This docum ent does not reflect the intent or official position of the bill sponsor or House of Representatives.
STORAGE NAME: h0959.RRS
DATE: 3/26/2023
HOUSE OF REPRESENTATIVES STAFF ANALYSIS
BILL #: HB 959 Dosage Form Animal Health Products
SPONSOR(S): Tuck
TIED BILLS: IDEN./SIM. BILLS: SB 1056
REFERENCE ACTION ANALYST STAFF DIRECTOR or
BUDGET/POLICY CHIEF
1) Regulatory Reform & Economic Development
Subcommittee
Thompson Anstead
2) Agriculture & Natural Resources Appropriations
Subcommittee
3) Commerce Committee
SUMMARY ANALYSIS
The Florida Commercial Feed Law (Commercial Feed Law) authorizes the Department of Agriculture and
Consumer Services (DACS) to regulate the distribution of commercial feed and feedstuff in Florida to ensure
these products are safe for human consumption. The DACS Division of Animal Industry (Division) is
responsible for enforcing the state’s animal industry law, which provides animal health regulations and protects
the state from animal pests and diseases.
Dosage form animal health supplements are animal health supplements that are similar to dietary supplements
for humans. According to the National Library of Medicine (NLM), such supplements are widely used but have
limited oversight and regulation. According to DACS, manufacturers and distributors of dosage form animal
products in Florida are currently governed by the state Commercial Feed Law due to the non-nutritional
character of these products. As a result, these entities are “required to comply with the registration, labeling,
and sampling requirements followed by distributors of other no- or low-nutritive value products allowed for use
as, or for mixing in, animal feed.”
Under federal law, the Dietary Supplement and Health Education Act (DSHEA) affects the way the Food and
Drug Administration (FDA) Center for Veterinary Medicine (CVM) regulates “food for humans.” Among other
things, it restricts substances from being food additives or drugs if the product meets the definition of a dietary
supplement. However, FDA’s assessment of DSHEA is that it was not intended to, and does not, apply to
animal feed, including pet food. Thus, products marketed as dietary supplements or “feed supplements” for
animals fall under Title 21, the Federal Food, Drug, & Cosmetics Act. These items are considered “foods” or
“drugs” depending on the intended use, or in some instances the articles may be, simultaneously, a food and a
drug.
The bill:
Requires a manufacturer or distributor of dosage form animal health products to register biennially with
DACS.
Authorizes DACS to waive the registration requirement under certain conditions and requires specified
information for registration applications.
Provides conditions under which dosage form animal health products are considered misbranded or
adulterated.
Specifies that dosage form animal health products may not be considered commercial feed, a drug, or
feedstuff as those terms are defined in the Commercial Feed Law.
The fiscal impact of the bill is indeterminate.
The effective date of the bill is July 1, 2023. STORAGE NAME: h0959.RRS PAGE: 2
DATE: 3/26/2023
FULL ANALYSIS
I. SUBSTANTIVE ANALYSIS
A. EFFECT OF PROPOSED CHANGES:
Current Situation
Commercial Feed and Feedstuff
The Florida Commercial Feed Law (Commercial Feed Law)
1
authorizes the Department of Agriculture
and Consumer Services (DACS) to regulate commercial feed and feedstuff for quality, safety, labeling
requirements, and standards.
2
A distributor of commercial feed is required to obtain a master
registration
3
and place on file a copy of the label for each brand of feed to be distributed in Florida.
4
Distributors are required to pay a licensing fee that is based on the weight of feed distributed in the
state.
5
The Commercial Feed Law preempts to DACS all authority in the state to regulate, inspect,
sample, and analyze any commercial feed or feedstuff, including assessment of penalties for
violations.
6
Samples of feed distributed in Florida must be periodically tested by a certified laboratory to determine
compliance with state standards.
7
The minimum standards for feed and feedstuff are those set forth in
the “Official Publication 2001” published by the Association of American Feed Control Officials.
8
DACS is authorized to adopt rules to enforce the Commercial Feed Law, which must be consistent with
the rules and standards of the United States Food and Drug Administration (FDA) and the United
States Department of Agriculture (USDA). The rules must include:
Establishing definitions and reasonable standards for commercial feed or feedstuff and
permissible tolerances for pesticide chemicals, chemical additives, nonnutritive ingredients, or
drugs in or on commercial feed or feedstuff in such amounts as will ensure the safety of
livestock and poultry and the products thereof used for human consumption.
