Posts Tagged ‘fda’

Vitamin B.  You’ve known of it, and likely taken it for years.  Whether through the foods you eat, or as a separate supplement, it’s a part of your life.  It supports metabolism, maintains skin and muscle tone, enhances your immune and nervous systems, and promotes cell growth.  It all sounds wonderful, doesn’t it?  So what could be so bad about it that the FDA is ruling that some varieties be pulled from the shelves and not sold as dietary supplements?  It’s not expensive enough.

Pyridoxamine is a compound that makes up vitamin B6.  It has been readily available, and easily sold for years upon years as a dietary supplement. Up until now, there has been no news about it.  Even now, the news that does exist is somewhat under the radar, which is why we’re bringing it to you now. In 2005, a pharmaceutical company called Biostratum began developing a new drug to treat diabetic kidney disease. The only hitch in the plan came when investors in the company found that the only active ingredient in this new drug (Pyidorin) was pyridoxamine.  Pyridorin had already gone through two phases of clinical trials, so by now they’ve reahed the “nothing is off limits, anything goes” phase in order to get their drug through.

After this revelation they lost funding for their third phase of clinical trials, even though the first two had been successful. Success that was due mainly to the inclusion of an existing dietary supplement. What to do now? Change the formulation? Rethink the original strategy? Ban the previously sold, naturally occurring supplement altogether? If you guessed the third option then you could probably secure a position in Biostratums board of directors because that’s exactly what they’re doing. Biostratum is fighting to ban all previously existing forms of pyridoxamine and labeling them as “adulterated”.

Citing no explanation for this adulteration, the request has taken plenty of time to fester and become exacerbated.  However, earlier this year the FDA ruled that pyridoxamine can no longer be sold and their direct comment on the issue was “To allow such an article to be marketed as a dietary supplement would not be fair to the pharmaceutical company that brought, or intends to bring, the drug to market.”

This is just another example of big government agencies being more concerned with filling their pockets than with the job that has been set before them.  The last time I checked, the FDA was still under the US Department of Health and Human Services.  It doesn’t seem that they’re serving all that appropriately.  Consider also that the FDA has recently called for Cheerios cereal to remove their advertisement that it can lower cholesterol unless it applies for a drug patent.

If you feel that behavior of this caliber is detrimental to our establishment and human rights, then your only real option is to file a citizen petition.  There are a few important things to remember when doing so.  They include:

1. 
   A description of the action you want addressed, such as a ruling or an order you want to have put in place, rewritten to include changes or revoked.
2. 
   The legal grounds on which you are making a petition and the facts to back up your claims. You do need to include all the supporting information that you can come up with.
3. 
   If your petition is one for which you are requesting approval of drugs, food additives, medical devices or for a food to be categorized as safe for consumption, you will have to provide information regarding the environmental impact of such a request.
4. 
   All petition letters must include the name, address and telephone number of the person initiating the petition.

The FDA does not accept emailed or online petitions, so once you have everything in order you can mail it to them at the following address:

Dockets Management Branch, HFA-305
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

If you keep up with this blog at all, you'll remember that we recently featured an article by world renowned dentist Dr. Tom McGuire about the dangers of mercury amalgam fillings and their potential for major health risks. (if not, click here)  For so long the FDA has remained silent on this issue, even going as far as to claim its safety for a number of years.  Of course they also say the same about fluoride, which is a known poison.

But, I digress.

The FDA has always been adamant about protecting animals from the dangers of mercury, all the while taking a rather casual approach to its warnings for humans.  An ointment used to help with lameness in horses that contained mercury was pulled from the market in 2002 after the death of a horse from Alabama raised speculation.

Were mercury fillings ever questioned?  No.

Not until now, not until a lawsuit.  If it took legal action to get me to do my job, well you probably wouldn't be reading this now would you?  Finally, a small national consumer group called Consumers For Dental Choice has sued the FDA in order to get a ruling on the dangers of mercury in "silver" fillings.  This, accompanied by letters from congress prompted the FDA to quickly update their website from proclaiming safety, to classifying it as a device and making mention of the little fact that it “may have neurotoxic effects on the nervous systems of developing children and fetuses.”

Maybe this legislation system will get something done finally.  Now, if we could only do something about fluoride.  Well, baby steps I guess…

Remember, you can read more about the dangers of mercury amalgam in fillings at Dr. Tom's website www.dentalwellness4u.com