the u.s. fda food safety modernization act (for exporters to the us)
TRANSCRIPT
The U.S. FDA Food Safety Modernization Act
(For Exporters to the USA)
Russell K Statman, Esq.Executive Director
Registrar CorpFebruary 29, 2012
Enacted by Congress and signed into law by President Barack Obama on
January 4, 2011
FSM
“FSMA”
FSM
FSMA Amends the Food, Drug and Cosmetic Act
FSMTIMELINE OF U.S. FOOD REGULATION
Until 1906 “The Jungle”
FSMTIMELINE OF U.S. FOOD REGULATION
1906 Meatpacking Scandal The Food and Drug Act
FSMTIMELINE OF U.S. FOOD REGULATION
1938 The Food, Drug and Cosmetic Act
Statutory Mandate to FDA Concerning Food:Respond to Food Safety Violations
FSMA will shift responsibility for verifying food safety to processors and importers
Implemented in phases by new sets of regulations to be issued by FDA through January 2016
Timeline in handout provided by Registrar Corp
FSMTIMELINE OF U.S. FOOD REGULATION2011-The FDA Food Safety Modernization ActStatutory Mandate to FDA Concerning Food:
Prevent Food Safety Violations
Registration Suspension
FDA may suspend the registration of food facilities (effectively closing them from the U.S. market)
Registration may be held in suspension until FDA determines that no further health consequences exist.
FDA may require “corrective action plans”
Prior Notice Filers need to indicate whether a food product
has been refused entry to another country
Issued February, 2012:Record-keeping Rules
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Awaiting Regulations
Were Due January 4, 2012:
Foreign Supplier Verification Program
Preventive Controls for Human and Animal Food
Produce Safety
Third Party Auditors
FSMA Foreign Facility Inspection Schedule
Double the previous year, minimum of:
2011- 600 Foreign inspections 2012- 1,200 Foreign Inspections 2013- 2,400 Foreign Inspections 2014- 4,800 Foreign Inspections 2015- 9,600 Foreign Inspections 2016- 19,200 Foreign Inspections
Later this year . . .
October-December 2012
Facility Registration and renewal.
Now Biennial (every even-numbered year)
United States Agent
Food facilities designate a “U.S. Agent” under the regulation when they first register with FDA
The “U.S. Agent” is not the same as a business agent like a customer or importer
The U.S. Agent is a communications link with FDA
FSM
FSMA Amends the Food, Drug and Cosmetic Act to Impose New Fees
New FSMA “User Fees”
May be Charged to:
Food Manufacturers
Food Owner
Importers
“U.S. Agents”
FSMA Reinspection Fees
Will be charged for a Follow-up “Re-inspection” if FDA's Initial Inspection Determines “Official Action Indicated” (“OAI”)
Facility Reinspection Billed to the facility’s designated “U.S. Agent”
Fee Rates
Fee Rates
FDA Hourly Rate For Reinspections and Reconditioning: $224 per hour, domestic
$325 per hour if foreign travel is required
“Reinspection” Fees
Fee is based on the number of direct hours, including:
time spent conducting the physical surveillance at the facility,
whatever components of such an inspection are deemed necessary
making preparations and arrangements for the reinspection
“Reinspection” Fees
Also includes time incurred: Traveling preparing any reports, analyzing any samples examining any labels if required performing other activities until
the facility is in compliance.
Reconditioning Fees (for products)
Will be charged where reconditioning is required to bring food into compliance
Fees must be paid by owner of food or importer, depending on circumstances
Fees must be paid at the hourly rate ($224/$325)
Reconditioning Fees
Reconditioning fees include: Arranging for, conducting and reviewing tests of the reconditioned product
Examinations of labeling All time incurred by FDA in evaluating the reconditioning proposal and reconditioned product
Fees Related to Import Alerts (DWPE)
Will be charged where food is detained by an Import Alert (DWPE) and proof is offered to show that the shipment is not adulterated.
FDA's Informal Policy Statements
Fees Related to Import Alerts (DWPE)
Exporters applying for removal from DWPE must pay FDA's hourly charges for evaluating the application, including the cost of inspecting the foreign facility if necessary.
New FDA User Fees
Not Complying with a Recall Order
Not initiating a recall as ordered by FDA
Not conducting the recall in the manner specified by FDA
Not providing FDA with information regarding the recall as ordered by FDA.
The Goal
Staying Out of Trouble with U.S. FDA
“May the Lord bless and Keep the Tsar ---- far from us.”
Food (Including Supplements)
• Facilities must be registered with FDA biennially and must designate a proper U.S. Agent for FDA communications
• Food must be labeled properly
• Good Manufacturing Practices must be followed
• Food must not be “Adulterated”
• For shelf-stable, sealed foods, “FCE” registration and process filing may be required
Tommy's rule of
thumb...
If it must be
refrigerated after
opening, it
probably requires a
process filing.
Food Canning Establishment (FCE)Low Acid and Acidified Foods (LACF)
Source: Registrar Corp Analysis of FDA Import Refusal Reports for May through July, 2009
Country
Number
Labeling % FCE % Unapproved New Drug
% Other
%
Bangladesh 54 5 9% 0 0% 13 24%
36 67%
Canada 263 123 47% 4 2% 29 11%
107 41%
China 568 116 20% 19 3% 62 11%
371 65%
France 77 23 30% 14 18% 12 16%
28 36%
Germany 229 114 50% 0% 9 4% 106 46%
India 433 124 29% 27 6% 77 18%
205 47%
Italy 118 40 34% 38 32% 14 12%
26 22%
Japan 137 43 31% 9 7% 4 3% 81 59%
South Korea 166 66 40% 17 10% 8 5% 75 45%
Malaysia 72 21 29% 4 6% 1 1% 46 64%
Mexico 589 201 34% 49 8% 23 4% 316 54%
Pakistan 227 19 8% 9 4% 36 16%
163 72%
Russia 110 4 4% 0 0% 45 41%
61 55%
South Africa 179 117 65% 11 6% 11 6% 40 22%
Sri Lanka 68 32 47% 8 12% 7 10%
21 31%
Taiwan 127 16 13% 24 19% 3 2% 84 66%
Thailand 77 13 17% 5 6% 2 3% 57 74%
UK 286 123 43% 64 22% 24 8% 75 26%
Vietnam 162 28 17% 6 4% 0 0% 128 79%
Source: Registrar Corp Analysis of FDA Import Refusal Reports for May through July, 2009
Label Labeling
http://www.healthysuppy.com/products
An “Unapproved New Drug”
might be a cosmetic product
or dietary supplement
that has been labeled in a
way that causes
FDA to deem it a
“drug.”
The intended use of a product determines whether it is a “Drug” or a “Dietary Supplement.”
Intended Use May be Established By
• Claims stated on the product labeling, in advertising, on the Internet, or in other promotion materials
• Consumer perception, which may be established through the product’s reputation
• Ingredients that may cause a product to be considered a drug because they have a well-known (to the public and industry) therapeutic use, or
• Any Other Factor
Checklist
Verify that the product is labeled properly for its intended use
Verify that facilities or establishments have been registered
Verify that process filings for low acid and acidified foods) have been accepted by FDA prior to shipping
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