Disclaimer:
The objective of this paper is NOT to give
legal advices. This article was NOT endorsed
by the Firms and Institutions which helped
me logistically. It just expresses my views
on this issue. If
you were considering action you should seek
your own professional advice.
1.
List of acronyms
2.
Customs aspects
a.
Entry documents
b.
Entry summary documentation
c.
Link with FDA: samples
d.
Rates of duty: 109 USC 1202
e.
Special requirements: quotas and licenses
f.
Marking of country of origin: art 304 Tariff
Act
g.
Patent and trademark protection from the
US Customs Service
3.
Labeling aspects and related issues
Food
a.
History
b.
Applicable foods: 21CFR §101.9 pt.a
c.
Summary of the main exemptions:
21CFR
§101.9 pt.j
d.
The nutrition panel title
e.
The information panel : 21CFR 101.5
f.
The problem of coloring agents
g.
Products without sugar
h.
Enforcement
i.
Which foods require warning statements
Spirits
and Beer
a.
Distilled spirits
b.
Malt beverages (beer)
4.
Internet sites
1.
List of acronyms
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APHIS
= Animal and Plant Health Inspection Service
BATF
= Bureau of Alcohol, Tobacco and Firearms
CCH
= Commercial Clearing House
CFE
= Criminal Fine Enforcement Act
CFR
= Code of Federal Regulations
CFSAN
= Center for Food Safety and Applied Nutrition
FDA
= Food and Drug Administration
FD&
C Act = Food, Drug and Cosmetic Act
FR
= Federal Register
GPO
= Government Printing Office
NLEA
= Nutrition Labeling and Education Act
NTIS
= National Technical Information Service
PTO
= Patent and Trademark Office
TD
=Treasury Decision
USC
= US Code
USDA
= US Department of Agriculture
2.
Customs aspects
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References:
1.
19CFR: Customs duties, GPO
2.
Importing into the US, GPO
3.
Compilation of selected Acts within the
jurisdiction of the committee on commerce,
GPO
Imports
must enter the USA only through authorized
ports of entry.
The
following formalities must be adhered to:
A.
Entry documents
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- They
must be presented to Customs within
five working days of the date of arrival.
- Failure
to file them within the time limit authorizes
the district or port director to place
the goods in a general order warehouse
at the risk and expense of the importer.
- If
the goods are not entered within one
year from the date of importation, they
can be sold at public auction. Perishable
goods may be sold sooner. The entry
documents are:
- Evidence
of right to make entry, i.e., goods
can be entered only by the owner,
purchaser or by a licensed Customs
broker.
When
the entry is made by a person or firm
certified by the carrier (carrier’s
certificate), that person or firm is
considered the “owner”.
Brokerage:
the only person authorized to act as
agent for the importer in the transaction
of Customs business are Customs brokers
licensed by the Customs service.
-
Entry
manifest (form 7533).
- Commercial
invoice written in English providing
among other things the following information:
- the
port of entry to which the merchandise
is destined;
- if
merchandise is sold or agreed to
be sold, the time, place and names
of buyer and seller; if consigned,
the time and origin of shipment,
and names of shipper and receiver;
- a
detailed description of the merchandise
stating what merchandise is contained
in each individual package and including
the name by which each item is known,
the grade or quality, and the marks,
numbers and symbols under which
sold by the seller or manufacturer
to the trade in the country of exportation;
- the
quantities in weights and measures;
- the
country of origin; if sold or agreed
to be sold, the purchase price of
each item in the currency of the
sale;
- if
the merchandise is shipped for consignment,
the value of each item, in the currency
in which the transactions are usually
made or, in the absence of such
value, the price in such currency
that the owner would have or was
willing to receive for such merchandise
if sold in the ordinary course of
trade.
-
Packing
list, if appropriate.
.
-
Other
documents necessary to determine merchandise
admissibility. Cfr infra special requirements,
country of origin, trademarks, labeling.
Entry
must be accompanied by evidence that bond
is posted with Customs to cover any potential
duties, taxes and penalties which may
accrue.
B.
Entry summary documentation
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Following
presentation of the entry papers, the
shipment may be released provided that
no legal or regulatory violations have
occurred. Entry summary documentation
is filed and estimated duties are deposited
within 10 working days of release of the
merchandise.
The
summary documentation consists of:
•the
entry package returned to the importer
after merchandise is released.
•entry
summary (Customs form 7501).
