Be it enacted by the legislature of the relevant jurisdiction:
Section 1 Short Title
This Act may be cited as the Kratom Alkaloid Consumer Safety and Fair Commerce Act.
Section 2 Purpose
The purpose of this Act is to protect public health and consumer safety while preserving lawful adult access to kratom alkaloid products through neutral, science-based regulation. This Act is intended to prevent contamination, adulteration, youth access, inaccurate labeling, deceptive practices, and abusive or arbitrary enforcement, while allowing lawful commerce in protected kratom alkaloids and creating a review process for novel kratom alkaloid products.
Section 3 Definitions
For purposes of this Act:
(a) “Agency” means the department, division, commission, bureau, or other public body designated to administer and enforce this Act.
(b) “Kratom alkaloid” means any alkaloid, alkaloid metabolite, alkaloid analog, alkaloid derivative, alkaloid isomer, alkaloid concentrate, alkaloid isolate, or chemically modified alkaloid associated with or derived from Mitragyna speciosa, whether naturally occurring, concentrated, isolated, synthesized, semi-synthesized, converted, extracted, refined, or otherwise produced.
(c) “Natural kratom alkaloid” means a kratom alkaloid naturally occurring in Mitragyna speciosa.
(d) “7-hydroxymitragynine” means 7- hydroxymitragynine in any form, including naturally occurring, extracted, concentrated, isolated, synthetic, semi-synthetic, converted, refined, imported, or otherwise produced.
(e) “Protected alkaloid” means: (1) any natural kratom alkaloid; and (2) 7-hydroxymitragynine in any form.
(f) “Kratom alkaloid product” means any product intended for human consumption that contains one or more kratom alkaloids.
(g) “Novel kratom alkaloid product” means any kratom-related alkaloid, alkaloid analog, derivative, isomer, metabolite, synthetic variant, semi-synthetic variant, modified compound, or active alkaloid formulation intended for human consumption that is not a protected alkaloid. A novel kratom alkaloid product does not include a protected alkaloid solely because it is imported, reformulated, repackaged, concentrated, or sold in a different lawful delivery form, unless it contains an additional non-protected active alkaloid.
(h) “Minor variation” means a change in formulation, flavoring, excipient, non-active ingredient, packaging, or concentration that does not create a new active alkaloid and does not materially alter the pharmacological identity of the product.
(i) “Business” means any person or entity that manufactures, processes, packages, distributes, imports, exports, transports, wholesales, or retails kratom alkaloid products.
(j) “Registered business” means a business lawfully registered under this Act.
(k) “Batch” means a specific quantity of product that is uniform in composition and produced according to a single production or packaging record.
(l) “Independent laboratory” means a laboratory with no disqualifying ownership or financial interest in the product or business being tested and that meets accreditation standards established by rule.
(m) “Certificate of analysis” means a written report identifying the batch tested, the methods used, the date of testing, and the analytical results.
(n) “Chain of custody” means documented control and transfer records sufficient to identify the origin, handling, transport, storage, testing, and disposition of a product or batch.
(o) “Dedicated retail establishment” means a commercial premises restricted to persons 21 years of age or older and primarily engaged in the sale of age-restricted regulated products.
(p) “Child-resistant packaging” means packaging meeting applicable child-resistant standards under state or federal law.
(q) “Adulterated product” means a product containing undisclosed substances, prohibited contaminants, materially inaccurate labeling, unsafe contamination, or any other condition that renders the product unsafe under this Act or duly adopted rules.
Section 4 Administration; Placement Within Existing Agency
(a) The program, division, office, or regulatory function established under this Act for administration of kratom alkaloid products shall, whenever feasible, be placed within an existing state agency, department, division, commission, bureau, or other public body that already possesses relevant authority, staff, infrastructure, or subject-matter competence related to consumer product safety, food or drug regulation, public health oversight, age-restricted product regulation, commercial licensing, or similar functions.
(b) A new standalone agency, department, or independent regulatory body may be created only if the legislature or other lawmaking authority makes written findings that: (1) no existing agency can reasonably administer this Act; (2) assigning administration to an existing agency would materially impair effective implementation of this Act; and (3) creation of a new agency is necessary to carry out the Act in a practical and accountable manner.
