Author Topic: FDA to Nzymes.com: Leave the H1N1 "cures" to us  (Read 2996 times)

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Offline Bacchanea

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FDA to Nzymes.com: Leave the H1N1 "cures" to us
« on: August 15, 2009, 12:13:41 am »
Just as a preface, I am NOT associated with this company, but I have to say their products are awesome. It saved the life of my dog who was hopelessly plagued with strange skin infections that caused boils, bleeding, hair loss, anorexia and depression. She is a rare breed indigenous to Thailand - not used to our western medicine or our water or our lifestyle. This stuff put her body back on track. My whole family uses it, particularly when we have cold/flu, and it it pretty much annihilates it. I came across this letter written to nzymes.com, basically warning them to not assert that they can cure or help H1N1 victims. Read the letter yourselves and go buy your nzymes.

NZYMES.COM 5/18/09
Department of Health and Human Services
Public Health Service
Food and Drug Administration
  5100 Paint Branch Parkway
College Park, MD 20740

TO: NZYMES.COM - A Division of Biopet, Inc., nzymes.com

FROM: Food and Drug Administration

RE: Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus

DATE: May 18, 2009


WARNING LETTER


This is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address http:llnzymes.com on May 18, 2009. The FDA has determined that your website offers a product for sale that is intended to diagnose, mitigate, prevent, treat or cure the H1N1 Flu Virus in people. This product has not been approved, cleared, or otherwise authorized by FDA for use in the diagnosis, mitigation, prevention, treatment, or cure of the H1N1 Flu Virus. This product is Ox-E-Drops. The marketing of this product violates the Federal Food, Drug, and Cosmetic Act (FFDC Act). 21 U.S.C. 331, 351, 352. We request that you immediately cease marketing unapproved, uncleared, or unauthorized products for the diagnosis, mitigation, prevention, treatment, or cure of the H1N1 Fiu Virus.

Some examples of the claims on your website include:

"Every few years, there comes along some new strain of the FLU, such as the recent Swine Flu, that threatens an epidemic.... That being said, we think everyone should know how effective the NZYMES Ox-E-Drops can be in either the preventive or healing realms for this type of illness. Though a doctor can normally provide no pharmaceutical that can deal with viral infection, that does not mean there are not other alternatives; OxE- Drops is busy proving itself as an effective option every day."

"In the case of the current Swine Flu ... There is no specific proof that the Ox-E-Drops can diffuse this type of virus; but, since the virus is acquired via airborne transmission and acquired in the respiratory areas, these factors give a strong clue that the Ox-EDrops could possibly wage an effective defense. The solid track record of using the OxE-Drops in a dual approach, internally + vaporizer, in dealing with similar infections (including pneumonia) makes the case for this product likely being very helpful in the case of a Swine viral infection."

The Secretary of Health and Human Services, under section 319 of the Public Health Service Act, 42 U.S.C. 247d, has determined that a public health emergency exists nationwide involving the H1N1 Fiu Virus that affects or has the significant potential to affect national security. Following this determination and in response to requests from the U.S. Centers for Disease Control and Prevention, FDA issued letters authorizing the emergency use of certain unapproved and uncleared products or unapproved or uncleared uses of approved or cleared products, provided certain criteria are met, under 21 U.S.C. 360bbb-3. The marketing and sale of unapproved or uncleared H1N1 Flu Virus -related products that are not authorized by and used in accordance with the conditions of an Emergency Use Authorization, is a potentially significant threat to the public health. Therefore, FDA is taking urgent measures to protect consumers from products that, without approval or authorization by FDA, claim to diagnose, mitigate, prevent, treat or cure H1N1 Flu Virus in people.