•other
invoices and documents necessary for the
assessment of duties, collection of statistics
or the determination that all import requirements
have been satisfied.
C.
Link with FDA: samples
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The
Customs shall (FD&C Act section 801)
deliver to the FDA, upon its request,
samples of food which are being imported
or offered for import into the US, giving
notice thereof to the owner or consignee.
The
FDA detains automatically certain imports
(see FDA import alert),i.e., air-dried
fish, honey, products that might contain
sulfites, but, in general, this surveillance
is applied to products of «exotic»
countries, hence not to Belgian products.
D.
Rates of duty : 109 USC 1202
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The
rate will be applied to the transaction
value of the goods,i.e., the price actually
paid or payable for the merchandise when
sold for exportation to the US, as determined
by Customs officers.
A
binding tariff classification can be obtained
by writing to any Customs district director
or to:
The
Area Director of Customs
New
York Seaport
World
Trade Center
New
York, NY 10048
User
fee: a merchandise processing fee exists
with an ad valorem rate of 0.19 % for
imports over $1250.
E.
Special requirements: quotas and licenses
a.
Absolute or quantitative quotas, which
can be global or allocated to specified
countries, and tariff-rate quotas, which
mean that there is no absolute limit,
but everything which enters the country
in excess of the quota is subject to higher
duty rates.
b.
Quotas assigned by the US Customs Service
and quotas assigned by the Department
of Agriculture (but administered through
the US Customs Service).
Some
products are subject to quotas and licenses.
1.
Cheese, milk and dairy
- milk:
import permit (Import milk Act) and
certificate declaring that the milk
or milk products were produced and
processed in a country free of rinderpest
and hoof-and-mouth diseases (9CFR
94.16).
- cheese
and cheese products: importation of
cheese generally requires an import
license and is subject to quotas.
How
to obtain a quota for cheeses: the Uruguay
Round Effects
Since
January 1, 1995 the absolute quota for
dairy products was replaced by a tariff-rate
quota system. Therefore, a license must
be obtained only to enter articles for
in-quota quantities. Amounts over-quota
and hence entering without a license are
subject to the applicable over-quota duty
treatment.
The
USDA is currently streamlining the licensing
structure.
Three
types of licenses are proposed
1)
Historical licenses:
2)
Nonhistorical rank-order lottery licenses:
It
consists of a series of random draws on
the basis of licensee-expressed rankings.
Once a licensee has received a nonhistorical
license, it would not be issued another
until all applicants have received one
nonhistorical license of their choice.
Eligibility:
level of imports.
- If
at least 3 separate entries were made:
the level of product must total not
less than 57,000 kg net weight, each
of the 3 entries not less than 2,000kg
net weight.
- If
at least 8 separate entries were made:
the level of products must total not
less than 19,000 kg net weight, each
of the 8 entries not less than 450
kg net weight with a minimum of 2
entries in each of at least three
quarters during that period.
3)
Designated license:
It
gives the option to all countries with
specific quotas to name « preferred
importers ». It must be remembered
that the countries of the European Union
minus Austria, Finland and Sweden are
treated as one country and therefore have
at their disposal one European »
quota.
Eligibility:
level of imports (cfr nonhistorical
rank-order lottery licenses).
Period
to apply for the quota
Only
between September 1 and October 15 of
the year preceding that for which license
application is made.
Where
to apply:
Dairy
Import Licensing Group
AG
Box 1021
Foreign
Agricultural Service
US
Department of Agriculture
Washington,
DC 20250-1021
Information
may be obtained at:
Diana
Wanamaker (Group Leader)
Import
Policies and Programs Division Room 5531-S
US
Department of Agriculture (Foreign Agricultural
Service)
14th
and Independence Avenue SW
Washington,
DC 20250
Tel:
(202) 720-2916
2.
Fruits, vegetables and nuts
- They
must meet standards of quality and
an inspection certificate must be
issued by the Food Safety and Inspection
Service.
3.
Meat and meat products
- All
products derived from cattle, swine,
goats and horses are subject to the
regulations of the USDA and must be
inspected by the APHIS (Animal and
Plant Health Inspection Service) and
the Food Safety and Inspection Service.
- Meat
products from other sources (including
wild game) are subject to APHIS regulations
and to the provisions of the FD&C
Act.
4.
Poultry and poultry products (eggs)
- These
products must meet the USDA requirement
and must be inspected by the APHIS
and the Food Safety and Inspection
Service.
- Permits
are required as well as special marking
and labeling and in some cases, foreign
inspection certification.
