Food Business News - July 10, 2018 - 36
F.D.A. going on offense with
food defense guidance
©VLADMIR GERASIMOV - STOCK.ADOBE.COM
he Food and Drug Administration
on June 19 began issuing draft
guidance designed to help industry
comply with the Intentional Adulteration (I.A.) Rule under the agency's Food
Safety Modernization Act.
The I.A. Rule addresses hazards
that intentionally may be introduced
to foods, including by acts of terrorism,
with the intent to cause widespread harm
to public health. The I.A. Rule requires
the food industry to implement risk-reducing strategies for processes in food
facilities that are significantly vulnerable
to intentional adulteration. The first
compliance date for the largest facilities
is July 2019.
The draft guidance released June 19
marks the first of three installments. It
includes chapters on components of the
food defense plan, how to conduct vulnerability assessments, how to identify
and implement mitigation strategies, and
food defense monitoring requirements.
The other guidance installments
will come out later this year. The second
installment will focus more specifically
on vulnerability assessments and training
F.D.A. seeking to improve
nutrition innovation strategy
he Food and Drug Administration has scheduled a meeting for July 26 and invited
interested parties to submit ideas for how the agency can improve its nutrition innovation strategy.
"It's incontrovertible that diet quality has a major impact on health," said Scott
Gottlieb, M.D., commissioner of the F.D.A. "This is relational. We
know, for example, that populations with better diet quality are
shown to have better outcomes. But it's also undeniably causal. We
know that diet affects health. And we know diet is modifiable.
"What we need is the policy framework that allows consumers
to identify healthier options and the market forces to inspire the
development of these opportunities at a cost that's affordable."
Mr. Gottlieb added that the F.D.A. wants to empower consumers
with modernized food labels that will make it easier to inform better
choices while at the same time providing incentives for food manufac©STOKKETE - STOCK.ADOBE.COM
turers to produce the more nutritious products consumers demand.
"Toward these goals, our innovation strategy seeks ways to provide incentives for manufacturers and foster competition to create more nutritious food offerings and have clearer labeling that's
more understandable to consumers," he said. "Providing a framework for encouraging industry to
compete on the nutritional attributes of their products can provide healthier choices for consumers
and enable more opportunities for these healthy options to also be more affordable options."
The meeting will cover three primary topics - modernizing labeling claims, modernizing ingredient labels, and modernizing standards of identity.
"Leveraging nutrition as a way to advance public health remains one of my top priorities as commissioner," Dr. Gottlieb said. "All of these efforts represent the broad range of
work the F.D.A. is currently conducting to create a safe and healthier food supply for American families, and to help consumers make more informed choices."
The meeting will be held July 26 at the Hilton Washington D.C./Rockville Hotel and run
from 8:30 a.m. until 5:30 p.m. FBN
Food Business News
requirements. The third installment will
give details on corrective action, verification, reanalysis and recordkeeping
requirements. The F.D.A. will hold a public
meeting on the draft guidance when the
second installment is released.
"This is new regulatory territory
for both the F.D.A. and industry," said
Scott Gottlieb, M.D., commissioner
of the F.D.A. "We've engaged directly
with stakeholders while drafting this
guidance to understand their perspectives and any concerns they have about
complying with this rule. We've listened
to their valuable feedback. Much of that
feedback is reflected in the draft guidance we're releasing today, as well as in
the next two parts of the guidance.
"For example, we heard consistently
from a variety of stakeholders that the
rule needed to be practical and that facilities needed flexibility when conducting
vulnerability assessments. The draft
guidance reflects this approach. The new
guidance illustrates different ways that
each facility can meet the requirements
of the rule, and the guidance provides
a range of options for identifying and
The final rule on intentional
adulteration, which targets potential
terrorist contamination of the food
supply, became effective on July 26, 2016.
It requires covered food facilities in the
United States and those abroad that
export food to the United States to implement a food defense plan that identifies
vulnerabilities and ways to reduce the
risk of intentional adulteration.
"To be successful, protecting the
U.S. food supply requires a partnership,"
Dr. Gottlieb said. "As we work toward the
July 2019 implementation date for large
facilities, we're committed to supporting
industry in its efforts." FBN
July 10, 2018