten.  It takes a lot time and energy.  I even had a pharmaceutical company tell me that their product may or may not have gluten so I should try it and see what happens.”

We hope this enticing cookbook will help L.P. further expand her meal options, and that the consultation with Tom helps to make her day-to-day challenges a little easier!

Share your Story for a Chance to Win a Nutritional Consultation and Fabulous Cookbook!

October is Celiac Disease Awareness Month, and to help increase awareness, NEEDS is offering a an amazing package for the winner of our contest. Write to us to share a story about how you discovered you were gluten sensitive or diagnosed with Celiac Disease, or creative ways on how you manage your gluten-free diet plan.  We will select the most interesting story, and the winner will receive a FREE Phone Consultation with Tom Malterre, CN,  author and gluten-sensitive specialist ($150 value), and a signed copy of the wonderful cookbook The Whole Life Nutrition Cookbook ($22.95 value).     

Tom Malterre received both his Bachelor’s and Master’s of Science in Nutrition from Bastyr University and is licensed by the state of Washington as a Certified Nutritionist. Tom travels throughout the United States and Canada lecturing at conferences on topics such as Vitamin D, Gluten Intolerance, and Digestive Health. He empowers people through classes, seminars, and private counseling with his insight and depth of knowledge on the biochemical interactions within our body and their relationship to our diet.

Click here to submit your story!
And everyone wins a free delicious recipe taken from The Whole Life Nutrition Cookbook for Coconut Vegetable Curry with Chickpeas below!

Coconut Vegetable Curry with Chickpeas

This quick curry can be made in a snap! Serve over brown jasmine rice for an easy weekday meal. Serves 4

 2 tablespoons virgin coconut oil or extra virgin olive oil

1 tablespoon finely chopped fresh ginger

1 ½ teaspoons cumin seeds

1 teaspoon black mustard seeds

3 small red potatoes, cut into cubes

3 medium carrots, diced

½ teaspoon turmeric

2 teaspoons coriander

1 teaspoon curry powder

1 tablespoon tomato paste

1 can coconut milk

¼ to ½ cup water

2 small zucchini, diced

1 cup frozen peas

2 cups cooked chickpeas (garbanzo beans)

2 teaspoons sea salt

½ cup cilantro

1.      In a large pot, heat olive oil over medium heat. Add ginger, cumin seeds, and black mustard seeds; cook for 1 to 2 minutes, or until the seeds begin to “pop”.

2.      Add potatoes, carrots, turmeric, coriander, and curry powder. Stir well and continue to cook for another minute or so. Add the tomato paste, coconut milk, water; stir well.

3.      Simmer, covered, for 5 to 10 minutes until potatoes and carrots are almost done but still a little crisp. Add zucchini, peas, chickpeas, and sea salt; cover the pot and simmer until vegetables are tender, about another 6 to 7 minutes. Remove from heat and stir in chopped cilantro.

 

Whole Life Nutrition Cookbook 2007

Don’t Believe the Cholesterol Hype!

Typically a discussion about cholesterol is in the context of how to lower it, suggesting it is a dangerous force that must be eradicated. However, cholesterol also serves extremely important functions in the body. It is critical to cell production, (as cell membranes are comprised of lipids), it is the foundation of hormone production, and it is necessary for the production of vitamin D through sun exposure. Cholesterol also affects the production of serotonin; in fact, excessively low cholesterol is linked with major depression and suicidal tendencies. Furthermore, HDL, the “good” cholesterol works to shuttle cholesterol away from the arteries to prevent atherosclerosis, and in fact it is so necessary that studies have shown that HDL levels under 40 create a significantly increased risk of developing coronary heart disease (CHD). Despite cholesterol’s importance, some doctors are driving their patients’ total cholesterol level below 150 and sometimes even close to 100 with the use of statin medications, all in the name of health.

Some research studies indicate that excessively low cholesterol levels may result in other health issues and increase mortality rates, and the level considered to be “healthy” (200) should be adjusted upwards. In a cholesterol study conducted in Japan, 11,869 people were monitored for almost 12 years. Their cholesterol was recorded and they were divided into one of four groups based on their total cholesterol levels. Those in the group with the lowest levels (<160) were shown to have significantly increased risk of hemorrhagic stroke and heart failure, excluding myocardial infarction, as compared to those with higher levels of cholesterol. They also found that there was not a significantly increased risk of those cardiovascular events in people with the highest levels of total cholesterol.¹

So if it isn’t all about total cholesterol as this and other studies suggest, then what are the major risk factors for cardiovascular disease, particularly atherosclerosis? One of the main concerns should be the factors that cause systemic inflammation, which can be measured in a lab test called CRP (C-reactive protein). Inflammation is a problem because it can damage the inner lining of blood vessels and cause damage. The role of cholesterol is to patch up the nicks and gouges that inflammation causes, but over time, too much cholesterol can accumulate in the vessels, building up plaque that develops into atherosclerosis.

