HB316INTRODUCED
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HB316
96QTMPM-1
By Representatives Butler, Harrison, Gidley, Robertson,
Wadsworth, Whorton, Wood (D), Yarbrough, Mooney, Bolton,
Fincher, Fidler, Stadthagen, Lamb
RFD: Health
First Read: 20-Feb-25
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7 96QTMPM-1 02/20/2025 ZAK (L)ma 2024-2653
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First Read: 20-Feb-25
SYNOPSIS:
Under existing law, the term "drug" is defined
for purposes of preventing the possession, sale, or
manufacture of adulterated or misbranded drugs.
This bill would include within the meaning of
the term "drug" all foods that contain a vaccine or
vaccine material.
This bill would specify that foods containing
vaccine material are misbranded if not packaged
according to certain requirements.
This bill would also make nonsubstantive,
technical revisions to update the existing code
language to current style.
A BILL
TO BE ENTITLED
AN ACT
Relating to drugs; to amend Sections 20-1-20 and
20-1-25, Code of Alabama 1975, to add foods that contain
vaccines or vaccine material to the definition of the term
"drug"; to define the term "vaccine or vaccine material"; to
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"drug"; to define the term "vaccine or vaccine material"; to
provide certain labeling requirements for food containing
vaccine material; and to make nonsubstantive, technical
revisions to update the existing code language to current
style.
BE IT ENACTED BY THE LEGISLATURE OF ALABAMA:
Section 1. Sections 20-1-20 and 20-1-25, Code of
Alabama 1975, are amended to read as follows:
"§20-1-20
When used in this chapter, the following words and
phrases shall terms have the following meanings, respectively,
unless the context clearly indicates otherwise:
(1) ARTICLE. When referring to food or drugs, such the
term is used in the broad and comprehensive sense and has
reference to the food product or the drug product in question.
(2) BABY FOOD. A food which that purports to be or is
represented for special dietary use as a food for babies by
reason of its special formulation or its particular
suitability for children under two years of age.
(3) BOARD. The State Board of Agriculture and
Industries.
(4) CLASS A FOODS. Baby food, infant formula, and
potentially hazardous food.
(5) COMMISSIONER. The Commissioner of Agriculture and
Industries.
(6) DEALER. A manufacturer, wholesaler, retailer,
jobber, and similar establishments, mobile or permanent,
engaged in the sale of food for consumption on premises.
(7) DEPARTMENT. The Department of Agriculture and
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(7) DEPARTMENT. The Department of Agriculture and
Industries.
(8) DRUG. All medicines and preparations recognized in
the United States pharmacopoeia or national formulary for
internal or external use and any substance or mixture of
substances to be used for the cure, mitigation, or prevention
of disease in man humans or domestic animals. The term
includes food that contains a vaccine or vaccine material.
(9) FOOD. All articles of food, drink, confectionery,
or condiment, whether simple, mixed, or compound, used or
intended for use by man humans or domestic animals.
(10) FOOD SALES ESTABLISHMENT. Retail and wholesale
stores and places of business, and similar establishments,
mobile or permanent, engaged in the sale of food primarily for
consumption off the premises.
(11) INFANT FORMULA. A food which purports to be or is
represented for special dietary use solely as a food for
infants by reason of its simulation of human milk or its
suitability as a complete or partial substitute for human
milk.
(12) LABEL. A display of written, printed, or graphic
matter upon the immediate container of any article.
(13) MISBRANDED. Such term shall apply to all drugs or
foods or articles which enter into the composition of food,
the The package or label of which any drug, food, article, or
ingredient or substance that enters into the composition of an
article shall bear or contain that bears or contains any
statement, design, or device regarding such the article or the
ingredients or substances contained therein which shall be
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ingredients or substances contained therein which shall be
that is false or misleading in any particular way, including
and to any food or drug product which is falsely branded as to
the state, territory, or country in which it is manufactured
or produced.