(c) This Section shall be construed to favor use of existing administrative structures in order to: (1) reduce unnecessary bureaucracy; (2) control public administrative costs; (3) avoid duplication of functions; (4) preserve legislative accountability; and (5) limit administrative expansion beyond the authority expressly granted by this Act.
(d) Whether administration is assigned to an existing agency or, if necessary, to a newly created body, the administering authority shall possess only those powers expressly granted by this Act and such implied powers as are strictly necessary to carry out those express powers.
(e) No administering authority may expand its jurisdiction, impose new substantive requirements, create new categories of prohibited products, or enlarge its enforcement authority except as expressly authorized by this Act or by duly adopted rules consistent with this Act.
(f) Nothing in this Act shall be construed to authorize the creation or exercise of general police power over lawful kratom alkaloid commerce beyond the specific powers and limitations set forth herein.
Section 5 Scope of Protection and Regulation
(a) This Act applies to all kratom alkaloid products.
(b) Protected alkaloids shall be lawful by default under this Act, subject to neutral requirements governing registration, testing, labeling, packaging, age restriction, recordkeeping, sanitation, and product safety.
(c) No agency, political subdivision, or officer acting under color of law may prohibit, restrict, cap, or condition a protected alkaloid solely because it is natural, concentrated, isolated, synthetic, semi-synthetic, converted, refined, imported, or otherwise produced.
(d) A protected alkaloid may be restricted only through: (1) formal rulemaking of general applicability; or (2) case-specific final agency action; supported by written findings establishing a specific and unreasonable public-health risk under the standards of this Act.
(e) Novel kratom alkaloid products are not automatically lawful and shall be subject to premarket review under Section 10.
(f) No person may evade this Act by renaming a kratom alkaloid, changing trade dress, altering descriptive language, or using trivial chemical modification to disguise a novel kratom alkaloid product as a protected alkaloid.
Section 6 Registration of Businesses
(a) No business may manufacture, process, package, distribute, import, transport, wholesale, or retail kratom alkaloid products without registration, except as provided during the transition period under Section 7.
(b) The Agency shall provide a clear and reasonably concise registration form limited to information reasonably necessary for administration and enforcement.
(c) The registration form may require only: (1) legal name and trade name of the applicant; (2) principal business address and each facility address used for regulated activities; (3) ownership and controlling persons; (4) categories of regulated activity; (5) contact information for compliance matters; (6) proof of insurance required by this Act; (7) designation of an agent for service of process if required by rule; and (8) any additional information specifically authorized by rule and reasonably necessary for administration.
(d) Registration shall be approved, conditionally approved, or denied within 60 days after receipt of a complete application.
(e) The Agency shall provide written notice of any application deficiency and at least 30 days to cure any non-fraudulent defect.
(f) Registration may be denied only for: (1) material falsification; (2) failure to provide required information after notice and opportunity to cure; (3) failure to maintain required insurance; (4) failure to maintain a compliant facility where applicable; or (5) other grounds specifically authorized by this Act.
Section 7 Transition for Existing Businesses
(a) A business lawfully operating on the effective date of this Act may continue operations during a transition period of 180 days without final registration if the business: (1) files a notice of intent to register within 30 days of the effective date; (2) files a completed registration application within 90 days of the effective date; and (3) complies immediately with the testing requirements of this Act.
(b) During the transition period, no batch may be sold, distributed, or offered for sale unless it has passed the required testing and has a certificate of analysis.
(c) A business that fails to file the notice of intent or completed application within the applicable period loses transition protection.
(d) A business operating under transition protection remains subject to inspection, stop-sale authority for unsafe products, age restrictions, packaging requirements, labeling requirements, and testing requirements.
Section 8 Facilities, Handling, and Records
(a) A registered business engaged in manufacturing, processing, packaging, import receiving, or bulk storage shall operate from a clean, dedicated commercial facility appropriate for its regulated activities.
(b) Raw materials, in-process materials, returned materials, rejected materials, failed batches, and finished goods shall be separated, organized, and clearly labeled to prevent contamination, adulteration, diversion, and mix-ups.
(c) Businesses shall maintain written chain-of-custody records sufficient to identify: (1) origin of material; (2) dates of transfer; (3) handlers and recipients; (4) batch creation and processing records; (5) testing records; (6) distribution records; and (7) corrective actions for failed or recalled product.
