Alabama 2025 Regular Session

Alabama House Bill HB316 Compare Versions

Only one version of the bill is available at this time.

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1	1	HB316INTRODUCED
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3	3	HB316
4	4	96QTMPM-1
5	5	By Representatives Butler, Harrison, Gidley, Robertson,
6	6	Wadsworth, Whorton, Wood (D), Yarbrough, Mooney, Bolton,
7	7	Fincher, Fidler, Stadthagen, Lamb
8	8	RFD: Health
9	9	First Read: 20-Feb-25
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16	16	7 96QTMPM-1 02/20/2025 ZAK (L)ma 2024-2653
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18	18	First Read: 20-Feb-25
19	19	SYNOPSIS:
20	20	Under existing law, the term "drug" is defined
21	21	for purposes of preventing the possession, sale, or
22	22	manufacture of adulterated or misbranded drugs.
23	23	This bill would include within the meaning of
24	24	the term "drug" all foods that contain a vaccine or
25	25	vaccine material.
26	26	This bill would specify that foods containing
27	27	vaccine material are misbranded if not packaged
28	28	according to certain requirements.
29	29	This bill would also make nonsubstantive,
30	30	technical revisions to update the existing code
31	31	language to current style.
32	32	A BILL
33	33	TO BE ENTITLED
34	34	AN ACT
35	35	Relating to drugs; to amend Sections 20-1-20 and
36	36	20-1-25, Code of Alabama 1975, to add foods that contain
37	37	vaccines or vaccine material to the definition of the term
38	38	"drug"; to define the term "vaccine or vaccine material"; to
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68	68	"drug"; to define the term "vaccine or vaccine material"; to
69	69	provide certain labeling requirements for food containing
70	70	vaccine material; and to make nonsubstantive, technical
71	71	revisions to update the existing code language to current
72	72	style.
73	73	BE IT ENACTED BY THE LEGISLATURE OF ALABAMA:
74	74	Section 1. Sections 20-1-20 and 20-1-25, Code of
75	75	Alabama 1975, are amended to read as follows:
76	76	"§20-1-20
77	77	When used in this chapter, the following words and
78	78	phrases shall terms have the following meanings, respectively,
79	79	unless the context clearly indicates otherwise:
80	80	(1) ARTICLE. When referring to food or drugs, such the
81	81	term is used in the broad and comprehensive sense and has
82	82	reference to the food product or the drug product in question.
83	83	(2) BABY FOOD. A food which that purports to be or is
84	84	represented for special dietary use as a food for babies by
85	85	reason of its special formulation or its particular
86	86	suitability for children under two years of age.
87	87	(3) BOARD. The State Board of Agriculture and
88	88	Industries.
89	89	(4) CLASS A FOODS. Baby food, infant formula, and
90	90	potentially hazardous food.
91	91	(5) COMMISSIONER. The Commissioner of Agriculture and
92	92	Industries.
93	93	(6) DEALER. A manufacturer, wholesaler, retailer,
94	94	jobber, and similar establishments, mobile or permanent,
95	95	engaged in the sale of food for consumption on premises.
96	96	(7) DEPARTMENT. The Department of Agriculture and
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126	126	(7) DEPARTMENT. The Department of Agriculture and
127	127	Industries.
128	128	(8) DRUG. All medicines and preparations recognized in
129	129	the United States pharmacopoeia or national formulary for
130	130	internal or external use and any substance or mixture of
131	131	substances to be used for the cure, mitigation, or prevention
132	132	of disease in man humans or domestic animals. The term
133	133	includes food that contains a vaccine or vaccine material.
134	134	(9) FOOD. All articles of food, drink, confectionery,
135	135	or condiment, whether simple, mixed, or compound, used or
136	136	intended for use by man humans or domestic animals.
137	137	(10) FOOD SALES ESTABLISHMENT. Retail and wholesale
138	138	stores and places of business, and similar establishments,
139	139	mobile or permanent, engaged in the sale of food primarily for
140	140	consumption off the premises.
141	141	(11) INFANT FORMULA. A food which purports to be or is
142	142	represented for special dietary use solely as a food for
143	143	infants by reason of its simulation of human milk or its
144	144	suitability as a complete or partial substitute for human
145	145	milk.
146	146	(12) LABEL. A display of written, printed, or graphic
147	147	matter upon the immediate container of any article.
148	148	(13) MISBRANDED. Such term shall apply to all drugs or
149	149	foods or articles which enter into the composition of food,
150	150	the The package or label of which any drug, food, article, or
151	151	ingredient or substance that enters into the composition of an
152	152	article shall bear or contain that bears or contains any
153	153	statement, design, or device regarding such the article or the
154	154	ingredients or substances contained therein which shall be
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184	184	ingredients or substances contained therein which shall be
185	185	that is false or misleading in any particular way, including
186	186	and to any food or drug product which is falsely branded as to
187	187	the state, territory, or country in which it is manufactured
188	188	or produced.
189	189	(14) OPEN-DATE STATEMENT. The terms "Sell By"; "Freeze
190	190	By"; "Sell or Freeze By"; "Not to be Sold After"; "Best if
191	191	Used By"; "Expiration"; or other terms as defined by rules or
192	192	regulations rule; or a date without additional words shall be
193	193	considered an open-date statement.
