0515-AttachA-21 USC 343q

Attachment A

Section 403(q) (21 U.S.C. 343 (q)) of the Federal Food, Drug, and Cosmetic Act

From the U.S. Code Online via GPO Access

[wais.access.gpo.gov]

[Laws in effect as of January 24, 2002]

[Document not affected by Public Laws enacted between

January 24, 2002 and December 19, 2002]

[CITE: 21USC343]

TITLE 21--FOOD AND DRUGS

CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER IV--FOOD

Sec. 343. Misbranded food

A food shall be deemed to be misbranded—

* * *

(q) Nutrition information

(1) Except as provided in subparagraphs (3), (4), and (5), if it is

a food intended for human consumption and is offered for sale, unless

its label or labeling bears nutrition information that provides--

(A)(i) the serving size which is an amount customarily consumed

and which is expressed in a common household measure that is

appropriate to the food, or

(ii) if the use of the food is not typically expressed in a

serving size, the common household unit of measure that expresses

the serving size of the food,

(B) the number of servings or other units of measure per

container,

(C) the total number of calories--

(i) derived from any source, and

(ii) derived from the total fat,

in each serving size or other unit of measure of the food,

(D) the amount of the following nutrients: Total fat, saturated

fat, cholesterol, sodium, total carbohydrates, complex

carbohydrates, sugars, dietary fiber, and total protein contained in

each serving size or other unit of measure,

(E) any vitamin, mineral, or other nutrient required to be

placed on the label and labeling of food under this chapter before

October 1, 1990, if the Secretary determines that such information

will assist consumers in maintaining healthy dietary practices.

The Secretary may by regulation require any information required to be

placed on the label or labeling by this subparagraph or subparagraph

(2)(A) to be highlighted on the label or labeling by larger type, bold

type, or contrasting color if the Secretary determines that such

highlighting will assist consumers in maintaining healthy dietary

practices.

(2)(A) If the Secretary determines that a nutrient other than a

nutrient required by subparagraph (1)(C), (1)(D), or (1)(E) should be

included in the label or labeling of food subject to subparagraph (1)

for purposes of providing information regarding the nutritional value of

such food that will assist consumers in maintaining healthy dietary

practices, the Secretary may by regulation require that information

relating to such additional nutrient be included in the label or

labeling of such food.

(B) If the Secretary determines that the information relating to a

nutrient required by subparagraph (1)(C), (1)(D), or (1)(E) or clause

(A) of this subparagraph to be included in the label or labeling of food

is not necessary to assist consumers in maintaining healthy dietary

practices, the Secretary may by regulation remove information relating

to such nutrient from such requirement.

(3) For food that is received in bulk containers at a retail

establishment, the Secretary may, by regulation, provide that the

nutrition information required by subparagraphs (1) and (2) be displayed

at the location in the retail establishment at which the food is offered

for sale.

(4)(A) The Secretary shall provide for furnishing the nutrition

information required by subparagraphs (1) and (2) with respect to raw

agricultural commodities and raw fish by issuing voluntary nutrition

guidelines, as provided by clause (B) or by issuing regulations that are

mandatory as provided by clause (D).

(B)(i) Upon the expiration of 12 months after November 8, 1990, the

Secretary, after providing an opportunity for comment, shall issue

guidelines for food retailers offering raw agricultural commodities or

raw fish to provide nutrition information specified in subparagraphs (1)

and (2). Such guidelines shall take into account the actions taken by

food retailers during such 12-month period to provide to consumers

nutrition information on raw agricultural commodities and raw fish. Such

guidelines shall only apply--

(I) in the case of raw agricultural commodities, to the 20

varieties of vegetables most frequently consumed during a year and

the 20 varieties of fruit most frequently consumed during a year,

and

(II) to the 20 varieties of raw fish most frequently consumed

during a year.

The vegetables, fruits, and raw fish to which such guidelines apply

shall be determined by the Secretary by regulation and the Secretary may

apply such guidelines regionally.

(ii) Upon the expiration of 12 months after November 8, 1990, the

Secretary shall issue a final regulation defining the circumstances that

constitute substantial compliance by food retailers with the guidelines

issued under subclause (i). The regulation shall provide that there is

not substantial compliance if a significant number of retailers have

failed to comply with the guidelines. The size of the retailers and the

portion of the market served by retailers in compliance with the

guidelines shall be considered in determining whether the substantial-

compliance standard has been met.

(C)(i) Upon the expiration of 30 months after November 8, 1990, the

Secretary shall issue a report on actions taken by food retailers to

provide consumers with nutrition information for raw agricultural

commodities and raw fish under the guidelines issued under clause (A).