5.
Seafoods
- The
requirements of the National Marine
Inspection Service must be respected.
6.
Alcoholic beverages
- A
basic permit is required to be engaged
in the business of importing distilled
spirits, wine or malt beverages into
the US (27CFR §1.20).
- The
procedure is described in 27CFR 200
and the person to contact is:
The
Director of ATF
Bureau
of Alcohol, Tobacco and Firearms
Washington,
DC 20226
Tel:
(202) 925-8110
F.
Marking of country of origin: art 304
Tariff Act
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Each
imported article produced abroad must
be marked in a conspicuous place as legibly,
indelibly and permanently as the nature
of the article permits, with the English
name of the country which is the country
of manufacture, production or growth of
the article.
The
altering of the product in a second country
changes the country of origin if the further
work or material added in the second country
constitutes a substantial transformation,
i.e., if a new article with a different
name, character or use is created.
Sanction:
10% of the Customs value unless the article
is exported, destroyed or properly marked
under Customs supervision.
Some
exemptions:
- art.
304 Tariff Act: natural products such
as vegetables, fruits, nuts, fish…
- an
article imported for use by the importer
and not intended for sale in its imported
form or in any other form.
- an
article which is to be processed in
the US by the importer or for his
account for purposes other than concealing
the origin of the article.
- articles
incapable of being marked.
- articles
for which the container will reasonably
indicate the origin of the articles.
- crude
substances.
G.
Patent and trademark protection from the
US Customs Service
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The
USA is a litigious country so, in order
to avoid being prevented from manufacturing
his own invention or using his own brand,
the Belgian exporter is cautioned to register
his patent and trademark.
References:
1.
Intellectual Property, Patents, Trademarks
and Copyright in a Nutshell by Arthur
R. Miller and Michael H. Davis, West Publishing,
1990
2.
37CFR Patents, Trademarks and Copyrights,
GPO
3.
CCH Intellectual Property Rights, Chicago
Ill
4.
How to Obtain Copyrights, Trademark and
Patent Protection from the US Customs
Service, GPO
5.
General Information Concerning Patents,
GPO
6.
Basic Facts About Registering a Trademark,
GPO
Patent
Any
person who invents or discovers any new
or useful process, machine, object or
composition of matter or any new and useful
improvements thereof, may obtain a patent
(35USC 101). This rule doesn’t embrace
every discovery. The laws of nature, physical
phenomena and abstract ideas are not patentable.
Duration
As
of August 6, 1995 the term of a patent
is 20 years with a maintenance fee which
must be paid periodically to keep the
patent in force. After the patent has
expired anyone may make, use or sell the
invention without permission of the patentee
provided that matter covered by other
unexpired patents is not used (35USC 154).
Conditions:
non obviousness (35USC 103) and novelty
(35USC 102).
An
invention cannot be patented if, among
other things:
a)
the invention was known or used by others
in the US (it doesn’t matter much whether
it’s the case abroad), or patented or
described in a printed publication in
the US or a foreign country, before the
invention thereof by the applicant for
patent, or
b)
the invention was patented or described
in a printed publication in the US or
a foreign country more than one year prior
to the application for patent in the US.
c)
the applicant did not himself invent the
subject matter sought to be patented.
N.B.:
It is useful to look in the Index of Patent.
Infringement
of patents: sanctions (35USC 271).
It
consists in the unauthorized making, using
or selling of the patented invention within
the territory of the US during the term
of the patent.
The
patentee may ask the court for (1) an
injunction to prevent the continuation
of the infringement (injunctive relief),
(2) damages to compensate the plaintiff,
(3) attorney’s fees in exceptional cases
and (4) costs.
Reexamination
Any
person may, at any time during the period
of enforceability of an issued patent
file a request for reexamination thereof
(37CFR 1.510).
Prior
art considered during reexamination is
limited to prior art patents or printed
publications applied under the appropriate
parts of USC 102 and 103.
Contact:
Magdalena
Y. Greenlief (Senior Legal Advisor)
Office
of the Deputy Assistant Commissioner for
Patent Policy
Commissioner
of Patents and Trademarks
Box
DAC
Washington,
DC 20231
Tel:
(703) 305-9285
Fax:
(703) 308-6916
Trademarks
A
trademark relates to any word, name, symbol
or device which is used in trade with
goods to indicate the source or origin
of the goods and to distinguish them from
the goods of others.