(d) Employees shall be provided appropriate personal protective equipment reasonably necessary for safe handling, testing, packaging, storage, cleaning, or production.
(e) Retail-only businesses shall not be subject to manufacturing-facility requirements that are unrelated to retail operations.
Section 9 Imported Protected Alkaloids and Imported 7-Hydroxymitragynine
(a) A protected alkaloid, including imported 7-hydroxymitragynine, may be lawfully imported, possessed, processed, distributed, or sold if it complies with this Act.
(b) Imported protected alkaloid products shall not be excluded solely because they originate outside the United States or outside the regulating jurisdiction.
(c) An imported protected alkaloid product shall be deemed acceptable for lawful commerce if: (1) chain of custody is documented from the source through importation and into the regulated market; (2) the product passes all testing required under this Act; (3) the product is accurately labeled under this Act; (4) the importing business is properly registered; and (5) the product is not otherwise adulterated or misbranded.
(d) The Agency may require documentation reasonably necessary to verify: (1) source identity; (2) shipment records; (3) batch identity; (4) testing records; (5) importer identity; and (6) lawful possession and transfer.
(e) The Agency may not impose additional or discriminatory testing, registration, fee, inspection, or documentation burdens on imported protected alkaloids unless such requirements are equally applied to materially similar domestic products or are specifically justified by written findings of a documented supply-chain safety risk.
(f) Imported protected alkaloids shall be subject to the same contamination, testing, labeling, age-restriction, packaging, and enforcement standards applicable to domestic protected alkaloids.
Section 10 Premarket Review for Novel Kratom Alkaloid Products
(a) A novel kratom alkaloid product may not be introduced into commerce unless approved by the Agency.
(b) Approval is required for: (1) any active kratom-related alkaloid not included in the protected alkaloid category; (2) any synthetic or semi-synthetic alkaloid other than 7-hydroxymitragynine; (3) any analog, derivative, isomer, or modified active compound marketed as producing kratom-like or alkaloid-like effects and not included within the protected alkaloid category; or (4) any materially distinct active alkaloid formulation designated by rule.
(c) Approval is not required for: (1) a protected alkaloid; (2) a minor variation of an already lawful product; or (3) a non-active formulation change that does not create a new active alkaloid or materially alter the pharmacological identity of the product.
(d) The Agency may reject attempts to classify a product as a minor variation where the change: (1) creates a distinct active alkaloid; (2) materially alters active identity; (3) materially changes expected pharmacological effect; or (4) is designed to evade review.
(e) A new alkaloid application shall include: (1) chemical identity; (2) source and production method; (3) available safety and toxicology information reasonably available to the applicant; (4) proposed labeling and warnings; (5) analytical methods sufficient to identify and quantify the product; (6) contamination-control measures; (7) dosage-form information; and (8) any additional information specifically required by published rule and reasonably necessary for review.
(f) The Agency shall approve, conditionally approve, or deny a complete application within 120 days.
(g) The Agency may extend the review period once for no more than 60 days by written notice stating good cause.
(h) The Agency may deny an application only upon written findings that: (1) the product cannot be reliably identified or tested; (2) the available evidence shows a specific and unreasonable public-health risk; (3) manufacturing controls are inadequate; (4) proposed labeling is materially misleading; or (5) the applicant failed to provide required information after notice and opportunity to cure.
(i) The Agency may not deny approval based solely on novelty, controversy, political pressure, or generalized hostility toward the industry.
Section 11 Insurance Requirements
(a) Every registered business shall maintain insurance appropriate to the scale and nature of its operations.
(b) Required insurance shall include: (1) occurrence-based product liability coverage; and (2) general commercial liability coverage.
(c) The insurance required under this Section may be satisfied through one or more policies, including primary coverage and umbrella or excess coverage, so long as the combination provides equivalent protection in the required amounts.
