The FDA may wipe out your vitamin, mineral and dietary supplements.
If the FDA’s proposed guidelines are enacted, almost all new (since 1994) vitamins and supplements will be classified as New Dietary Ingredients (NDI) and will be subject to the “approval” rather than the originally intended “notification” requirement. Developers and manufacturers of vitamins and supplements can never recover the funds necessary to get FDA approval because substances that already exist in nature can’t be patented. Therefore, the requirement for NDIs to go through the FDA approval process insures that there will be no new supplements and all those introduced since enactment of the Dietary Supplement Health and Education Act (DSHEA) in 1994, will be removed from the market.
In fact, what was recommended by congress as a “notification” system has been expanded by the FDA’s proposed guidelines into a system of FDA “approval”. This means that vitamin and supplement manufacturers and developers will now have to jump through the same hoops to get “approval” for any new supplement formulation or vitamin dosage that is required by the pharmaceutical companies to get a new patented drug approved for distribution.
When a drug is patented, the pharmaceutical company that “invented” it can charge whatever they want and other companies can’t compete. Therefore, the potential profit involved allows the pharmaceutical company to make the substantial investment required for FDA “approval”. This is not the case for most dietary supplements, herbs and vitamins. Because they are natural substances, they cannot be patented and prices, until now, have remained reasonable due to competition.
According to a recent study, 33.8% of American adults and 17% of children and adolescents (aged 2-19) are obese. That is an increase of nearly 300% in the last 30 years! Other alarming statistics point to dramatic increases in the number of people diagnosed with diabetes, heart disease and cancer, over the same period.
Experts agree that these epidemics are due, at least in part, to the modern diet. The groceries we buy in the supermarket today, along with the growing number of fast-food meals we consume, are further adulterated by the addition of hydrogenated oil, trans-fats, GMOs, preservatives, added refined sugar, monosodium glutamate (MSG) and food coloring. As a result, millions of health conscious Americans have turned to vitamins and dietary supplements to insure they are getting the nutrients they need to live long, healthy lives.
Although many vitamins and supplements are used to cure or alleviate the symptoms of specific ailments, the majority are taken, on a regular basis, to maintain healthy lifestyles. For millennia, people were able to get the vitamins and minerals their bodies needed from the food they ate. Since the recent introduction of corporate agriculture in the mid-20th century, however, our food has been stripped of many of the nutrients needed to sustain good health. This has been attributed to the increasing use of petroleum based fertilizers, depletion of the soil by land use policies that discourage crop rotation and wide use of antibiotics and genetically modified organisms (GMO).
It should come as no surprise to hear that the FDA has recently proposed guidelines for “New Dietary Ingredients” (NDIs) that will treat vitamins, herbs and dietary supplements as synthetic food preservatives. This will result in many of the most popular vitamins, herbs and supplements being removed from the market. The rest will be subject to regulation that dramatically increases costs and limits availability.
The bottom line is that if the FDA is successful in enacting their “new” guidelines, you will not be able to supplement or (fix) the nutrient starved and genetically modified American diet. Securing a food source rich in nutrition or growing your own food will be the only “legal” ways to insure balanced nutrition in your diet.
In each piece of “cloudy” news we can sometimes find a silver lining. In the case of the FDA’s proposed guidelines, it is difficult. However, if this threat can encourage us to seek out and consume nutrient-rich food, thus establishing healthy-food dietary practices without the need for supplementation, a valuable objective will have been accomplished.
This article was posted: Thursday, February 2, 2012 at 2:34 pm