FDA: Import Operations Seminar
A Joint Collaboration between the FDA
& the AIFBA of Atlanta.
November 10, 2015
Karen Dodson, Compliance Officer
1
Compliance Operations
at a Glance
Notices of FDA Action
The "Notice of FDA Action," satisfies the
requirements of the law for "giving notice
thereof to the owner or consignee." as defined
in Sec. 801 (21 USC 381)
2
Compliance Operations
at a Glance
Notices of FDA Action
A Notice of FDA Action provides specific
information on the actions taken broken down
by each entry line; for example:
•
•
•
•
Sample collected
Detained
Released
Refused
3
Compliance Operations
at a Glance
Notices of FDA Action
Release
– Release: Product released after examination. This is not
assurance of compliance and it does not preclude future
action.
– Release after detention
– Release with comment:
• Product appears to have minor violations
• The agency exercises its enforcement discretion
• Future entries violating the Act may be detained
4
Compliance Operations
at a Glance
Notices of FDA Action
Detention and Hearing
– Product appears to be in violation of the law or,
– It may be subject to refusal of admission under
acts and regulations enforced by FDA.
– The notice shall specify the nature of the
violation.
5
Compliance Operations
at a Glance
Notices of FDA Action
Detention and Hearing
– Is issued to the filer (Broker), the importer of record (IOR)
and the consignee.
– The importer is entitled an informal hearing and is given
10 days to introduce testimony in support of admissibility
of the article.
– To indicate why the material should not be refused entry
or to discuss how the product will be brought into
compliance with the law.
6
Compliance Operations
at a Glance
Notices of FDA Action
Refusal
• Final Decision indicating that an entry of merchandise
appears violative and that it is refused admission into
the U.S.
• This occurs after the importer has been provided an
opportunity to present testimony concerning the
violation.
• The shipment must be exported or destroyed under
FDA or CBP’s supervision within 90 days.
7
Notice of Detention and
Hearing
• Imported articles which appear
violative under the laws FDA
enforces must be held intact.
• Detained articles may be released if
brought into compliance, otherwise
they will be refused.
8
Notice of Detention and
Hearing
1.The "Notice of Detention and Hearing" gives
notice of the right to a hearing on the
detention for appearance of a violation (21
CFR 1.94).
2.Identifies charges that an import entry may
violate under the Federal Food, Drug, and
Cosmetic Act (FD&C Act), Public Health
Service Act (PHS Act) or other acts enforced
by the Food and Drug Administration.
9
Notice of Detention and
Hearing
Who can introduce evidence during the
detention process?
• The IOR: person who has the right under the provisions of the
law (19 USC 1483; 1484; 1485). Owner or consignee as defined
in 21 CFR 1.83.
• The Customs Broker who will exercise “responsible supervision
and control” over Customs business it conducts (19 USC
1641(b)(4).
• Any other party appointed in writing by the IOR (i.e., Attorneys,
Private Laboratory Representative, etc.).
10
COMMON VIOLATIONS
REASONS FOR DETENTIONS
11
Acidified & Low-Acid Canned
Foods
REASONS FOR PRODUCT DETENTION
– Establishment is not registered (FCE #)
– Establishment has not filed process information with
the FDA (SID #)
– Maybe subject to Import Alert 99-12 and 99-37
12
Acidified & Low-Acid Canned
Foods
REASONS FOR PRODUCT DETENTION
– SAMPLES COLLECTED BY FDA:
• Microbiological Findings
• Water Activity Controlled Products Based on pH
and Aw Findings
• A can with a seam defect (droops, false seams,
loose seams, etc.)
13
Reasons for detentions
Food Items Common Label violations
• Label is not in English
• Incorrect or missing statement of identity, or name of the food
• Label lacks the name and place of business of the manufacturer,
packer, or distributor
• Fails to list potential allergens
• Fails to declare ingredients
• Fails to bear nutrition labeling or the nutrition label is in incorrect
14
format.
Reasons for detentions
Food Items Common Label violations
• Color additives
– Unsafe or not declared on label
– Color additives declared using unaccepted codes (i.e. E102 or
CI15985) not accepted.
– Natural Colors need common name (i.e. carotene)
– Color additives have to be from an FDA certified batch unless
exempted (FD&C Yellow #6)
– Product contains non-permitted color additives
15
Reasons for detentions
Food Items Common Label violations
• Food Additives that are unsafe or not declared in label. (i.e. sulfites
agents in seafood).
