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 What!? Are they nuts? FDA must be working for big pharma 
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Ascorbate Wizard
Ascorbate Wizard

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Post What!? Are they nuts? FDA must be working for big pharma
http://www.star-telegram.com/238/story/1686632.html
FDA warns Procter & Gamble for adding vitamin C to cold medicines

http://www.google.com/hostednews/ap/art ... gD9BB21DO0
FDA warns P&G for adding vitamin C to Nyquil


Time to write Congress people!

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Owen R. Fonorow, Orthomolecular Naturopath


Thu Oct 15, 2009 3:16 am
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Ascorbate Wizard
Ascorbate Wizard

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Post Re: What!? Are they nuts? FDA must be working for big pharma
When you write, and you should, please include this study,

http://www.ncbi.nlm.nih.gov/sites/entre ... d_current=

Quote:
RESULTS: Overall, reported flu and cold symptoms in the test group decreased 85% compared with the control group after the administration of megadose Vitamin C. CONCLUSION: Vitamin C in megadoses administered before or after the appearance of cold and flu symptoms relieved and prevented the symptoms in the test population compared with the control group.


Even more importantly, for reasons of public safety, all drugs, especially cold medicines should be required to include vitamin C - ascorbate - to ensure patient safety from the toxicity of the drugs, especially children.

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Owen R. Fonorow, Orthomolecular Naturopath


Thu Oct 15, 2009 3:30 am
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Ascorbate Wizard
Ascorbate Wizard

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Post Re: What!? Are they nuts? FDA must be working for big pharma
FYI: FDA Commissioner's page:

http://www.fda.gov/AboutFDA/Commissione ... efault.htm

Unbelievably, the following emails are just for FDA Public Affairs Specialists

Field Public Affairs Specialists (PASs) are key links between the Agency and our constituents throughout the United States and Puerto Rico. They serve as FDA's community-based educators.


Alan.Bennett@fda.hhs.gov,
Gilbert.Meza@fda.hhs.gov,
Rosario.Vior@fda.hhs.gov,
Laurel.Eu@fda.hhs.gov,
MaryEllen.Taylor@fda.hhs.gov,
Janet.McDonald@fda.hhs.gov,
Devin.Koontz@fda.hhs.gov,
Tywanna.Paul@fda.hhs.gov,
Sheryl.McConnell@fda.hhs.gov,
Maria.Velasco@fda.hhs.gov,
Sylvia.Gaytan@fda.hhs.gov,
natalie.guidry@fda.hhs.gov,
Charles.Watson@fda.hhs.gov,
Faye.Bronner@fda.hhs.gov,
JoAnn.Pittman@fda.hhs.gov,
Ruth.Marcano@fda.hhs.gov,
Nilda.Villegas@fda.hhs.gov,
Kathleen.Rozewicz@fda.hhs.gov,
Susan.Seefeld@fda.hhs.gov,
Carolann.Gallagher@fda.hhs.gov,
Brenda.Zimmer@fda.hhs.gov,
Stephen.King@fda.hhs.gov,
Anitra.Brownreed@fda.hhs.gov,
Joan.Lytle@fda.hhs.gov,
Diana.Monaco@fda.hhs.gov,
Mary.Yebba@fda.hhs.gov,
Susan.Small@fda.hhs.gov

added Oct 20, 2009. For the Record here is the FDA response and my additional query..


Quote:
In a message dated 10/15/2009 2:14:40 P.M. Central Daylight Time, Anitra.BrownReed@fda.hhs.gov writes:

Yesterday, a warning letter to Procter & Gamble regarding Vicks DayQuil Plus Vitamin C and Vicks Nyquil Plus Vitamin C products was posted to the FDA Web site in error. The posting occurred due to an internal systems error, and no warning letter has been sent to Procter & Gamble. The agency regrets any confusion caused by the posting.




Quote:
Dear Anitra Brown,

Thank you for this response. However, I am interested in why the letter was written in the first place, and how it was instigated and by whom. Can you provide me with this information, or would I have to file a Freedom of Information Act request?

