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Autism Coach

Pending FDA Regulations to Destroy Supplement Industry


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Oct 3, 2011.  We in the autism community need to stand together to protect our right to obtain supplements and for supplement companies to develop supplements to help our children.  The vast majority of children who are diagnosed with autism and later lose their labels take supplements.  Today may be the last day we have to lobby our congress and senators to defeat this stealthful attempt to destroy the supplement industry so it is imperative to act ASAP!
 
In what appears to be a deal brokered the Obama administration with the healthcare and pharmaceutical industries in exchange for supporting his health care plan, the Obama administration recently appointed Dr. Daniel Fabricant to be director of the FDA's Dietary Supplement Program and appears to given have him a mandate to destroy the supplement industry. 
 
Dr. Fabricant was a former lobbyest for the supplement industry as he was employeed with the Natural Products Association as Vice President of Scientific and Regulatory Affairs - and was one year the association's CEO.  He has basically turned against the supplement industry and is advocating for positions that are the opposite of what he advocated for while employed with the Natural Products Association. 
 
Specifically, Dr. Fabricant issued a Draft Guidance for New Dietary Ingredients (NDIs) and this draft must be commented on by October 3. 
 
In this draft, which has not received adequate input from the supplement industry:
 
1.  Only ingredients found in the typical food supply can be sold as supplements, limiting the number of products on the market. 
2.  All supplement ingredients would be banned that were approved after 1994.  This would result in thousands of supplements being taken off the market.
3.  Every ingredient and even each supplement formula would require an NDIN (New Dietary Ingredient Notification), creating even longer delays for product release. 
4.  So far the FDA has rejected 75-83% of all NDINs submitted to them by supplement companies. 
5.  Each company would have to file it's own NDIN for the same ingredient every other company is using.  Each "new" formulation using the same old ingredients will require an NDIN.
6.  This will add millions of dollars to the costs the supplement industry must incur to bring products to market, resulting in increased costs to consumers.
7. The government is broke and will not have the manpower to enforce these cumbersome regulations resulting in unimaginable delays at least and at most likely preventing the development and release of promising new supplements. 
8.  In effect, the FDA's scheme will drive most products off the shelf and most supplements companies out of business. 
 
The FDA’s New Dietary Ingredient regulations are estimated to remove tens of thousands of safe and effective dietary supplements from the market. In fact, the process has already begun. In January 2009, the FDA announced that the active form of vitamin B6, or pyridoxamine dihydrochloride, was a “new drug,” meaning any substance containing pyridoxamine could not be marketed as a dietary supplement. While pyridoxamine dihydrochloride is naturally present in foods such as fish, chicken, whole grain products, vegetables, nuts and bananas, among others, any supplements containing the active form of this nutrient are considered adulterated and illegal by the FDA. This ban on active B-6 is a clear example of what is to come for all of our supplements if we don’t take proper action!! 

Are we going to need a prescription from a doctor to buy an overpriced chicken "manufactured" by a pharmaceutical company because it has the active form of B6 in it?  This is ridiculous and efforts should be made to overturn this patent and set a precedent against the patenting of naturally occurrng substances.  Unfortunately, patent laws are currently being revised to allow such outrages and these efforts should also be fought and defeated.
 
These new FDA guidelines clearly highlight the collusion between the FDA and the heavy-handed pharmaceutical industry to which dietary supplements are in direct competition with. The extreme emphasis on profit by the pharmaceutical industry is evident in their direct attack on the natural product industry, especially now that hundreds of name brand drugs have expired patents, thus allowing them to be sold generically at the expense of Big Pharma’s previously excessive profits. In fact, the main reason for the ban on B-6 is that it is now the active ingredient in a pharmaceutical drug, and thus protected by their patents.
 
The economic impact is believed to be in the tens of billions of dollars. Under the new proposed regulations, smaller supplement companies will be forced out of business due to the insurmountable testing requirements and doubtful FDA approval for each new formulation, preparation or dosage recommendation of even a traditionally used common herb or nutrient such as vitamin C or chamomile. With small companies out of business and with the upcoming revised patent law, pharmaceutical leaders can patent and sell these common products at enormous price increases, preventing most Americans from affording critical health-promoting nutrients that are not available in our current food supply due to over-processing. Economic impact aside, the public health impact of these new requirements is grave and should be considered in all enormities by congressional leaders and decision makers.
 
Dr. Fabricant should be removed as director and from any federal position regarding creating rules and guidelines for the supplement industry because his previous employment with the Natural Products Association constitutes a conflict of interest.  He is in violation of non-disclosure agreements with the Natural Products Association.  He has also acted unethcially in charging people in the supplement industry money just to hear his presentation of an FDA webinar.
 
With the exception of the dedicated Defeat Autism Now practitioners, for the most part mainstream medicine and pharmaceuticals have been of little help in improving the prognosis of children within the autism spectrum.  Don't let them take away your child's future and your freedom to choose alternative therapies.  Demand freedom of choice to obtain the supplements that have been helping your child and eliminate these proposed regulations that would prevent supplement companies from developing innovative new products.  
 
Please email your senators and federal congressman to ask that they oppose these guidelines and ask for the removal of Dr. Fabricant from any within the FDA involving formulation of regulations for the supplement industry.

 

To email your congressman, go to: https://writerep.house.gov/writerep/welcome.shtml
To email your President Obama, go to: http://www.whitehouse.gov/contact
 
Here are links to a couple of other articles on this issue: