the u.s. fda food safety modernization act (for exporters to the us)

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

FSM

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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