Inspections, Compliance, Enforcement, and Criminal Investigations
Department of Health and Human Services
Public Health Service
555 Winderley PI., Ste. 200
November 30, 2005
Allen S. Josephs, M.D., President
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.
Emma K. Singleton
Director, Florida District