Adopting standards for the manufacture and distribution of medicated feed.
Establishing definitions and reasonable standards for the certification of laboratories for the
conduct of testing and analyses as required.
Establishing product labeling requirements for distributors.
Limiting the use of drugs in commercial feed and prescribing feeding directions to be used to
ensure safe usage of medicated feed.
Establishing standards for evaluating quality-assurance/quality-control plans, including testing
protocols, for exemptions to certified laboratory testing requirements.
Establishing standards for the sale, use, and distribution of commercial feed or feedstuff to
ensure usage that is consistent with animal safety and well-being and, to the extent that meat,
poultry, and other animal products for human consumption may be affected by commercial feed
or feedstuff, to ensure that these products are safe for human consumption.
o Such standards must be developed in consultation with the Agricultural Feed, Seed, and
Fertilizer Advisory Council created under s. 570.451, F.S.
1
See ch. 580, F.S.
2
S. 580.036, F.S.
3
S. 580.041, F.S.
4
S. 580.051, F.S.
5
S. 580.041, F.S.
6
S. 580.0365, F.S.
7
S. 580.091, F.S.
8
R. 5E-3.013, F.A.C. The Association of American Feed Control Officials (AAFCO) is an independent organization that has been
guiding state, federal and international feed regulators with ingredient definitions, label standards and laboratory standards for more
than 110 years, while supporting the health and safety of people and animals. AAFCO members are charged by their local, state or
federal laws to regulate the sale and distribution of animal feeds and animal drug remedies. STORAGE NAME: h0959.RRS PAGE: 3
DATE: 3/26/2023
DACS is required to establish the standards that a laboratory must meet to become certified in any of
the following areas of testing:
9
Nutrient.
Mycotoxins.
Microbiological organisms.
Pesticide residues.
Drugs.
DACS is guided by the methods published by the Association of Official Analytical Chemists, the United
States Environmental Protection Agency (EPA), the FDA, or other generally recognized authorities in
developing the standards for the laboratory certifications.
10
The Commercial Feed Law prohibits distribution of an adulterated commercial feed or feedstuff.
Commercial feed or feedstuff is deemed adulterated if it includes any of the following:
11
Any poisonous, deleterious, or nonnutritive substance that may render it injurious to animal or
human health.
o However, if the substance is not an additive, the feed shall not be considered
adulterated if the quantity of the substance does not ordinarily render it injurious to
animal or human health.
Any food additive or added poisonous, deleterious, or nonnutritive substance that is unsafe
within the meaning of s. 406 of the Federal Food, Drug, and Cosmetic Act, other than a
pesticide chemical in or on a raw agricultural commodity.
Any food additive or color additive that is unsafe within the meaning of s. 409 or s. 512 of the
Federal Food, Drug, and Cosmetic Act.
A raw agricultural commodity that bears or contains a pesticide chemical that is unsafe within
the meaning of s. 408(a) of the Federal Food, Drug, and Cosmetic Act.
o However, where a pesticide chemical has been used in or on a raw agricultural
commodity in conformity with an exemption granted or a tolerance prescribed under s.
408 of the Federal Food, Drug, and Cosmetic Act and that raw agricultural commodity
has been subjected to processing such as canning, cooking, freezing, dehydrating, or
milling, the processed feed will result, or is likely to result, in pesticide residue in the
edible product of the animal which is unsafe within the meaning of s. 408(a) of the
Federal Food, Drug, and Cosmetic Act.
Any new animal drug that is unsafe within the meaning of s. 512 of the Federal Food, Drug, and
Cosmetic Act.
Any filthy, putrid, or decomposed substance or is otherwise unfit for feed.
If it is prepared, packaged, or held under unsanitary conditions in which it may have become
contaminated with filth or rendered injurious to health.
If it is the product of a diseased animal or of an animal that has died by a means other than
slaughter which is unsafe within the meaning of s. 402(a)(1) or (2) of the Federal Food, Drug,
and Cosmetic Act.
The Commercial Feed Law prohibits misbranded commercial feed or feedstuff. A commercial feed or
feedstuff is deemed misbranded, as follows:
12
If its labeling is false or misleading in any particular.
If it is distributed under the name of another commercial feed or feedstuff.
If it is not labeled as required by this chapter or the rules promulgated hereunder.
