IMPORTING WITHOUT UNEXPECTED FDA DETENTION

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IMPORTING WITHOUTUNEXPECTED FDA DETENTION
Presented by Russell K Statman Executive
Director Registrar Corp
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The Goal
Clear Customs and FDA without detention
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Products Regulated by the FDA

• Food and Beverages
• Dietary Supplements
• Food additives and food contact substances
• Drugs
• Cosmetics
• Medical Devices
• Also Radiation Emitting Devices, Biologics,
  Tobacco

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What Gets Refused and Why?
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Source Registrar Corp Analysis of FDA Import
Refusal Reports for May through July, 2009
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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
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Background
Some Basic Requirements
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Drugs

• Establishments must be registered with FDA
• Drugs must be listed with FDA
• Drugs must be labeled properly
• Good Manufacturing Practices must be followed
• Drugs must not be Adulterated

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Firms Manufacturing, Labeling, Distributing, and
Promoting Must
Follow the Drug Monograph for that
drug OR Follow the approved New Drug
Application (NDA) for that drug Some
exception exist for grandfathered drugs,
research, etc.
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Drug Monograph
The recipe for an approved drug
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DRUG MONOGRAPHS United States Code of Federal
Regulations TITLE 21 C.F.R. Food and
Drugs CHAPTER I FOOD AND DRUG
ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES SUBCHAPTER D DRUGS FOR HUMAN USE
PART 331 ANTACID PRODUCTS FOR
OVER-THE-COUNTER (OTC) HUMAN USE PART 332
ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN
USE PART 333 TOPICAL ANTIMICROBIAL DRUG
PRODUCTS FOR OVER-THE-COUNTER HUMAN USE PART
335 ANTIDIARRHEAL DRUG PRODUCTS FOR
OVER-THE-COUNTER HUMAN USE PART 336
ANTIEMETIC DRUG PRODUCTS FOR OVER-THE-COUNTER
HUMAN USE PART 338 NIGHTTIME SLEEP-AID
DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
PART 340 STIMULANT DRUG PRODUCTS FOR
OVER-THE-COUNTER HUMAN USE PART 341 COLD,
COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC
DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
PART 343 INTERNAL ANALGESIC, ANTIPYRETIC, AND
ANTIRHEUMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER
HUMAN USE PART 344 TOPICAL OTIC DRUG
PRODUCTS FOR OVER-THE-COUNTER HUMAN USE PART
346 ANORECTAL DRUG PRODUCTS FOR
OVER-THE-COUNTER HUMAN USE PART 347 SKIN
PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER
HUMAN USE PART 348 EXTERNAL ANALGESIC DRUG
PRODUCTS FOR OVER-THE-COUNTER HUMAN USE PART
349 OPHTHALMIC DRUG PRODUCTS FOR
OVER-THE-COUNTER HUMAN USE PART 350
ANTIPERSPIRANT DRUG PRODUCTS FOR OVER-THE-COUNTER
HUMAN USE PART 352 SUNSCREEN DRUG PRODUCTS
FOR OVER-THE-COUNTER HUMAN USE STAYED
INDEFINITELY PART 355 ANTICARIES DRUG
PRODUCTS FOR OVER-THE-COUNTER HUMAN USE PART
357 MISCELLANEOUS INTERNAL DRUG PRODUCTS FOR
OVER-THE-COUNTER HUMAN USE PART 358
MISCELLANEOUS EXTERNAL DRUG PRODUCTS FOR
OVER-THE-COUNTER HUMAN USE
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New Drug Application(NDA or ANDA)
Must be approved by FDA
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Any product that has the intended use of a drug
may be deemed a New Drug unless there is an
approved monograph
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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.
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The intended use of a product determines whether
it is a Drug, a Cosmetic, or both.
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Drug an article intended for use in the
diagnosis, cure, mitigation, treatment, or
prevention of disease or intended to affect
the structure or function of the body Cosmetic
an article intended to be applied to the human
body for cleansing, beatifying, promoting
attractiveness, or altering the appearance
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What cosmetic claims are acceptable?
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Cosmetics

• Must be labeled properly
• Good Manufacturing Practices must be followed
• Registration of Cosmetic Establishments and
  filing of Cosmetic Product Ingredient
  Statements are voluntary.

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Drug Cosmetic
Source http//www.drorganic.co.uk/lavender-produc
ts.asp
Source http//www.supplierlist.com/photo_images/2
4976/Deodorant.jpg
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Food (Including Supplements)

• Facilities must be registered with FDA
  (Bioterrorism Act)
• 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

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The intended use of a product determines whether
it is a Drug or a Dietary Supplement.
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Drug an article intended for use in the
diagnosis, cure, mitigation, treatment, or
prevention of disease or intended to affect the
structure or function of the body Dietary
supplement - a product taken by mouth that
contains a "dietary ingredient" intended to
supplement the diet.
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Example Calcium Supplement Claim Calcium
Builds Strong Bones Dietary Supplement Claim
Calcium Prevents Osteoporosis Drug
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Food Canning Establishment (FCE) Low Acid and
Acidified Foods (LACF)
Tommy's rule of thumb... If it must be
refrigerated after opening, it probably requires
a process filing.
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Medical Devices

• Establishments must be registered with FDA
• Devices must be listed with FDA
• Devices must be labeled properly
• Good Manufacturing Practices must be followed
• For some devices, a 510(k) pre-market
  notification or PMA (premarket approval) may
  be required

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The intended use of a product determines whether
it is a Medical Device and how it is
classified as a Medical Device.
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Device - an instrument, apparatus, implement,
machine, contrivance, implant, in vitro reagent,
or other similar or related article . . .
intended for use in the diagnosis of disease or
other conditions, or in the cure, mitigation,
treatment, or prevention of disease, in man or
other animals, or intended to affect the
structure or any function of the body of man or
other animals, and which does not achieve its
primary intended purposes through chemical action
within or on the body of man or other animals
and which is not dependent upon being
metabolized for the achievement of its primary
intended purposes.
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Medical Devices

• A product that typically is not a Medical Device
  could have labeling claims that may cause FDA
  to deem it a Medical Device
• Some devices are detained for failure to obtain
  a 510(k) because of labeling claims that may
  cause FDA to require a 510(k) for a device which
  may be otherwise exempt

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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 products 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

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Label Labeling
http//www.healthysuppy.com/products
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Source Registrar Corp Analysis of FDA Import
Refusal Reports for May through July, 2009
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Anti-Detention Checklist

• Verify that the product is labeled properly for
  its intended use
• Verify that facilities or establishments have
  been registered
• Verify that listings (for drugs and medical
  devices) or process filings (for low acid and
  acidified foods) have been accepted by FDA
  prior to shipping

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Questions and Answers
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