uled and held a series of Public Meetings to receive feedback
from food industry representatives and consumers. FDA
initially stated in the proposed rules that it would consider
written comments received by May 16, 2013. However, FDA
received numerous requests for an extension to provide written comments given the complexity of these rules as well
as the fact that they are highly intertwined with three other
major rules (foreign supplier verification program, preventive
controls designed to reduce the likelihood of contamination
in animal food and certification of third-party audits) that
have yet to be published. Based on these requests, the agency
extended the comment period by another 120 days to give industry and consumers a chance to fully comment on the rules,
so now the new date for filing written comments is September
The final regulations may include changes requested by
commenters and will likely have variable, effective compliance
dates for different provisions and for different categories or
sizes of businesses (small and very small businesses will likely
have longer to come into compliance than larger companies).
Given the impact FDA’s regulations will have on companies
large and small, however, it is crucial for any and all affected
companies to understand the proposed rules and to make
their views, objections and constructive suggestions known to
FDA as part of the rulemaking process.
The issuance of these proposed rules marks the start of
what will be a lengthy and challenging rulemaking proceeding.
There are many issues within the rules, and industry may want
FDA to modify or relax its proposals around them. FDA may
be flexible on some issues, but on others, the agency’s views
will be difficult or impossible to change. n
Sonali Gunawardhana is a member of Wiley Rein’s food and
drug law practice group. She worked for nearly 10 years as an
attorney at FDA and also served in FDA’s Center for Food Safety
and Applied Nutrition. She can be reached at 202.719.7454 or
James N. Czaban is a member of Wiley
Rein’s food and drug law practice group. He has extensive experience in government regulation of food, pharmaceutical, biotechnology, medical device and healthcare-related companies. He can
be reached at 202.719.7411 or email@example.com.
1. Taylor, M.R. 2012. Progress on FSMA, Changes within the FDA Foods
Program, and on Partnerships. FDA Science Writers Symposium, Silver
2. FDA Warning Letter issued to Lucky Taco, April 2, 2012.
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