Facilities in compliance with FDA’s seafood, juice or low-acid
canned food product requirements are exempt from FSVP. The exemption relating to low-acid canned foods applies only with respect to
microbiological hazards. Also exempt are foods imported in small
quantities for research and evaluation purposes or for personal consumption. FDA previously used discretion when allowing such entries
into the country. The new law makes provisions for such shipments.
FDA has the authority to require that high-risk imported foods be
accompanied by a credible third-party certification or other assurance
of compliance as a condition of entry into the U.S. FDA will base its
decision on known safety risks associated with the food as well as the
country territory or region of origin of the food and any history that
indicates that the food safety programs systems/standard of the country territory or region are inadequate.
Certification may be provided in the form of a shipment-specific
certificate, a listing of certified facilities or such other form specified.
The FSVP is a general requirement applicable to all food importers,
unless there’s an exemption. In contrast, certification is needed only
in those situations where FDA requires it.
The FSMA establishes a mandated inspection frequency based on
risk. All high-risk domestic facilities must be inspected within five years
of enactment and no less than every three years thereafter. FDA will
have access to industry food safety plans and the new facility records
that will now be required to document implementation.
The FSMA provides FDA with authority to issue a mandatory recall
when a company fails to voluntarily recall unsafe food after being
asked to by the FDA. The FSMA provides FDA with a more flexible
standard for administratively detaining products that are potentially in
FDA’s Current High-Risk Food Commodities Include:
• modified-atmosphere packaged products
• acidified and low-acid canned foods
• custard-filled bakery products
• dairy products, including soft, semisoft, soft ripened cheese and cheese products
• unpasteurized juices
• sprouts ready-to-eat
• fresh fruits and vegetables/processed fruits and vegetables
• shell eggs
• prepared salads
• infant formula
• medical foods
This list is not inclusive because FDA’s identification of high-risk food is dynamic and
subject to change in response to new information. For example, FDA has in recent years
added that even if an item doesn’t contain an allergenic ingredient, if it is processed in a
facility with allergens, there is a high risk of the product inadvertently containing an aller-
gen that is not declared on the label. Common allergenic substances include milk, eggs,
fish, crustaceans, tree nuts, peanuts and soybeans.
violation of the law (administrative
detention is the procedure FDA uses
to keep suspect food from being
moved). Under the new law, FDA can
detain a product it has reason to be-
lieve may be adulterated or mis-
branded. The old standard was
credible evidence or information in-
dicating that such an article presents
a threat of “serious adverse health
consequence or death to humans or
Section 302 of the statute requires
FDA to establish a user-fee-funded
voluntary qualified importer program
(VQIP) to expedite entry into the
United States of imported food from
eligible, qualified importers. To be
eligible to participate in VQIP, an im-
porter must offer food for importa-
tion from a facility that has a
certification from an accredited third
party. FDA will qualify eligible im-
porters to participate in VQIP based
on risk considerations. The new law
directs FDA to issue guidance on
compliance with VQIP.
The changes to the Food Drug
and Cosmetic Act include a provision
that specifically prohibits importing
foods without an FSVP. An importer
who ignores the verification requirements does so at the risk of misdemeanor or felony prosecution.
Importing Dos and Don’ts
Looking at these changes, some
recommendations for food importers
• Keep abreast of developments by
visiting FDA’s website regularly.
• Establish good relationships with
suppliers and determine whether
they meet FDA’s standards.
• Find out who’s who at your local
FDA District Office and the roles
they play in the importing process.
• Don’t overly concern yourself with
the FDA’s new ability to impose
fees. The majority of fees will be
charged only if a firm fails to do
the right thing the first time. Rein-