Such report shall include a determination of whether there is

substantial compliance with the guidelines.

(ii) If the Secretary finds that there is substantial compliance

with the guidelines, the Secretary shall issue a report and make a

determination of the type required in subclause (i) every two years.

(D)(i) If the Secretary determines that there is not substantial

compliance with the guidelines issued under clause (A), the Secretary

shall at the time such determination is made issue proposed regulations

requiring that any person who offers raw agricultural commodities or raw

fish to consumers provide, in a manner prescribed by regulations, the

nutrition information required by subparagraphs (1) and (2). The

Secretary shall issue final regulations imposing such requirements 6

months after issuing the proposed regulations. The final regulations

shall become effective 6 months after the date of their promulgation.

(ii) Regulations issued under subclause (i) may require that the

nutrition information required by subparagraphs (1) and (2) be provided

for more than 20 varieties of vegetables, 20 varieties of fruit, and 20

varieties of fish most frequently consumed during a year if the

Secretary finds that a larger number of such products are frequently

consumed. Such regulations shall permit such information to be provided

in a single location in each area in which raw agricultural commodities

and raw fish are offered for sale. Such regulations may provide that

information shall be expressed as an average or range per serving of the

same type of raw agricultural commodity or raw fish. The Secretary shall

develop and make available to the persons who offer such food to

consumers the information required by subparagraphs (1) and (2).

(iii) Regulations issued under subclause (i) shall permit the

required information to be provided in each area of an establishment in

which raw agricultural commodities and raw fish are offered for sale.

The regulations shall permit food retailers to display the required

information by supplying copies of the information provided by the

Secretary, by making the information available in brochure, notebook or

leaflet form, or by posting a sign disclosing the information. Such

regulations shall also permit presentation of the required information

to be supplemented by a video, live demonstration, or other media which

the Secretary approves.

(E) For purposes of this subparagraph, the term ``fish'' includes

freshwater or marine fin fish, crustaceans, and mollusks, including

shellfish, amphibians, and other forms of aquatic animal life.

(F) No person who offers raw agricultural commodities or raw fish to

consumers may be prosecuted for minor violations of this subparagraph if

there has been substantial compliance with the requirements of this

paragraph.

(5)(A) Subparagraphs (1), (2), (3), and (4) shall not apply to

food--

(i) which is served in restaurants or other establishments in

which food is served for immediate human consumption or which is

sold for sale or use in such establishments,

(ii) which is processed and prepared primarily in a retail

establishment, which is ready for human consumption, which is of the

type described in subclause (i), and which is offered for sale to

consumers but not for immediate human consumption in such

establishment and which is not offered for sale outside such

establishment,

(iii) which is an infant formula subject to section 350a of this

title,

(iv) which is a medical food as defined in section 360ee(b) of

this title, or

(v) which is described in section 345(2) of this title.

(B) Subparagraphs (1) and (2) shall not apply to the label of a food

if the Secretary determines by regulations that compliance with such

subparagraphs is impracticable because the package of such food is too

small to comply with the requirements of such subparagraphs and if the

label of such food does not contain any nutrition information.

(C) If a food contains insignificant amounts, as determined by the

Secretary, of all the nutrients required by subparagraphs (1) and (2) to

be listed in the label or labeling of food, the requirements of such

subparagraphs shall not apply to such food if the label, labeling, or

advertising of such food does not make any claim with respect to the

nutritional value of such food. If a food contains insignificant

amounts, as determined by the Secretary, of more than one-half the

nutrients required by subparagraphs (1) and (2) to be in the label or

labeling of the food, the Secretary shall require the amounts of such

nutrients to be stated in a simplified form prescribed by the Secretary.

(D) If a person offers food for sale and has annual gross sales made

or business done in sales to consumers which is not more than $500,000

or has annual gross sales made or business done in sales of food to

consumers which is not more than $50,000, the requirements of

subparagraphs (1), (2), (3), and (4) shall not apply with respect to

food sold by such person to consumers unless the label or labeling of

food offered by such person provides nutrition information or makes a

nutrition claim.

(E)(i) During the 12-month period for which an exemption from

subparagraphs (1) and (2) is claimed pursuant to this subclause, the

requirements of such subparagraphs shall not apply to any food product

if--

(I) the labeling for such product does not provide nutrition

information or make a claim subject to paragraph (r),

(II) the person who claims for such product an exemption from

such subparagraphs employed fewer than an average of 100 full-time

equivalent employees,

(III) such person provided the notice described in subclause

(iii), and

(IV) in the case of a food product which was sold in the 12-

month period preceding the period for which an exemption was

claimed, fewer than 100,000 units of such product were sold in the

United States during such preceding period, or in the case of a food

product which was not sold in the 12-month period preceding the

period for which such exemption is claimed, fewer than 100,000 units

of such product are reasonably anticipated to be sold in the United

States during the period for which such exemption is claimed.