If it does not conform to the definition of identity and standard of quality as prescribed by rule.
If any word, statement, or other information required by this chapter to appear on the label or
labeling is not prominently and conspicuously placed thereon in such terms as to render it likely
to be read and understood by the ordinary individual under customary conditions of purchase
and use.
9
S. 580.065, F.S.
10
Id.
11
S. 580.071, F.S.
12
S. 580.081, F.S. STORAGE NAME: h0959.RRS PAGE: 4
DATE: 3/26/2023
If it is not appropriate for its intended or purported use.
If a nutrient test, conducted by a laboratory certified in nutrient testing, shows the presence of
any ingredient not listed on the label or the absence of any ingredient shown on the label.
The following acts are prohibited by the Commercial Feed Law:
13
Distribution of any commercial feed or feedstuff that is adulterated or misbranded.
Adulteration or misbranding of any commercial feed or feedstuff.
Distribution of commercial feed or feedstuff that has not been sampled or analyzed by a
department-certified laboratory.
Distribution of agricultural commodities such as whole seed, hay, straw, stover, silage, cobs,
husks, and hulls which are adulterated.
Dissemination of any false advertisement with reference to the distribution of any commercial
feed or feedstuff.
Refusal to permit entry, inspection, or collection of samples of commercial feed or feedstuff by
authorized department personnel.
Removal or disposal of a lot of commercial feed or feedstuff that has had a stop-sale, stop-use,
removal, or hold order issued, prior to release by the department or the court.
Use of any label that does not comply with the provisions of this chapter.
Forging, counterfeiting, simulating, or false representing of any label.
Placing or permitting to be placed any false advertisement or misleading statement on a label.
Redistribution of a customer-formula commercial feed.
Using or placing of fasteners that may be injurious to animals on any commercial feed or
feedstuff or bags of any commercial feed or feedstuff, except those distributed exclusively for
poultry.
Failure or refusal to register, pay inspection fees, or file reports, or perform any other affirmative
act required by this chapter or rule promulgated hereunder.
Distribution of a feed or feedstuff which is prohibited by federal law or regulation.
DACS is authorized to impose one or more of the following penalties against any person who violates
the Commercial Feed Law:
14
Issuance of a warning letter.
A Class I fine for each occurrence.
15
Revocation or suspension of the master registration, laboratory certification, or quality-
assurance/quality-control plan approval.
Probation for up to six months.
The severity of the penalty imposed must be commensurate with the degree of risk to human or animal
safety or the level of financial harm to the consumer that is created by the violation.
16
Violations of the Commercial Feed Law are a second degree misdemeanor, punishable by a 60 day
term in prison and a $500 fine.
17
The Commercial Feed Law defines “commercial feed” as all materials or combinations of materials
that are distributed or intended to be distributed for use as feed or for mixing in a feed for animals
other than humans, except:
18
Unmixed whole seeds, including physically altered entire unmixed seeds, when such seeds are
not chemically changed or are not adulterated;
13
S. 580.112, F.S.
14
S. 580.121, F.S.
15
S. 570.971, F.S., provides that for each violation in the Class I category, a fine not to exceed $1,000 may be imposed.
16
S. 580.121, F.S.
17
Ss. 775.082, and 775.083, F.S.
18
S. 580.031(2), F.S. STORAGE NAME: h0959.RRS PAGE: 5
DATE: 3/26/2023
Unground hay, straw, stover, silage, cobs, husks, and hulls, and individual chemical compounds
or substances, when such commodities, compounds, or substances are unmixed with other
substances and are not adulterated; and
Feed mixed by the consumer for the consumer’s own use made entirely or in part from products
raised on the consumer’s farm.
“Feedstuff” is defined as edible materials, other than commercial feed, that are distributed for animal
consumption and that contribute energy or nutrients, or both, to an animal diet.
19
Animal Industry
The DACS Division of Animal Industry (Division) is responsible for enforcing the state’s animal industry
law, which provides animal health regulations and protects the state from animal pests and diseases.
20
District veterinarians and animal health inspectors throughout the state work with producers, animal
owners and private veterinarians to monitor and enhance the health and welfare of Florida's animals.
21
Under Florida's Comprehensive Emergency Management Plan, the Division serves as the lead agency
for animal and agricultural issues, planning and coordinating the state's response to emergencies
ranging from hurricanes to animal disease outbreaks.
