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Why You Need to Actively Oppose the FDA’s NDI (New Dietary Ingredient) Draft Guidance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 at the bottom of this article 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 theUS.

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the FDA is finally attempting to “clarify” the NDI requirements in a document now known as NDI (New Dietary Ingredient) Draft Guidance.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.

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

 

 

 

 

 

 

Three Supplements to Prevent Diabetes & Inflammation

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

Chew Your way to Weight Loss

What if you could loose weight by simply changing how you eat, rather than what you eat? A small, but interesting study from China recently posed that question by comparing the effects of chewing on calorie consumption and hormone production. In this study, 16 normal weight young men and 14 obese young men were observed for their chewing habits. It was found that the obese group had a lower average number of chews per bite as compared to the moderate weight group. Both groups took similar size bites, but the obese group averaged 15 chews per bite, versus 40 chews per bite in the normal weight group. It was found that the number of chews correlated inversely to the amount of food consumed. The group that averaged 40 chews ingested almost 12% less food than the group that averaged 15 chews. The greater number of chews also resulted in lower postpradandial ghrelin concentration (a hormone that stimulates appetite) and higher postprandial glucagon-like peptide 1 (the satiety signal) and cholecystokinin concentrations (a hormone that lowers appetite).

This study verifies the common sense wisdom that chewing food completely, thus eating slower and more thoughtfully, results in lower consumption of calories. Yet many questions still remain: Are thinner people naturally programmed to chew their food longer? Can an overweight person lose pounds by changing their eating habits and chewing thoroughly? We may not have definitive answers to these questions, but out of all the weight loss tips you can experiment with, this one may be the easiest you can try!    

Am J Clin Nutr September 2011 vol. 94 no. 3 709-716

An Easier Way to Eat Healthy Whole Foods?

When people ask me what they can do to loose weight, or improve their general health, I always start with the recommendation to eat a whole foods- based diet, and in some cases, it should be gluten free. Without this basic foundation, it would be impossible to achieve optimal health. Unfortunately, I have found that many people don’t even know what whole foods are, let alone how to plan a meal with them. That’s why I was so excited when I picked up The Whole Life Nutrition Cookbook. America is experiencing a frightening obesity epidemic, so anyone who wants to to make significant  improvements in their health by changing their diet should keep this book in their kitchen as both a reference guide and meal planner. 

The Whole Life Nutrition Cookbook is written by Tom Malterre, MS, CN and is co-authored by his wife, Alissa Segersten. They met while studying Anatomy and Physiology together atBastyrUniversity inSeattle,WA. They created a cookbook full of nutritious, gluten-free (and some dairy and egg free) recipes with a busy family in mind. Some recipes are adaptations of traditional favorites that we know and love, and some are new and interesting combinations that please the palate. Tom and Alissa make it easy to try new recipes, and take the time to explain unusual ingredients or processes, so there is no reason to be intimidated by cooking.

 Gluten sensitivity is becoming more common, partially due to the fact that it has become ubiquitous in our food choices. It is known to be present in wheat, spelt, kamut, barley, rye, and sometimes oats are contaminated by it. Gluten is hidden everywhere in restaurant and packaged foods, so if you really want to minimize or eliminate its impact, be prepared to do your own cooking.

 There are various degrees of gluten sensitivity, from mild intolerance to full- blown celiac disease. Exposure to gluten when sensitive can cause damage to the gastrointestinal tract, and ultimately cause health problems and nutritional deficiencies due to malabsorption. Some of the many symptoms caused by sensitivities include recurring abdominal bloating and pain, inflammation, acid reflux, fatigue, muscle cramps, infertility and joint pain.

 Even if you aren’t certified gluten sensitive, it’s always good to take a break from it to prevent future problems. This cookbook makes it simple to create a  gluten free meal, with meat or vegetarian. One of the recipes I really loved was the Quinoa and Black Bean Salad. Lime, cilantro, and jalapeno merge to make a tasty Mexican inspired salad, which would be delicious paired with guacamole and organic corn chips.  Another mouth-watering and off-the-charts nutritious recipe is the Beet, Kale, and Walnut Salad, which combines some unexpected ingredients that meld together perfectly. If you would like to learn more about this cookbook or purchase it, check out www.nourishingmeals.com. It has become my go-to cookbook this summer!

