The purpose of this rulemaking is to implement statutory changes passed during the 2023 Legislative Session.

 

DEPARTMENT OF AGRICULTURE AND CONSUMER SERVICES

Division of Food Safety

RULE NO.:RULE TITLE:

5K-4.034Hemp Extract for Human Consumption

PURPOSE AND EFFECT: The purpose of this rulemaking is to implement statutory changes passed during the 2023 Legislative Session.

SUMMARY: The proposed rule updates definitions, penalties for violations and the requirements regarding hemp and hemp extract for human consumption, including the operation of a Hemp Food Establishment, contaminants and limits, packaging, labeling, advertising, and the use of self-service machines.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION:

The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the Agency.

The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: The proposed changes to Rule 5K-4.034, F.A.C., clarify existing fine authority for certain violations and clarify existing statutory requirements, including prohibitions on product labeling, packaging, and advertising that is attractive to children. Fines are only imposed in the event of a violation, so there is no additional cost to regulated entities. Furthermore, the prohibitions on labeling and packaging that is attractive to children and on advertising that targets or is attractive to children are already in statute, so there is no additional cost to businesses as a result of this rule.

Therefore, no adverse impact or regulatory cost is associated with this rule that exceeds the criteria in section 120.541(2)(a), F.S. Based upon this analysis, the Department has determined that the proposed rule is not expected to require legislative ratification.

Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.

RULEMAKING AUTHORITY: 500.09, 500.12, 570.07(23), 581.217(12), F.S.

LAW IMPLEMENTED: 500.03, 500.04, 500.09, 500.10, 500.11, 500.12, 500.121, 500.13, 500.172, 581.217, F.S.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAR.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Brenda Noble, [e-mail]

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

5K-4.034 Hemp Extract for Human Consumption. 

(1) Products.  

(a) Section 500.03, F.S., defines “food” to include hemp extract as defined in Section 581.217, F.S. Section 581.217(7)(b), F.S., provides that Hemp Extract distributed or sold in violation of Section 581.217, F.S., shall be considered adulterated or misbranded pursuant to Chapter 500, F.S. As such, products consisting of or containing Hemp or Hemp Extract intended for Human Consumption are subject to the requirements of Chapter 500, F.S., Section 581.217, F.S., and Rules 5K-4.002, 5K-4.004, 5K-4.020, 5K-4.021, and 5K-4.035, F.A.C., in addition to the requirements of this rule. 

(b) Hemp or Hemp Extract intended for Human Consumption that is not clearly labeled as intended for Inhalation or Ingestion must meet all of the requirements for products intended for both Inhalation and Ingestion as provided in this rule. If In the event that there are different requirements, the stricter standard shall apply. 

(2) Definitions. The definitions provided in Sections 500.03 and 581.217, F.S., and the following shall apply to this rule: 

(a) “Approved Source” for the purposes of this rule means an establishment processing or manufacturing products consisting of or containing Hemp or Hemp Extract intended for Human Consumption Ingestion that meets the requirements of Section 581.217(7)(a)1.d., F.S. local, state, or federal regulatory food safety or health standards from the jurisdiction of origin.  

(b) “Attractive to children” is as defined in Section 581.217(3)(a), F.S. 

(b) renumbered (c) No change.  

(d) “Color Additive” is as defined in s. 500.03(1)(g), F.S. Food additives which contribute their own natural color when mixed with foods or other food ingredients are not regarded as color additives, except when used for the purpose of adding color to a food product. 

(e) “Common Household Measure” is defined in 21 C.F.R. 101.9(b)(5) which is incorporated by reference in Rule 5K-4.002, F.A.C. 

(f)(c) “Expiration Date” means the month and year as determined by the processor, manufacturer, packer, or distributor based on the basis of tests or other information showing that the product, until that date, under the conditions of handling, storage, preparation, and use per label directions, will when consumed, contain not less than the quantity of each ingredient as set forth on its label. 

(g)(d) “Hemp” is defined in Section 581.217(3)(e), F.S. 581.217(3)(d), F.S. 

(h)(e) “Hemp Extract” is defined in Section 581.217(3)(f), F.S. 581.217(3)(e), F.S. 

