Fla. Admin. Code Ann. R. 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. 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 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:
(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 Consumptionthat meets requirements of Section
581.217(7)(a)1.d., F.S.
(b)
"Attractive to children" is as defined in Section
581.217(3)(a),
F.S.
(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.
(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) "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.
(g) "Hemp"
is defined in Section
581.217(3)(e),
F.S.
(h) "Hemp Extract" is defined
in Section 581.217(3)(f),
F.S.
(i) "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.
(j) "Human Consumption"
includes products intended for human Ingestion and/or human
Inhalation but does not include topical
applications.
(k) "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) "Inhalation" means
the process of consuming Hemp or Hemp Extract through the mouth or nasal
passages into the respiratory system.
(m) "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.
(n) "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.
(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) "Total
delta-9 tetrahydrocannabinol concentration" means [delta-9
tetrahydrocannabinol] + (0.877 x [delta-9 tetrahydrocannabinolic
acid]).
(r) "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.
(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) 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:
(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 Inhalationmust 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.
(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) 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.
(e) Hemp or Hemp Extract intended for Human
Consumption shall not contain a Total delta-9 tetrahydrocannabinol
concentration of more than 0.3%.
(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.
(g) 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) The following substances are
prohibited in Hemp Extract intended for Inhalation:
1. Vitamin E acetate.
2. 2,3-butanedione (Diacetyl).
3. Myclobutanil
(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.
(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) 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. [BETA]-Apo-8'-carotenal
8. [BETA]-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) 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.
(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:
(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.
(c) If cannabinoids are marketed, the number
of milligrams of each cannabinoid per serving and the serving size must be
declared on the label.
(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.
(e) Hemp Extract
intended solely for Inhalation must be clearly labeled with the statement "Not
Intended For Ingestion - Do Not Eat."
(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 FoodSafety@FDACS.gov.
(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.
(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.
(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.
(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.
(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:
(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;
(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
(c)
The use of any wording that references illegal or unlawful substances or
promotes the use of marijuana.
(10) Penalties.
(a) Violations of this rule will be evaluated
and penalties imposed in accordance with Rule
5K-4.035, F.A.C.
(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.
(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.
(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 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.
(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.
Notes
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.
New 1-1-20, Amended 9-27-21.
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