Enacts the "synthetic kratom kills act" to prohibit harmful synthetic and adulterated kratom products; provides that no person, manufacturer, retailer, or other entity shall manufacture, distribute, sell, or offer for sale: synthesized kratom material; any adulterated kratom product; a kratom product that is combustible or intended to be used for vaporization, aerosolization, or injection; a kratom product that is incorporated into, or marketed or labeled as, a conventional food or beverage product; a kratom product that contains flavoring agents or additives specifically designed or marketed to appeal to individuals under twenty-one years of age; a kratom product not contained in child-resistant packaging; a kratom product that mimics a candy product or is manufactured, packaged, or advertised in a way that can be reasonably considered to appeal to individuals under twenty-one years of age; any kratom product to an individual under twenty-one years of age; and any kratom product in which the concentration of 7-hydroxymitragynine exceeds two percent of the concentration of total alkaloids; requires testing and clear labeling.
STATE OF NEW YORK
________________________________________________________________________
10969
IN ASSEMBLY
April 14, 2026
___________
Introduced by M. of A. BLUMENCRANZ -- read once and referred to the
Committee on Health
AN ACT to amend the public health law, in relation to prohibiting harm-
ful synthetic and adulterated kratom products, and requiring testing,
labeling, and enforcement for natural kratom products
The People of the State of New York, represented in Senate and Assem-bly, do enact as follows:
1 Section 1. This act shall be known and may be cited as the "synthetic
2 kratom kills act".
3 § 2. Legislative intent. The legislature hereby finds and declares
4 that:
5 1. Kratom (Mitragyna speciosa), a plant-based product, is used by many
6 New Yorkers for potential benefits such as pain relief, mood support,
7 and aid for conditions like PTSD among veterans, when derived from
8 natural leaf in moderate forms.
9 2. However, dangerous synthetic or semi-synthetic kratom products,
10 including those with elevated levels of 7-hydroxymitragynine (7-OH) or
11 chemical alterations, have been linked to serious adverse events,
12 including deaths and overdoses, as reported in public health data.
13 3. Existing mechanisms, including recent prohibitions on sales to
14 those under 21 and mandatory warning labels, are important but insuffi-
15 cient to fully address adulteration, untested potency, misleading
16 marketing, and youth appeal in synthetic variants.
17 4. Evidence from other jurisdictions demonstrates that unregulated
18 synthetics pose significant risks, while regulated natural leaf with
19 quality controls reduces harm without eliminating access.
20 5. Modern testing capabilities, including third-party laboratories,
21 allow for verification of alkaloid content, absence of contaminants, and
22 product safety prior to sale.
23 6. At the same time, consumer education through detailed labeling is
24 essential to promote safe, informed use and prevent interactions or
25 misuse.
26 7. It is the intent of the legislature to ban harmful synthetics and
27 adulterated products outright, while regulating natural kratom through
EXPLANATION--Matter in italics (underscored) is new; matter in brackets
[] is old law to be omitted.
LBD15506-01-6
A. 10969 2
1 testing, labeling, age restrictions, and local enforcement to protect
2 public health, ensure consumer safety, and preserve access to beneficial
3 natural forms.
4 8. The legislature further intends to focus on civil enforcement
5 tools, avoiding criminalization of natural products, to deter violations
6 effectively while supporting responsible commerce.
7 § 3. The public health law is amended by adding a new section
8 1399-mmmm to read as follows:
9 § 1399-mmmm. Kratom consumer protection and regulation. 1. For the
10 purposes of this section, the following terms shall have the following
11 meanings:
12 (a) "Kratom leaf" means the leaf of the kratom plant, also known as
13 Mitragyna speciosa, in fresh, dehydrated, or dried form that undergoes
14 no postharvest processing other than drying or size reduction, by
15 cutting, milling, or similar procedure or by cleaning or sterilization
16 through application of heat, steam, pressurization, irradiation, or
17 other standard treatments applied to food ingredients. Nothing in this
18 paragraph shall be construed to limit the naturally occurring total
19 alkaloid content of kratom leaf, provided that alkaloid levels are veri-
20 fied as naturally occurring and unadulterated through third-party labo-
21 ratory testing as required under subdivision three of this section.
22 (b) "Kratom product" means a product marketed for human consumption
23 containing any part of the leaf of the plant Mitragyna speciosa, includ-
24 ing any such product sold or marketed under an alternative name, trade
25 name, or labeling that does not identify the product as kratom, and does
26 not contain any synthesized kratom material.
27 (c) "Synthesized kratom material" means: (i) an alkaloid or alkaloid
28 derivative that has been created by chemical synthesis or biosynthetic
29 means (including but not limited to: fermentation, recombinant tech-
30 niques, yeast derived, enzymatic techniques), rather than traditional
31 food preparation techniques such as heating or extracting that synthet-
32 ically alters the molecular structure of any kratom alkaloid or constit-
33 uent; or (ii) an alkaloid or alkaloid derivative contained in kratom
34 that has been exposed to chemicals or processes that would confer a
35 structural change in the alkaloids.