Trademark
rights stem from either:
- the
use of the mark or
- the
filing of an application to register
a mark in the Patent and Trademark
Office. It is advisable to do so because
it secures benefits beyond the rights
acquired by simply using a mark ,e.g.,
to be eligible for recordation with
Customs trademarks must first be registered
at the PTO.
The
PTO does not conduct searches for the
public to determine if a conflicting mark
is registered or is the subject of a pending
application, except when acting on an
application.
Duration
Trademark
rights can last indefinitely if the owner
continues to use the mark to identify
its goods or services.
A
registration lasts 10 years.
Infringement:
sanctions USC §1117
The
likelihood of confusion is the reason
for being sued and the trademark owner
may ask the court for (1) an injunctive
relief, (2) an accounting of profits,
(3) damages, (4) attorney’s fees in exceptional
cases and (5) costs.
Contact:
The
Assistant Commissioner for Trademarks
2900
Crystal Drive
Arlington,
VA 22202
Trademarks,
Patent and Customs
Trademarks
Customs
protects trademarks that have been recorded
with the Intellectual Property Rights
branch of the Customs department provided
that these trademarks are registered at
the PTO 19CFR 133.1-7.
Once
a trademark has been recorded, Customs
has the authority to deny entry to or
to seize goods that infringe upon the
recorded right 19CFR 133 §2.1.
Patent
Customs
can also assist owners of US patents.
Customs enforces exclusion orders or seizure
and forfeiture orders issued by the International
Trade Commission (Unfair Competition)
19CFR §12.39.
Contacts
US
Customs Service
Intellectual
Property Right Branch (OR&R)
Franklin
Court
1301
Constitution Avenue NW
Washington,
DC 20229
Tel:
(202) 482-6960
Fax:
(202) 482-6943
3.
Labeling aspects and related issues
1.
Food Labeling: Questions and Answers,
GPO
2.
Food Labeling Guide, GPO
3.
21CFR Food and Drug, GPO
4.
CCH The Food Reporter, Chicago Ill
5.
America’s Foods: Health Messages and Claims:
Scientific, Regulatory and Legal issues
RC Press, 1993
6.
27CFR Alcohol, Tobacco Products and Firearms,
GPO
7.
CCH Liquor Control Law Reporter vol.1
and 2, Chicago Ill
Food
Division
of Progams and Enforcement Policy
Office
of Food Labeling
Center
for Food Safety and Applied Nutrition
Food
and Drug Administration
200
C Street, SW
Washington,
DC 20204
Tel:
(202) 205-5229
Food
Labeling Division
FSIS
Regulatory Programs
US
Dept of Agriculture
Washington,
DC 20250
Tel:
(202) 254-2590
Oppenheimer,
Wolff, Foster, Shepard and Donnelley
153
E 53rd Street 26th floor
New
York, NY 10022
Tel:
(212) 826-5000
Fax:
(212) 486-0708
A.
History
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to Index
The
food label requirements were established
to improve public health by:
- making
consumers aware of the nutritional
value of the food they eat;
- providing
nutrition information which will help
consumers in select foods consistent
with their dietary needs.
- focusing
the manufacturers' attention on the
use of nutritional principles in food
formulation.
Nutrition
information relating to food shall be
provided for all products intended for
human consumption including chewing gum
(and also foods for animals) offered for
sale unless an exemption is provided.
All
imported products are required to have
nutrition labeling unless the manufacturer,
packer, distributor qualifies for an exemption.
Meat
and poultry are regulated by the USDA
requirements
See
Meat and Poultry Inspection Act (9CFR
chapter 3: those regulations closely parallel
FDA's rules), Wholesome Meat Act and the
Imported Meat Act.
C.
Summary of the main exemptions: 21CFR
§101.9 pt.j
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Warning:
All the exemptions are allowed provided
that the food bears no nutrition claims
or other nutrition information in any
content on the label or in labeling or
advertising. Claims or other nutrition
information subject the food to the labeling
regulations.
A
nutrient content claim is a claim on a
food product that directly or by implication
characterizes the level of a nutrient
in the food (e.g., "low fat" ). Nutrient
content claims are also known as "descriptors".
21CFR 101.13(b)
N.B.:
When importing exempt products, FDA "encourages"
importers to attach an addendum to the
entry form certifying that the manufacturer/packer/distributor
or product qualifies for exemption.
1.
Donated food that is given free to the
consumer : the law applies only to food
that is "offered for sale".
2.
Small business exemption.
