Current through all regulations passed and filed through September 16, 2024
(A)
All hemp products, except for those made exclusively
from hemp fibers, shall be labeled:
(1)
In accordance with the following standards:
(a)
The labeling
requirements found in rule 901:3-1-11 of the Administrative Code.
(b)
The standard of identity requirements found in rule 901:3-1-12 of the Administrative Code.
(c)
The food coloring
requirements found in rule 901:3-1-13 of the Administrative Code.
(2)
With the
milligrams per serving for all cannabinoids as identified on the product label,
if the hemp product meets the definitions of either a food or dietary
supplement as found in rule 901:14-2-01 of the Administrative Code.
(3)
With the total milligrams per unit for all cannabinoids
as identified on the product label, if the hemp product meets the definitions
of a cosmetic product as found in rule 901:14-2-01 of the Administrative Code.
(4)
With the cannabinoid profile of the product that
matches the laboratory reporting for each unique batch or lot as required in
paragraph (A)(9) of rule 901:14-2-15 of the Administrative Code, if the hemp
product does not meet the definitions of food, dietary supplement, or cosmetic
products as found in rule 901:14-2-01 of the Administrative Code.
(5)
With the unique batch or lot coding that will match the
hemp product with a batch or lot, in order to facilitate any warnings or
recalls the department deems appropriate.
(a)
Each container or
product shall be marked with an identifying code permanently visible to the
naked eye.
(b)
The required identification shall specify in code the
establishment where the product was packed, the product contained therein, and
the year, day, and period during which it was packed.
(c)
The packing
period code shall be changed often enough to enable ready identification of
lots during their sale and distribution.
(d)
Codes may be
changed periodically on one of the following bases:
(i)
Intervals of four
to five hours;
(ii)
Personnel shift changes; or
(iii)
Batches, as
long as the containers constituting the batch do not represent those processed
during more than one personnel shift.
(6)
With a statement,
if the products contain cannabinoids, indicating that consumers should consult
a licensed healthcare professional if pregnant, breast feeding, currently
taking medications, or under eighteen years of age.
This statement shall appear prominently
and conspicuously as compared to other words, statements, or designs on the
information panel of the immediate container label, but in no case may the
letters be less than one-sixteenth inch in height. Where the immediate
container is not the retail package, this warning statement shall also appear
prominently and conspicuously on the information panel of the retail package
label.
This requirement does not apply to
products derived exclusively from hemp seed
oil.
(B)
Hemp product labeling requirements by
classification:
(1)
All hemp products which meet the definition of a food
as found in rule 901:14-2-01 of the Administrative Code shall meet the labeling requirements in 21 C.F.R. 101.9 (2018).
(2)
All hemp products
which meet the definition of a dietary supplement as found in rule 901:14-2-01 of the Administrative Code shall meet the labeling requirements in 21 C.F.R. 101.36 (2018).
(3)
All cosmetic
products shall be labeled in accordance with 21 C.F.R. Part 701 (1974) and 21 C.F.R. 714 (2019) as applicable.