(d) Minimum insurance requirements shall be set by revenue tier and business type as follows: (1) Retail-only businesses under $500,000 in annual gross revenue: (A) minimum $500,000 occurrence-based product liability coverage; and (B) minimum $500,000 general commercial liability coverage. (2) Retail-only businesses with $500,000 to under $2,000,000 in annual gross revenue: (A) minimum $1,000,000 occurrence-based product liability coverage; and (B) minimum $1,000,000 general commercial liability coverage. (3) Manufacturers, processors, importers, wholesalers, or distributors under $2,000,000 in annual gross revenue: (A) minimum $1,000,000 occurrence-based product liability coverage; and (B) minimum $1,000,000 general commercial liability coverage. (4) Manufacturers, processors, importers, wholesalers, or distributors with $2,000,000 to under $10,000,000 in annual gross revenue: (A) minimum $2,000,000 occurrence-based product liability coverage; and (B) minimum $2,000,000 general commercial liability coverage. (5) Manufacturers, processors, importers, wholesalers, or distributors with $10,000,000 or more in annual gross revenue: (A) minimum $3,000,000 occurrence-based product liability coverage; and (B) minimum $3,000,000 general commercial liability coverage.
(e) The Agency may not require claims-made-only coverage where occurrence-based coverage is commercially available.
(f) The Agency shall accept commercially reasonable equivalents, including approved captive coverage, pooled industry coverage, bond-backed responsibility, or other substantially equivalent mechanisms where occurrence-based coverage is commercially unavailable.
(g) The Agency may not increase insurance thresholds except by rule supported by written findings that: (1) the increased coverage is commercially available; (2) the increase is reasonably related to actual product or operational risk; and (3) the increase will not function as a de facto prohibition on lawful commerce.
(h) A business shall have 90 days to cure a non-intentional lapse or deficiency in coverage where no consumer injury occurred.
Section 12 Testing Requirements
(a) No batch may be sold, distributed, imported into commerce, or offered for sale unless it has passed required testing and has a certificate of analysis.
(b) Required testing shall include: (1) total kratom alkaloids; (2) labeled active alkaloids; (3) residual solvents; (4) heavy metals; (5) microbial contamination; (6) fungal contamination or mycotoxins where applicable; and (7) any additional analyte specifically required by published rule based on documented public-health need.
(c) The Agency shall publish action limits, sampling procedures, and testing methods.
(d) A failed batch may not be sold.
(e) Before final enforcement for a failed batch, the affected business shall have the right to confirmatory testing by a second independent laboratory, except in a documented emergency involving immediate and substantial public danger.
Section 13 No Alkaloid Caps; Mandatory Disclosure
(a) No agency may impose a numerical cap, percentage cap, concentration cap, alkaloid-fraction cap, or ratio cap on a protected alkaloid solely on the basis of potency, concentration, or alkaloid percentage.
(b) Consumer protection for potent products shall be achieved through testing, disclosure, packaging, labeling, age restriction, contamination controls, and product-specific findings of demonstrated risk rather than arbitrary caps.
(c) Every kratom alkaloid product shall disclose on its label: (1) total alkaloid content per package; (2) labeled active alkaloid content per package; (3) labeled active alkaloid content per serving, if servings are defined; (4) number of servings per package, if applicable; (5) ingredient list; (6) batch number; and (7) any additional neutral potency disclosure required by published rule for consumer clarity.
(d) Products meeting potency-disclosure thresholds established by published rule may be required to bear enhanced warnings, but may not be prohibited solely because of potency.
(e) Enhanced warnings may address addiction, dependence, delayed onset, cumulative exposure, impairment, or interaction risks where supported by evidence.
(f) The Agency may restrict or remove a specific product from commerce only upon written findings, supported by substantial evidence, that the product presents a specific and unreasonable public-health risk that cannot be adequately addressed through testing, labeling, packaging, age restriction, or manufacturing controls.
(g) The Agency may not rely on potency alone as sufficient grounds for prohibition.
Section 14 Packaging, Labeling, and Marketing
(a) All kratom alkaloid products shall be sold in child-resistant packaging.
(b) Labels shall include: (1) product identity; (2) batch number; (3) ingredient list; (4) total alkaloid content; (5) labeled active alkaloid content; (6) manufacturer, processor, importer, or responsible distributor contact information; (7) adult-use warning; (8) keep out of reach of children warning; (9) addiction and dependence warning; and (10) any other science-based warning required by published rule.
(c) Labels may not be false, misleading, or materially incomplete.