For
foreign firms that ship foods into the
U.S., the business activities to be included
for consideration under the small business
exemption will be the total amount of
food sales, as well as other sales to
consumers, by the firm in the U.S.
Warning:
for meat and poultry (USDA), the exemption
is based on the number of employees and
volume of product, so firms subject to
both USDA and FDA regulations should calculate
the dollar volume of retail sales, including
meat and poultry, to determine if they
meet the criteria for FDA exemption.
3.
Raw fruits, vegetables, and raw fish.
Concept
: the term "fish" includes fresh-water
or marine fin fish, crustaceans and mollusks,
including shellfish, amphibians, and other
forms of aquatic animal life.
FDA's
rules set up (for a list cfr 21CFR 101.44)
voluntary programs for nutrition information
for the 20 most frequently eaten raw fruits,
vegetables and raw fish (the USDA does
the same for the 45 best-selling cuts
of meat).
Contact:
Division
of Nutrition (HFF-260)
CFSAN
200
C Street SW
Washington,
DC 20204
4.
Medical foods.
Concept
: 21USC 360ee(b)(3) : a medical food is
a food which is formulated to be consumed
or administered enterally under the supervision
of a physician (it’s the criterion) and
which is intended for the specific dietary
management of a disease or condition for
which distinctive nutritional requirements,
based on recognized scientific principles,
are established by medical evaluation.
5.
Foods that provide no significant nutrition.
- Concept
: an insignificant amount of a nutrient
or food component shall be that amount
that allows a declaration of zero
in nutrition labeling, except that
for total carbohydrate, dietary fiber
and protein, it shall be an amount
that allows a declaration of "less
than 1 gram".
- Foods
that are exempt include mineral water,
coffee beans (whole or ground), tea
leaves, plain unsweetened instant
coffee and tea, condiment-type dehydrated
vegetables, flavor extracts and food
colors.
6.
Bulk foods shipped for further processing
or packaging before retail sale.
7.
Game meats,i.e., animal products not covered
under the Federal Meat Inspection Act
or the Poultry Products Inspection Act
such as flesh products from deer, bison,
rabbit or ostrich.
8.
Food in small packages ,e.g., with total
surface area available to bear labeling
of less than 12 square inches.
9.
Certain egg cartons (nutrition information
inside lid or on insert in carton).
10.
Infant formula, and infant and junior
foods to 4 years (modified label provisions
for these categories).
11.
Malt beverages because they are defined
as beverages made by alcoholic fermentation
of specific materials and not characterized
by specific alcohol content. Hence they
come under the BATF requirements.
D.
The nutrition panel title
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to Index
Cfr.
"FDA Backgrounder BG 94-2" : explains
the different requirements.
"Food
Labeling Questions and Answers"
"FDA
Backgrounder BG94-2"
a.
name and address of the manufacturer
b.
street address
c.
city or town
d.
state (or country if outside the USA)
and ...
e.
zip code (or mailing code used in countries
other than the USA)
F.
The problem of coloring agents
The
term "color additive" means a material
which, when added or applied to a food,
is capable of imparting color. Food ingredients
such as cherries, green or red peppers,
chocolate and orange juice which contribute
their own natural color when mixed with
other foods are not regarded as color
additives; but when a food substance such
as beet juice is deliberately used as
a color, as in pink lemonade, it is a
color additive (21CFR§70.3(f)).
b.
What is prohibited
All
the color additives that are found to
be unsafe and to induce cancer when ingested
by humans or animals (FD&C Act section
721(b)(5)(B)(i)) are prohibited. The FDA
only allows the use of a color additive
if it is established (by the manufacturer)
that the substance is safe for its
intended use.
c.
What is allowed: the concept of premarket
approval
There
is a main division (FD&C Act Section
401) between :
i.
standardized foods
i.e.,
foods for which the Secretary of Health
and Human Services has promulgated regulations
fixing a reasonable definition, standard
of identity and of quality: more or less
400 products.
Principle:
the addition of a coloring agent to a
food when the standard doesn’t permit
it is not allowable. Nevertheless, it
is still possible to add a coloring agent
not included in the standard if another
name for the food or the word “imitation”
is written.
N.B.:
21CFR §70.10 : when a petition is
received for amendment (coloring) of standardized
food, the procedure of 21CFR 71 will apply
($3000 fee).