Several factors can contribute to inflammation. Consumption of simple carbohydrates, such as sugar, refined grains, and even fruit will increase blood sugar levels significantly, causing glycation (the binding of sugar and protein), which increases free radical production and inflammation. Also cortisol, the hormone produced by the adrenals, is produced excessively under stress and increases inflammation. Another contributing factor to inflammation is the presence of bacteria or a low-grade infection. And the accumulation of toxins such as heavy metals and chemicals, which we have ALL been exposed to, will trigger inflammation.

Lowering inflammation with just a few easy steps will certainly improve cardiovascular health. Food is the foundation of an anti-inflammatory program, so be sure to consume lots of whole foods with complex carbohydrates, fiber, and protein, and minimize sugar. You can moderate cortisol levels with good stress-coping techniques, like exercise and meditation.

To lower inflammation, supplementation may need to be added to a healthy diet. Crucial nutrients often missing in the typical American diet are omega-3 fatty acids, derived from cold-water fish and plant sources such as flax oil and chia seeds. Much of the fats found in our diet (saturated fats and omega-6 fats) are pro-inflammatory because they are converted to certain types of chemicals which cause inflammation throughout the body. Omega-3 fatty acids are the only type of fat that are always converted to anti-inflammatory chemicals, so they are critical to balancing the other types of fat that dominate our diet. The most effective, non-toxic way to consistently boost omega-3 fatty acids is through supplementation of a high-quality fish oil, calamari oil, or krill oil. The dosage is two grams daily at a minimum; however, higher doses are indicated in the presence of inflammatory related diseases such as cardiovascular disease, any type of arthritis, and ulcerative colitis.

Another potent anti-inflammatory nutrient that has been in the spotlight recently is vitamin D. Like omega- 3 fatty acids, this is another nutrient that is frequently deficient in Americans, particularly those in the Northern latitudes where sunshine is limited in winter months. As mentioned previously, vitamin D synthesis is triggered by sun exposure and requires cholesterol as the foundation. Vitamin D is able to lower CRP levels and a study showed an inverse correlation between vitamin D levels and an inflammatory marker called TNF.² Low vitamin D levels may predispose diabetics to atherosclerosis because it limits their ability to process cholesterol adequately, as shown in one study.³

Niacin is a wellresearched nutrient that lowers CRP and increases HDL, which has the important duty of ushering out the “bad” cholesterol that causes plaque.⁴ Niacin can cause itching or flushing, which is a redness and warmth that can be quite uncomfortable. Taking sustained-release niacin slows the rate at which the niacin is released into the body, helping to avoid a reaction. Niacin-Time, by Carlson is a 500 mg sustained release tablet designed to raise HDL.

Cholesterol is something you should keep your eye on, but it doesn’t tell the whole story about heart health. Go back to the basics of a healthy diet, moderate stress levels, and consider a few supplements, and you should be able to keep your heart healthy!

References:
1. J Epidemiol 2011;21(1):67-74
2. Journal of Inflammation 2008, 5:10
3. Circulation 2009, vol. 120(8);pp. 687-698
4. Postgrad Med. 2011 Mar;123(2):70-83

Protect Your Teeth from Bacterial Growth with Xylitol

By Dr. Jen Morganti

Xylitol is a sugar alcohol that is derived from corn fiber, although it does not contain any corn allergens. It has the same sweetness as sugar, yet has 40% less calories. This makes it an appropriate sugar substitute (in moderate amounts) for those with diabetes and even those with candida. But the most significant activity of xylitol is its antibacterial effects.

An in vitro study has confirmed that xylitol inhibits the growth of bacteria. “In vitro” means that the study has been conducted in a lab setting rather than on people. In this study, the xylitol was applied to petri dishes that contained a variety of bacteria known to cause dental problems and periodontal disease. The scientists found that very little of the bacteria remained after the xylitol application. They concluded that xylitol would be effective at preventing oral diseases that are caused by plaque formation.¹

Xylitol also makes the saliva more alkaline and protects tooth enamel. It is most effective when used 4-5 times daily, which can be easily accomplished by using toothpaste or mouthwash and gum as well. Be sure the xylitol products you choose have adequate amounts to be effective; some brands contain just a sprinkling of xylitol, just enough to be able to claim it on the label.

Reference:
1. Oral Health Prev Dent. 2008;6(4):337-41.

Probiotics are Great for Immune Support!

One of my top picks for vitamin must-haves is probiotics, those beneficial bacteria that naturally reside in the intestinal tract, but are often insufficient. Probiotics are an obvious choice for treating digestive disorders of course, but a lesser-known, but equally important benefit is that they support the intestinal tract’s own immune system, called gut associated lymphoid tissue or GALT. An even more compelling reason to choose probiotics as a “must-have” is the ample clinical research to support their efficacy.

