Department of Health and Human Services
Public Health Service
1431 Harbor Bay Pkwy
July 23, 1997
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED
Paul Atlas, President
Morris Levin & Son
1816 S K St
Tulare, CA 93274
Ref. No. 29-53447
Dear Mr Atlas:
This letter is written in reference to your marketing and distribution of colloidal silver solution intended for inter-mammary and topical administration for dairy cows. An inspection ofyourfirm on June 12, 1997 by Food and Drug Administration (FDA) Investigator Robert J. Anderson has revealed serious violation of the Federal Food, Drug, and Cosmetic Act (Act). Because the labeling and/or promotional materials for the colloidal silver solution you distribute states or suggests that it is intended for the cure, mitigation, treatment, or prevention of diseases in dairy cows, or affects the structure or function of the body, this product is a drug within the meaning of Section 201(g). Colloidal silver solution is a new animal drug within the meaning of Section 201(v) since it is not generally recognized as safe and effective for the uses for which it is recommended in the labeling.
The Silver Wain-Water brand of colloidal solution you market is adulterated under Section 501(a)(5) of the Act, in that it is a new animal drug within the meaning of Section 201(v) and is unsafe within the meaning of Section 512(a) of the Act since no applications have been approved pursuant to Section 512(b) for this drug.
The introduction or delivery for introduction of an adulterated drug into interstate commerce is a violation of Section 301(a) of the Act.
The receipt in interstate commerce of an adulterated drug, and the delivery or proffered delivery for pay or otherwise is a violation of Section 301(c) of the Act.
This is not intended to be an all-inclusive list of violations. It is your responsibility to ensure that requirements of the Act and regulations are being met. Failure to achieve prompt corrective action may result in enforcement action without further notice, including seizure and/or injunction.
Within fifteen (15) days of the receipt ofthis letter, notify our Fresno office in writing of the specific steps you have taken to correct these violations and preclude their recurrence. Direct your reply to Robert J. Anderson, Investigator at PO Box 169, Fresno, CA 93707.
This page was posted on August 20, 2006.