(i)(f) “Hemp Food Establishment” means an establishment as defined in Section 500.03(1)(p), F.S., extracting, manufacturing, processing, packing, holding, preparing, or selling Hemp or Hemp Extract intended for Human Consumption at wholesale or retail.  

(g) renumbered (j)  No change.  

(k)(h) “Ingestion” means the process of consuming Hemp or Hemp Extract through the mouth, whether by swallowing into the gastrointestinal system or through tissue absorption. 

(l)(i) “Inhalation” means the process of consuming Hemp or Hemp Extract through the mouth or nasal passages into the respiratory system. 

(m)(j) “Manufacturing” or “Processing” for the purposes of this rule means any post-harvest preparation preparing and/or packaging products consisting of Hemp or or containing Hemp Extract intended for Human Consumption. 

(k) “Processor” or “Extractor” means the establishment that removes the Hemp Extract oil from the Hemp plant. 

(n)(l) “Self-service merchandising” means a an open display of unpackaged Hemp or Hemp Extract products to which the public has access without the intervention of the vendor or a store employee. 

(o) “Serving” or “Serving Size” means the amount of product intended to be consumed in a single serving as declared on the label expressed in a Common Household Measure. A serving size shall not be a fraction of a piece. 

(p) “Synthetic Cannabinoid” means any cannabinoid identified in section 893.03(1)(a)190., F.S. 

(q)(m) “Total delta-9 tetrahydrocannabinol concentration” means [delta-9 tetrahydrocannabinol] + (0.877 x [delta-9 tetrahydrocannabinolic acid]). 

(r)(n) “Vending machines” for the purpose of this rule are defined as any self-service device which, upon completion of payment, dispense Hemp or Hhemp Eextract products as defined in Section 581.217(3), F.S., without the necessity of replenishing the device between each operation. 

(3) Permits.  

(a) Each establishment distributing products consisting of or containing Hemp or Hemp Extract intended for Human Consumption must be permitted as a Hemp Food Establishments pursuant to Section 500.12, F.S., and Rule 5K-4.020, F.A.C. 

(b) No change. 

(4) Requirements. In addition to the requirements of Chapter 500 and Section 581.217, F.S. the following requirements apply to Hemp and Hemp Extract intended for Human Consumption: 

(a) Hemp or Hemp Extract intended for Ingestion must be processed or manufactured by an Approved Source. The Hemp Food Establishment shall provide a valid food license/permit and the most recent food safety or health inspection report from the Approved Source to the department upon request.  

(b) Hemp or Hemp Extract intended for Inhalation must be processed or manufactured by a source permitted to process manufacture Hemp or Hemp Extract intended for Inhalation. The Hemp Food Establishment shall provide a valid license/permit and the most recent inspection report from the permitting source to the department upon request. 

(c) Hemp and Hemp Extract intended for Human Consumption may not be manufactured, processed, packed, held, prepared, or sold under the Cottage Food Operations Law in Section 500.80, F.S. 

(d) If a Food Extract intended for Ingestion is considered a Potentially Hazardous Food (PHF) or a Food requiring Time and Temperature Control for Safety (TCS Food) as defined in Rule 5K-4.0010, F.A.C., it must be stored in accordance with Rule 5K-4.002, F.A.C.  

(e) Hemp Extract intended Human Consumption must be packaged in containers minimizing the exposure to light to prevent degradation of the Cannabinoids. 

(f) renumbered (d) No change.  

(e)(g) Hemp or Hemp Extract intended for Human Consumption shall not contain a Total delta-9 tetrahydrocannabinol concentration of more than 0.3%. 

(h) renumbered (f) No change. 

(g)(i) Hemp or Hemp Extract intended for Human Consumption shall not be offered for sale by means of vending machines or self-service merchandising. 

(h) Hemp or Hemp Extract intended for Human Consumption held beyond the Expiration Date required in section 581.217(7)(a)2., F.S., shall not be further distributed or offered for sale. 

(i) The water activity for Hemp or Hemp Extract for Human Consumption in the form of Cannabis flower or leaves shall be 0.60 (± 0.05). 