According to the massive research we are aware of, Vitamin C levels are depleted during illness and this is at least one reason why over-the-counter cold medicines for children are so dangerous. It is in the public interest for companies to add vitamin C to their cold medications.

Owen Fonorow
The Vitamin C Foundation
vitaminCFoundation.org


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Owen R. Fonorow, Orthomolecular Naturopath


Thu Oct 15, 2009 4:19 am
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Post Re: What!? Are they nuts? FDA must be working for big pharma
I sent an email to all of them. Two of them emailed back so far (within 3 hours). Here's what I received from them:

1.
Quote:
Yesterday, a warning letter to Procter & Gamble regarding Vicks DayQuil
Plus Vitamin C and Vicks Nyquil Plus Vitamin C products was posted to
the FDA Web site in error. The posting occurred due to an internal
systems error, and no warning letter has been sent to Procter & Gamble.
The agency regrets any confusion caused by the posting.


Anitra
Public Affairs Specialist;
CER\Philadelphia District
215-717-3004
anitra.brownreed@fda.hhs.gov
If God brings You to it, He will bring You through it!


2.
Quote:
Yesterday, a warning letter to Procter & Gamble regarding Vicks DayQuil
Plus Vitamin C and Vicks Nyquil Plus Vitamin C products was posted to
the FDA Web site in error. The posting occurred due to an internal
systems error, and no warning letter has been sent to Procter & Gamble.
The agency regrets any confusion caused by the posting.

Sincerely,
Stephen King
FDA Public Affairs Specialist
Baltimore District Office


My thoughts:
1. These FDA mouthpieces are using the same form letter.
2. I expect any more responses from FDA employees to be carbon copies of these ones.
3. I have to wonder if this whole exercise may not have been a planned operation, a psychological operation (PSYOP), one definitely involving the FDA and likely involving even the Procter & Gamble executives themselves.
4. That tag line (about if God brings me to it) make me go WTF? Uh, Ms. Brownreed, have you ever heard about a little something called the separation of church and state??

Thanks Owen for this. But I wonder if we're not just pawns in some twisted game of theirs.


Thu Oct 15, 2009 11:26 am
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Ascorbate Wizard
Ascorbate Wizard

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Post Re: What!? Are they nuts? FDA must be working for big pharma
I suppose that is good news, however why was the letter even written?

I believe your instincts are correct, although I doubt P&G had anything to do with it. This was a cleverly designed scare tactic. Most people aren't paying attention, but most parents know that the FDA has warned in the past that cold meds are dangerous for children. So the hope is that parents would associate the added C with the "danger" I guess.

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Fri Oct 16, 2009 2:46 am
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Enthusiast
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Post Social networks spread the word
Social networks spread the word...

We need to counter this! Owen, please consider a VC foundation page on Face Book. I recently joined my friends and family on it and I've promoted vitamin C for colds and flu with the proper data but it would be great to be able to send folks to a face book vitamin C page - an extension of the foundation giving people quick reads and links without having to leave face book.Many organizations do this- it's a great way to network information to a whole lot of people.


Sun Oct 18, 2009 2:23 am
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Ascorbate Wizard
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Post Re: What!? Are they nuts? FDA must be working for big pharma
Good idea. I am at the facebook page - they are asking for name, email, etc. Do you get to choose your "screen name" later on, or should I make "VitaminCFoundation" my name?
Thx


also, note the following (4th) update,
http://www.reuters.com/article/CHMMFG/i ... 5720091014

It doesn't say Proctor & Gamble wasn't warned, just that the letter was not supposed to be made public!!?

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Owen R. Fonorow, Orthomolecular Naturopath


Sun Oct 18, 2009 4:33 am
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Enthusiast
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I just went to my page and under the "settings" button it gives an option of changing everything including your profile name.
Yay!...I can't wait to see it and participate on it.