(ii) During the 12-month period after the applicable date referred

to in this sentence, the requirements of subparagraphs (1) and (2) shall

not apply to any food product which was first introduced into interstate

commerce before May 8, 1994, if the labeling for such product does not

provide nutrition information or make a claim subject to paragraph (r),

if such person provided the notice described in subclause (iii), and

if--

(I) during the 12-month period preceding May 8, 1994, the person

who claims for such product an exemption from such subparagraphs

employed fewer than an average of 300 full-time equivalent employees

and fewer than 600,000 units of such product were sold in the United

States,

(II) during the 12-month period preceding May 8, 1995, the

person who claims for such product an exemption from such

subparagraphs employed fewer than an average of 300 full-time

equivalent employees and fewer than 400,000 units of such product

were sold in the United States, or

(III) during the 12-month period preceding May 8, 1996, the

person who claims for such product an exemption from such

subparagraphs employed fewer than an average of 200 full-time

equivalent employees and fewer than 200,000 units of such product

were sold in the United States.

(iii) The notice referred to in subclauses (i) and (ii) shall be

given to the Secretary prior to the beginning of the period during which

the exemption under subclause (i) or (ii) is to be in effect, shall

state that the person claiming such exemption for a food product has

complied with the applicable requirements of subclause (i) or (ii), and

shall--

(I) state the average number of full-time equivalent employees

such person employed during the 12 months preceding the date such

person claims such exemption,

(II) state the approximate number of units the person claiming

the exemption sold in the United States,

(III) if the exemption is claimed for a food product which was

sold in the 12-month period preceding the period for which the

exemption was claimed, state the approximate number of units of such

product which were sold in the United States during such preceding

period, and, if the exemption is claimed for a food product which

was not sold in such preceding period, state the number of units of

such product which such person reasonably anticipates will be sold

in the United States during the period for which the exemption was

claimed, and

(IV) contain such information as the Secretary may require to

verify the information required by the preceding provisions of this

subclause if the Secretary has questioned the validity of such

information.

If a person is not an importer, has fewer than 10 full-time equivalent

employees, and sells fewer than 10,000 units of any food product in any

year, such person is not required to file a notice for such product

under this subclause for such year.

(iv) In the case of a person who claimed an exemption under

subclause (i) or (ii), if, during the period of such exemption, the

number of full-time equivalent employees of such person exceeds the

number in such subclause or if the number of food products sold in the

United States exceeds the number in such subclause, such exemption shall

extend to the expiration of 18 months after the date the number of full-

time equivalent employees or food products sold exceeded the applicable

number.

(v) For any food product first introduced into interstate commerce

after May 8, 2002, the Secretary may by regulation lower the employee or

units of food products requirement of subclause (i) if the Secretary

determines that the cost of compliance with such lower requirement will

not place an undue burden on persons subject to such lower requirement.

(vi) For purposes of subclauses (i), (ii), (iii), (iv), and (v)--

(I) the term ``unit'' means the packaging or, if there is no

packaging, the form in which a food product is offered for sale to

consumers,

(II) the term ``food product'' means food in any sized package

which is manufactured by a single manufacturer or which bears the

same brand name, which bears the same statement of identity, and

which has similar preparation methods, and

(III) the term ``person'' in the case of a corporation includes

all domestic and foreign affiliates of the corporation.

(F) A dietary supplement product (including a food to which section

350 of this title applies) shall comply with the requirements of

subparagraphs (1) and (2) in a manner which is appropriate for the

product and which is specified in regulations of the Secretary which

shall provide that--

(i) nutrition information shall first list those dietary

ingredients that are present in the product in a significant amount

and for which a recommendation for daily consumption has been

established by the Secretary, except that a dietary ingredient shall

not be required to be listed if it is not present in a significant

amount, and shall list any other dietary ingredient present and

identified as having no such recommendation;

(ii) the listing of dietary ingredients shall include the

quantity of each such ingredient (or of a proprietary blend of such

ingredients) per serving;

(iii) the listing of dietary ingredients may include the source

of a dietary ingredient; and

(iv) the nutrition information shall immediately precede the

ingredient information required under subclause (i), except that no

ingredient identified pursuant to subclause (i) shall be required to

be identified a second time.

(G) Subparagraphs (1), (2), (3), and (4) shall not apply to food

which is sold by a food distributor if the food distributor principally

sells food to restaurants or other establishments in which food is

served for immediate human consumption and does not manufacture,

process, or repackage the food it sells.