• Net Quantity (both Metric and U.S. Customary System ) e.g. Net
wt. 1 lb. 8 oz. (680g) 21 CFR 101.105.
16
Guidance for Industry: A Food
Labeling Guide
http://www.fda.gov/Food/GuidanceRegulation
/GuidanceDocumentsRegulatoryInformation/
LabelingNutrition/ucm2006828.htm
17
Common Violations
Dietary Supplements
Health Claims
• Product labeling is making unauthorized health claims.
“Assists in the treatment and prevention of diabetes.”
" Better Than Viagra”
“is … a natural anti-inflammatory and is commonly used to ease stiffness
and pain [from] arthritis….”
If a dietary supplement claims to cure, mitigate, or treat a disease, it would
be considered an unauthorized new drug and in violation of the applicable
regulations and statutes.
18
Common Violations
Dietary Supplements
Health Claims
• Undeclared Active Ingredients in Products Marketed as Dietary Supplements
FDA investigations have discovered products marketed as dietary
supplements that contain the same active ingredients as in FDA-approved
drug products. An example would be a product marketed as Herbal Viagra,
which contained the undisclosed prescription drug ingredient Sildenafil or
similar substances.
19
Dietary supplements common
labeling problems
• Lacks a (“Supplement Facts” panel), which is required under
21 CFR 101.36.
• These are examples of correct Supplement Facts Panels
20
Dietary supplements common
labeling problems
•
Label lacks name of product and the term “dietary supplement” or “ herbal
supplement” (see 21 CFR 101.3(g))
•
Net quantity of contents
•
Name and place of business of manufacturer, packer, or distributor
•
Directions for use / Warnings
•
Label is not in English
•
Import alerts 54-13, 54-12 and 54-11
•
“Disclaimer”: this product is not intended to "diagnose, treat, cure or prevent any
disease,"
21
Cosmetics Common Violations
Adulterated:
• Micro contamination
• Manufactured or held under insanitary conditions
• Contains a non-permitted color additive
Misbranded:
• Label not in English
• Lacks ingredient labeling and statement of the net
quantity of contents
• Lacks the name and place of business of responsible
firm
• Lacks warnings and adequate directions for safe use
22
Most currently marketed cosmetics which are also
drugs are over-the-counter drugs.
Examples of products which are drugs (OTC) as well as
cosmetics :
anticavity toothpaste (e.g., "fluoride" toothpaste)
sun tanning preparations intended to protect against
sunburn
antiperspirants that are also deodorants
antidandruff shampoos.
This products need to be listed (NDC number) and have a
drug facts label.
23
Therapeutic claims in cosmetic
label
• Certain claims may cause a product to be considered a drug,
even if the product is marketed as a cosmetic.
Erase dark spots, clears acne, skin retraction
• Ingredients that may cause a product to be considered a drug
because they have a well known therapeutic use.
An example is fluoride in toothpaste
24
Therapeutic claims in cosmetic
label
IA 66-38 Import Alert in effect for cosmetics labeled with drug claims
• There are numerous skin care products on the market
with exaggerated "anti aging" claims which cause the
products to be unapproved new drugs. Examples of
such claims are that the products "counteract,"
"retard," or "control" the aging process. Claims that
the product will "rejuvenate," "repair," or "restructure"
the skin may also be drug claims. A claim such as
"molecules absorb and expand, exerting upward
pressure to 'lift' wrinkles upward" is a claim for an
inner structural change that would usually cause a
product to be a drug.
25
Common Violations
Drug Products
• All foreign firms :
– Register and list all drug products imported
or offered for import into the U.S.
– Listed Drug products (API’s, finish drugs,
OTC drugs, assigned National drug code
(NDC #).
– Non-listed products are misbranded
[502(0)] and in violation of 801(a)(3).
26
Common Violations
Active Pharmaceutical Ingredients (API)
• Label in English
• Adequate directions for use [502(f)(1) & 21 CFR 201]
• API needs proper labeling…
– “Caution: For manufacturing, processing, or repacking”
– “Caution: For manufacturing, processing, or repacking of new drug
limited by Federal Law to investigational use”
– “Caution: Federal law prohibits dispensing without prescription”
27
Common Violations
Active Pharmaceutical Ingredients (API)
• The API is intended for use in a product without an approved NDA or
ANDA.
• The API is not listed.
Depending on the API end use : for approved Rx or OTC, for Clinical
studies, for pending NDA/ANDA, for teaching or Research, pharmacy
compounding. An End-Use Letter may be required to explain the
intended use of the API.
