Health food firm cited for 23 GMP violations, company decries "FDA raid on premises".

Alternative Health & Herbs Remedies, Albany, OR, Bothell, WA, District

An herbal food manufacturer in Albany, OR, was written up for 23 GMP violations but claimed in strong terms in its written response that it was not a drug manufacturer but was rather a food manufacturer and was in compliance with FDA food regulations.

Alternative Health & Herbs Remedies was cited for a lack of a quality control unit, no procedures to handle complaints, lack of an investigation system and no change control system. The report was written by investigator Terri Dodds from the Bothell, WA, District Office.

FDA documents stated the firm's production of tinctures for use as eye rinses were manufactured in such a way that sterility could not be assured. "Other than using non-sterile gloves, there were no precautions taken to prevent contamination of product during manufacturing," the report stated.

The firm stated in response: "We have not failed to comply. We are not a drug manufacturer and GMP does not apply to food manufacturers to the best of [our] knowledge."

The company further stated: "We have complied immediately, and conformed to all the changes that FDA investigators to improve our food manufacturing process.

"At first we thought it was an FDA mistake, now it is clear that FDA is obsessed with referring to us as a drug manufacturer in an attempt to modify facts for FDA purposes. We never purported any of our food products to be sterile. Drugs are sterile pharmaceuticals, the word being derived from the Greek word 'pharmakia,' meaning 'witchcraft.' We are a Christian church and our food manufacturing is not drug/witchcraft."

The company further asserted that it had instituted sterilization procedures and had purchased a dishwasher for sterilizing caps, droppers and other uses for manufacturing of its food products. "We did manufacture herbal foods that are used traditionally for ophthalmic use, which now are not manufactured by our non-profit church at FDA request ... We complied immediately during the FDA seven-day raid on our church premises."

FDA also stated that the company failed to keep adequate records; failed to keep a lot number system; failed to maintain its facilities to prevent contamination; failed to segregate manufacturing from raw material storage; failed to keep microbial limits; failed to keep control over labeling; and failed to keep control over raw materials handling.

For all violations, the firm maintained that it was not a drug manufacturer: "We comply with food manufacturing procedures and cannot comply with drug manufacturing as there is not one drug in our building."

The company could not be reached for comment.

Alternative Health & Herbs Remedies, Albany, OR, 9/13-17/04, Doc. 109915M, $15 plus retrieval.