22
The animal industry law authorizes the Division to:
23
Establish, maintain, and enforce quarantine areas within the state, or the entire state.
Restrict, regulate, or prohibit the movement or transportation of animals found, determined, or
suspected to be carriers of certain contagious, infectious, or communicable disease.
The animal industry law authorizes the Division to adopt rules to:
24
Govern the introduction of animals into or within the state.
Govern the disposal or destruction of carcasses of animals to prevent the spread or
continuance of the contagion or infection.
Condemn and destroy any barn, yard, shed, corral, or pen that may convey infection or
contagion.
Violations of the animal feed law are subject to a Class I fine for each occurrence.
25
For repeated
violations, DACS is authorized to seek administrative enforcement, including declaratory relief or a
maximum fine of $1,000.
26
Unless otherwise provided, violations of the animal industry law are a second degree misdemeanor,
punishable by a 60 day term in prison and a $500 fine.
27
Dosage Form Animal Products
The humanization of certain species, including horses, dogs, and cats, has resulted in the emergence
of animal health supplements, referred to as “dosage form supplements.” These supplements are
19
S. 580.031(10), F.S.
20
See ch. 585, F.S.
21
Department of Agriculture and Consumer Services, Division of Animal Industry, https://www.fdacs.gov/Divisions-Offices/Animal-
Industry (last visited Mar. 25, 2023).
22
Id.
23
S. 585.08(1), F.S.
24
S. 585.08(2), F.S.
25
S. 570.971, F.S., provides that for each violation in the Class I category, a fine not to exceed $1,000 may be imposed.
26
S. 585.007, F.S.
27
Ss. 775.082, and 775.083, F.S. STORAGE NAME: h0959.RRS PAGE: 6
DATE: 3/26/2023
similar to dietary supplements for humans.
28
In dogs and cats, the most popular supplements include
joint and digestive health supplements, followed by supplements to aid with cognition, skin/coat and
heart health. For horses, owners can use supplements to treat or prevent osteoarthritis, joint disease,
digestion, hoof growth, coat, and behavior.
29
According to the National Library of Medicine (NLM), such pet supplements and nutraceuticals are
widely used and generate millions of dollars in revenue for manufacturers. Despite the widespread use
of these veterinary products, oversight and regulation remain limited as compared to human dietary
supplement regulations. The NLM also provides that scientific information on veterinary pet
supplements and nutraceuticals is increasing; however, there is a lack of quality control, safety and
efficacy data for the majority of the substances marketed in pet supplements and the resulting products
for purchase currently available. Despite this lack of evidence, the use of veterinary supplements and
nutraceuticals continues to increase.”
30
Food and Drug Administration
The U.S. Food and Drug Administration (FDA) Center for Food Safety and Applied Nutrition (CFSAN)
31
regulates the safety of dietary supplements in humans. The term “dietary supplement” is defined in the
Dietary Supplement Health and Education Act (DSHEA) of 1994,
32
as a product taken by mouth in
humans that contains a “dietary ingredient” intended to supplement the diet. A “dietary ingredient” can
include vitamins, minerals, herbs or other botanicals, amino acids and substances such as enzymes,
organ tissues and metabolites. The definition of ‘‘dietary supplement’’ does not explicitly state whether
it includes or excludes products intended for use in animals other than man.
33
The FDA Center for Veterinary Medicine (CVM)
34
is responsible for the regulation of animal food
products. The CVM has mechanisms for food additive approval, which apply to any product unless it is
generally recognized as safe for that intended use (i.e. forages, grains and most mineral and vitamins).
This regulation applies to animal food additives that could affect the target animal’s safety.
Under Section 201(s) of the Federal Food, Drug, and Cosmetic Act (FD&C Act),
35
the definition of a
food additive does not include any ingredient in or intended for use in a dietary supplement. Although
the dietary ingredient used in the dietary supplement must not adulterate the supplement, it does not
have to be Generally Recognized As Safe (GRAS) for its intended use in the supplement. However,
non-dietary ingredients (binders, fillers, etc.) are not exempt from the food additive definition. If any
product claims to cure, treat, prevent or mitigate disease, the product should be considered a “new
animal drug.”
