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Why You Need to Actively Oppose the FDA’s NDI (New Dietary Ingredient) Draft Guidance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

Sign the Petition Here

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FDA is finally attempting to “clarify” the NDI requirements in a document now known as NDI (New Dietary Ingredient) Draft Guidance.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