28
Common Violations
New Drug
– Contains a new chemical or
– A chemical not previously used in medicine or
– A different dosage
A new drug must be covered by an approved new drug
application (NDA/ANDA) to be marketed in the U.S.
29
OTC drugs
Drugs that can be used safely without
medical supervision
Pre-approval is not required for OTC drugs
subject to a final monograph. (labeling and
formula must meet final rule).
Must be listed (NDC #).
30
Medical Devices
Common Violations
• Medical device not listed
• Foreign Manufacturer not registered
• Initial distributor (Importer) is not registered
• Investigational Device Needs IDE #
• False or misleading labeling
• Lack of PMA or 510(k)
31
Detention Without Physical
Examination
DWPE
(Import Alerts)
32
AUTHORITY
• Section 801 provides the importer with the right to
"introduce testimony bearing on the admissibility of
the articles”
• Information such as an article's violative history, among other
things, may cause an article to appear adulterated, misbranded,
or otherwise in violation of the FD&C Act, as described in
Section 801(a).
33
Importers should not wait until
the Agency has issued a Notice
of Detention to determine
whether articles they are offering
for import comply with the Act
34
DWPE places the responsibility
for ensuring compliance with the
law on the Importer
35
Import Alerts
Most Common
•
IA 16-81 - "Detention Without Physical Examination of Seafood
Products Due to the Presence of Salmonella”
•
IA 16-131 - "Detention Without Physical Examination of
Aquacultured Catfish, Basa, Shrimp, Dace, and Eel from ChinaPresence of New Animal Drugs and/or Unsafe Food Additives"
•
IA 45-02 - "Detention Without Physical Examination and Guidance
of Foods Containing Illegal and/or Undeclared Colors"
•
IA 99-05 - "Detention Without Physical Examination Of Raw
Agricultural Products for Pesticides"
•
IA 99-14 - "Countrywide Detention Without Physical Examination
Of Raw Agricultural Products for Pesticides"
36
Private Laboratory Testing
• Testing must be performed by an accredited US
laboratory.
http://www.fda.gov/downloads/ScienceResearch/Fiel
dScience/LaboratoryManual/UCM092191.pdf
• FDA does not endorse or recommend any laboratory
in particular.
• For questions regarding science, science policy,
sample collection, analysis, preparation, analytical
methodology or confirmation tests, contact the Office
of Regulatory Science.
37
Private Laboratory Testing
• The laboratory will evaluate if the
analytical package is acceptable
according to published guidance.
• Then the laboratory will interpret and
evaluate the analytical data.
• Results will be reported to the
Compliance Officer handling the case.
38
Private Laboratory Testing
In the case the package is acceptable and
the results indicate negative the product
is releasable
39
Private Laboratory Testing
In the case the package is not acceptable
the results will not be evaluated and a
Notice of FDA Action will be issued
Importer might be given the opportunity to
present corrected or new evidence.
40
Private Laboratory Testing
In the case of confirmed positive results
or lack of timely action by the importer,
the product will be refused and entry
into the US will be denied.
41
Reconditioning Form FDA 766
•
Application for Authorization to Recondition or
to Perform Other Action.
•
Is Formal request for permission to bring
adulterated or misbranded products into
compliance (i.e., relabeling, irradiation, etc.).
•
Valid only during the detention period.
•
Must be approved by a Compliance Officer.
42
Reconditioning Form FDA 766
•
Submissions should include:
– A Complete description of proposal (attachments
in original).
– Sampling ratio, segregate and identify lots,
analytical / processing data, private lab
methodology, example of proposed labeling, or
other information as applicable.
43
Reconditioning Form FDA 766
•
Maintain control over goods, do not distribute.
•
Wait for its approval by a Compliance Officer.
•
Report location upon completion to schedule FDA
examination.
44
Reconditioning Form FDA 766
• Any sorting, reprocessing, or relabeling must be
supervised by FDA, at the expense of the importer.
Note: Charges for Supervision Time and Travel apply.
Form is available on the web at:
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/F
orms/UCM072766.pdf
45
Refused Products
46
Refusal Notice
• FDA determines product is not “in compliance”
• FDA Notice of Refusal is considered a FINAL Action
• FDA Notice of Refusal issued to IOR, consignee and
filer
• Product must be exported or destroyed within 90
days
47
Refusal Notice
Importer’s Options
• Destruction
– Customs Form 3499
– Contact FDA office to schedule destruction
• Exportation
– Customs Form 7512
– Contact CBP office for exportation
48
?
Questions
49