Fla. Admin. Code R. 5K-4.034 – Hemp Extract for Human Consumption

(1) Products.
1. (a) Section 500.03, F.S., defines “food” to include hemp extract as defined in Section 581.217, 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.
2. (b) Hemp or Hemp Extract intended for Human Consumption that is not clearly labeled as intended for Inhalation or Ingestion must meet the requirements for products intended for both Inhalation and Ingestion as provided in this rule. If 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:
1. (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 that meets requirements of Section 581.217(7)(a)1.d., F.S.
2. (b) “Attractive to children” is as defined in Section 581.217(3)(a), F.S.
3. (c) “Batch” or “Lot” means the Hemp Extract produced during a period of time under similar conditions and identified by a specific code that allows traceability.
4. (d) “Cartoon” means any drawing or other depiction of an object, person, animal, creature, or any similar caricature that satisfies any of the following criteria:
  1. The use of comically exaggerated features;
  2. The attribution of human characteristics to animals, plants, or other objects, or the similar use of anthropomorphic technique; or
  3. The attribution of unnatural or extra-human abilities, such as imperviousness to pain or injury, X-ray vision, tunnelling at very high speeds, or transformation.
5. (e) “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.
6. (f) “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.
7. (g) “Expiration Date” means the month and year as determined by the processor, manufacturer, packer, or distributor based on 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.
8. (h) “Hemp” is defined in Section 581.217(3)(e), F.S.
9. (i) “Hemp Extract” is defined in Section 581.217(3)(f), F.S.
10. (j) “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.
11. (k) “Human Consumption” includes products intended for human Ingestion and/or human Inhalation but does not include topical applications.
12. (l) “Ingestion” means the process of consuming Hemp or Hemp Extract through the mouth, whether by swallowing into the gastrointestinal system or through tissue absorption.
13. (m) “Inhalation” means the process of consuming Hemp or Hemp Extract through the mouth or nasal passages into the respiratory system.
14. (n) “Manufacturing” or “Processing” for the purposes of this rule means any post-harvest preparation and/or packaging of or containing Hemp or Hemp Extract intended for Human Consumption.
15. (o) “Self-service merchandising” means a display of unpackaged Hemp or Hemp Extract products to which the public has access without the intervention of the vendor or a store employee.
16. (p) “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.
17. (q) “Synthetic Cannabinoid” means any cannabinoid identified in section 893.03(1)(a)190., F.S.
18. (r) “Total delta-9 tetrahydrocannabinol concentration” means [delta-9 tetrahydrocannabinol] + (0.877 x [delta-9 tetrahydrocannabinolic acid]).
19. (s) “Vending machines” for the purpose of this rule are defined as any self-service device which, upon completion of payment, dispense Hemp or Hemp Extract products as defined in Section 581.217(3), F.S. without the necessity of replenishing the device between each operation.
(3) Permits.
1. (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.
2. (b) The annual permit fee for a Hemp Food Establishment is $650.00.
(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:
1. (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.
2. (b) Hemp or Hemp Extract intended for Inhalation must be processed or manufactured by a source permitted to 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.
3. (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.
4. (d) Containers used with Hemp Extract intended for Human Consumption must comply with the requirements provided in 21 CFR 170, as incorporated by reference in Rule 5K-4.002, F.A.C.
5. (e) Hemp or Hemp Extract intended for Human Consumption shall not contain a Total delta-9 tetrahydrocannabinol concentration of more than 0.3%.
6. (f) Hemp Extract intended for Human Consumption shall not be manufactured, processed, packed, held, or prepared in a private home or in a room used as living or sleeping quarters.
7. (g) Hemp or Hemp Extract intended for Human Consumption shall not be offered for sale by means of vending machines or self-service merchandising.
8. (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.
9. (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.
1. (a) The following substances are prohibited in Hemp Extract intended for Inhalation:
  1. Vitamin E acetate.
  2. 2,3-butanedione (Diacetyl).
