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FDA Goes Against Promise for New Supplement Rules
The controversy over the NDI (New Dietary Ingredients) Guidelines for supplements continues as the FDA plows ahead to wreak havoc in the world of vitamins and supplements. The FDA made a promise to not begin any enforcement of the NDI Guidelines, until they were completely approved. However, it seems they are ignoring their own promise as they decided to proclaim that synthetic botanicals are no longer to be considered as New Dietary Ingredients and cannot be sold as supplements, but instead, as drugs.
The FDA sent warning letters to 10 companies that sell supplements containing dimethylamylamine (DMAA) which is a synthetic botanical that is advertised commercially to increase concentration, energy and metabolism. The manufacturer of DMAA indicated that it is derived from the geranium oil from an Asian geranium. The letters from the FDA warned that these supplements are now considered as a class of ‘adulterated’ due to the fact that DMAA has never gone through the notification process of the NDI and that it is a synthetic product from a botanical and is therefore not an NDI. But here’s the problem: there is nothing in the laws governing supplements nor in the DSHEA (Dietary Supplement Health and Education Act of 1994) that indicates a synthetic botanical is not a dietary ingredient. The new change in distinction is derived specifically from the NDI draft guidance, which has not been approved as of yet. In the integrative industry, these tactics are now being called a “perversion of congressional intent”.
Many of the drugs that are currently on the market have been derived from medicinal plants. The process that the pharmaceutical companies take is often not only to change the plant base, but to add other additives that do not have anything to do with the treatment. The purpose of the new NDI guidelines is to make a major shift in how vitamin and supplement companies prove their products are food additives and reclassify them as drugs. Since the supplement companies do not have the same standards set in place for clinical trials and testing for drugs, this industry will be turned over to the pharmaceutical companies that do have these procedures set in place. Vitamin and supplement companies all over the world will then go out of business; however, the new business will be freely handed over to the pharmaceutical companies.
There is already sufficient evidence that the pharmaceutical companies, working with the FDA and other government institutions have skewed clinical and trial results to release ‘cash cow’ drugs to the market. The new NDI Guidelines are another way to add to the income of the pharmaceutical companies. This correlates to around 29,000 supplements with an approximate economic loss of around $5.6 billion-$10.5 billion. It also relates to the loss of around 55,720-104,475 jobs within the industry of supplement manufacturing.
What does this mean for you? Worse case scenario is that you won’t be able to get a vitamin or supplement without a prescription. Best case scenario is that if the vitamins and supplements continue to be over the counter, they will have a pharmaceutical company brand name on them. In a time when we are supposed to be encouraging business in our country, this diabolical NDI Guideline is a set up against all vitamin and supplement companies, under the guise of a health watch for the people.
Health stores around the country are currently participating in petitions that you can sign to place your objection to this government interference. Some are posting the information on their websites and you can add your name to the ‘don’t take my vitamins away’.
The information supplied in this article is not to be considered as medical advice and is for educational purposes only.
|American Health Care31 May 2012|