194	194	(15) OUT-OF-DATE. Any article with a label containing
195	195	an open-date statement with a date affixed thereto which that
196	196	has passed.
197	197	(16) PERSON. An individual, partnership, corporation,
198	198	or association, or any combination thereof.
199	199	(17) POTENTIALLY HAZARDOUS FOOD. A food that is natural
200	200	or synthetic and that requires temperature control because it
201	201	is in a form capable of supporting rapid and progressive
202	202	growth of infectious or toxigenic microorganisms , or the
203	203	growth and toxin production of Clostridium botulinum , or the
204	204	growth of Salmonella Enteritidis. The term does not include
205	205	foods which that have a pH level 1 of 4.6 or below ; or, a
206	206	water activity (a sub w) of 0.85 or less ;, or food products in
207	207	hermetically sealed containers processed to achieve and
208	208	maintain commercial sterility under unrefrigerated conditions.
209	209	The foregoing notwithstanding, the board may by rule adopt the
210	210	definition for "Potentially Hazardous Food" set out in
211	211	subparagraph 1-201.10 (B)(61), Food Code, 1999 Recommendations
212	212	of the United States Public Health Service, Food and Drug
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242	242	of the United States Public Health Service, Food and Drug
243	243	Administration, National Technical Information Service
244	244	Publication, PB99-115929.
245	245	(18) STANDARD OF PURITY OR QUALITY. The standards of
246	246	purity for food products promulgated adopted by the State
247	247	Board of Agriculture and Industries and by statutes of this
248	248	state.
249	249	(19) VACCINE or VACCINE MATERIAL. A substance intended
250	250	for use in humans to stimulate the production of antibodies
251	251	and provide immunity against a disease that is prepared from
252	252	the causative agent of the disease, its products, or a
253	253	synthetic substitute; treated to act as an antigen without
254	254	inducing the disease; and that is authorized or approved by
255	255	the United States Food and Drug Administration. "
256	256	"§20-1-25
257	257	An article of food shall be deemed misbranded in all of
258	258	the following cases:
259	259	(1) If it is offered for sale under the name of another
260	260	article;.
261	261	(2) If it is labeled or branded so as to deceive or
262	262	mislead the purchaser, or purports to be a foreign product
263	263	when not so it is not or if the contents of the package as
264	264	originally put up shall have been removed in whole or in part
265	265	and other contents shall have been placed in such the
266	266	package;.
267	267	(3) If, in package form, the name of the article
268	268	together with the quantity of the contents in terms of weight,
269	269	measure, or numerical count and the name and principal address
270	270	of the manufacturer or other person responsible for placing
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300	300	of the manufacturer or other person responsible for placing
301	301	the article on the market are not plainly and conspicuously
302	302	marked on the outside of the package ;.
303	303	(4) If, in package form, the package is not filled with
304	304	the food it purports to contain within the limits of tolerance
305	305	fixed by the State Board of Agriculture and Industries,
306	306	irrespective of whether the quantity of the contents is
307	307	plainly and conspicuously marked on the outside of the package
308	308	in terms of weight, measure, or numerical count ;.
309	309	(5) If the package containing it or its label shall
310	310	bear bears any statement, design, or device regarding the
311	311	ingredients or the substances contained therein , which and the
312	312	statement, design, or device shall be is false or misleading
313	313	in any particular ;.
314	314	(6) If, in bulk, it is colored so as to deceive or
315	315	mislead the purchaser ;.
316	316	(7) If it is offered for sale under false
317	317	representations;.
318	318	(8) If it is an imitation of another article and is not
319	319	marked with the word "imitation," followed, without
320	320	intervening descriptive matter, by a list of the ingredients
321	321	contained therein ;.
322	322	(9) If it is a compound for which no standard of purity
323	323	or quality has been established, and it is not labeled with
324	324	the word "compound" followed, without intervening descriptive
325	325	matter, by a list of the ingredients; provided, that in the
326	326	case of a compound which that may be now or from time to time
327	327	hereafter known as an article of food under its own
328	328	distinctive name and which is not an imitation of or offered
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358	358	distinctive name and which is not an imitation of or offered
359	359	for sale under the name of another article , it. It shall not
360	360	be deemed to be misbranded if the name of the article is
361	361	accompanied on the same label or brand with a statement of the
362	362	place where such the article was manufactured or produced ; or.
363	363	(10) If the package, label, or brand fails to give the
364	364	ingredients or substances by their common names.
365	365	(11) If it contains a vaccine or vaccine material and
366	366	the package, label, or brand fails to bear, in a font of
367	367	uniform size and prominence, the words "Contains Vaccine or
368	368	Vaccine Material" and does not specify that the article of
369	369	food is classified as drug under this chapter. "
370	370	Section 2. This act shall become effective on October
371	371	1, 2025.
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