Pet food, including pet treats but not pet supplements, falls under the Association of American Feed
Control Officials (AAFCO) and is regulated on a federal and state level. For now, AAFCO only
regulates labeling of “food-type” supplements, although it will monitor for any ingredient
misrepresentation of all animal supplements. Seven states, including Texas, Oregon, Michigan, North
28
State of Wisconsin Department of Agriculture, Trade and Consumer Protection, Labeling of Dosage Form Animal Health
Supplements for Non-human Food Producing Animals, https://datcp.wi.gov/Documents/Feed-
DosageFormAnimalHealthSuppPolicy.pdf (last visited Mar. 25, 2023).
29
National Library of Medicine, Veterinary Pet Supplements and Nutraceuticals,
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7802882/ (last visited Mar. 25, 2023).
30
Id.
31
U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, https://www.fda.gov/about-fda/fda-
organization/center-food-safety-and-applied-nutrition-cfsan (last visited Mar. 25, 2023).
32
Pub. L. No. 103-417.
33
National Library of Medicine, Veterinary Pet Supplements and Nutraceuticals,
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7802882/ (last visited Mar. 25, 2023).
34
U.S. Food and Drug Administration, Center for Veterinary Medicine, https://www.fda.gov/about-fda/fda-organization/center-
veterinary-medicine (last visited Mar. 25, 2023).
35
21 U.S.C. § 301-399. STORAGE NAME: h0959.RRS PAGE: 7
DATE: 3/26/2023
Dakota, South Dakota, Virginia and Wyoming have enacted “remedy laws” to regulate pet supplements
that do not qualify as “foods” according to the AAFCO definition.
36
The DSHEA controls the way the FDA regulates “food for humans.” Among other things, it restricts
substances from being food additives or drugs if the product meets the definition of a dietary
supplement. Supplements intended for companion animals (i.e. not food animals for human
consumption) do not fall under the DSHEA and therefore undergo less regulatory oversight than human
dietary supplements.
37
According to the FDA, the DSHEA does not apply to animal products.
38
Thus, products marketed as
dietary supplements or “feed supplements” for animals still fall under the FD&C Act. These items are
considered “foods” or “drugs” depending on the intended use, or in some instances the articles may be,
simultaneously, a food and a drug. The FD&C Act defines the term "food" as an article used for food or
drink for man or other animals including components of such articles. Thus, any nutrient ingredient
(e.g., vitamins, minerals, and amino acids) which is added to a food is also a food by definition. The
FD&C Act also defines the term "drug" as including any article intended for use as a component of a
drug. A nutrient ingredient used as a component of a dosage form drug must meet the requirements for
a drug. A nutrient ingredient used as a component of all other medicated products must meet the
requirements for a food. While a nutrient ingredient of a non-dosage form product is also a drug when it
is intended for use as a component of a drug, the nutrient will be primarily regulated as a food and need
not be shown to serve an active drug purpose provided no drug claims are made or implied for the
nutrient.
39
The regulatory status of an article is determined by CVM on a case-by-case basis. Under the FD&C
Act, "animal feeds/foods" refers to feed for livestock, poultry, or other animals, and pet food. These
articles may ordinarily be thought of as foods under the Act, and also, in some cases, as food additives.
However, based upon the claims made for these articles, their intended uses may bring them within the
definition of a drug under the Act. In such instances, the articles may, as a matter of law, be both a food
and a drug simultaneously.
40
According to DACS, manufacturers and distributors of dosage form animal products in Florida are
currently being regulated under the Commercial Feed Law due to the products’ non-nutritional
character. As a result, marketers of “dosage form animal health products” are required to comply with
the registration, labeling, and sampling requirements followed by distributors of other no- or low-
nutritive value products allowed for use as, or for mixing in, animal feed.
41
Proposed Changes
The bill provides biennial registration and labelling requirements for manufacturers of dosage form
animal products with DACS, including responsibilities regarding application, labelling, misbranding,
adulteration, and rulemaking authority.
The bill requires a manufacturer or distributor that manufactures or distributes the finished form of a
dosage form animal health product in the state to submit a registration application to DACS every two
years as prescribed by DACS rule.
36
National Library of Medicine, Veterinary Pet Supplements and Nutraceuticals,
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7802882/ (last visited Mar. 25, 2023).
37
State of Wisconsin Department of Agriculture, Trade and Consumer Protection, Labeling of Dosage Form Animal Health
Supplements for Non-human Food Producing Animals, https://datcp.wi.gov/Documents/Feed-
DosageFormAnimalHealthSuppPolicy.pdf (last visited Mar. 25, 2023).