Book Review on Balancing Ph: The Acid Alkaline Diet for Optimal Health, Christopher Vasey, ND

Balance is the key to great health. One of the many impressive balancing acts that occurs in the body on a continuous basis is the creation of acid by metabolic processes, countered by the neutralization of acid by alkaline substances.  This determines the pH of the body, which can be measured in the blood, urine, sweat, and saliva. When acid dominates the environment on a consistent basis, health problems ensue. In his book The Acid Alkaline Diet for Optimal Health, Christopher Vasey, ND discusses ways in which you can achieve an ideal acid-alkaline balance in your body. 

 How do I know if I have an acid problem?

Are you excessively fatigued, have you lost enthusiasm and drive, or are you worried, depressed or anxious? Are you sensitive to cold, have low blood pressure and maybe low blood sugar? Do you have a suppressed immune system and suffer from multiple infections? These are all vague and general symptoms that could be pointing to an acidic pH, usually caused by a diet high in acid generating foods and a stressful lifestyle. If you are having a difficult time bringing your health up to the next level, monitoring your pH and alkalizing may be just what you need to progress.

 pH can be measured in bodily fluids, but not all of them accurately reflect the body and tissues’ overall pH. Blood pH does not reflect tissue acidity because the blood quickly transfers out acids in order to maintain a verynarrow acceptable pH range. If the blood pH were to stray outside the narrow requirements, illness or even death could ensue. Because it is so tightly regulated, blood pH is not a good way to determine overall body tissue pH.  Urine and sweat are good indicators of overall acidity, and pH can easily be measured with pH test strips. The kidneys and skin are both mechanisms in which the body eliminates acids, so a low pH (or high acidity) in their fluids indicates high levels of acid in the body. Dr. Vasey provides detailed instructions on how to measure pH of the urine, which he believes to be the most accurate method.

 How does acidity cause health problems?

Urine, blood and sweat will transfer acids out as they are produced, but these mechanisms can become overloaded fairly easily. When acid levels exceed the elimination capacity, the overage gets stored in tissues, and then they interfere with enzymatic reactions, inflammation, and demineralization.

 For example, enzymes, which  elicit a multitude of critical biochemical reactions in the body, are very sensitive to their environment. They function only in a very narrow pH range, so an acidic environment will disrupt their activity and cause health problems, from minor to very serious. Extra acid in the tissues can also be corrosive and irritating, causing inflammation, manifesting as a skin rash, painful urination, arthritis, or intestinal inflammation. Demineralization is another consequence of a chronically acidic state. Bones and teeth, which store large amounts of calcium, will sacrifice this alkalizing mineral to improve the pH of blood and tissues, resulting in osteoporosis and loss of teeth.

 Consuming an alkaline focused diet is important for dealing with current acid production, but it is not efficient enough to neutralize built up acids stored in the tissues. Suggestions for meal choices can be found in the book. To truly alkalize the deep in the tissues, supplements must be added to the regime. Supplementation will help alkalize and resolve symptoms, but to thoroughly neutralize the acid in deep tissues, be prepared to stay on the program  for the long term.

 Minerals are the foundation of the alkalizing therapy. Calcium, potassium, magnesium, and  manganese are the main minerals to look for in a supplement. Sodium is in some products, but is not appropriate for those who are salt-sensitive and hypertensive. Silica may be present, although it is acidic, it is usually found in small quantities, and is beneficial for those with weak nails, bones, teeth, and joint pains.

 Alkalizing minerals may come in the form of  carbonate, tartrate, sulfate, gluconate and lactate. TriSalts is a powdered formula containing a combination of calcium, magnesium and potassium in the carbonate and bicarbonate forms, and is popular for alkalizing and quelching allergic reactions quickly. Leafy green vegetables are very alkalizing, and an easy way to supplement your vegetable consumption is with high quality powdered green drinks, particularly those containing green vegetables rather than just grasses.

There are no specific dosage recommendations for alkalizing supplements. Dr. Vasey simply recommends taking alkalizing supplements several times a day, in moderate doses to cause an increase the urinary pH to about 7- 7.5. It is common to make the mistake to not take enough of the supplements for a long enough period to achieve full cleansing of the stored acid waste. It can take several months or up to a few years of supplementation to achieve a balanced pH. To determine if therapy is successful, one should have a pH of over 7, without taking supplements. Even when the supplementation period is over, one must continue to follow an alkaline diet for optimal health.