  3. Myclobutanil
2. (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. Abamectin, 300 parts per billion for Ingestion; 100 parts per billion for Inhalation.
  2. Acephate, 3,000 parts per billion for Ingestion; 100 parts per billion for Inhalation.
  3. Acequinocyl, 2,000 parts per billion for Ingestion; 100 parts per billion for Inhalation.
  4. Acetamiprid, 3,000 parts per billion for Ingestion; 100 parts per billion for Inhalation.
  5. Aldicarb, 100 parts per billion for Ingestion or Inhalation.
  6. Azoxystrobin, 3,000 parts per billion for Ingestion; 100 parts per billion for Inhalation.
  7. Bifenazate, 3,000 parts per billion for Ingestion; 100 parts per billion for Inhalation.
  8. Bifenthrin, 500 parts per billion for Ingestion; 100 parts per billion for Inhalation.
  9. Boscalid, 3,000 parts per billion for Ingestion; 100 parts per billion for Inhalation.
  10. Captan, 3,000 parts per billion for Ingestion; 700 parts per billion for Inhalation.
  11. Carbaryl, 500 parts per billion for Ingestion or; Inhalation.
  12. Carbofuran, 100 parts per billion for Ingestion or Inhalation.
  13. Chlorantraniliprole, 3,000 parts per billion for Ingestion; 1,000 parts per billion for Inhalation.
  14. Chlordane, 100 parts per billion for Ingestion or Inhalation.
  15. Chlorfenapyr, 100 parts per billion for Ingestion or Inhalation.
  16. Chlormequat chloride, 3,000 parts per billion for Ingestion; 1,000 parts per billion for Inhalation.
  17. Chlorpyrifos, 100 parts per billion for Ingestion or Inhalation.
  18. Clofentezine, 500 parts per billion for Ingestion; 200 parts per billion for Inhalation.
  19. Coumaphos, 100 parts per billion for Ingestion or Inhalation.
  20. Cyfluthrin, 1,000 parts per billion for Ingestion; 500 parts per billion for Inhalation.
  21. Cypermethrin, 1,000 parts per billion for Ingestion; 500 parts per billion for Inhalation.
  22. Daminozide, 100 parts per billion for Ingestion or Inhalation.
  23. DDVP (Dichlorvos), 100 parts per billion for Ingestion or Inhalation.
  24. Diazinon, 200 parts per billion for Ingestion; 100 parts per billion for Inhalation.
  25. Dimethoate, 100 parts per billion for Ingestion or Inhalation.
  26. Dimethomorph, 3,000 parts per billion for Ingestion; 200 parts per billion for Inhalation.
  27. Ethoprop(hos), 100 parts per billion for Ingestion or Inhalation.
  28. Etofenprox, 100 parts per billion for Ingestion or Inhalation.
  29. Etoxazole, 1,500 parts per billion for Ingestion; 100 parts per billion for Inhalation.
  30. Fenhexamid, 3,000 parts per billion for Ingestion; 100 parts per billion for Inhalation.
  31. Fenoxycarb, 100 parts per billion for Ingestion or Inhalation.
  32. Fenpyroximate, 2,000 parts per billion for Ingestion; 100 parts per billion for Inhalation.
  33. Fipronil, 100 parts per billion for Ingestion or Inhalation.
  34. Flonicamid, 2,000 parts per billion for Ingestion; 100 parts per billion for Inhalation.
  35. Fludioxonil, 3,000 parts per billion for Ingestion; 100 parts per billion for Inhalation.
  36. Hexythiazox, 2,000 parts per billion for Ingestion; 100 parts per billion for Inhalation.
  37. Imazalil, 100 parts per billion for Ingestion or Inhalation.
  38. Imidacloprid, 3,000 parts per billion for Ingestion; 400 parts per billion for Inhalation.
  39. Kresoxim-methyl, 1,000 parts per billion for Ingestion; 100 parts per billion for Inhalation.
