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The QMN Weekly Bulletin

Labeling Claims for Colostrum Products Make Them Unapproved Drugs

Sept. 1, 2017

The FDA cited multiple problems with labeling claims at a Phoenix manufacturer that specializes in colostrum, the milk produced by maternal mammals immediately after giving birth.

APS Biogroup collects the colostrum from dairy cows and processes it for human consumption. The product is high in antibodies and growth stimulants.

In a warning letter to the company, the FDA said claims that some of the firm’s products provide defense against pathogens, viruses and bacteria categorize them as drugs, and the products have not been approved by the agency as drugs.

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