Sun Oct 18, 2009 1:55 pm
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Ascorbate Wizard
Ascorbate Wizard

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Post Re: What!? Are they nuts? FDA must be working for big pharma
With my son's help, I am giving this a shot. I created my personal account, and then we created a "page" for the Vitamin C Foundation, which looked like it should have been facebook.com/pages/The-Vitamin-C-Foundation, but I can not locate the page after publishing?? (Search only finds the Facebook Vitamin C Foundation or South Africa? Which was news to us.) Any ideas? As a last resort, I'll change my profile, but somehow a few people have already become friends from the Alt. Med. community !?

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Owen R. Fonorow, Orthomolecular Naturopath


Mon Oct 19, 2009 3:07 am
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Ascorbate Wizard
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Post Re: What!? Are they nuts? FDA must be working for big pharma
I sent P&G the link to that megadose vitamin C study and received this interesting response:

Quote:
Thanks for contacting Vicks NyQuil, Owen.

We appreciate the time you took to share this article with us, and I've shared it with the appropriate individuals on our team. For more than 30 years, NyQuil has provided safe and effective medicines to reduce the symptoms of cold and flu. Research has shown that levels of Vitamin C are depleted during times of illness. Vicks NyQuil Plus Vitamin C contains the combination of active ingredients to relieve cold and flu symptoms, and Vitamin C to replenish the body.

Thanks again for getting in touch.

Karen
Vicks NyQuil Team

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Owen R. Fonorow, Orthomolecular Naturopath


Mon Oct 19, 2009 3:24 am
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Ascorbate Wizard
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Post Re: What!? Are they nuts? FDA must be working for big pharma
Well I came close to getting on the radio with Michael Savage yesterday to discuss this. When I got through, they told me to call back in an hour (he was on a different topic) but I wasn't able to get through again. I may try again this evening.

I may also file a Freedom of Information Act. As we all know, it is clear this isn't being done in the public interest. So who's interest is the FDA acting in? One of the reasons cold medicines are dangerous for children is because of vitamin C depletion during the illness. The toxins in the medications exacerbate the problem, and the FDA should be requiring companies to add vitamin C to children's medicines. Maybe this is happening, and this might be the reason for this "counter attack." Someone had to initiate this. I want to find out who. Some person must have noticed that cold medicines have added vitamin C and filed a complaint? And someone in the FDA must have approved the idea to warn Proctor & Gamble.

p.s. baby steps at facebook - you should be able to look me up as Owen Fonorow, and I have a link to the page I made - The-Vitamin-C-Foundation. I guess you can become a fan to link it from your page.

And there is now this, http://industry.bnet.com/pharma/1000482 ... in-nyquil/
FDA Flip-Flops on P&G Warning Over Vitamin C in NyQuil

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Owen R. Fonorow, Orthomolecular Naturopath


Tue Oct 20, 2009 2:39 am
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Ascorbate Wizard
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Post Re: What!? Are they nuts? FDA must be working for big pharma
I asked them who initiated the FDA letter to P&G, or whether I needed a Freedom of Information request, and they emailed the following:

Quote:
It’s been suggested that you contact the FOI department and obtain that information through them.



FOI contact information:

If you wish to visit an FDA Public Reading Room in person, they are located at:

Division of Freedom of Information, 5600 Fishers Lane, HFI-35, Room 6-30, Rockville, MD 20857
Division of Dockets Management, 5630 Fishers Lane, Room 1061, Mail Stop HFA-305, Rockville, MD 20852.
Hours of operation for both sites are 9 a.m. to 4 p.m., Monday through Friday.

~or~

All FOIA requests made in writing should include the following information:

A. Requestor's name, address, and telephone number.

B. A description of the records being sought. The records should be identified as specifically as possible. A request for specific records that are releasable to the public can be processed much more quickly than a request for "all information" on a particular subject. Also fees for a more specific and limited request will generally be less.

C. Separate requests should be submitted for each firm or product involved.

D. A statement concerning willingness to pay fees, including any limitations.

Questions relating to FOI requests may be addressed to the Division of the Freedom of Information Offices at 301-827-6567.

