Search This Blog

Saturday, November 12, 2011

Labels as Tables of Contents


Last month I attended Supply Side West where my company, in conjunction with Nosco, Inc (, presented information on packaging, labeling and compliance.  I spoke to a small group of attendees about how labels function as the table of contents to information about your product; information that can guide an inspection of your manufacturing facility.  For instance, the net contents statement clues an inspector in on the type of equipment they will be reviewing: liquid or powder fill, tableting or encapsulation.  Whether the product is a food, drug, cosmetic or dietary supplement, the statement of identity, along with product claims, determines which regulations apply.  Claims used on the product label also convey the amount and type of data that should be on file to support the claims so that you can comply with the requirement that all claims be truthful, not misleading and supported by data.

If the product is a dietary supplement, the supplement facts box outlines the manufacturing process.  If the facts box lists a proprietary blend, then the standard operating procedure or SOP should reflect a blending step.  The supplement facts box can provide a list of herbs that may require identity testing or that may need to be the subject of a new dietary ingredient notification. Nutrition Facts boxes on foods or Drug Facts boxes on over the counter drug products guide inspectors to look for data to support the values declared or to demonstrate adherence to applicable monographs.The ingredient list is another place when an inspector may look for ingredients that may not be permitted in products marketed in the United States.

Finally, the signature line listing the name and place of business of the company introducing the product into the marketplace, assigns responsibility for compliance with labeling regulations, good manufacturing practices and adverse event reporting system. In the event an inspector finds something amiss, the signature line names the company that will get the 483 or possible warning letter.

With so much riding on the information listed on your product label, don’t ignore the importance of ensuring that your labeling is correct and complies with FDA regulations.   Visit our websites, or for more information on labeling or other FDA compliance issues.  This blog discusses issues pertinent to FDA-regulated industries. Post a comment to let us know if you would like to subscribe to occasional email updates targeted to your industry sector.

Copyright 2011 Bioscience Translation & Application

No comments:

Post a Comment