(5) Contaminants and Limits. In addition to the requirements listed in Chapter 500, F.S., and Rule 5K-4.002, F.A.C., Hemp or Hemp Extract intended for Human Consumption shall be considered adulterated pursuant to Section 500.10(1)(a), F.S., if contaminants are detected at levels greater than the limits listed in this rule.  

(a) No change. 

(b) Pesticide Limits. The following list of contaminants does not constitute authorization to use or apply any of the following during Hemp cultivation or processing. 

1. through 10. No change. 

11. Carbaryl, 500 parts per billion for Ingestion or; 500 parts per billion for Inhalation. 

12. through 64. No change.  

65. Thiacloprid, 100 parts per billion for Ingestion or; 100 parts per billion for Inhalation.  

66. through 67. No change. 

(c) through (h) No change. 

(i) Color additives prohibited for Hemp or Hemp Extract for Human Consumption:  

1. FD&C Blue No. 1  

2. FD&C Blue No. 2  

3. FD&C Green No. 3  

4. Orange B  

5. Citrus Red No. 2  

6. FD&C Red No. 3  

7. FD&C Red No. 40 (Allura Red) 

8. FD&C Yellow No. 5  

9. FD&C Yellow No. 6  

10. FD&C Red No. 3 

11. Cochineal extract  

12. Carmine  

13. Mica-based pearlescent pigments  

14. Quinoline Yellow (FD&C Yellow No. 10)  

15. Yellow 2G  

16. FD&C Green No. 1 

17. FD&C Green No. 2 

18. FD&C Red No. 1 

19. FD&C Red No. 2, Amaranth 

20. FD&C Red No. 4, Ponceau SX 

21. FD&C Violet No. 1 

22. Azorubine Carmoisine  

23. Ponceau 4R, Ponceau Red, Cochineal Red A  

24. Patent Blue V  

25. Green S  

26. Brilliant Black BN, Black PN  

27. Brown FK 

28. Brown HT, Chocolate Brown 

29. Cuttlefish Black 

30. Cuttle Black 

31. Alkanet (Alkane) 

32. Carbon Black, Vegetable Carbon  

33. Charcoal-NF XI 

34. Cudbear 

35. Ferric Chloride 

36. Ferrous Sulfate 

37. Logwood, Chip & Extract 

(j)  The following substances are prohibited for use in Hemp or Hemp Extract for Human Consumption when used as a color additive: 

1. Annatto extract  

2. Dehydrated beets (beet powder)  

3. Butterfly pea flower extract  

4. Calcium carbonate  

5. Canthaxanthin  

6. Caramel  

7. β-Apo-8'-carotenal  

8. β-Carotene  

9. Sodium copper chlorophyllin  

10. Toasted partially defatted cooked cottonseed flour  

11. Ferrous gluconate  

12. Ferrous lactate  

13. Grape color extract  

14. Grape skin extract (enocianina)  

15. Synthetic iron oxide  

16. Fruit juice  

17. Vegetable juice  

18. Carrot oil  

19. Paprika  

20. Paprika oleoresin  

21. Riboflavin  

22. Saffron  

23. Soy Leghemoglobin  

24. Spirulina extract  

25. Titanium dioxide  

26. Tomato lycopene extract  

27. Tomato lycopene concentrate  

28. Tumeric  

29. Tumeric oleoresin  

(k)(i) If a testing sample is found to contain levels of any pathogen, toxicant, residual solvent, metal, color additive, controlled substance, drug, or pesticide not enumerated in this rule or by Florida law, then the Hemp or Hemp Extract for Human Consumption shall be considered adulterated. 

(j) renumbered (l) No change.  

(6) Product, Packaging, and Labeling. Hemp and Hemp Extract products intended for Human Consumption shall comply with the following requirements for the product, packaging, and labeling, including the certificate of analysis: 

(a) Hemp or Hemp Extract intended for Human Consumption must be packaged and labeled as required by Chapter 500, F.S., and Section 581.217(7), F.S. 

(b) Hemp or Hemp Extract intended for Human Consumption may only be distributed or sold in a container that is not attractive to children as provided in 581.217, F.S. 