All FOIA requests must be in writing. At this time, FDA does not accept FOIA requests sent via e-mail. Requests should be mailed to the following address:

Food and Drug Administration

Division of Freedom of Information (HFI-35)

Office of Shared Services

Office of Public Information and Library Services

5600 Fishers Lane

Rockville, MD 20857

Or requests may be sent via fax to: fax number 301-443-1726 or 301-443-1719. If experience difficulty sending a fax, please call (301) 443-2414.





Anitra

Public Affairs Specialist;

CER\Philadelphia District

215-717-3004

anitra.brownreed@fda.hhs.gov

If God brings You to it, He will bring You through it!

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Owen R. Fonorow, Orthomolecular Naturopath


Thu Oct 22, 2009 3:03 am
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Vitamin C Expert
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Post Re: What!? Are they nuts? FDA must be working for big pharma
The title is pretty amusing, considering Procter & Gamble is part of "Big Pharma". :wink:


Mon Oct 26, 2009 4:27 pm
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Ascorbate Wizard
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Post Re: What!? Are they nuts? FDA must be working for big pharma
Your perspective is different than mine. In my world, P&G is a consumer products company that may have medical/pharmaceutical products.

But you avoided commenting on the fact that someone in the FDA even wrote the letter in the first place!

Here is another communication to me from an FDA official:


Quote:
Hello,
The press release noted below will show that the posting of the subject
warning letter was truly a mistake.

If After reading the press release, you still have issues you wish to
discuss, feel free to write back or call me here in the office.

Best Regards.

Susan Seefeld, Public Affairs
U.S. Food and Drug Administration
Minneapolis District Office
250 Marquette Ave. - Suite 600
Minneapolis, MN 55401
Phone: 612-758-7130
Susan.Seefeld@FDA.HHS.GOV

For Immediate Release: Oct. 15, 2009
Contact: Christopher Kelly, 301-796-4676, christopher.kelly@fda.hhs.gov

FDA: Procter & Gamble Warning Posted in Error

Yesterday, a warning letter to Procter & Gamble regarding Vicks DayQuil
Plus Vitamin C and Vicks Nyquil Plus Vitamin C products was posted to
the FDA Web site in error. The posting occurred due to an internal
systems error, and no warning letter has been sent to Procter & Gamble.
The agency regrets any confusion caused by the posting.

#

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Owen R. Fonorow, Orthomolecular Naturopath


Tue Oct 27, 2009 3:57 am
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Vitamin C Expert
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Post Re: What!? Are they nuts? FDA must be working for big pharma
ofonorow wrote:
[color=#000080]Your perspective is different than mine. In my world, P&G is a consumer products company that may have medical/pharmaceutical products.


Well, now that they have sold their prescription-drug business to Warner Chilcott, you might have a point. Before that however, P&G's pharma division had a portfolio that included the blockbuster drug, Actonel and brought the company billions of dollars in revenue.

P&G still has their consumer health business, which includes products like Prilosec OTC. Although I would estimate that it only accounts for 10% of P&G's overall revenue, this is still probably in the billions.

Besides, many large pharmaceutical companies are looking at diversification. Would you also consider Johnson & Johnson to be a consumer products company? They've been a diversified company for decades, but their pharmaceuticals business is still huge.

Quote:
But you avoided commenting on the fact that someone in the FDA even wrote the letter in the first place!


I find it strange that this internal systems error occured in the first place. Without having seen the letter, I can't comment on its contents - but if it's about any marketing claims associated with the product, then I wouldn't be surprised. However silly the rules may seem, they are there to ensure that companies cannot simply make claims about their products without substantiating them. If Vitamin C is beneficial, then I would assume that P&G submitted the appropriate documentation to support their claim. I don't see this as the FDA clamping down on vitamin use per se...it's simply a byproduct of their bureaucratic process. FYI, here is a list of warning letters that the FDA has sent to various pharmaceutical companies this year alone:
http://www.fda.gov/Drugs/GuidanceCompli ... 055773.htm


Tue Oct 27, 2009 12:00 pm
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