  40. Malathion, 2,000 parts per billion for Ingestion; 200 parts per billion for Inhalation.
  41. Metalaxyl, 3,000 parts per billion for Ingestion; 100 parts per billion for Inhalation.
  42. Methiocarb, 100 parts per billion for Ingestion or Inhalation.
  43. Methomyl, 100 parts per billion for Ingestion or Inhalation.
  44. Methyl parathion, 100 parts per billion for Ingestion or Inhalation.
  45. Mevinphos, 100 parts per billion for Ingestion or Inhalation.
  46. Myclobutanil, 3,000 parts per billion for Ingestion; prohibited at any concentration for Inhalation.
  47. Naled, 500 parts per billion for Ingestion; 250 parts per billion for Inhalation.
  48. Oxamyl, 500 parts per billion for Ingestion or Inhalation.
  49. Paclobutrazol, 100 parts per billion for Ingestion or Inhalation.
  50. Pentachloronitrobenzene, 200 parts per billion for Ingestion; 150 parts per billion for Inhalation.
  51. Permethrin, 1,000 parts per billion for Ingestion; 100 parts per billion for Inhalation.
  52. Phosmet, 200 parts per billion for Ingestion; 100 parts per billion for Inhalation.
  53. Piperonyl butoxide, 3,000 parts per billion for Ingestion or Inhalation.
  54. Prallethrin, 400 parts per billion for Ingestion; 100 parts per billion for Inhalation.
  55. Propiconazole, 1,000 parts per billion for Ingestion; 100 parts per billion for Inhalation.
  56. Propoxur, 100 parts per billion for Ingestion or Inhalation.
  57. Pyrethrins, 1,000 parts per billion for Ingestion; 500 parts per billion for Inhalation.
  58. Pyridaben, 3,000 parts per billion for Ingestion; 200 parts per billion for Inhalation.
  59. Spinetoram, 3,000 parts per billion for Ingestion; 200 parts per billion for Inhalation.
  60. Spinosad A & D, 3,000 parts per billion for Ingestion; 100 parts per billion for Inhalation.
  61. Spiromesifen, 3,000 parts per billion for Ingestion; 100 parts per billion for Inhalation.
  62. Spirotetramat, 3,000 parts per billion for Ingestion; 100 parts per billion for Inhalation.
  63. Spiroxamine, 100 parts per billion for Ingestion or Inhalation.
  64. Tebuconazole, 1,000 parts per billion for Ingestion; 100 parts per billion for Inhalation.
  65. Thiacloprid, 100 parts per billion for Ingestion or; Inhalation.
  66. Thiamethoxam, 1,000 parts per billion for Ingestion; 500 parts per billion for Inhalation.
  67. Trifloxystrobin, 3,000 parts per billion for Ingestion; 100 parts per billion for Inhalation.
3. (c) Residual Solvent Limits for Ingestion or Inhalation.
  1. 1,2-Dichloroethane, 2 parts per million.
  2. 1,1-Dichloroethene, 8 parts per million.
  3. Acetone, 750 parts per million.
  4. Acetonitrile, 60 parts per million.
  5. Benzene, 1 part per million.
  6. Butane, 5,000 parts per million.
  7. Chloroform, 2 parts per million.
  8. Ethanol, 5,000 parts per million.
  9. Ethyl Acetate, 400 parts per million.
  10. Ethyl Ether, 500 parts per million.
  11. Ethylene Oxide, 5 parts per million.
  12. Heptane, 5,000 parts per million.
  13. Hexane, 250 parts per million.
  14. Isopropyl Alcohol, 500 parts per million.
  15. Methanol, 250 parts per million.
  16. Methylene Chloride, 125 parts per million.
  17. Pentane, 750 parts per million.
  18. Propane, 5,000 parts per million.
  19. Toluene, 150 parts per million.
  20. Trichloroethylene 25 parts per million.
  21. Xylenes, Total (ortho-, meta-, para-), 150 parts per million.
4. (d) Metals Limits.
