Current through Register Vol. 46, No. 39, September 25, 2024
(a) All cannabinoid hemp products distributed
or offered for retail sale in New York State shall:
(1) be manufactured in accordance with Parts
101, 111 or 117 of Title 21 of the Code of Federal Regulations, as appropriate
for the type of product being manufactured and as otherwise determined
appropriate by the office in guidance or future regulation.
(2) contain no more than three-tenths of a
percent (0.3%) total [DELTA] 9-Tetrahydrocannabinol concentration;
(3) except for flower products or topical
products, contain a ratio of CBD to THC that is 15:1 or higher, provided
however, if CBD is not the primary marketed cannabinoid, the sum of
cannabinoids excluding THC must have a ratio of 15:1 THC or higher;
(4) not contain liquor, wine, beer, cider or
meet the definition of an alcoholic beverage as defined in section 3 of the
Alcohol Beverage Control Law;
(5)
not contain tobacco or nicotine in the product;
(6) not be in the form of an injectable,
inhaler, product including cigarette, cigar or pre-roll, or any other
disallowed form as determined by the office;
(7) accurately reflect testing results and
not contain less than 80 percent or more than 120 percent of the concentration
of total cannabinoid content as listed on the product label;
(8) comply with packaging and labeling
standards in section
114.9 of this Part;
(9) be prepackaged and not added to food or
any other consumable products at the point of sale;
(10) comply with product testing standards in
section 114.10 of this Part; and
(11) not contain synthetic cannabinoids,
artificially derived cannabinoids, or cannabinoids created through
isomerization, including, but not limited to, [DELTA] 8-tetrahydrocannabinol
and [DELTA] 10-tetrahydrocannabinol.
(b) All cannabinoid hemp products distributed
or offered for retail sale in New York State shall meet the following
additional requirements:
(1) if the
cannabinoid hemp product is an orally consumed product it shall not contain
more than :
(i) 10 milligrams total THC per
package, with no more than 1 milligram total THC per serving; and
(ii) 3,000 milligrams of total cannabinoids
per package, with no more than 100 milligrams of total cannabinoids per
individual serving, provided however, if the orally consumed product is in the
form of a tincture it shall not contain more than:
(a) 100 milligrams of total THC per package;
and
(b) 4,000 milligrams of
cannabinoids per package.
(2) for cannabinoid hemp products other than
flower products, topical products, orally consumed products, or concentrated
cannabinoid hemp products, cannabinoid hemp product information must be
submitted for review and approval to the office prior to making the product
available for sale to retailers and consumers.
(c) If the cannabinoid hemp product contains
multiple servings which are not individually wrapped, premeasured, separated or
delineated, it shall include a measuring device such as a measuring cap, cup or
dropper with the product packaging. Hash marks on the package shall not qualify
as a measuring device. This provision shall not apply to flower products,
topical products, or concentrated cannabinoid hemp products intended for
inhalation or vaporization. Products that consist of more than a single serving
shall be:
(1) packaged in a manner such that a
single serving is readily identifiable;
(2) packaged in resealable packaging;
and
(3) if an orally consumed
product in the form of a beverage, packaged in a manner that shall not have
more than a single serving per package, provided however, multiple packages of
beverage products can be sold together.
(d) All concentrated cannabinoid hemp
products intended for inhalation or vaporization shall meet the following
additional requirements:
(1) be a closed
system with a pre-filled disposable cartridge that attaches to a rechargeable
battery, or a single-use product that cannot be recharged;
(2) electronic vaporization devices shall
have internal or external temperature controls to prevent combustion and have a
heating element made of inert material such as glass, ceramic or stainless
steel and not plastic or rubber;
(3) except for hemp-derived terpenes,
excipients and ingredients must be pharmaceutical grade unless otherwise
approved by the office, and shall not include:
(i) synthetic terpenes;
(ii) polyethylene glycol (PEG);
(iii) vitamin E acetate;
(iv) medium chain triglycerides (MCT
oil);
(v) medicinal
compounds;
(vi) illegal or
controlled substances;
(vii)
artificial food coloring;
(viii)
benzoic acid;
(ix) diketones;
and
(x) any other compound or
ingredient as determined by the office in regulation;
(4) not contain any flavors or flavoring
agents, except for hemp-derived terpenes; and
(5) include an office approved symbol, as set
out in future regulation, in a manner that is clear and conspicuous.