(d) Nothing in this Act shall be construed to require any label to state or imply that a protected alkaloid is unlawful solely because it is natural, concentrated, isolated, synthetic, semi-synthetic, converted, or imported.
(e) No kratom alkaloid product shall be named, branded, labeled, advertised, or otherwise marketed using: (1) the name of, or a name confusingly similar to, a controlled substance scheduled under state or federal law; (2) a common street, slang, or colloquial name for a controlled substance; (3) the proprietary or generic name of a prescription drug, or a name confusingly similar to such a name; or (4) any term, mark, or trade dress that represents or implies that the product is a pharmaceutical, is medically indicated, or has been approved, evaluated, or endorsed by a public health agency, where no such approval, evaluation, or endorsement exists.
(f) No kratom alkaloid product shall be named, branded, packaged, advertised, or otherwise marketed in a manner primarily directed at persons under 21 years of age, including through: (1) cartoon characters, mascots, or imagery primarily appealing to minors; (2) imitation of the name, trade dress, or packaging of candy, snack food, or beverage products primarily marketed to minors; or (3) placement or advertising in media, venues, or locations where the predominant audience is reasonably expected to be under 21 years of age.
(g) Subsection (e) shall not be construed to prohibit: (1) accurate use of a botanical or chemical name, including “Mitragyna speciosa,” “mitragynine,” or “7-hydroxymitragynine”; (2) any disclosure of alkaloid identity or content required by Section 13 or this Section; or (3) accurate, non-misleading description of the product’s contents, origin, or composition.
Section 15 Youth Access Restrictions
(a) No person under 21 years of age may purchase, possess, or be sold a kratom alkaloid product.
(b) Retail sales shall require age verification by government-issued photographic identification.
(c) No self-service sale accessible to minors shall be permitted.
Section 16 Retail Sales; Dedicated Establishments and Online Sales Only
(a) The retail restrictions of this Act are adopted for age-control, traceability, and consumer-safety purposes and not to prohibit lawful adult access.
(b) Kratom alkaloid products may be sold at retail only through: (1) dedicated age-restricted retail establishments; or (2) online retail sales conducted in compliance with this Section.
(c) No general retail establishment, convenience store, gas station, grocery store, smoke shop open to minors, or other mixed-access retail premises may sell kratom alkaloid products unless it qualifies as a dedicated age-restricted retail establishment under this Act.
(d) A dedicated retail establishment shall: (1) restrict entry to persons 21 years of age or older; (2) verify government-issued photographic identification before entry; (3) verify age at the point of sale; (4) prevent self-service access by unauthorized persons; (5) maintain employee training regarding age verification and product compliance; and (6) operate in compliance with all labeling, testing, packaging, and recordkeeping requirements of this Act.
(e) Online retail sales are permitted only if the seller: (1) is a registered business under this Act; (2) uses a commercially reasonable age-verification program or age-checking service designed to verify that the purchaser is at least 21 years of age before sale completion; (3) uses a commercially reasonable identity-matching or fraud-prevention process sufficient to reduce underage purchases and unlawful diversion; (4) ships only to jurisdictions where the sale is lawful; (5) uses delivery procedures reasonably designed to prevent transfer to persons under 21 years of age, including adult-signature delivery where required by rule or where risk factors justify enhanced controls; (6) maintains records of age-verification and transaction compliance for the period required by this Act; (7) clearly discloses warnings, potency information, and age restrictions before sale completion; and (8) complies with all packaging, labeling, testing, and chain-of-custody requirements applicable to retail products.
(f) An online seller may not: (1) knowingly complete a sale to a person under 21 years of age; (2) use marketing, branding, or website design primarily directed at minors; (3) evade age-verification through sham checkboxes, unsupported self-attestation, or plainly inadequate screening methods; (4) misrepresent product identity, potency, origin, testing status, or compliance status; or (5) ship a product that has not passed required testing.
(g) The Agency may adopt rules establishing minimum standards for age-verification technology, fraud screening, delivery controls, record retention, and online compliance practices, provided such rules are: (1) published; (2) technologically neutral where feasible; (3) commercially reasonable; and (4) not designed to function as a de facto ban on lawful online commerce.
