Inspections, Compliance, Enforcement, and Criminal Investigations
North American Herb & Spice 22-Mar-06
Department of Health and Human Services
Public Health Service
March 22, 2006
RETURN RECEIPT REQUESTED
Ms. Judy K. Gray, Owner
North American Herb & Spice
1455 Lakeside Drive
Dear Ms. Gray:
The Food and Drug Administration (FDA) has reviewed your web sites at the Internet addresses http://www.oreganol.com and http://www.p-73.com, and has concluded that your product "kid e kare™ Cold & Flu Gelcaps" is 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 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, 21 U.S.C. 321(g)(1)(B)]. The name of your product, "kid e kare™ Cold & Flu Gelcaps," is an implied claim that your product is useful in preventing and/or treating the common cold and influenza in children.
This claim causes 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 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.
You must immediately correct these violations. If you do not immediately correct them, you may be subject to enforcement action without further 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 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 15 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 George F. Bailey, at the above address.
Scott J. MacIntire