What are the Regulations on Net Content Statements, Specifically for Protein Drinks?

December 4, 2007

We are installing a automated powder filling machine for our protein drink. We are trying to set the tolerances. If the label says we have 450 grams of product, how much under and over can we be and still be within FDC or FDA regulations?



Section 403(e) of the Food Drug and Cosmetic Act mandates that the net contents statement be "accurate." Under a FDA Compliance Policy Guide, FDA selects a sample of 48 units, and considers the sample to be in compliance if the mean of the sample is within 1% of the declared contents. Most states use a more complicated sampling plan modeled after the provision of Handbook 67, prepared by the National Bureau of Standards. This handbook has recently been superseded by Handbook 133, and it is likely that most states will adopt Handbook 133 in the future.