 It may seem tricky at first, but once you get the hang of taming acidity, you will see some significant health benefits. And feeling great is the best motivator for keeping on track!

 

Sugar = Inflammation

Do you know how much sugar you consume every day? It is amazing how it sneaks into our diet and how much it adds up. Sugar causes inflammation, and inflammation causes weight gain, diabetes, cardiovascular disease, joint pain and more. Here are some great visual representations of how much sugar is in common foods. It’s enough to make your teeth hurt!

Weight Gain and Inflammation- Can You Get Off the Rollercoaster?

Weight loss can be a frustrating topic- extreme diets and low calorie torture can’t be maintained and it isn’t just because you don’t have self-restraint. A weight loss program won’t be successful if the focus is just about calorie reduction and exercise because so many other factors come into play. One of the most important is the relationship between obesity and chronic inflammation. How does inflammation contribute to obesity, and how does that knowledge contribute to a better weight loss plan?

There are likely two factors contributing to the obesity/ inflammation cycle. Fat cells are known to generate inflammatory chemical messengers (called cytokines), and those chemicals eventually trigger a reaction for cells to stop listening to two useful messengers: insulin and leptin. When cells become resistant to insulin and leptin, watch out, because the weight will start piling on!

The role of insulin is to shuttle glucose to tissue cells to store for use as energy. When cells’ insulin receptors are resistant to insulin, they ignore the delivery, and the glucose remains in the blood longer. Blood glucose needs to stay within a narrow range, so eventually it needs to go somewhere. Ultimately it gets converted into fatty acids and stored as fat instead of being used as energy. So insulin resistance will always cause weight gain because the body can’t utilize glucose properly.

Another thing that inflammation does is cause leptin resistance. Leptin is the chemical that tells the brain that we had enough to eat and we are full. People with fully functioning leptin recpetors have fairly natural weight control, so they just stop eating when full. In the case of leptin resistance, it works just like insulin resistance. The leptin goes to deliver its message to stop eating, but cells ignore it, so you just keep eating.

Insulin resistance will always cause weight gain because the body can’t utilize glucose properly and so it converts it to fatty acids that get stored in fat cells. In the case of leptin, if cells are resistant to it, they will fail to hear the message that the body is satiated, so the person remains hungry and continues to consume excess calories.

Science has sufficiently proven that fat cells do cause inflammation, but it appears there is also a possibility that inflammation itself triggers weight gain, because inflammation has been shown to effect a specific part of the brain (the hypothalamus), causing it to become insulin and leptin resistant. In either case, inflammation, whether generated from fat cells, junk food, stress, poor sleep, candida, or toxin overload, causes insulin and leptin resistance.

Whether fat causes inflammation or inflammation causes fat, the key factor that needs to be addressed in a weight loss program is to decrease inflammation in order to increase cells sensitivity to insulin and leptin. This requires eliminating foods that are inflammatory, such as sugar and saturated fats, and foods to which a person is allergic. The focus must be on a whole foods diet chock full of fruits, vegetables and whole grains, which are all naturally anti-inflammatory.

Focusing on “low-fat” and “diet” processed foods may lower the calorie count, but these foods are typically pro-inflammatory, which explains why they don’t aid weight loss. They also aren’t satiating, and some of the chemicals in these foods actually trigger hunger signals.

In addition to switching to a whole foods based diet, anti-inflammatory supplements should be added. Omega-3 fatty acids from fish and krill oil should be at the top of the list, as well as magnesium, curcumin and ginger.

In the long term, eating a whole foods-based diet and taking anti-inflammatory supplements is a sustainable and healthy way to maintain optimal weight, and helps to resolve related health issues without medication.

Reference: Endocrinology, April 2011, 152(4).

Three Great Reasons You Need More Magnesium

Magnesium is a basic but significant mineral that is involved with over 320 biochemical reactions in the body. Because it’s such a critical nutrient, it’s a serious 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 associated with an increased risk of heart disease.   

Magnesium comes in many forms, but be sure to avoid the oxide form. 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!