FDA has issued a request for comments on a proposed information collection
that will add the manufacturers of certain beers as respondents to its labeling
regulations and seeks Office of Management and Budget approval of allergen
labeling for these beers.

The agency explains that after the Alcohol and Tobacco Tax and Trade Bureau
determined that certain beers, which are made from substitutes for malted
barley, such as sorghum, rice or wheat, do not meet the definition of “malt
beverage” and are thus not subject to its regulations, the Food and Drug
Administration (FDA) prepared draft guidance to assist these manufacturers
in complying with its labeling regulations.

On the basis of the labeling regulations discussed in the guidance, the agency
provides estimates of the average burden per disclosure for each regulation—
that is, “12 respondents will each label 2 products annually, for a total of 24
labels” and “the manufacturers will spend 7.25 hours on each label to comply
with FDA’s labeling regulations and the requirements of section 403(w)(1) of
the [Food, Drug, and Cosmetic] Act, for a total of 174 hours.” Comments on the
burden estimates are requested by August 23, 2012. See Federal Register, July
24, 2012.

About The Author


For decades, manufacturers, distributors and retailers at every link in the food chain have come to Shook, Hardy & Bacon to partner with a legal team that understands the issues they face in today's evolving food production industry. Shook attorneys work with some of the world's largest food, beverage and agribusiness companies to establish preventative measures, conduct internal audits, develop public relations strategies, and advance tort reform initiatives.

Leave a Reply

Your email address will not be published. Required fields are marked *

You may use these HTML tags and attributes: <a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <s> <strike> <strong>