SB 1056 — Dosage Form Animal Health Products

Subsection (1) of section 580.051, Florida Statutes, is amended to read:

580.051 Labels;

requirements;

penalty.— (1) Any commercial feed or feedstuff distributed in this state, except a customer-formula feed and feed distributed through an integrated poultry operation or by a cooperative to its members, shall be accompanied by a legible label bearing all information required by the federal Food and Drug Administration and the following information:

(a) An accurate statement of the net weight.

(b) The name and principal address of the registrant.

(c) The brand name and product name, if any, under which Page 2 of 5 CODING:

Florida Senate - 2023 CS for SB 1056 22-00860-23601-03982-23 20231056__20231056c1 product in the statecommercial mustfeed submitis adistributed. registration application to the department every 2 years as prescribed by department rule.

The departmentword may“medicated” waiveshall thebe registrationincorporated requirementas ifpart aof manufacturerthe brand or distributorproduct isname registeredif underthe anothercommercial federalfeed orcontains statea lawdrug. in compliance with department rule.

(b)1. The department may require a registration application to include a copy of the label and labeling for each dosage form animal health product.

(3)The Adepartment dosagemay formrequire animalfeeding healthdirections productand precautionary statements to be placed on the label mustfor contain,the atsafe aand minimum,effective alluse of themedicated followingand information:other feed as deemed necessary.

(a)2. The net weight or count of the product.

(b)Labels Theon productmedicated namefeed andshall brandinclude name,all ifof any, under which the productfollowing: is manufactured or distributed.

(c)a. 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.

(d)Any Thefeeding establisheddirections nameprescribed ofby each inactive ingredient in the productdepartment andto theensure amountsafe ofusage. each inactive ingredient per serving in alphabetical order.

(e)b. Adequate directions and precautionary statements and warnings necessary to ensure safe and effective use of the product.

(f) The namestated andpurpose principalof mailingthe addressmedication ofcontained in the manufacturerfeed oras distributor.stated in the claim statement.

Onlyc. the name, city, state, and zip code are required for a manufacturer or distributor listed in a local telephone directory.

(g)The Aestablished structure-functionname claimof statingeach theactive intendeddrug non-ingredient. nutritional benefit of the product.

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The level of each drug used in the final mixture expressed in metric units as well as the required avoirdupois.

(d) The date of manufacture or expiration date of commercial feed sold at retail as the department may by rule require.

(e) The 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.

However, products sold solely as dosage form animal products and guaranteed as specified in this section need not show a guaranteed analysis.

1.

The guaranteed analysis, listing the minimum percentage of crude protein, minimum percentage of crude fat, and maximum percentage of crude fiber and, when more than 10 percent mineral Page 3 of 5 CODING:

Florida Senate - 2023 CS for SB 1056 22-00860-23601-03982-23 20231056__20231056c1 (h)ingredients Theare expirationpresent, date.the minimum or maximum percentages of mineral elements or compounds as provided by rule.

(4)2. A dosage form animal health product is considered misbranded if the product label or labeling:

(a)Vitamin Doesingredients, notwhen provideguaranteed, theshall informationbe requiredshown in subsectionamounts (3) in a prominent and conspicuousterms mannerprovided whichby canrule. be easily identified and understood under customary conditions of purchase and use.

(b)For Includesmineral feed, the termlist “guaranteedshall analysis.”include (c)the Isfollowing: false or misleading.

(5)maximum Aor dosageminimum formpercentages animalof healthcalcium product(Ca), isphosphorus considered(P), adulteratedsalt if:(NaCl), iron (Fe), copper (Cu), cobalt (Co), magnesium (Mg), manganese (Mn), potassium (K), selenium (Se), zinc (Zn), and fluorine (F) if ingredients used as sources of any of these constituents are declared.

(a)All Themixtures productthat containscontain anymineral poisonous or deleteriousvitamin substanceingredients generally regarded as dietary factors essential for the normal nutrition of animals and that are sold or represented for the primary purpose of supplying these minerals or vitamins as additions to rations in which these same mineral or vitamin factors may be injuriousdeficient toshall animalbe health.classified as mineral or vitamin supplements.

(b)Products Anysold valuablesolely ingredientas ofmineral theor productvitamin hassupplements beenand inguaranteed wholeas orspecified in partthis omittedsection orneed removed.not show guarantees for protein, fat, and fiber.

(c)3. Any valuable ingredient of the product has been in whole or in part substituted by any less valuable ingredient.

(d)Other Thenutritional compositionsubstances or qualityelements ofdeterminable theby productlaboratory fallsmethods belowmay be guaranteed by permission of, or differsshall frombe whatguaranteed at the labelrequest orof, labelingthe purportsdepartment oras represents.may be provided by rule.

(e)(f) The methodscommon or controlsusual usedname toof manufactureeach oringredient packageused in the productmanufacture doof notthe conformcommercial tofeed; current good manufacturing practice.

(6)however, Dosagefor formall animalcommercial healthfeed productsexcept mayhorse notfeed, bethe considereddepartment commercialby feed,rule amay drug,permit orthe feedstuffuse asof thosecollective terms arefor defineda ingroup s.of ingredients which perform a similar nutritional function.

580.031.(g) A label on a dosage form animal product must contain all of the following:

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ThisWords actstricken shallare takedeletions; effect July 1, 2023.

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Florida Senate - 2023 CS for SB 1056 601-03982-23 20231056c1 1.

An accurate statement of the net weight.

2.

The name and principal address of the registrant.

3.

The brand name and product name, if any, under which the dosage form animal product is distributed.

4.

The date of manufacture or expiration date of the dosage form animal product sold at retail as the department may by rule require.

5.

The amount of each active ingredient per serving.

6.

The common or usual name of each inactive ingredient contained in the dosage form animal product.

7.

A statement that identifies how the dosage form animal product supports the structure or function of the animal.

8.

Precautionary statements and warnings required to ensure the safe and effective use of the dosage form animal product.

9.

Recommended dosage by animal weight.

10.

The statement “Not for human consumption.” Section 3.

This act shall take effect October 1, 2023.

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