Threatening letter from the FDA

[Guest guest]

I found this by accident on Google, and it's from the horse's mouth:

http://www.fda.gov/foi/warning_letters/g5633d.htm According to the

FDA, if chicken soup helped cure my cold, then it is a drug.

 

Well maybe Vitacost published claims, but if they are true, there

shouldn't a law against publishing them.

 

Either way, this already proves that there is a conspiracy to limit

our access to the truth, and to limit our health freedom. And if you

think that CODEX isn't a threat, I think you're ignorant. Anyone who

lives in the USA should have already figured out that it is a mistake

to take freedom for granted.

 

And while I'm at it I suggest that you all encourage people like Gary

Null to actively campaign against CODEX. Because if Gary Null

campaigned against CODEX, maybe the health food stores would take the

threat more seriously.

 

The truth is that we don't know how serious the CODEX threat is,

because we don't have access to enough information. But the laws of

politics, power, and history should tell us that we can't sit on our

asses and do nothing.

 

Anyway, enjoy this ridiculous letter from the FDA.

 

-------------

 

Department of Health and Human Services

Public Health Service

Food and Drug Administration

 

 

555 Winderley PI., Ste. 200

Maitland, FL 32751

 

 

 

 

Warning Letter

 

November 30, 2005

 

CERTIFIED MAIL

RETURNED RECEIPT

 

FLA-06-06

 

Allen S. Josephs, M.D., President

Vitacost.com, Inc.

2055 High Ridge Road

Boynton Beach, FL 33426

 

Dear Dr. Josephs:

 

The Food and Drug Administration (FDA) has reviewed your web site at

the Internet address http://www.vitacost.com and has concluded. that

claims in your labeling cause your products NSI GliSODin®, NSI

Superior Ester-C with Quercetin and Bioflavonoids; NSI Vitamin C; NSI

Green Tea Extract, NSI Activated Quercetin Complex, NSI Probiotic with

Acidophilus, Rhamnosus, Thermophilus and Bulgaricus, NSI AHCC+ Immune

Power, and NSI L-Optizinc to be a drug as defined in section

201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21

U.S.C. 321 (g)(1)(B)]. You can find the Act and FDA's regulations

through links on FDA's Internet homepage: http://www.fda.gov.

 

Under the Act, articles intended for use in the diagnosis, cure,

mitigation, treatment or prevention of disease in man are drugs

[section 201 (g)(1)(B) of the Act, 21 U.S.C. 321(g)(1)(B)] . Your web

site promotes your products for the prevention and treatment of avian

flu and other forms of influenza by listing them as " Featured

Products " next to your eNewsletter article entitled " Guard Yourself

Against The Deadly Avian Flu Now! " . The article also makes the

following explicit flu prevention and treatment claims for ingredients

or components of the products:

 

*

 

In a study published in the Brazilian Journal of Medical and

Biological, Research from 1997, mice were infected intra-nasally with

influenza virus A. On days five, six, seven, and eight after the

infection, these mice were given the injections of SOD [superoxide

dismutase]. Forty-five percent of the mice that received this

treatment survived for 20 days. When the same treatment was started

one day earlier and given on days four to eight, survival increased to

75%. There is anew in oral form [sic] launched recently . . . called

GliSODin®. It is the first form in humans to promote the body's

production of SOD. "

 

*

 

" In another study published in the Journal of Manipulative Physiology

Therapy from 1999, 252 students . . . were asked to take 1,000 mg of

Vitamin C every hour for the first six hours after onset of . . . flu

symptoms, followed by 1,000 mg doses three times daily thereafter. A

control group of 463 students took normal pain relievers and

decongestants. It was found that overall flu . . . symptoms in the

treated group decreased 85% compared with the controlled. "

 

*

 

" There have been multiple animal studies in the medical literature

indicating that ECGC [a component of tea] . . . had direct anti-viral

effects on influenza virus.... "

 

" [Q]uercetin may be useful as an agent in reducing the oxidative

stress induced by influenza virus of the lung. . . . "

 

 

 

These claims cause your product to be a drug, as defined in section

201(g)(1)(B) of the Act [21 U.S.C. 321 (g)(1)(B)]. Because your

product is not generally recognized as safe and effective when used as

labeled, it is also a new drug as defined in section 201(p) of the Act

[21 U.S.C. 321(p)]. Under section 505 of the Act [21 U.S.C. 355 (a)],

a new drug may not be legally marketed in the United States without an

approved New Drug Application (NDA). This drug is also misbranded

within the meaning of section 502(a) of the Act [21 U.S.C. 352(a)]

because their labeling is false and misleading in that it suggests

that this drug is effective for the prevention and treatment of avian

flu and other forms of influenza when, in fact, these claims are not

supported by competent and reliable scientific evidence.

 

This letter an all-inclusive review of your website and the products

that your form markets. It is your responsibility to ensure that all

products marketed by your firm comply with the Act and its

implementing regulations.

 

You must immediately correct these violations. If you do not

immediately correct them, you may be subject to enforcement action

without notice. The Act provides for seizure of illegal products and

for injunctions against the manufacturers and distributors of illegal

products [21 U.S.C. 332 and 334]. Individuals and businesses that

violate the Act may also be subject to criminal prosecution.

 

Please advise this office, in writing and within fifteen (15) working

days of the receipt of this letter, as to the specific steps you haven

taken to correct the violations noted above and to ensure that similar

violations do not occur. If corrective actions cannot be completed

within fifteen working days, state the reason for the delay and the

time within which the corrections will be completed.

 

Your reply should be addressed to Shari H. Shambaugh, Compliance

Officer, Food and Drug Administration, 555 Winderley Place, Suite 200,

Maitland; Florida 32751.

 

Sincerely,

 

/s/

Emma K. Singleton, Florida District