FDA Globalization Act (Dingell Bill) Summary Jan 2009
Summary of the Food and Drug Administration
Globalization Act of 2009
1) Creates an up-to-date registry of all food facilities serving American
consumers: Requires all facilities operating within the US or importing
food to the US to register with the FDA annually.
2) Generates resources to support FDA oversight of food safety:
Requires payment of a registration fee per facility that would generate
revenue for food safety activities at the FDA. The registration fee would
be waived for small businesses and facilities that solely serve as
3) Prevents food safety problems before they occur: Requires foreign
and domestic food facilities to have safety plans in place to identify and
mitigate hazards. Safety plans would be subject to review by FDA
inspectors and third-party certifiers.
4) Increases inspections: Requires FDA to establish a risk-based schedule
for inspecting foreign and domestic food facilities. Sets a minimum
inspection frequency of once every four years. Refusing, impeding or
delaying an inspection would be cause for suspension of registration and
for barring entry into the US.
5) Requires food imports to demonstrate safety: Requires foreign food
manufacturers to be certified as meeting all US food safety requirements
by third parties accredited by FDA. Uncertified facilities would be
prohibited from exporting to the US.
6) Creates fast-track import process for food meeting security
standards: Directs FDA to develop voluntary security guidelines for
imported foods. Importers meeting the guidelines would receive expedited
7) Requires safety plans for fresh produce: Directs FDA to issue
regulations for ensuring the safe production and harvesting of fruits and
8) Improves traceability: Significantly expands FDA traceback capabilites
in the event of an outbreak of foodborne illness by filling the loopholes in
the current requirements in the Bioterrorism Act of 2002:
• Includes farms and restaurants in the traceback requirement. Under
current law, these two entities were exempted.
• Mandates a standardized electronic record to ensure fast and efficient
traceback. Current law only requires entities to hold a record in any
form - paper or electronic.
• Requires a standardized lot number for each shipment to ensure the
number for the same shipment is consistent throughout the supply
9) Requires country-of-origin labeling and disclosure: Requires all
processed food labels to indicate the country in which final processing
occurred. Requires food manufacturers to identify the country of origin for
all ingredients on their websites. Requires country-of-origin labeling for all
10) Expands laboratory testing capacity: Requires any testing done to
meet certain safety requirements to be performed only by a laboratory
accredited by the FDA. Requires laboratories to send any test results to
11) Provides strong, flexible enforcement tools: Provide FDA new
authority to issue mandatory recalls of tainted foods. Strengthens fines
imposed on food facilities that fail to comply with safety requirements.
12) Clarifies consumer labeling for certain foods treated with carbon
monoxide: Requires meat, poultry and seafood products to which carbon
monoxide has been added to be labeled with a consumer notice that the
freshness of the product should not be judged by color.
13) Advances the science of food safety: Directs the Secretary to include
food in an active surveillance system to assess more accurately the
frequency and sources of human illness. The Secretary is also directed to
identify industry and regulatory approaches to minimize hazards in the
14) Makes GRAS determinations public: Requires publication of the
request for a “generally recognized as safe” (GRAS) decision and FDA’s
15) Allows FDA to charge a fee to domestic firms requiring export
Drug and Device Safety
1) Creates an up-to-date registry of all drug and device facilities serving
American consumers: Requires all domestic drug and device facilities
and foreign facilities exporting to the US to register with FDA annually and
pay a registration fee.
2) Generates funding for increased GMP inspections for brand and
generic drugs: Registration fees would fund increased inspections by
FDA and to improve information systems Funding will supplement, not
supplant existing appropriations. Failure to register or pay the fee is a
cause for denying entry of the facility’s product into the US.
