Wednesday, September 14, 2011

Public Comment Period for FDA Vitamin and Supplement Regs is On!!!

I've been absent for awhile.  Childhood cancer has, unfortunately, been keeping me busier than usual.  Still, the world keeps turning.  And so does politics in America and all of its attendant messiness.  It's late and I'm not in the mood to edit so please read with a forgiving spirit.

Two political issues are at the forefront of my mind tonight as I shelve the idea of catching any sleep in favor of putting those issues into your minds.  They are our president’s willingness to cave on the emissions standards and the FDA’s eagerness to ban supplements.  I’m feeling a little grumpy about these, so be forewarned. 



Regarding the first, I feel that the decision has been made.  The president is willing to delay the regulations because the standards are based on 2006 science, and a review is set for 2013.  (That was the official reason, anyway.)  Sounds like a done deal.  With the economy as it is, who is really willing to risk being "anti-jobs?"  I'm disappointed, but not surprised.  As for the second . . .

I hope you all have found your representatives (http://www.congress.org/) and entered their Washington numbers into your cell phone contacts and jammed up those cell towers.  But today’s call to action requires contacting an executive agency, and it works a little differently there.  Regulations get implemented only after a “notice and comment” period.  (I am really not going to summarize administrative law here.)  That means the public gets its say-so before the new regs go into effect.  And the regs we're going to talk about are in the "notice and comment" period.  So, let’s say!!!  Let’s inundate the FDA with our comments in opposition to their proposed regulations. 

And speaking of say, let me just say:  I am usually all for regulations.  They protect us, the public, from overreaching private entities.  But this time, I am completely opposed to the regulations.  They don’t protect the public.  They protect industry interests instead.  Of course, we all know here that the FDA is pretty much in industry’s pocket so that should come as no surprise.    These regs are bad news for us.

One might question why the FDA is suddenly so interested in what vitamins and supplements we’re buying, especially since our mainstream food is full of non-food products, but the answer would be deeply disturbing.  Someone wants to get a hold on these products, don’t they?   Every supplement carries the warning “these statements have not been evaluated by the FDA” as a sort of disclaimer against any therapeutic effect, yet Americans have become increasingly more literate about our vitamins and supplements.  Name a symptom and I’ll have a solution for you.  I can quote the relative benefits and comparison between flax seed oil and hemp seed oil; I can tell you why turmeric and oregano are more than just delicious to the palate.  And I am in good company. 

Parents everywhere have embraced the vitamin and supplement concept for better health.  Imagine, then, what will happen if the parents of an autistic child can’t buy their sublingual b-12 shots anymore?  Or their melatonin?  Will these be available by prescription only?  Or only available from companies that can afford the drawn-out process of getting the FDA to approve?  Will we see the products available from only a handful of companies, who will then charge a premium, just because they can?  Folks are fairly fond of calling America “capitalist,”  but the trend in every single area has been toward less competition, even monopolizing markets.  Not very American.  And now the vitamin- and-supplement industry will follow suit.  Is it a response from the mainstream healthcare system to the rising popularity of alternative therapies?

September is childhood cancer awareness month, so I’m going to use the cancer example to illustrate a point.  The powers-that-be in childhood cancer world are fond of boasting about the “great progress [that] has been made in the fight against children’s cancer,” but in reality cancer remains the leading cause of death by disease in children:  36 children are diagnosed with it every day, and of those kids, one in five will lose the battle within the first five years.  The other four will make it past the five year mark, be it five years and a day or ten years (there’s no statistical distinction made between those distinctly different outcomes.)  Those who “win” will experience “significant, sometimes life-threatening long-term side effects” from their treatment, rather than their cancer in most cases.  No wonder some parents are opting for another approach.


What if your kid has autism?  Once upon a day, the medical establishment blamed moms for the condition.  Talk about burying the head in the sand . . . luckily, a doctor’s kid got it and that theory was sent to bed.  Since then, a lot of parents have foregone the pharmaceutical remedy (and dealing with a supposedly unalterable fate) in favor of natural therapies, and many of them have had good results.  Some claim to have cured their children’s autism.  That’s amazing! 

Skeptical?  Fine.  That’s your right.  But there are plenty of studies showing that people can rid themselves of their dependence on pharmaceutical remedies through proper diet.  This has been done in cases of heart disease, diabetes, cancer, allergies and asthma . . . so if you’re trying to set a child’s physiology straight, you’re going to need some supplements.  And why is that, you might ask?  Well . . . kids can be particular.  They don’t always want to drink the wheatgrass smoothie you made, you know?  But you might be able to stir some wheatgrass powder into the apple juice.  Unless the FDA removes that powder from the shelf, right?

And speaking of “right . . .” isn’t it your right as a parent to see to your child’s needs as you see fit?  Even if it’s slightly outside the mainstream (which has so deficiently served the needs of our children, anyway?) 

So, if you agree . . . Follow this link:  http://www.citizens.org/?p=2551  Good stuff.   I especially appreciated the little comment on the relative safety of supplements compared to pharmaceutical remedies.  If you click on the “ask the FDA to withdraw the guidance” link, you’ll find yourself connected to an FDA contact form.  Fill it out!  When we asked for food safety, we were talking about tracking E. coli in the beef slaughterhouses, not pau d’arco!!!  And why the laxity with profitable pharmaceutical formulations?  How can a thousands-years old herb be scarier than a chemical concoction fast-tracked for human use in exchange for a fee?  It’s about choice.

Lots of people say that having a sick kid takes up all of their time, and they don’t have any time left over to get involved in the political process.  To them, I say:  our system is flawed.  We have a bigger stake in the betterment of that system than most, because our kids are the ones dangling over the edge, aren’t they?  Take a few minutes to read the linked article.  And then, do as you will.  
Just putting it out there . . .

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