Useful
information
- list
of definitions and standards of identity
or composition for meat products:
9CFR319;
- list
of US standards for grades: 7CFR 51,52,58,810,etc…
: it affects many vegetables and fruits
(including juices) and also some frozen
fish products;
- for
other products from cheeses to bottled
water through cacao products: 21 CFR130-169;
- organic
foods (i.e., produced without the
use of synthetic chemicals unless
authorized): Organic food production
Act of 1990, 7USC 6502.
-
ii.
non-standardized foods
There
are 2 regulatory categories of color additives:
1.
Those exempt from certification : cfr.
listing of color additives exempt from
certification : 21CFR73.1 to 73.615.
2.
Those subject to certification (premarket
approval): cfr. listing of color additives
subject to certification : 21CFR74.101
to 74.706.
Procedure:
Color
additive certification 21CFR80. Before
a color additive may be used legally,
the manufacturer must submit a petition
to the FDA which includes test data demonstrating
the safety and suitability of the substance.
If a petition establishes an adequate
basis for finding that use of the substance
is safe, the Agency issues a regulation
prescribing safe conditions of use that
is published in the Federal Register.
Miscellaneous
a.
Silver dragees
The
FDA will not object to the presence of
silver on dragees when they are used as
cake ornements only. In this case, they
are not considered as confectionery.
Cfr
FDA compliance policy guide n°7117.03
June 27, 1988
b.
Silver-colored almonds
They
are an adulterated food containing an
unapproved and nonnutritive color additive,
silver coloring and are, therefore, subject
to seizure or detention.
The
silver-colored almonds are marketed as
cake decoration but there is no guarantee
that they will be used only for this purpose
or that they will not be eaten.
Cfr
FDA Compliance Policy Guide n°7117.03
June 27, 1988
c.
Use of alcohol in confectionery, FD&C
Act section 402 (d)
A
confectionery shall be adulterated if
it bears or contains any alcohol unless
the alcohol was derived solely from flavoring
extracts and doesn’t exceed 0.5% by volume.
Nevertheless,
sincel 1986, the States can permit higher
levels of alcohol in confectionery.
For
further information on the Northeastern
states of the USA, see the survey conducted
by the Belgian Consulate, 1330 Avenue
of the Americas (26th floor) New York,
NY 10019.
G.
Products without sugar
Criteria
for use of the terms "sugar free" and
"no added sugar" on the labeling are provided
in 21CFR§101.60 (c).
Foods
for diabetics : 21CFR105.67.
A
food that purports to be represented for
special dietary use because of usefulness
in the diet of diabetics shall bear the
common labeling and the statement:
"Diabetics
: this product may be useful in your diet
on the advice of a physician. This food
is not a reduced calorie food.”
Nevertheless,
if the food is useful in maintaining or
reducing calorie intake or body weight,
the last sentence may be eliminated (but
the product will have to bear the specific
labeling regarding weight 21CFR§105.66).
H.
Enforcement
A
food shall be deemed to be misbranded
if its labeling is false or misleading
in any particular or if any word, statement
or if other information required to appear
on the label is not prominently placed
with conspicuousness and in such terms
as to render it likely to be read and
understood by the ordinary individual
under customary conditions of purchase
and use.
Coloring
additives: FD&C Act section 402:A
food shall be deemed to be adulterated
if it bears or contains a color additive
which is unsafe, i.e, if the additive
is not in the meaning of section 721 (a).
Penalties:
Minor
violations:
In
practice the FDA has the power to refrain
from reporting minor violations for prosecution.
Instead of reporting the violation, the
FDA will issue a warning to the person
involved. There is no limit to the number
of warnings.
Customs
protection:
If
the article is adulterated or misbranded,
Customs (FD&C Act § 801(b)) must
refuse admission of the product.
Nevertheless,
if it appears that the article can be
brought into compliance, the owner may
be authorized to recondition the article
under the supervision of the FDA (the
cost of supervision must be paid by the
owner) 21CFR 1.19.
Criminal
prosecution:
i.
Under the FD&C Act:
The
introduction or delivery for introduction
into interstate commerce of any food that
is adulterated is prohibited 301(a).
Any
person who violates that shall be imprisoned
for not more than one year or fined not
more than $1000 or both. Nevertheless,
in the event of a subsequent offense or
if the violation was committed with the
intention to defraud or mislead, imprisonment
can be up to 3 years and the fine up to
$10,000 (or both).
It’s
possible to get a penalty for each offense.
ii.Under
the Criminal Fine Enforcement Act ( CFE
) of 1984:
The
fine can be as high as $100,000 for misdemeanors
not resulting in death.