38
61 C.F.R. § 17706.
39
U.S. Food and Drug Administration, Nutritional Ingredients in Animal Drugs and Feeds, https://fda.report/media/70108/Guide-
1240.3420-Nutritional-Ingredients-in-Animal-Drugs-and-Feeds.pdf (last visited Mar. 25, 2023).
40
U.S. Food and Drug Administration, FDA/CVM Program Policy and Procedures Manual Guide 1240.3605,
https://www.fda.gov/media/69982/download (last visited Mar. 25, 2023).
41
Florida Department of Agriculture and Consumer Services, Agency Analysis of House Bill 959, pgs. 1 and 2 (Mar. 9, 2023). STORAGE NAME: h0959.RRS PAGE: 8
DATE: 3/26/2023
The bill authorizes DACS to waive the registration requirement if a manufacturer or distributor is
registered under another federal or state law in compliance with DACS rule.
The bill authorizes DACS to require a registration application to include a copy of the label and labeling
for each dosage form animal health product.
The bill requires a dosage form animal health product label to contain, at a minimum, all of the following
information:
The net weight or count of the product.
The product name and brand name, if any, under which the product is manufactured or
distributed.
The established name of each active ingredient in the product and the amount of each active
ingredient per serving in descending order by predominance of the ingredient in the product.
The established name of each inactive ingredient in the product and the amount of each
inactive ingredient per serving in alphabetical order.
Adequate directions and precautionary statements and warnings necessary to ensure safe and
effective use of the product.
The name and principal mailing address of the manufacturer or distributor.
o Only the name, city, state, and zip code are required for a manufacturer or distributor
listed in a local telephone directory.
A structure-function claim stating the intended non-nutritional benefit of the product.
The expiration date.
The bill provides that a dosage form animal health product is considered misbranded if the product
label or labeling:
Does not provide the required labeling information in a prominent and conspicuous manner
which can be easily identified and understood under customary conditions of purchase and use.
Includes the term "guaranteed analysis."
Is false or misleading.
The bill provides that a dosage form animal health product is considered adulterated if:
The product contains any poisonous or deleterious substance that may be injurious to animal
health.
Any valuable ingredient of the product has been in whole or in part omitted or removed.
Any valuable ingredient of the product has been in whole or in part substituted by any less
valuable ingredient.
The composition or quality of the product falls below or differs from what the label or labeling
purports or represents.
The methods or controls used to manufacture or package the product do not conform to current
good manufacturing practice.
The bill prohibits dosage form animal health products from being considered commercial feed, a drug,
or feedstuff as those terms are defined in s. 580.031, F.S., of the Commercial Feed Law.
The bill provides the following definitions:
"Brand name" means any distinguishing word, name, symbol, or device, or combination thereof,
identifying the dosage form animal health product of a manufacturer or distributor.
"Distribute" means to offer for sale, sell, barter, or exchange a dosage form animal health
product or to supply, furnish, or otherwise provide such a product for use by any consumer or
customer in the state.
"Distributor" means a person or entity that distributes dosage form animal health products.
"Dosage form animal health product" means any product, including oils, tinctures, capsules,
tablets, liquids, soft chews, and chewable limited dose products, intended to affect the structure
or function of an animal's body other than by providing nutrition to the animal. The term does
not include animal feed supplements, products represented as a primary meal for the intended STORAGE NAME: h0959.RRS PAGE: 9
DATE: 3/26/2023
animal species, products intended as a snack treat or behavioral reward treat, or dental
products providing mechanical or abrasive action.
"Label" means a display of written, printed, or graphic matter upon or affixed to the container in
which a dosage form animal health product is distributed, or on the invoice or delivery slip with
which the product is distributed.
"Labeling" means all labels and other written, printed, or graphic matter upon a dosage form
animal health product or any of its containers; all wrappers accompanying the product; and all
advertisements, brochures, posters, or television or radio announcements used in promoting the
sale of the product.
"Manufacture" means the grinding, mixing, blending, or further processing of a dosage form
animal health product for distribution.
"Manufacturer" means a person or entity that manufactures dosage form animal health
products.
"Product name" means the name of a dosage form animal health product which identifies the
kind, class, or specific use of the product.
The effective date of the bill is July 1, 2023.