In one of the many existing clinical trials, researchers looked at the immune activity of probiotics by monitoring their effects in a small group of healthy, elderly volunteers over the course of 12 weeks. Half the group drank plain milk and the other half drank milk supplemented with Bifidobacterium lactis twice a day. They were tested for specific immune parameters, including interferon production (known to have antiviral activity), and phagocyte activity (immune cell that digests foreign microbes). It was found that drinking the probiotic fortified milk significantly increased the immune parameters within six weeks as compared to drinking the plain milk.¹

Another small study compared the immune effects of Lactobacillus acidophilus versus Bifidobacterium bifidum in healthy adults and found that both strains significantly enhanced phagocyte activity in just three weeks. ²

Taking a different approach, one study examined the effects of Lactobacillus  casei in smokers, a population known to have suppressed immune systems, looking specifically at natural killer cell activity (direct killing immune cells). Half the group drank milk fortified with the probiotic and half drank the placebo milk. All the smokers were found to have supressed immune reponses before starting the supplementation, but in the group supplementing with L. casei, there was significant improvement in the natural killer cell activity as compared to the group taking placebo. ³

So how do they work? Probiotics reside all the way from the mouth down to the intestines, but the majority of the beneficial bacteria are concentrated in the large intestines. They help line the intestinal wall and prevent microbes from being absorbed systemically, thus improving intestinal permeability (aka leaky gut). Probiotics stimulate the different parts of the immune system, but most importantly, they have the dual ability to the ability to act as a “modulator” by boosting immune cells that are sluggish or calming an overactive immune system. ⁴

Probiotics may not be an obvious choice for immune support, but when added to your supplement regime, you’ll find it can make a big difference in your overall wellbeing!

References:

1)European Journal of Clinical Nutrition (2000) 54, 263±267

2) Journal of Dairy Science Vol. 78, No. 3. 1995

3) Preventive Medicine 40 (2005) 589–594

4) Am J Clin Nutr 2001;73(suppl):444S–50S.

Sugar and Inflammation

Do you know how much sugar you consume everyday? Sugar creates inflammation, and inflammation leads to weight gain, joint pain, cardiovascular disease, diabetes, and many other health problems. Sometimes we aren’t aware of how much sugar is in our food and drinks, but it is surprising how fast it can add up! These visual aids are pretty compelling…

Healing with Honey

What are the benefits of Manuka honey? The last time we checked, there were 75 scientific studies revealing a wide array of benefits. It has been shown to have great antimicrobial effects when applied directly to wounds to speed healing, and in some cases was shown to be a good alternative to antibiotic-resistant infections such as MRSA. One study proposed the antimicrobial activity was partially due to the fact that honey lowers the pH of the tissue, making it impossible for bacteria to survive. It is used in some hospitals as wound dressing and has been particularly useful for treating ulcerated skin, with no known side effects.

Internally, Manuka honey acts as a prebiotic and helps promote the growth and activity of bifidobacteria in the intestine. It has been shown to alleviate dyspepsia and other chronic intestinal issues. It has natural antioxidant qualities and can be used in beauty treatments such as facials and hair conditioner.

Y.S Organic Bee Farms Raw Manuka Honey Active 15+ is tested and verified to have 15% phenol solution, indicating its antimicrobial and antioxidant activity. Y.S Organic Bee Farms offer only certified-organic honey granted by U.S.D.A. / N.O.P. (United States Department of Agriculture / National Organic Program) organic certification.

Experience the power of Manuka honey! You will not be disappointed.

Three Reasons You May Need More Magnesium

Magnesium is a basic but significant mineral that is involved with over 325 biochemical reactions in the body. Because it’s such a critical nutrient, it’s a problem that over 60% of Americans are deficient in this key nutrient. Some of the reasons for deficiency include the fact that our food has lower magnesium content due to poor quality soil, we lose magnesium when stressed, and sweating causes magnesium depletion.

You probably don’t want to read a list of the 325 biochemical reactions that rely on magnesium, so let’s just stick with the three “I” s: Insomnia, Inflammation, and Insulin resistance.

Insomnia can be caused by many reasons, with magnesium deficiency being at the top. Magnesium calms the nervous system, relaxes muscles and counters stress. Replenishing magnesium can lead to a longer, uninterrupted sleep pattern.

Insulin resistance is when cells don’t respond adequately to insulin’s attempt to shuttle glucose into the cell after eating, resulting in elevated blood sugar and increased fat storage. It is the hallmark of pre-diabetes and metabolic syndrome. Research shows that people with adequate magnesium levels have improved insulin sensitivity. People with the highest magnesium levels have a lower risk of developing diabetes, even if they have the risk factors such as smoking, low activity level and excessive weight.

Inflammation is at the root cause of so many health problems, such as arthritis, heart disease and obesity. Magnesium has been shown to act as an anti-inflammatory. More than one study has shown that as magnesium levels decrease, CRP (a marker for inflammation) increases. Elevated CRP is also associated with an increased risk of heart disease.

Magnesium comes in many forms, but be sure to avoid the oxide form. You may want to try powdered magnesium citrate. To determine the appropriate dosage, start with one or two pills, and increase the dosage over the course of a few days, until it has a laxative effect, then decrease the dosage slightly. This method determines the appropriate dosage for your individual body, based on your level of deficiency. Magnesium is a simple nutrient, but it can make a huge impact on your health!