  1. Cadmium, 500 parts per billion for Ingestion; 200 parts per billion for Inhalation.
  2. Lead, 500 parts per billion for Ingestion or Inhalation.
  3. Arsenic, 1,500 parts per billion for Ingestion; 200 parts per billion for Inhalation.
  4. Mercury, 3,000 parts per billion for Ingestion; 200 parts per billion for Inhalation.
5. (e) Biological Limits for Ingestion or Inhalation.
  1. Shiga toxin-producing Escherichia coli (STEC E. coli) and other pathogenic E. coli, 1 CFU per gram.
  2. Salmonella, 1 CFU per gram.
  3. Aspergillus niger, Aspergillus fumigatus, Aspergillus flavus, Aspergillus terreus, 1 CFU per gram.
6. (f) Mycotoxin Limits.
  1. Total Aflatoxin (B1, B2, G1, G2), 20 parts per billion for Ingestion or Inhalation.
  2. Ochratoxin, 20 parts per billion for Ingestion or Inhalation.
7. (g) Total Combined Yeast and Mold – 100,000 CFU per gram for Ingestion or Inhalation.
8. (h) Cannabinoid Limits. Total delta-9 tetrahydrocannabinol concentration shall not exceed 0.3%.
9. (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
10. (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
11. (k) 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.
12. (l) Devices used during the Inhalation process must not introduce contaminants over the limits listed in this rule into the Hemp Extract product.
(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:
1. (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.
2. (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.
3. (c) If cannabinoids are marketed, the number of milligrams of each cannabinoid per serving and the serving size must be declared on the label.
4. (d) The label and advertisement shall not contain claims indicating the product is intended for diagnosis, cure, mitigation, treatment, or prevention of disease, rendering it a drug as defined in 21 U.S.C. 321(g)(1). Pursuant to Section 500.03(1)(n)4., F.S., such articles shall be considered misbranded.
5. (e) Hemp Extract intended solely for Inhalation must be clearly labeled with the statement “Not Intended For Ingestion – Do Not Eat.”
6. (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.
7. (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.
8. (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.
9. (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.
10. (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.
11. (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.
12. (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.
13. (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.
14. (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.
15. (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.
16. (p) The certificate of analysis shall state whether the pathogens listed in subsection (5)(e) are present or absent in each batch.
(7) Disposal.
1. (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 HYPERLINK "http://www.flrules.org/Gateway/reference.asp?No=Ref-11452" http://www.flrules.org/Gateway/reference.asp?No=Ref-11452 and by email request to the department at FoodSafety@FDACS.gov.
2. (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.
(8) Age Limit for Hemp or Hemp Extract intended for Human Consumption.
1. (a) Any retailer that sells Hemp or Hemp Extract intended for Human Consumption 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 TO PERSONS UNDER THE AGE OF 21 IS PROHIBITED. PROOF OF AGE IS REQUIRED FOR PURCHASE.
2. (b) Hemp or Hemp Extract intended for Human Consumption 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.
3. (c) 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.
4. (d) The giving or sampling of Hemp or Hemp Extract intended for Human Consumption 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:
1. (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 candy or food products that could be mistaken for branded products, especially by children;
2. (b) The use of wording, images, designs, representations, pictures, or illustrations that portray or are similar to those used in marketing or advertising of commercially available products that are intended for children; or
3. (c) The use of any wording that references illegal or unlawful substances or promotes the use of marijuana.
(10) Penalties.
1. (a) Violations of this rule will be evaluated and penalties imposed in accordance with Rule 5K-4.035, F.A.C.
2. (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.
3. (c) Hemp Extract Products intended for Human Consumption must meet the requirements of this rule. Such products not meeting the requirements of this rule may not be distributed or sold in this state.
4. (d) Violations of this rule shall result in the imposition of stop-sale/stop-use orders, an administrative fine of up to $5,000 per violation, permit suspension, permit revocation, or any combination thereof.
5. (e) The sale of Hemp or Hemp Extract intended for Human Consumption 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.
6. (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, Amended 9-27-21, 3-12-25, 11-2-25.