You should take immediate action to ensure that your firm is not marketing, and does not market in the future, products intended to diagnose, mitigate, prevent, treat or cure the H1N1 Flu Virus that have not been approved, cleared, or authorized by the FDA. The above is not meant to be an all-inclusive list of violations. It is your responsibility to ensure that the products you market are in compliance with the FFDC Act and FDA's implementing regulations. We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that the claims you make for your products do not adulterate or misbrand the products in violation of the FFDC Act. 21 U.S.C. 331, 351, 352. Within 48 hours, please send an email to FDAFLUTASKFORCECFSAN@fda.hhs.gov, describing the actions that you have taken or plan to take to address your firm's violations. If your firm fails to take corrective action immediately, FDA may take enforcement action, such as seizure or injunction for violations of the FFDC Act without further notice. Firms that fail to take corrective action may also be referred to FDA's Office of Criminal Investigations for possible criminal prosecution for violations of the FFDC Act and other federal laws.

FDA is advising consumers not to purchase or use H1N1 Flu Virus-related products offered for sale that have not been approved, cleared, or authorized by FDA. Your firm will be added to a published list on FDA's website of firms and websites thai have received warning letters from FDA concerning marketing unapproved, uncleared, and unauthorized H1N1 Flu Virus-related products in violation of the FFDC Act. This list can be found at www.accessdata.fda.gov/scriptslh1n1flu. Once the violative claims and/or products have been removed from your website, and these corrective actions have been confirmed by the FDA, the published list will be updated to indicate that your firm has taken appropriate corrective action.

If you are not located in the United States, please note that unapproved, uncleared, or unauthorized products intended to diagnose, mitigate, prevent, treat, or cure the H1N1 Flu Virus offered for importation into the United States are subject to detention and refusal of admission.

We will advise the appropriate regulatory or law enforcement officials in the country from which you operate that FDA considers your product listed above to be an unapproved, uncleared, or unauthorized product that cannot be legally sold to consumers in the United States.

Please direct any inquiries concerning this letter to FDA at FDAFLUTASKFORCECFSAN@fda.hhs.gov or by contacting Quyen Tien at 215-717-3705.


Sincerely,

/S/

Roberta Wagner
Director
Office of Compliance
Center for Food Safety
and Applied Nutrition



sociostudent

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Re: FDA to Nzymes.com: Leave the H1N1 "cures" to us
« Reply #1 on: August 15, 2009, 01:03:12 am »
return it, with a note saying :
"I appreciate your "concern", but YOUR "product" over at Novartis isn't exactly approved by the FDA, either."

Offline Volitzar

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Re: FDA to Nzymes.com: Leave the H1N1 "cures" to us
« Reply #2 on: August 15, 2009, 01:38:40 am »
Yeah I'll bet Vitamin C and echinacea will be considered contraband too in the near future.

Offline Southern Patriot

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Re: FDA to Nzymes.com: Leave the H1N1 "cures" to us
« Reply #3 on: August 15, 2009, 08:42:28 am »
  Whatever happened to that dangerous drug the FDA was trying to remove from the market? I think it was for lowering cholesterol....Oh yeah, I remember now...It was Cheerios. Well, I'm sick of this gestapo shit and I am going to post a recipe for my "miracle tonic" right here right now.
  My miracle tonic cures what ails ya, from mail pattern baldness to government created pandemics. From Acne to Zooloo fever, from booboos and cuts to H1N1 and bird flu it's nuts.
Just one swig and you'll be glad you did.

Here you go:

1 Pint olive oil
1 Clove crushed raw garlic
5 Sprigs of fresh oregano
3 Fresh chopped bay leaves
2 Table spoons crushed red pepper or peppercorns
8 500mg vitamin c (asorbic acid) crushed to a fine powder
8 500mg echinacea capsules (make sure to empty them into the potion)

Mix all the above ingredients together, give it a week to sit so the ingredients can combine with the oil. Then use it on your pasta, pizza, salad, or whatever other food you can think to put it on. (It tastes pretty damn good). You can also just take a tablespoon when your feeling sick. (Doesn't taste as good this way)

Disclaimer: This product has not been tested or approved by the FDA to diagnose, cure, prevent, or treat any disease, ailment, condition, or government created pandemic even though that is exactly what it does. The poster of this post is not responsible for any adverse side affects such as feeling better, having more energy, not catching a cold, not needing a vaccine for a hoax virus, etc.. Further more, the poster is not suggesting you buy a Berkey or reverse osmosis water filter to collect rain water for drinking to avoid fluoride ingestion. The poster does not think that HFCS and aspartame are bad either and is not suggesting that you stop drinking any and all sodas immediately. This post is for informational purposes only and does not necessarily reflect the views of Alex Jones, Infowars.com, PrisonPlanet.com, the PrisonPlanet Forum, it's advertisers, employees, moderators, family members, close friends, old college roommates, or random people they met in an elevator. The poster didn't say to avoid industrial corn products either. Thank you.

