|Subject:||Labeling/New Drug Application|
|Issuer:||Center for Food Safety and Applied Nutrition|
|Issued:||Jan. 7, 2005||Closed:||
Department of Health and Human Services
Public Health Service
5100 Paint Branch Pkwy HFS-607
JAN 7 2005
754 Washington St.
Eugene, OR 97401
To Whom It May Concern:
The Food and Drug Administration (FDA) has reviewed your web site at the Internet address http://www.quantumhealth.com and has concluded that claims in your labeling cause your products "Thera Zinc Lozenges," "Thera Zinc Spray," "Thera Zinc Zinc+Echinacea Drops," "ZincEchinacea Lozenges," "Zinc Elderberry Lozenges," "Zinc Echinacea Lozenge Rolls," "Elderberry Syrup," "Elderberry Lozenges," "Elderberry Standardized Extract," "Elderberry Liquid Extract," "Flu Fighter Pack," "Common Cold & Flu Season Medicine Chest," and "Common Cold & Flu Protection Kit" to be drugs as defined in section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act). You can find the Act and FDA's regulations through links on FDA's Internet home page: 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]. Your web site claims that your products are useful in the prevention and treatment of influenza and the common cold.
The Internet labeling of your products bears the following claims:
" (Elderberry products) "Studies show the herb Elderberry can cure the duration of the flu in half."
" (Zinc-containing lozenge products) "Studies show Zinc Lozenges can cut the duration of common colds in half."
" (Thera Zinc Lozenges) "The Original Zinc Lozenges Make the Common Cold Disappear Fast"
" "Thera Zinc Spray is a super common cold stopping and prevention formula. . . ."
" (Thera Zinc Zinc+Echinacea Drops) "[T]he same common cold stopping power of the regular lozenges . . . ."
" (ZincEchinacea Lozenges) "For Fast Common Cold Relief"
" (Zinc Elderberry Lozenges) "Combining the cold stopping power of zinc with elderberry . . .."
" (Elderberry Syrup) "The powerful essence of Elderberry . . . has been clinically studied for its use as a flu remedy. The results show that Elderberry can reduce flu days and/or the severity of symptoms."
" (Flu Fighter Pack) "Elderberry Extract Capsules- The flu fighting herb."
" "Flu vaccine alternatives? . . . [C]lick here to review Quantum's special Flu Fighter Pack."
" (Common Cold & Flu Prevention Kit) "Don't get sick this year! This little kit includes products designed . . .to help fight the common cold this season. Use the Thera Zinc drops daily for prevention . . . . Elderberry has been shown to fight flu."
These claims cause your products to be drugs, as defined in section 201(g)(1)(B) of the Act. Because the products are not generally recognized as safe and effective when used as labeled, they are also new drugs as defined in section 201(p) of the Act. Under section 505 of the Act, a new drug may not be legally marketed in the United States without an approved New Drug Application (NDA). These drugs are also misbranded within the meaning of section 502(a) of the Act because their labeling is false and misleading in that it suggests that these drugs are effective for the prevention and treatment of influenza and the common cold, when, in fact, these claims are not supported by competent and reliable scientific evidence.
This letter is not an all-inclusive review of your websites and the products that your firm markets. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations.
The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products. You should take prompt action to correct these deviations and prevent their future recurrence . Failure to do so may result in enforcement action without further notice.
Please advise this office, in writing and within fifteen (15) working days of the receipt of this letter, as to the specific steps you have 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 Compliance Officer Quyen Tien at the above address.
Joseph R. Baca
Office of Compliance
Center for Food Safety and Applied Nutrition