(b) through (d) renumbered (c) through (e) No change. 

(f) The label for all retail products containing Hemp or Hemp Extract intended for Human Consumption must include the serving size and servings per container expressed in Common Household Measures and the net contents expressed in both the appropriate International System of Units (SI) and United States customary units.  

(g) For single serving packages and for individually wrapped single serving products within a multi-serving package, a description of the individual container or wrapped product shall be used for the serving size.  

(h) If the label of any container of Hemp or Hemp Extract intended for Human Consumption is too small to accommodate all the information required by this subsection, labeling information shall be physically attached to the container. 

(i) The label of a product containing Hemp or Hemp Extract intended for Human Consumption in packaged form shall specify conspicuously the name and place of business of the processor, packer, or distributor. 

(j) Hemp or Hemp Extract intended for Human Consumption shall be sold and distributed in packaging compliant with ASTM International D3475-20, Standard Classification of Child Resistant Packages, hereby incorporated by reference, and meet one or more of the descriptions of child-resistant packages set out in Table 1 therein. It is a violation of copyright law to post the materials incorporated in this rule on the Internet for public viewing. Accordingly, the public may obtain a copy of ASTM International D 3475-20, Standard Classification of Child Resistant Packages, by purchasing a copy from: ASTM International, 100 Barr Harbor Drive, P.O. Box C 700, West Conshohocken, PA 19428-2959, or at www.astm.org. Copies of the incorporated materials are also available for viewing during regular business hours at the Florida Department of Agriculture and Consumer Services, Division of Food Safety offices located at 3125 Conner Blvd., Suite D, Tallahassee, Florida 32399-1650. 

(k) The scannable barcode or quick response code required in Section 581.217(7)(a)2., F.S., shall be conspicuously marked and link directly to a webpage where the required certificate of analysis may be found in three or fewer steps.  

(l) The scannable barcode or quick response code required in Section 581.217(7)(a)2. F.S., shall be operational for at least 90 days after the expiration date of the product. 

(m) The certificate of analysis shall state the name, address, and International Organization for Standardization (ISO) certification number of the independent testing laboratory that conducted the analysis. 

(n) The certificate of analysis shall state the name and address of the facility where the batch was processed, the current and valid permit number for the facility issued by a human health or food safety regulatory entity with authority over the facility, and that the facility meets the human health or food safety sanitization requirements of the regulatory entity as documented by the regulatory entity. 

(o) The certificate of analysis shall state the concentration of total delta-9 tetrahydrocannabinol and of each prohibited substance, toxicant, residual solvent, metal, and pesticide listed in subsection (5) of this rule that is contained in each batch. 

(p) The certificate of analysis shall state whether the pathogens listed in subsection (5)(e) are present or absent in each batch. 

(7) Disposal.  

(a) Laboratory samples found to contain more than a Total delta-9 tetrahydrocannabinol concentration of 0.3% shall be disposed of in accordance with 21 CFR 1317. 21 CFR 1317 (Revised April 1, 2019) is hereby incorporated by reference and available online at http://www.flrules.org/Gateway/reference.asp?No=Ref-11452 and by email request to the department at [e-mail].  

(b) Hemp or Hemp Extract intended for Human Consumption containing a Total delta-9 tetrahydrocannabinol concentration that exceeds 0.3% shall be detained pursuant to Section 500.172, F.S. Hemp or Hemp Extract intended for Human Consumption containing a Total delta-9 tetrahydrocannabinol concentration that exceeds 0.3% which has been detained pursuant to Section 500.172, F.S., shall not be further subdivided or renumbered such that the integrity of the lot is not maintained. The establishment shall not dispose of the violative Hemp or Hemp Extract intended for Human Consumption in any manner until written permission for removal, use, or disposal is given by the department or a court of competent jurisdiction. 

(c) Upon receipt of written permission by the department or a court of competent jurisdiction, the Hemp Extract intended for Human Consumption shall be disposed of in accordance with the Hemp Waste Disposal Manual FDACS-08115, 12/19, incorporated in paragraph 5B-57.014(6)(b), F.A.C., or in a manner approved by a court of competent jurisdiction. 