(h) Online sellers shall be subject to enhanced consumer protection obligations, including: (1) maintenance of verifiable transaction records; (2) preservation of certificates of analysis for products sold; (3) disclosure of responsible seller identity and contact information; (4) accessible consumer complaint procedures; (5) prompt response to recall or safety notices; and (6) retention of shipping and delivery records sufficient to support traceability and enforcement.
(i) No online seller shall be held in violation of this Section solely because an age- verification or delivery system fails in an isolated instance despite the seller’s good-faith use of compliant systems, unless the seller knew of the deficiency, recklessly disregarded it, or failed to correct repeated failures after notice.
(j) The Agency may bring enforcement action against online sellers that engage in repeated, reckless, fraudulent, or knowingly noncompliant conduct, including sales to minors, falsification of records, or shipment of untested or adulterated product.
(k) Nothing in this Section shall be construed to permit the Agency to prohibit lawful online sales by compliant registered businesses through informal guidance, unpublished standards, or discriminatory enforcement.
Section 17 Excise Tax and Dedicated Fund
(a) A 6 percent excise tax is imposed on retail sales of kratom alkaloid products.
(b) All revenue collected under this Section shall be deposited into a dedicated fund and used only for: (1) addiction treatment and recovery services; (2) public education related to dependence and substance misuse; (3) product compliance and random testing programs; (4) reasonable administrative costs of implementing this Act; and (5) public reporting and program evaluation.
(c) The tax established under this Section shall be subject to later review not later than 24 months after implementation and periodically thereafter.
(d) The review shall evaluate: (1) whether the tax rate is sufficient to support the public purposes of this Act; (2) whether the tax rate is excessive or distortive; (3) whether the tax materially drives consumers into unregulated channels; (4) whether the tax unduly burdens lawful businesses; and (5) whether the tax should be maintained, reduced, or otherwise modified.
(e) No increase in the tax rate may occur without legislative action or other lawmaking action required by the adopting jurisdiction.
Section 18 Random Compliance Testing
(a) The Agency shall establish a random compliance testing program for products sold by registered businesses.
(b) Sampling shall be neutral, documented, and non-retaliatory.
(c) If a product fails random testing, the affected business shall receive: (1) written notice of the findings; (2) the analytical basis for the finding; (3) an opportunity for confirmatory testing; and (4) an opportunity to respond before final sanctions, except in a documented emergency.
Section 19 Prohibited Acts
It is unlawful to: (a) operate without required registration; (b) sell or distribute an untested batch; (c) falsify records, labels, or test results; (d) sell an adulterated or materially mislabeled product; (e) sell to a person under 21 years of age; (f) misrepresent a novel kratom alkaloid product as a protected alkaloid; (g) evade review through trivial chemical modification intended to disguise a novel product; (h) obstruct a lawful inspection or investigation; or (i) name, brand, package, advertise, or market a product in violation of Section 14(e) or Section 14(f).
Section 20 Penalties
(a) Civil penalties shall be scaled by: (1) annual gross revenue; (2) severity of violation; (3) consumer risk; (4) whether the violation was intentional, repeated, reckless, or fraudulent; and (5) corrective actions taken.
(b) The Agency shall distinguish among: (1) technical administrative violations; (2) negligent testing or labeling violations; (3) repeated safety violations; (4) intentional fraud; (5) sale to minors; and (6) knowing sale of adulterated product.
(c) First-time non-safety paperwork violations shall ordinarily result in notice and opportunity to cure before monetary penalties.
(d) Penalties may not be structured primarily to destroy lawful businesses for curable or technical violations.
(e) For online retail violations, penalties shall take into account: (1) the seller’s use of commercially reasonable age-verification systems; (2) whether the violation resulted from isolated technical failure or systemic neglect; (3) whether the seller acted in good faith to correct identified deficiencies; (4) whether minors actually received product; and (5) whether the seller knowingly, recklessly, or repeatedly failed to comply with this Act.
Section 21 Suspension and Revocation
(a) Registration may be suspended or revoked only for: (1) repeated serious violations; (2) intentional falsification; (3) refusal to comply with a final lawful order; (4) knowing sale of adulterated product presenting significant public-health risk; or (5) continued operation without required insurance after cure periods have elapsed.