3) Generates funding for pre-approval inspections for generic drugs:
Currently generic drugs, unlike brand drugs, do not pay fees under
PDUDA to support FDA activities related to drug approvals, including pre-
approval inspections. The lack of resources impedes FDA’s ability to
conduct the necessary inspections of this type of manufacturer,
particularly since the majority are now located abroad. This legislation
would require generic drug manufacturers to pay a fee to cover the cost of
4) Increases pre-approval inspections: To address the concern that FDA
is failing to conduct pre-approval inspections of foreign drug facilities with
very questionable safety records, this legislation would require that pre-
approval inspections to be conducted unless FDA makes a determination
that, based on the inspectional history of the facility, an inspection isn’t
needed to ensure compliance with GMPs, verify the data in the application
or otherwise ensure the safety of the product.
5) Requires parity between foreign and domestic inspections: Requires
FDA to inspect foreign and domestic drug facilities every two years.
Allows FDA to modify an individual facility’s inspection schedule only if
FDA determines that sufficient information exists about that facility’s
inspection history and compliance record to justify less frequent
6) Denies entry to drugs coming from facilities that limit, delay or deny
7) Prohibits the entry of drugs into the US lacking documentation of
safety: Rather than solely relying on FDA to determine if a drug shipment
appears to be dangerous based on the limited information currently
provided at the border, the legislation would require drug importers to
affirmatively demonstrate their products come from registered facilities
and meet all requirements related to safety and quality.
8) Requires manufacturers to know their supply chain: To aid in
preventing and investigating incidents like the heparin crisis, requires
manufacturers, when requested by FDA, to provide documentation of their
complete supply chain, back to the raw materials, and to document
measures taken to secure their supply chain.
9) Requires manufacturers to identify and mitigate risk throughout their
supply chain: Requires finished dose and active ingredient
manufacturers to have in place written plans to identify and control risks
specific to the drug being produced. Requires manufacturers to conduct
on-site audits of ingredient and raw material suppliers. Requires
manufacturers to test for likely contaminants.
10) Country of Origin labeling: Requires drug manufacturers to list on their
website the country of origin for all drug ingredients and for the finished
11) Provides strong new enforcement tools:
• Destruction: Allows FDA to destroy counterfeit or adulterated imports
if they pose a risk of injury or death.
• Civil monetary penalties: Creates new authority to impose fines for
any violation of the Food, Drug and Cosmetic Act related to drugs.
Significantly increases fines for repeat offenders.
• Criminal penalties: Increases penalties related to counterfeit drugs to
20 years from one year. Increases the penalty up to life in prison if the
use of the counterfeit product causes death.
• Mandatory recall: Gives FDA new authority to mandate recalls of
• Administrative detention: Gives FDA new authority to detain unsafe
drug discovered during the course of an inspection.
• Subpoena: Gives FDA new authority to subpoena records related to
1) Creates an up-to-date registry of all cosmetic facilities serving
American consumers: Requires all facilities operating within the US or
exporting cosmetics to the US to register with the FDA annually.
2) Requires adverse event reporting: Requires all cosmetic facilities
operating within the US or exporting cosmetics to the US to report adverse
events resulting from the use of their products to FDA.
3) Requires compliance with GMPs: Requires all cosmetic facilities
operating within the US or exporting cosmetics to the US to comply with
good manufacturing practices established by the Secretary.
1) Creates an up-to-date registry of importers: Requires all importers of
drugs, devices, foods, and cosmetics to register with the FDA annually
and pay a registration fee.
2) Requires unique identification numbers for facilities and importers:
To improve the accuracy of data and the ability of FDA to more quickly
identify involved parties in a crisis situation, creates unique identification
numbers for all drug, device, food, and cosmetic facilities and importers.
3) Creates a dedicated foreign inspectorate: Increases the capacity of
FDA to monitor foreign facilities producing food, drugs, devices, and
cosmetics for American consumers.
4) Continues operation of field laboratories: Prohibits FDA from closing
or consolidating field laboratories or district offices.
5) Prohibits false or misleading reporting to the FDA: Extends the
current prohibition against making false or misleading reports related to
devices to include food, drugs, and cosmetics.
6) Provides protection for whistleblowers that bring attention to
important safety information: Prohibits entities regulated by the FDA
from discriminating against an employee in retaliation for assisting in any
investigation regarding any conduct which the employee reasonably
believes constitutes a violation of federal law.