(8) Age Limit for Hemp or Hemp Extract intended for Human Consumption Inhalation. 

(a) Any retailer that sells Hemp or Hemp Extract intended for Human Consumption Inhalation shall post a clear and conspicuous sign directly adjacent to the display of the product which states the following: THE SALE OF HEMP OR HEMP EXTRACT INTENDED FOR HUMAN CONSUMPTION INHALATION TO PERSONS UNDER THE AGE OF 21 IS PROHIBITED. PROOF OF AGE IS REQUIRED FOR PURCHASE. 

(b) Hemp or Hemp Extract intended for Human Consumption Inhalation may not be mailed, shipped, or otherwise delivered to a purchaser, including in-store sales, unless, before the delivery to the purchaser, the Hemp Food Establishment obtains confirmation that the purchaser is 21 years of age or older. 

(c) Hemp Food Establishments shall require proof of age from a purchaser of any product containing Hemp Extract intended for Inhalation before selling the product to that person. Hemp Food Establishments shall exercise due diligence in the management and supervision of their premises and in the supervision and training of their employees to prevent the underage sale of these products. 

(d) Hemp Extract intended for Inhalation shall not be offered for sale by means of self-service merchandising unless proof of age has been verified before allowing access to the self-service merchandising. 

(d)(e) The giving or sampling of Hemp or Hemp Extract intended for Human Consumption Inhalation products by a Hemp Food Establishment to any person under the age of 21 is prohibited. 

(9) Advertising of Hemp or Hemp Extract Intended for Human Consumption.  Hemp or Hemp Extract intended for Human Consumption may not be marketed or advertised, including business names and logos, in a manner that is attractive to children or specifically targets children. Marketing and advertising for Hemp or Hemp Extract Products intended for Human Consumption shall not contain: 

(a) The use of any words, initialisms, acronyms, phrases, colors or color combinations, visual patterns, logos, images, concepts, names, or slogans that duplicate, imitate, or bear a reasonable resemblance to words, initialisms, acronyms, phrases, colors or color combinations, visual patterns, logos, images, concepts, names, or slogans used in connection with commercially available branded products and services.  

(b) Wording or images commonly associated with marketing or advertising that targets or is attractive to children, including any statement, design, representation, picture, or illustration portraying a person under the age of 18 years old, colors or color combinations that target children, or the use of toys, humans, animals, cartoon characters, or similar images; 

(c)  Wording that uses street or slang words or names for marijuana, hemp, hemp extract, or the intoxicating effects of marijuana; 

(d) Statements identical or similar to the name of an unlawful product or substance, including a street or slang name for illicit drugs or drug paraphernalia; or 

(e) References to unlawful activity. 

(10) (9) Penalties. 

(a) No change. 

(b) Hemp or Hemp Extract intended for Human Consumption distributed or sold in violation of this rule shall be considered adulterated or misbranded pursuant to Chapter 500, F.S., as provided in Section 581.217(7)(b), F.S. 

(c) Hemp Extract Products intended for Human Consumption must meet the requirements of this rule. Such products not meeting the requirements of this rule or without the documentation required in paragraphs (4)(a)-(b) of this rule may not be distributed or sold in this state. 

(d) No change. 

(e) The sale of Hemp or Hemp Extract intended for Human Consumption Inhalation to persons under the age of 21 is punishable as provided in section 581.217(7)(d), F.S., and shall result in an administrative fine of $5,000 per occurrence. 

(f) Hemp or Hemp Extract for Human Consumption distributed or sold in violation of this rule is subject to Section 500.172, F.S. and penalties as provided in Section 500.121, F.S. 

Rulemaking Authority 500.09, 500.12, 570.07(23), 581.217(12) FS. Law Implemented 500.03, 500.04, 500.09, 500.10, 500.11, 500.12, 500.121, 500.13, 500.172, 581.217 FS. History–New 1-1-20, 9-27-21, Amended           . 

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Matthew D. Curran, Ph.D., Director, Division of Food Safety

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Wilton Simpson, Commissioner of Agriculture

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: September 18, 2024

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: 09/20/2024