The Florida Senate
BILL ANALYSIS AND FISCAL IMPACT STATEMENT
(This document is based on the provisions contained in the legislation as of the latest date listed below.)
Prepared By: The Professional Staff of the Committee on Fiscal Policy
BILL: CS/SB 1056
INTRODUCER: Appropriations Committee on Agriculture, Environment, and General Government; and
Senator Gruters
SUBJECT: Dosage Form Animal Health Products
DATE: April 24, 2023 REVISED:
ANALYST STAFF DIRECTOR REFERENCE ACTION
1. Burse Becker AG Favorable
2. Blizzard Betta AEG Fav/CS
3. Burse Yeatman FP Favorable
Please see Section IX. for Additional Information:
COMMITTEE SUBSTITUTE - Substantial Changes
I. Summary:
CS/SB 1056 defines a “dosage form animal product” as a regulated feedstuff under the Florida
Commercial Feed Law, requiring such products to be subject to related fees, quality, safety, and
labeling requirements, pursuant to ch. 580, Florida Statutes. The Department of Agriculture and
Consumer Services (department) administers and enforces the Florida Commercial Feed Law.
The bill includes specific labeling requirements and clarifies that a dosage form animal product
does not apply to drugs that are administered or used to treat animals as defined under federal
law.
The bill is expected to have an indeterminate impact on state revenues and a negative operational
fiscal impact on state expenditures. See Section V. Fiscal Impact Statement.
The bill takes effect July 1, 2023.
BILL: CS/SB 1056 Page 2
II. Present Situation:
The Florida Commercial Feed Law
The Florida Commercial Feed Law (Commercial Feed Law)1 authorizes the Department of
Agriculture and Consumer Services (department) 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 registration3 and place on file with the department, 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 the department 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
Any commercial feed distributed in this state, except a customer-formula feed and feed
distributed through an integrated poultry operation or by a cooperative to its members, must be
accompanied by a legible label bearing all information required by the federal Food and Drug
Administration (FDA) and the following information:9
 An accurate statement of the net weight.
 The name and principal address of the registrant.
 The brand name and product name, if any, under which the commercial feed is distributed.
The word “medicated” must be incorporated as part of the brand or product name if the
commercial feed contains a drug.
The department is authorized to require feeding directions and precautionary statements to be
placed on the label for the safe and effective use of medicated and other feed as deemed
necessary.10
Labels on medicated feed must include all of the following:
1
See ch. 580, F.S.
2
Section 580.036, F.S.
3
Section 580.041, F.S.
4
Section 580.051, F.S.
5
Section 580.041, F.S.
6
Section 580.0365, F.S
7
Section 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
standard s 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.
9
Section 580.051(1), F.S.
10
Id.
BILL: CS/SB 1056 Page 3
 Any feeding directions prescribed by the department to ensure safe usage.
 The stated purpose of the medication contained in the feed as stated in the claim statement.
 The established name of each active drug ingredient.
 The level of each drug used in the final mixture expressed in metric units as well as the
required weight measurement.
Commercial feed labels must also include a guaranteed analysis stated in terms that advise the
consumer of the composition of the feed or feedstuff or support claims made in the labeling. In
all cases, the elements or compounds listed in the analysis must be determinable by laboratory
methods approved by the department.11
The department 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 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.
The department is required to establish the standards that a laboratory must meet to become
certified in any of the following areas of testing:12
 Nutrient.
 Mycotoxins.
 Microbiological organisms.
 Pesticide residues.
 Drugs.
11
Id.
12
Section 580.065, F.S.
BILL: CS/SB 1056 Page 4
The department 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.13
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:14
 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:15
 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 ch. 580, F.S, to appear on the label
or labeling is not prominently and conspicuously placed thereon in such terms as to render it
13
Id.
14
Section 580.071, F.S.
15
Section 580.081, F.S
BILL: CS/SB 1056 Page 5
likely to be read and understood by the ordinary individual under customary conditions of
purchase and use.
 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:16
 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 ch. 580, F.S.
 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.
The department is authorized to impose one or more of the following penalties against any
person who violates the Commercial Feed Law:17
 Issuance of a warning letter.
 A Class I fine for each occurrence.18
 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.19
16
Section 580.112, F.S.
17
Section 580.121, F.S.
18
Section 570.971, F.S., provides that for each violation in the Class I category, a fine not to exceed $1,000 may be imposed.
19
Section 580.121, F.S.
BILL: CS/SB 1056 Page 6
Violations of the Commercial Feed Law are a second-degree misdemeanor, punishable by a 60
day term in prison and a $500 fine.20
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:21
 Unmixed whole seeds, including physically altered entire unmixed seeds, when such seeds
are not chemically changed or are not adulterated;
 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.22
Dosage-Form Animal Products
The National Animal Supplement Council (council) defines dosage form animal health products
as articles (other than food) intended to affect the structure or any function of the body other than
providing nutrition.23 The council lists the following as examples of dosage form animal health
products:
 Hip & Joint Support;
 Calming Aids;
 Antioxidants;
 Organ-Specific Support such as heart, bladder or brain;
 Immune Support; and
 Most Herbal Products.24
Vermont
In May 2021, Vermont Governor Phil Scott signed Act No. 41 (S.102) into law.25 The law
provides rules and fees for registration, labeling requirements, and conditions under which
dosage form animal health products are considered misbranded or adulterated.26 The law also
provides additional rules and administrative penalties for person distributing dosage form animal
health product within the state.27
20
Sections 775.082, and 775.083, F.S.
21
Section 580.031(2), F.S.
22
Section 580.031(10), F.S.
23
See https://www.nasc.cc/news/how-to-read-a-label/ (last visited March 8, 2023).
24
Id.
25
See https://legislature.vermont.gov/bill/status/2022/S.102 (last visited March 8, 2023).
26
See https://legislature.vermont.gov/Documents/2022/Docs/ACTS/ACT041/ACT041%20As%20Enacted.pdf (last visited
March 8, 2023).
27
Id.
BILL: CS/SB 1056 Page 7
III. Effect of Proposed Changes:
The bill includes “dosage form animal products”