REGULATORY LETTER

CERTIFIED MAIL DEC 11, 1984 In reply, please refer to
84-HFN-314-2

James M. Lyons, President
Botanical Laboratories, Inc.
1441 West Smith Road
Bellingham WA 98226

Dear Mr. Lyons:

An investigation conducted at your firm by investigator Kim A. Rice of our Seattle office (on November 1, 1984) indicates that you manufacture and/or distribute into interstate commerce numerous homeopathic remedies labeled for the treatment of various serious disease conditions~

Our review of the labeling for Micro-Biotic No. 2 Aurinatia states that this product is indicated for the treatment of angina pectoris; arrhythmia, tachycardia, etc. Labeling for Micro-Biotic No. 33 Spasrepilin states that this product is indicated for the treatment of epilepsy. Our review of promotional literature (labeling) for other homeopathic products manufactured and/or distributed by your firm indicates that subject products are labeled for such disease conditions as hypoglycemia, gout, disturbances in cerebral function, pneumonia, lung abscess, etc.

It is the Food and Drug Administration’s position that these products are drugs as defined in section 201(g) of the Federal Food, Drug, and Cosmetic Act. Further, we are unaware of any substantial scientific evidence which demonstrates any of your marketed homeopathic drugs are generally recognized as safe and effective for their intended use. Accordingly, continued marketing of these drugs is a serious violation of the Federal Food, Drug, and Cosmetic Act as follows:

SECTION BRIEF DESCRIPTION
505(a) The products, "Micro-Biotic No. 2 Aurinatia", “Micro-Biotic No. 33 Spasrepilin" and all other homeopathic drugs marketed by you are new drugs within the meaning of section 201(p) of the Federal Food, Drug, and Cosmetic Act (Act) since no approvals of application filed pursuant to section 505(b) are effective with respect to such drugs.

The violation listed above is not intended to be all-inclusive. It is your responsibility as a drug manufacturer and distributor to market drug products which are in compliance with the Federal Food, Drug, and Cosmetic Act.

We request that you take prompt action to correct the above violation. If such action is not taken, the Food and Drug Administration is prepared to invoke regulatory action such as seizure and/or injunction. Please advise us within ten (10) days as to specific actions you have taken to correct the above violation including the discontinuance of all marketed homeopathic drugs.

Your response should be directed to:

William G. Nychis,
National Coordinator. Drugs and Biologics Fraud Branch (HFN-314)
Division of Drug Labeling Compliance
Office of Compliance - CDB
5600 Fishers Lane
Rockville MD 20857

Sincerely yours,

________________________
Daniel L. Michels, Director
Office of Compliance
Center for Drugs and Biologics

This page was posted on August 23, 2009.

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