|Company:||Nich Marketers Inc.|
|Issuer:||Cincinnati District Office|
|Issued:||March 15, 2007||Closed:||
Department of Health and Human Services
Public Health Service
Cincinnati District Office
VIA FEDERAL EXPRESS
March 15, 2007
Edgar L. Erlanger, President
Nich Marketers Inc.
340 Gudrun Road
Columbus, Ohio 43202
Dear Mr. Erlanger:
An investigation of your own label distributing facility located in Columbus, Ohio, conducted by a representative of the U.S. Food and Drug Administration (FDA)on January 23, 2007, confirmed that you are marketing the following animal products; Sorb-A-Tox Suspension, BIS-CO-SORB Suspension, Aspir-SLO, Colloidal Silver, B-Mune™ Capsules (Beta-1,3-D glucan), Nich UAAGel® (Universal Animal Antidote Gel), and "Tongue.to Tail." The FDA investigator collected copies of product labels, labeling, and other promotional material with respect to animal products that you distribute. In addition, as late as February 8, 2007, are view your firm's website found that several of the aforementioned products are being promoted for various animal uses.
Under section 201(g) [21 U.S.C. 321 (g)] of the Federal Food, Drug, and Cosmetic Act (the Act), any article "intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals" or any article, other than food, "intended to affect the structure or any function of the or body of man or other animals" is defined as a "drug." Because the labels, labeling, and other promotional materials for several of these products include statements that represent and suggest that the products are intended to be used in the cure, mitigation, treatment or prevention of disease, or are intended to affect the structure or function of animals, these products are drugs within the meaning of section 201(g) [21 U.S.C. 321 (g)] of the Act.
In addition to being "drugs", Sorb-A-Tox Suspension, BIS-CO-SORB Suspension, Aspir-SLO, Nich UAAGel® (Universal Animal Antidote Gel), and "Tongue to Tail" are also "new animal drugs" under section 201(v) of the Act [21 USC 321(v)] because they are not generally recognized as safe and effective by scientific experts for their labeled intended uses. New animal drugs that are not covered by approved New Animal Drug Applications (NADAs), as required by section 512(a)(1)(A) of the Act [21 U.S.C. 360b(1)(1)(A)], cannot be legally marketed in the United States. Because the new animal drugs listed above are not covered by approved NADAs,they are adulterated pursuant to section 501(a)(5) of the Act [21 U.S.C. 351(a)(5)].
The drugs Colloidal Silver, B-Mune™ Capsules (Beta-1,3-D glucan), and',"Tongue to Tail", are misbranded within the meaning of section 502(f)(1) [21 U.S.C. 352(f)(1)] of the Act because the labeling fails to bear adequate directions for the intended uses. Colloidal Silver and B-Mune™ do not include instructions for use and "Tongue to Tail" does not include the species for which it is intended for use. Additionally, the drug Sorb-A-Tox Suspension, is misbranded within the meaning of section 502(a) [21 U.S.C. 352 (a)] of the Act because its labeling is false or misleading in that it contains a false National Drug Code (NDC) number.
The above is not intended to be an all-inclusive list of violations. As a distributor of drugs, you are responsible for assuring that your overall operations and the products you distribute are in compliance with the law. You should take prompt action to correct these violations and to establish procedures to prevent their recurrence. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.
You should notify this office in writing within fifteen (15) working days of receipt of this letter, of the specific steps you have taken to correct the noted violations, including a explanation of each step being taken to prevent the recurrence of similar violations. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the time within which the corrections will be completed. Also include copies of any available documentation demonstrating that corrections have been made.
Your reply should be directed to Stephen J. Rabe, Compliance Officer at U.S. Food & Drug Administration, 6751 Steger Drive, Cincinnati, Ohio 45237-3097
If you have any questions or need clarification regarding this letter, you may contact Mr. Rabe at telephone number (513) 679-2700 extension 163.
Carol A. Heppe