Ingredients
Importing Ingredients:
Understanding FDA’s New Food Safety Rules
By Joseph R. Baca
“As we’re all aware, FSMA is the most sweeping reform of our food laws in more than 70 years. It promises a safer food
supply—whether domestic or imported—than we
enjoy today. It promises to protect and promote the
public welfare. …And it promises to bolster industry
by building consumer trust.”
— Margaret A. Hamburg, M.D.,
Commissioner of Food and Drugs,
Washington, DC, October 4, 2011
The new Food Safety Modernization Act
(FSMA) signed into law just one year ago, on
January 4, 2011, will change the way imported
and domestically produced food is regulated—placing the responsibility for ensuring
imported foods are safe squarely on the shoulders of food importers. Rather than having
the industry and Food and Drug Administration (FDA) react to outbreaks through press
releases and recalls, from now on, all conventional and organic food importers, manufacturers and producers will be required to take
proactive measures in accordance with FDA
food safety regulations.
The Background
Although FDA has always maintained that
importing is a privilege, not a right, the
agency’s scarce resources and regulations
made many companies take this privilege for
granted. In the ’70s and ’80s, FDA reviewers
were usually swamped with piles of paper doc-
uments from ports across the country, and the
ability to follow up on entries was limited by
manpower and availability of investigational
and laboratory resources. Importers were very
casual about filling out the paperwork, and
frequently the biggest obstacle to sampling an
entry was locating it. After the North Ameri-
can Free Trade Agreement became law, the
dam broke and the numbers and variety of
products crossing our borders and arriving at
our sea- and airports skyrocketed. Increased
trade with China and other countries in the
past couple of decades added significantly to
the FDA import workload. The exponential
increase in food and other FDA-regulated im-
port entries was not matched with increased
numbers of investigators and laboratory per-
sonnel. I recall the staff at the Port of Laredo,
TX, saying their situation was reminiscent of
the movie 300, in which a few hundred Spar-
tans fought thousands of adversaries head-on.
The workload was overwhelming.