(b) Except in emergencies, the Agency shall provide notice and opportunity for hearing before suspension or revocation.
Section 22 Agency Powers and Anti-Abuse Protections
(a) The Agency may inspect registered facilities, review required records, collect compliance samples, and investigate credible complaints.
(b) The Agency may not: (1) impose unpublished standards; (2) demand records unrelated to regulated activities; (3) retaliate against a business for advocacy, litigation, criticism, or association membership; (4) use selective enforcement to favor one business or class of business over another; (5) disclose trade secrets except as required by law; (6) condition approval on requirements not found in statute or duly adopted rule; (7) use emergency powers without written findings describing a specific and immediate threat; or (8) prohibit, cap, or suppress protected alkaloids through informal guidance, advisories, or unofficial policy statements.
(c) Any restriction on a protected alkaloid must occur only through formal rulemaking or case-specific final agency action with notice, hearing rights, written findings, and judicial review.
(d) Routine inspections shall occur only during normal business hours, absent consent or emergency.
(e) Inspection frequency shall be risk-based and published in advance by rule.
(f) The Agency shall provide a written inspection report identifying each alleged violation with reasonable specificity.
(g) A business may request supervisory review of an inspection finding before formal enforcement begins.
(h) Where practicable, inspection staff, rulemaking staff, licensing staff, and adjudicatory staff shall be functionally separated.
Section 23 Notice, Cure, Hearings, and Appeals
(a) Except for fraud, sale to minors, or immediate public danger, a business shall receive written notice and a reasonable opportunity to cure before formal penalties are imposed.
(b) The notice shall state: (1) the alleged violation; (2) the factual basis; (3) the governing legal provision; (4) the proposed sanction; and (5) the process for response.
(c) A business may contest an adverse action through an administrative hearing before an impartial hearing officer.
(d) Final agency action shall include written findings of fact and conclusions of law.
(e) A business aggrieved by final agency action may seek judicial review under applicable administrative procedure law.
Section 24 Emergency Orders
(a) The Agency may issue an emergency stop-sale, quarantine, suspension, or detention order only upon written findings that a specific product, batch, or practice presents an immediate and substantial public-health threat.
(b) Emergency authority shall be narrowly tailored and may not be used as a substitute for ordinary enforcement.
(c) An affected business shall be entitled to prompt notice and an expedited hearing.
Section 25 Transparency and Small Business Fairness
(a) The Agency shall publish: (1) registration procedures; (2) testing standards and action limits; (3) enforcement guidance; (4) annual inspection and penalty statistics; (5) annual appeal statistics; and (6) annual fund expenditure reports.
(b) The Agency shall provide plain-language forms and compliance assistance materials.
(c) Electronic submission of records, applications, and testing documents shall be permitted.
(d) The Agency may establish a voluntary compliance consultation process that assists businesses in achieving compliance without automatic penalty exposure for good-faith disclosed issues, unless immediate public danger exists.
Section 26 Rulemaking Standards
(a) Before adopting a rule under this Act, the Agency shall publish: (1) the proposed text; (2) the public-safety justification; (3) estimated compliance costs; (4) less burdensome alternatives considered; and (5) any small-business impact assessment required by law.
(b) No rule materially increasing testing burdens, insurance thresholds, or administrative obligations may take effect unless the Agency makes written findings that the rule is necessary and will not operate as a de facto ban on lawful commerce.
Section 27 Construction
(a) This Act shall be construed liberally in favor of: (1) lawful adult access; (2) accurate disclosure; (3) neutral safety regulation; (4) fair treatment of lawful businesses; and (5) protection against contamination, adulteration, youth access, and deceptive practices.
(b) This Act shall not be construed to authorize prohibition by indirection through: (1) arbitrary insurance demands; (2) unpublished standards; (3) alkaloid caps; (4) indefinite application delay; (5) discriminatory treatment of imported protected alkaloids; or (6) informal suppression of protected alkaloids.
Section 28 Severability
If any provision of this Act or its application to any person or circumstance is held invalid, the invalidity does not affect other provisions or applications that can be given effect without the invalid provision or application.
Section 29 Effective Date
This Act takes effect on a date specified by the adopting jurisdiction, except that the Agency may immediately begin rulemaking, preparation of forms, and administrative implementation.