Offline adissenter2

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Re: FDA to Nzymes.com: Leave the H1N1 "cures" to us
« Reply #4 on: August 15, 2009, 09:25:07 am »
the FDA is the disease

abolish it

abolish the whole mess

another Declaration of Independence is way overdue!
ΜΟΛΩΝ ΛΑΒΕ! Molon Labe! Come and take them!

Offline Satyagraha

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Re: FDA to Nzymes.com: Leave the H1N1 "cures" to us
« Reply #5 on: August 15, 2009, 09:35:31 am »
  Whatever happened to that dangerous drug the FDA was trying to remove from the market? I think it was for lowering cholesterol....Oh yeah, I remember now...It was Cheerios. Well, I'm sick of this gestapo shit and I am going to post a recipe for my "miracle tonic" right here right now.
  My miracle tonic cures what ails ya, from mail pattern baldness to government created pandemics. From Acne to Zooloo fever, from booboos and cuts to H1N1 and bird flu it's nuts.
Just one swig and you'll be glad you did.

Here you go:

1 Pint olive oil
1 Clove crushed raw garlic
5 Sprigs of fresh oregano
3 Fresh chopped bay leaves
2 Table spoons crushed red pepper or peppercorns
8 500mg vitamin c (asorbic acid) crushed to a fine powder
8 500mg echinacea capsules (make sure to empty them into the potion)

Mix all the above ingredients together, give it a week to sit so the ingredients can combine with the oil. Then use it on your pasta, pizza, salad, or whatever other food you can think to put it on. (It tastes pretty damn good). You can also just take a tablespoon when your feeling sick. (Doesn't taste as good this way)

Disclaimer: This product has not been tested or approved by the FDA to diagnose, cure, prevent, or treat any disease, ailment, condition, or government created pandemic even though that is exactly what it does. The poster of this post is not responsible for any adverse side affects such as feeling better, having more energy, not catching a cold, not needing a vaccine for a hoax virus, etc.. Further more, the poster is not suggesting you buy a Berkey or reverse osmosis water filter to collect rain water for drinking to avoid fluoride ingestion. The poster does not think that HFCS and aspartame are bad either and is not suggesting that you stop drinking any and all sodas immediately. This post is for informational purposes only and does not necessarily reflect the views of Alex Jones, Infowars.com, PrisonPlanet.com, the PrisonPlanet Forum, it's advertisers, employees, moderators, family members, close friends, old college roommates, or random people they met in an elevator. The poster didn't say to avoid industrial corn products either. Thank you.

YOU and NZymes are BOTH interfering with the potential revenue streams that Pharma expects from the swine/pig/human flu. This is your last warning. (We have also heard from Kraft Foods that your so-called-medicine is violating a patent on their olive oil-based salad dressings.) You have been warned.
And  the King shall answer and say unto them, Verily I say unto you, 
Inasmuch as ye have done it unto one of the least of these my brethren,  ye have done it unto me.

Matthew 25:40

Offline Southern Patriot

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Re: FDA to Nzymes.com: Leave the H1N1 "cures" to us
« Reply #6 on: September 13, 2009, 07:22:01 am »
Wife and I both got the H1N1 and are pretty much over it already. Nagging cold symptoms are all that is left. It hits hard and fast then lingers for days afterwards. All in all, I would not venture to say it is worse than any other flu I've ever had.

Mike Philbin

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Re: FDA to Nzymes.com: Leave the H1N1 "cures" to us
« Reply #7 on: September 13, 2009, 07:29:04 am »
Yeah I'll bet Vitamin C and echinacea will be considered contraband too in the near future.

look up Codex Alimentarius - nasty fascism awaits.