B. SECTION DIRECTORY:
Section 1: Creates s. 585.012, F.S.; requiring manufacturers and distributors of dosage form animal
health products to register with DACS; providing requirements for registration; providing
conditions under which products are considered misbranded or adulterated.
Section 2: Provides an effective date.
II. FISCAL ANALYSIS & ECONOMIC IMPACT STATEMENT
A. FISCAL IMPACT ON STATE GOVERNMENT:
1. Revenues:
See Fiscal Comments.
2. Expenditures:
See Fiscal Comments.
B. FISCAL IMPACT ON LOCAL GOVERNMENTS:
1. Revenues:
None.
2. Expenditures:
None.
C. DIRECT ECONOMIC IMPACT ON PRIVATE SECTOR:
The bill will require certain manufacturers of dosage form animal products to register and comply with
labelling requirements with DACS. According to DACS, the department will need to charge a fee not to
exceed $200 for registration. See Fiscal Comments.
Dosage form animal health products that are currently on sale may need to be recalled to be accurately
labelled, which may have a negative fiscal impact to the distributors and business owners of those
products.
D. FISCAL COMMENTS: STORAGE NAME: h0959.RRS PAGE: 10
DATE: 3/26/2023
According to DACS, “the bill would require the registration of manufactures and distributors of dosage
form animal health products. Additionally, enforcement and inspection activities relating to registration
requirements, Feed Marketplace inspections, label evaluations, and consumer complaints would
necessitate additional inspection and lab staff. Associated cost for lab analysis would be expected to
run around $350 per sample depending on the screen. Revenues associated with violations of the
proposed bill cannot be estimated at this time. Current law allows for the imposition of a Class III, up to
$10,000 fine per violations of the chapter.”
42
“The specific process for registration, to include cost, will need to be established through rulemaking
and in accordance with s. 585.002, F.S., but would not exceed $200 per registration. It is estimated
approximately 100 entities will be affected by the proposed legislation. The bill does not contain any
penalty provisions, but Chapter 585, allows for the imposition of an administrative fine of up to $10,000
per violation of the chapter or associated rules.”
43
“Registration fees imposed on manufacturers and distributors of “dosage form animal health products”
that are currently registered under Ch. 580, F.S., would be eliminated. Ch. 580, F.S,. registration fees
are based on volume of distribution; therefore, most affected entities are required to pay $40
annually.”
44
“Cost of registration under proposed HB 959 is not contemplated but fee authority under Chapter 585,
F.S., allows for the department, by rule, to establish a fee schedule to cover the approximate costs
associated with carrying out the provisions of the chapter, not to exceed $200.”
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III. COMMENTS
A. CONSTITUTIONAL ISSUES:
1. Applicability of Municipality/County Mandates Provision:
Not applicable. This bill does not appear to require counties or municipalities to spend funds or take
action requiring the expenditures of funds; reduce the authority that counties or municipalities have
to raise revenues in the aggregate; or reduce the percentage of state tax shared with counties or
municipalities.
2. Other:
Article VII, Section 19 of the Florida Constitution requires a supermajority vote to impose or raise a
tax or fee. Under this provision, “Raise” means:
a. “To increase or authorize an increase in the rate of a state tax or fee imposed on a
percentage or per mill basis;
b. To increase or authorize an increase in the amount of a state tax or fee imposed on a flat or
fixed amount basis; or
c. To decrease or eliminate a state tax or fee exemption or credit.”
The bill allows DACS to implement the provisions of the bill by rule. DACS has indicated that this will
necessitate the imposition of a $200 registration fee. It is unclear as to whether this would constitute the
“raising” of a fee as defined in Art. VII s. 19.
B. RULE-MAKING AUTHORITY:
The bill authorizes DACS to prescribe rules to administer the registration of certain manufacturers of
dosage form animal health products pursuant to the animal industry law. According to DACS, these
entities are currently being regulated under the Commercial Feed Law, and r. 5E-3, F.A.C.
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Florida Department of Agriculture and Consumer Services, Agency Analysis of House Bill 959, p. 2 (Mar. 9, 2023).
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Id.
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Id.
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Id. STORAGE NAME: h0959.RRS PAGE: 11
DATE: 3/26/2023
However, the animal industry law provides the department with sufficient rulemaking authority to
implement the bill.
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C. DRAFTING ISSUES OR OTHER COMMENTS:
None.
IV. AMENDMENTS/COMMITTEE SUBSTITUTE CHANGES
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S. 585.002, F.S.