(14) OPEN-DATE STATEMENT. The terms "Sell By"; "Freeze
By"; "Sell or Freeze By"; "Not to be Sold After"; "Best if
Used By"; "Expiration"; or other terms as defined by rules or
regulations rule; or a date without additional words shall be
considered an open-date statement.
(15) OUT-OF-DATE. Any article with a label containing
an open-date statement with a date affixed thereto which that
has passed.
(16) PERSON. An individual, partnership, corporation,
or association, or any combination thereof.
(17) POTENTIALLY HAZARDOUS FOOD. A food that is natural
or synthetic and that requires temperature control because it
is in a form capable of supporting rapid and progressive
growth of infectious or toxigenic microorganisms , or the
growth and toxin production of Clostridium botulinum , or the
growth of Salmonella Enteritidis. The term does not include
foods which that have a pH level 1 of 4.6 or below ; or, a
water activity (a sub w) of 0.85 or less ;, or food products in
hermetically sealed containers processed to achieve and
maintain commercial sterility under unrefrigerated conditions.
The foregoing notwithstanding, the board may by rule adopt the
definition for "Potentially Hazardous Food" set out in
subparagraph 1-201.10 (B)(61), Food Code, 1999 Recommendations
of the United States Public Health Service, Food and Drug
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of the United States Public Health Service, Food and Drug
Administration, National Technical Information Service
Publication, PB99-115929.
(18) STANDARD OF PURITY OR QUALITY. The standards of
purity for food products promulgated adopted by the State
Board of Agriculture and Industries and by statutes of this
state.
(19) VACCINE or VACCINE MATERIAL. A substance intended
for use in humans to stimulate the production of antibodies
and provide immunity against a disease that is prepared from
the causative agent of the disease, its products, or a
synthetic substitute; treated to act as an antigen without
inducing the disease; and that is authorized or approved by
the United States Food and Drug Administration. "
"§20-1-25
An article of food shall be deemed misbranded in all of
the following cases:
(1) If it is offered for sale under the name of another
article;.
(2) If it is labeled or branded so as to deceive or
mislead the purchaser, or purports to be a foreign product
when not so it is not or if the contents of the package as
originally put up shall have been removed in whole or in part
and other contents shall have been placed in such the
package;.
(3) If, in package form, the name of the article
together with the quantity of the contents in terms of weight,
measure, or numerical count and the name and principal address
of the manufacturer or other person responsible for placing
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of the manufacturer or other person responsible for placing
the article on the market are not plainly and conspicuously
marked on the outside of the package ;.
(4) If, in package form, the package is not filled with
the food it purports to contain within the limits of tolerance
fixed by the State Board of Agriculture and Industries,
irrespective of whether the quantity of the contents is
plainly and conspicuously marked on the outside of the package
in terms of weight, measure, or numerical count ;.
(5) If the package containing it or its label shall
bear bears any statement, design, or device regarding the
ingredients or the substances contained therein , which and the
statement, design, or device shall be is false or misleading
in any particular ;.
(6) If, in bulk, it is colored so as to deceive or
mislead the purchaser ;.
(7) If it is offered for sale under false
representations;.
(8) If it is an imitation of another article and is not
marked with the word "imitation," followed, without
intervening descriptive matter, by a list of the ingredients
contained therein ;.
(9) If it is a compound for which no standard of purity
or quality has been established, and it is not labeled with
the word "compound" followed, without intervening descriptive
matter, by a list of the ingredients; provided, that in the
case of a compound which that may be now or from time to time
hereafter known as an article of food under its own
distinctive name and which is not an imitation of or offered
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distinctive name and which is not an imitation of or offered
for sale under the name of another article , it. It shall not
be deemed to be misbranded if the name of the article is
accompanied on the same label or brand with a statement of the
place where such the article was manufactured or produced ; or.
(10) If the package, label, or brand fails to give the
ingredients or substances by their common names.
(11) If it contains a vaccine or vaccine material and
the package, label, or brand fails to bear, in a font of
uniform size and prominence, the words "Contains Vaccine or
Vaccine Material" and does not specify that the article of
food is classified as drug under this chapter. "
Section 2. This act shall become effective on October
1, 2025.
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