For
misdemeanors resulting in death, the fine
can be $250,000 for individuals and $500,000
for corporations.
Seizure:
FD&C Act section 304.
Any
article of food that is adulterated or
misbranded and proceeded against shall
be liable to seizure (and therefore might
be disposed of by destruction or sale).
I.
Which foods require warning statements
Back
to Index
Warnings
are required on self-pressurized food
containers and on some protein-based reduction
products and dietary supplements(21CFR
101.17).
Bureau
of Alcohol, Tobacco and Firearms
Washington,
DC 20226
Tel:
(202) 927-8110
A.
Distilled spirits
Distilled
spirits are ethyl alcohol, hydrated oxide
of ethyl, spirits of wine, gin, geneva,
brandy and other distilled spirits for
nonindustrial use (27CFR § 5.11).
Uses
regarded as industrial: 27CFR §2.10.
Standards
of identity for distilled spirits: 27CFR§5.22
classifies and defines different spirits
(like neutral spirits, grain spirits,
applejack, cordials and liqueurs, etc...)
in classes.
ee
27 CFR §5.22 (k) for the problem
of geographical designations.
Rem:
the addition of any coloring, flavoring
or blending materials to any class and
type of distilled spirits alters the class
and type and thereof the product must
be appropriately redesignated: 27 CFR
5.23 ( exeption: 27CFR § 5.23(c)
).
A
bottle is any container, irrespective
of the materials from which made, used
for the sale of distilled spirits at retail
27 CFR § 5.47.
b.
Mandatory labeling requirements (27 CFR
§ 5.32) and sanctions.
It's
unlawful to sell, ship or deliver for
sale any distilled spirits in bottles
unless such bottles are adequately marked,
branded, labeled and packaged (27 CFR
§ 5.31).
Warning:
27 CFR § 5.41: an individual covering,
carton or other container of the bottle
used for sale at retail (other than a
shipping container) shall not contain
any labeling statement unless the bottle
is enclosed in a sealed opaque covering.
In this case such covering must bear all
mandatory label information.
There
shall be stated:
i.
on the brand label (among other things):
•
brand name.
•
class and type (in accordance with 27
CFR § 5.35).
•
alcohol content (in accordance with 27
CFR § 5.37: percent-alcohol- by volume).
ii.on
the brand label or on the back label (among
other things):
•
in the case of imported spirits, the country
of origin, in accordance with 27 CFR §
5.36.
•
coloring or flavoring in accordance with
27 CFR § 5.39.
•
a specific statement if saccharin is present.
•
declaration of sulfites.
•
percentage of neutral spirits and name
of commodity from which distilled.
•
a statement of age or age and percentage,
when required in accordance with 27 CFR§
5.40. (age may be understated but shall
not be overstated, age or similar statements
of neutral spirits, gin, liqueurs, cordials,…
are misleading and are prohibited from
being stated on any label.
c.
Additional requirements(27 CFR §
5.33) among others:
•
contrasting background.
•
location of statement and size and type.
•
English language (except that the brand
name need not to be in English).
•
contents of bottles (27 CFR § 38):
for containers other than cans the authorized
standards of fill are: 50, 100, 200, 375,
750 milliliters, 1 liter and 1.75 liter
(in the metric system).
d.
Sanctions: no Customs release.
e.
Requirements for withdrawal from Customs
Custody of bottled imported distilled
spirits
Label
approval and release: 27 CFR § 5.51
Bottled
distilled spirits will be released from
Customs custody only if the original or
a photostatic copy of an approved certificate
of label approval, ATF form 5100.31 is
deposited with the appropriate Customs
officer at the port of entry.
"Public
use forms" (ATF Publication 1322.1) is
a numerical listing of forms issued or
used by the ATF. This publication is available
at the GPO.
Forms
are available at the ATF Distribution
Center, 3800 South Four Mile Run Drive,
Arlington, VA 22206.
Relabeling:
Imported
distilled spirits in US Customs custody
which are not labeled in conformity with
certificates of label approval issued
by the Director of ATF must be relabeled
prior to release.
Certificate
of age and origin: 27 CFR § 5.52
(b)and (e)
Brandy,
cognac, rum and distilled spirits (other
than Scotch, Irish, Canadian whiskies
and Cognac) in bottles will be released
from US Customs custody if the invoice
is accompanied by a certificate of origin
issued by a duly authorized official of
the appropriate foreign government.
B.
