FDA Issues Draft Guidance on Inorganic Arsenic in Rice Cereals for Infants
The U.S. Food and Drug Administration (FDA) has issued draft guidance
proposing an action level of 100 µg/kg for inorganic arsenic in rice
cereals for infants.
The agency has also released supporting documentation for its proposal
as well as a risk assessment that includes (i) “a quantitative estimate of
lung and bladder cancer risk from long-term exposure to these products
and the predicted impact of various scenarios to reduce the risk,” and (ii)
“a qualitative assessment of certain potential non-cancer risks, in certain
susceptible life stages.”
“We conclude that the 100 µg/kg action level will help protect the public
health and is achievable with the use of current good manufacturing
practice, but we especially welcome comments and information bearing
on the achievability and public health benefits and risks of 100 µg/kg, as
compared with other potential action levels (including no action level),”
states FDA, which will consider comments submitted by July 5, 2016.
“If the guidance is finalized consistent with the draft, we intend to
consider the action level of 100 µg/kg or 100 ppb inorganic arsenic,
in addition to other factors, when considering whether to bring enforcement
action in a particular case.” See Federal Register, April 6, 2016.
Meanwhile, in an April 1, 2016, statement, U.S. Rep. Rosa DeLauro
(D-Conn.) called on FDA to set action levels for inorganic arsenic in all
rice products, not just infant rice cereals.
“The FDA’s new draft guidance for limiting the levels of inorganic arsenic
found in infant rice cereal is a great first step in protecting the health of
infants and I am pleased that the agency is finally taking action on this
important public health issue,” DeLauro said. “However, the new guidance
does not go far enough in ensuring the health of all Americans… The
FDA should immediately expand the guidance to include proposed action
levels on all rice based products. In the meantime, Congress should pass
the Reducing food-based Inorganic Compounds Exposure (RICE) Act,
which would do just that.”
Issue 599