36 (d) "Adulterated kratom product" means a kratom product that is adul-
37 terated with a dangerous substance other than kratom or with a substance
38 that affects the quality or strength of the kratom product to a degree
39 as to render the kratom product injurious to a consumer.
40 (e) "Manufacturer" means a person or business that produces, prepares,
41 compounds, or processes kratom products, including any person or busi-
42 ness packaging, repackaging, labeling, or relabeling of kratom products.
43 (f) "Retailer" means a person or business that sells or maintains
44 kratom products or that advertises, represents or holds itself out as
45 selling or maintaining kratom products.
46 (g) "Distributor" means any person or business entity engaged in the
47 business of purchasing kratom products from a manufacturer and selling
48 or otherwise distributing such products to retailers or other persons
49 for resale. A common carrier shall not be considered a distributor sole-
50 ly by virtue of transporting kratom products in the ordinary course of
51 business.
52 (h) "Third-party laboratory" means a laboratory that has no direct
53 interest in a manufacturer or distributor of kratom products, that is
54 accredited pursuant to ISO/IEC 17025 or an equivalent standard recog-
55 nized by the department of health, and that can perform mandated testing
56 utilizing validated methods.
A. 10969 3
1 (i) "Total alkaloids" means the aggregate concentration of all alka-
2 loids present in a kratom product, measured in milligrams per gram of
3 product, as determined by third-party laboratory testing conducted
4 pursuant to subdivision three of this section.
5 (j) "Alkaloid" means a naturally occurring nitrogen-containing organic
6 compound produced by or derived from the kratom plant that has pharmaco-
7 logical activity, including but not limited to mitragynine and 7-hydrox-
8 ymitragynine.
9 2. No person, manufacturer, retailer, or other entity shall manufac-
10 ture, distribute, sell, or offer for sale:
11 (a) Synthesized kratom material;
12 (b) Any adulterated kratom product;
13 (c) A kratom product that is combustible or intended to be used for
14 vaporization, aerosolization, or injection;
15 (d) A kratom product that is incorporated into, or marketed or labeled
16 as, a conventional food or beverage product; provided, however, that
17 kratom leaf prepared as an aqueous infusion or traditional tea prepara-
18 tion, without added food ingredients beyond those otherwise permitted
19 under this section, shall not be considered a conventional food or
20 beverage for the purposes of this paragraph;
21 (e) A kratom product that contains flavoring agents or additives
22 specifically designed or marketed to appeal to individuals under twen-
23 ty-one years of age;
24 (f) A kratom product not contained in child-resistant packaging that
25 meets standards set forth in 16 C.F.R. 1700.15(b) when tested in accord-
26 ance with 16 C.F.R. 1700.20;
27 (g) A kratom product that mimics a candy product or is manufactured,
28 packaged, or advertised in a way that can be reasonably considered to
29 appeal to individuals under twenty-one years of age; or
30 (h) Any kratom product in which the concentration of 7-hydroxymitragy-
31 nine exceeds two percent of the concentration of total alkaloids, as
32 determined by third-party laboratory testing conducted pursuant to
33 subdivision three of this section.
34 3. All kratom products sold or otherwise distributed in this state
35 must be tested by a third-party laboratory prior to the sale or distrib-
36 ution of each batch or lot, and found to be free from: (i) heavy metals
37 at levels exceeding applicable United States Food and Drug Adminis-
38 tration food safety thresholds; (ii) microbial contamination, including
39 Salmonella, E. coli O157:H7, and total combined yeast and mold, at
40 levels exceeding applicable federal food safety thresholds; (iii) pesti-
41 cide residues at levels exceeding applicable federal food safety thresh-
42 olds; (iv) fentanyl and other controlled substances as defined under New
43 York law; and (v) synthesized kratom material as defined in paragraph
44 (c) of subdivision one of this section. Such testing shall further
45 include quantification of total alkaloid content, mitragynine concen-
46 tration, and 7-hydroxymitragynine concentration in milligrams per gram
47 of product, to verify compliance with paragraph (h) of subdivision two
48 of this section and to support the labeling requirements of paragraph
49 (b) of subdivision four of this section. All such products shall be
50 affixed with a label verifying such testing and the information listed
51 in subdivision four of this section. Manufacturers shall maintain
52 certificates of analysis and make them available upon request.
