FDA regulation for food and beverage labels

Q: I have been asked to do a quality audit of a label manufacturer whose products are used on beverages and food packaging. They are currently asking to be audited using 21CFR211 (pharmaceuticals). Is there another standard that is more appropriate for their product?

A: 21CFR211 is the FDA regulation for cGMP for finished pharmaceuticals. This regulation does not apply to the labeling of food and beverages. The proper FDA regulation is 21CFR101. I suggest that you first start on the FDA web page on food labeling and nutrition.

John G. Surak, PhD
Surak and Associates
Clemson, SC
A member of Stratecon International Consultants
www.stratecon-intl.com/jsurak.html

Related Resources: 

Browse the free, open access content below, or find more in the ASQ Knowledge Center.

Can Do: An effective overseas food-safety audit is possible—if you know what to expect,” Quality Progress

The challenges inherent in food-safety audits become more problematic when foreign suppliers are targeted. Language and social barriers, as well as varying compliance requirements, are the biggest hurdles. With a careful plan and an emphasis on keeping things simple, auditors can overcome the challenges. Read more.

Kano’s Theory of Attractive Quality and Packaging,” Quality Management Journal

The role of consumer products packaging has moved beyond that of merely protecting the contents to a more vital role as a marketing vehicle. This raises the issue of how packaging should be designed to relay an association with high quality to the consumer. An empirical investigation based on Kano’s theory of attractive quality was conducted to determine how 24 quality attributes of packages are perceived by customers. Read more.

Explore the ASQ Knowledge Center for more case studies, articles, benchmarking reports, and more.

Browse articles from ASQ magazines and journals here.

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