Section 5K-4.034 - Hemp Extract for Human Consumption(1) Products. (a) 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 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 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. 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 manufacturing products consisting of or containing Hemp Extract intended for Ingestion that meets local, state, or federal regulatory food safety or health standards from the jurisdiction of origin.(b) "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.(c) "Expiration Date" means the month and year as determined by the manufacturer, packer, or distributor 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.(d) "Hemp" is defined in Section 581.217(3)(d), F.S.(e) "Hemp Extract" is defined in Section 581.217(3)(e), F.S.(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 Extract intended for Human Consumption at wholesale or retail.(g) "Human Consumption" includes products intended for human Ingestion and/or human Inhalation but does not include topical applications.(h) "Ingestion" means the process of consuming Hemp Extract through the mouth, whether by swallowing into the gastrointestinal system or through tissue absorption.(i) "Inhalation" means the process of consuming Hemp Extract through the mouth or nasal passages into the respiratory system.(j) "Manufacturing" for the purposes of this rule means preparing and/or packaging products consisting of 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.(l) "Self-service merchandising" means an open display of Hemp Extract products to which the public has access without the intervention of the vendor or a store employee.(m) "Total delta-9 tetrahydrocannabinol concentration" means [delta-9 tetrahydrocannabinol] + (0.877 x [tetrahydrocannabinolic acid]).(n) "Vending machines" for the purpose of this rule are defined as any self-service device which, upon completion of payment, dispense hemp extract 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 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) The annual permit fee for a Hemp Food Establishment is $650.00.(4) Requirements. (a) Hemp or Hemp Extract intended for Ingestion must be 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 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.(c) 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 containing Hemp 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) 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.(g) Hemp Extract intended for Human Consumption shall not contain a Total delta-9 tetrahydrocannabinol concentration of more than 0.3%.(h) 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.(i) Hemp Extract intended for Human Consumption shall not be offered for sale by means of vending machines.(5) Contaminants and Limits. In addition to the requirements listed in Chapter 500, F.S., and Rule 5K-4.002, F.A.C. 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) The following substances are prohibited in Hemp Extract intended for Inhalation: 2. 2, 3-butanedione (Diacetyl).(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; 500 parts per billion for 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; 100 parts per billion for 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.(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.(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.(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.(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.(g) Total Combined Yeast and Mold - 100, 000 CFU per gram for Ingestion or Inhalation.(h) Cannabinoid Limits. Total delta-9 tetrahydrocannabinol concentration shall not exceed 0.3%.(i) If a testing sample is found to contain levels of any pathogen, toxicant, residual solvent, metal, or pesticide not enumerated in this rule or by Florida law, then the Hemp Extract shall be considered adulterated.(j) Devices used during the Inhalation process must not introduce contaminants over the limits listed in this rule into the Hemp Extract product.(6) Labeling. (a) Hemp Extract intended for Human Consumption must be labeled as required by Chapter 500, F.S., and Section 581.217(7), F.S.(b) If cannabinoids are marketed, the number of milligrams of each cannabinoid per serving and the serving size must be declared on the label.(c) 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.(d) Hemp Extract intended solely for Inhalation must be clearly labeled with the statement "Not Intended For Ingestion - Do Not Eat."(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.(b) 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 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 Hemp Extract intended for Human Consumption in any manner until written permission 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 Extract intended for Inhalation.(a) Any retailer that sells Hemp Extract intended for Inhalation shall post a clear and conspicuous sign directly adjacent to the display of the product which states the following: THE SALE OF HEMP EXTRACT INTENDED FOR INHALATION TO PERSONS UNDER THE AGE OF 21 IS PROHIBITED. PROOF OF AGE IS REQUIRED FOR PURCHASE.(b) Hemp Extract intended for Inhalation may not be mailed, shipped, or otherwise delivered to a purchaser 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 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.(e) The giving or sampling of Hemp Extract intended for Inhalation products by a Hemp Food Establishment to any person under the age of 21 is prohibited.(9) Penalties. (a) Violations of this rule will be evaluated and penalties imposed in accordance with Rule 5K-4.035, F.A.C.(b) 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 or Hemp Extract Products 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 sold in this state.(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.(e) The sale of Hemp Extract intended for Inhalation to persons under the age of 21 shall result in an administrative fine of $5,000 per occurrence.Fla. Admin. Code Ann. R. 5K-4.034
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.
Adopted by Florida Register Volume 45, Number 243, December 17, 2019 effective 1/1/2020, Amended by Florida Register Volume 47, Number 178, September 14, 2021 effective 9/27/2021.New 1-1-20, Amended 9-27-21.