53 4. All kratom products sold or otherwise distributed in this state
54 shall be accompanied by a clear label that provides adequate information
55 for safe and effective use by consumers that includes but is not limited
56 to:
A. 10969 4
1 (a) A list of ingredients used in the manufacturing of the kratom
2 product;
3 (b) The amount of mitragynine and 7-hydroxymitragynine contained in
4 the kratom product, expressed in milligrams per serving and milligrams
5 per container;
6 (c) The recommended serving size of the kratom product;
7 (d) The manufacturer's recommended maximum number of servings per
8 twenty-four-hour period;
9 (e) The number of servings per container of the kratom product;
10 (f) The name and principal street address of the manufacturer of the
11 kratom product;
12 (g) A unique batch or lot number specifically linking each kratom
13 product to a specific batch or lot manufactured by the kratom manufac-
14 turer;
15 (h) A recommendation to consult a healthcare professional prior to
16 use;
17 (i) A statement that kratom is not safe for use while pregnant or
18 breastfeeding;
19 (j) A statement that the kratom product should be stored safely and
20 out of the reach of children;
21 (k) A statement that the sale or transfer of possession to another
22 person under twenty-one years of age is prohibited;
23 (l) A warning that the product may result in dangerous medication
24 interactions; and
25 (m) A disclaimer that the kratom product is not intended to diagnose,
26 treat, cure, or prevent any medical condition or disease.
27 If there is not sufficient room on the kratom product label, the
28 kratom product shall display on the label a scannable bar code, QR code,
29 or web address linked to a document containing the information required
30 in this subdivision.
31 5. Kratom products shall not be sold through vending machines or other
32 automated self-service devices.
33 6. (a) The department of health, county and municipal health depart-
34 ments, and law enforcement shall have authority to inspect establish-
35 ments, investigate complaints, seize prohibited products, and conduct
36 hearings.
37 (b) Any person or entity violating this section shall receive a notice
38 of violation. It shall be the responsibility of the owner and/or the
39 owner's manager or business agent to ensure compliance; the owner shall
40 be liable for violations committed by employees or agents acting within
41 the scope of their employment or agency. It shall be an affirmative
42 defense that the owner maintained written compliance policies, conducted
43 training of employees regarding the requirements of this section, and
44 that the specific violation occurred without the owner's knowledge
45 despite such policies and training.
46 (c) Penalties shall be as follows:
47 (1) First violation: civil fine of five hundred dollars plus confis-
48 cation of all involved products.
49 (2) Second violation within thirty-six months: civil fine of one thou-
50 sand dollars, seven-day suspension of any applicable state or local
51 business license or permit, plus confiscation.
52 (3) Third or subsequent violation within thirty-six months: civil fine
53 of five thousand dollars, thirty-day suspension of any applicable state
54 or local business license or permit, plus confiscation.
55 (4) Four or more violations within thirty-six months or two or more
56 violations involving the sale of synthesized kratom material, adulterat-
A. 10969 5
1 ed kratom products, or kratom products to individuals under twenty-one
2 years of age (each constituting an "egregious violation"): referral to
3 the applicable licensing authority for permanent revocation of any
4 applicable state or local business license or permit, following notice
5 and a hearing before the department or local board of health.
6 (d) Each day a violation exists shall constitute a separate offense.
7 Separate but simultaneous violations shall be treated as separate
8 violations provided, however, that the total civil fines imposed upon
9 any single person or entity for continuing violations of the same
10 provision shall not exceed twenty-five thousand dollars within any thir-
11 ty-six month period.
12 (e) Before suspending or revoking any applicable business license or
13 permit pursuant to this section, the department or board shall provide
14 notice and an opportunity for a hearing.
15 (f) Affirmative defense for age verification. It shall be an affirma-
16 tive defense to a charge of violating paragraph (h) of subdivision two
17 of this section that the seller in good faith demanded and examined a
18 government-issued photographic identification document indicating that
19 the purchaser was twenty-one years of age or older, and that the iden-
20 tification document presented by the purchaser reasonably appeared to be
21 genuine and valid at the time of sale.
22 7. Manufacturers, distributors, and retailers shall maintain certif-
23 icates of analysis and written records of adverse events, consumer
24 complaints, and product safety concerns (collectively, "incident
25 reports") for a period of not less than three years and shall make such
26 records available for inspection upon request by the department, county
27 or municipal health department, or law enforcement authority. The
28 department is authorized to promulgate rules and regulations as needed
29 to implement this section; however, implementation shall be accomplished
30 utilizing existing departmental resources and personnel, and no new
31 program, office, or additional appropriation shall be required solely by
32 reason of this section. The department is further authorized to promul-
33 gate rules updating testing standards, contaminant thresholds, or the
34 list of prohibited substances under this section as scientific or public
35 health evidence warrants, provided that any such updates shall be accom-
36 plished within existing appropriations.
37 8. If any provision of this section is held invalid, the remainder
38 shall continue in full force and effect.
39 9. Nothing in this section shall be construed to preempt any county,
40 city, town, or village from enacting local laws or ordinances that
41 impose restrictions on the sale or distribution of kratom products that
42 are more stringent than those provided in this section.
43 10. Manufacturers of kratom products already in commercial distrib-
44 ution prior to the effective date of this section shall have one hundred
45 eighty days from such effective date to achieve compliance with the
46 testing requirements of subdivision three of this section.
47 § 4. This act shall take effect ninety days after it shall have become
48 a law, provided that the commissioner of health is authorized to promul-
49 gate any necessary rules and regulations prior to such effective date.