Malt beverages (beer)
Malt
beverages: see text.
Container:
any can, bottle, barrel, keg or other
closed receptacle, irrespective of size
or of the material from which made, for
use for the sale of malt beverages at
retail.
Geographical
designations: 27 CFR 7.24(f) and sanctions
27 CFR 7.22.
b.
Labeling requirements for malt beverages
Application:
27CFR7.20(a):
The
requirements shall apply to malt beverages
sold or shipped or delivered for shipment,
or otherwise introduced into or received
in any State from any place outside thereof,
only to the extent that the law of such
State imposes similar requirements with
respect to the labeling of malt beverages
not sold or shipped or delivered for shipment
or otherwise introduced into or received
in such State from any place outside thereof.
Principle:
27CFR7.20(b):
It’s
unlawful to sell, ship, deliver for sale
or shipment or remove from Customs custody
any malt beverages in containers unless
the packages are labeled.
Remark:
The
regional director of ATF (compliance)
may, upon written application (procedure:
27CFR7.20(b)(2)), permit additional labeling
or relabeling of malt beverages in containers
if, in his judgment, the facts show that
the additional labeling or relabeling
is for the purpose of compliance with
the requirements of the ATF regulations
or of state law.
There
shall be stated:
i.
on the brand label:
1)
Brand name in accordance with §7.23:
the product shall bear a brand name except
that if not sold under a brand name, then
the name of the person required to appear
on the brand label shall be deemed a brand
name.
2)
Class and type in accordance with §
7.24:
•
“near beer”: if less than 0.5% of alcohol
by volume;
•“ale”
and “stout” can be used only for a malt
beverage fermented at a comparatively
high temperature and produced without
the use of coloring or flavoring materials
(other than those recognized in standard
brewing practices).
3)
Name and address in accordance with §
7.25:
Imported
malt beverages: on labels of containers
of imported malt beverages, there shall
be stated the words “imported by” or a
singular appropriate phrase, and immediately
thereafter the name of the permittee who
is the importer or agent or other person
responsible for the importation, together
with the principal place of business in
the US of such person.
4)
Net content in accordance with §
7.22, i.e., in US measures.
Malt
beverages are not subject to metric standards
of fill like distilled spirits.
ii.on
the brand label or on a separate label
(back or front): 27CFR § 7.22(b)
Among
other things:
1)
in the case of imported malt beverages,
name and address of importer in accordance
with § 7.25;
2)
in the case of malt beverages bottled
or packed for the holder of a permit or
a retailer, the name and address of the
bottler or packer, in accordance with
§ 7.25;
3)
alcoholic content, when required by state
law, in accordance with §7.71;
alcohol
free: a malt beverage may not be labeled
with an alcoholic content of 0.0% alcohol
by volume unless it is also labeled as
“alcohol free” and contains no alcohol.
low
alcohol and reduced alcohol: only
if the beverage contains less than 2.5%
alcohol by volume.
non-alcoholic:
less than 0.5%.
4)
a specific statement if saccharin is used;
5)
declaration of sulfite;
6)
declaration of aspartame.
c.
Additonal requirements: 27 CFR 7.28
•
contrasting background;
•
size of type;
•
English language: all information, other
than the brand name, shall be in English.
d.
Prohibited practices: 27 CFR § 7.29
Among
other statements on labels that are forbidden:
•
use of words “strong”, “full strength”
and similar words likely to be considered
as tatement of alcoholic content, unless
required by state law.
•
use of numerals likely considered as statement
of alcoholic content, unless required
by tate law, or as permitted by §
7.71.
e.
Sanctions: no Customs release.
f.
Requirements for withdrawal of imported
malt beverages from Customs custody
This
section applies only if the law from the
State in which the products are withdrawn
from Customs custody requires labeling
in conformity with the ATF requirements.
Label
approval and release (§7.31): deposit
with the appropriate Customs officer at
the port of entry of the original or a
photostatic copy of an approved certificate
of label approval, ATF form 5100.31 is
necessary to withdraw the product.
Note:
the remark I made about the ATF forms
in the distilled spirits section applies
to this section.
C.
Alcoholic beverage health warning statement
Back
to Index
It
targets any beverage in liquid form which
contains not less than 0.5% of alcohol
by volume and is intended for human consumption.
Principle:
27CFR §16.20:
No
person shall import for sale or distribution
in the United States any alcoholic beverage
unless the container of such beverage
bears the health warning statement (see
16.21).
