mostlycbd.com · The Regulation Gap

SAME PLANT.
SAME STATE.
TWO SETS OF RULES.

In Pennsylvania, a medical cannabis product clears more than a dozen regulatory checkpoints before it reaches a patient. A hemp-derived THC gummy at a gas station clears zero. This is the legislation that built that gap — and the consequences we're living with.
March 2026 · Cannabis Policy · mostlycbd.com
01

THE PREMISE

This isn't an argument against hemp. It's an argument against the absence of rules.

When Congress passed the Agriculture Improvement Act of 2018 — the Farm Bill — the intent was to legalize industrial hemp for agriculture. Rope, textiles, seed oil, building materials. The slogan at the time was "Rope, not dope." The legislation defined hemp as cannabis containing no more than 0.3% delta-9 THC by dry weight. It said nothing about delta-8, delta-10, THCA, HHC, or any other intoxicating cannabinoid.

That silence created a loophole. And that loophole built a $28.4 billion market with no federal testing requirements, no labeling standards, no age restrictions, and no potency limits — operating right alongside one of the most regulated cannabis programs in the country.

Congress did not establish baseline quality control regulations because it did not intend to create a commercial market for intoxicating hemp-derived consumables. Producers capitalized on that gap.

Pennsylvania is a case study in how the gap plays out. The same plant — Cannabis sativa L. — produces two categories of product living under entirely different rules. One is tracked from seed to sale, tested twice by independent labs, dispensed by licensed professionals. The other is synthesized in unregulated facilities, sold next to energy drinks, and marketed in packaging designed to look like children's candy.

02

THE SIDE-BY-SIDE

Eight regulatory checkpoints. PA medical cannabis must clear all eight. Hemp-derived THC products must clear none.

Category PA Medical Dispensary Hemp-Derived (Gas Station / Online)
Licensing ■ RequiredState permit: $5K–$10K application, $30K per dispensary location, $200K for grower/processors. Background checks on all principals and employees.35 P.S. §§ 10231.101–2110; 28 Pa. Code § 1141a.31 ■ NoneNo state license. No application. No background checks. Any retail business can sell.No PA statute addresses licensing for hemp-derived consumables
Lab Testing ■ MandatoryISO/IEC 17025-accredited labs. Every harvest batch tested before processing. Every process lot tested by a second independent lab before sale. Tests: cannabinoid profile, heavy metals (Hg, Pb, Cd, As), pesticides, microbial impurities, foreign material.28 Pa. Code §§ 1171a.29–1171a.31; § 1171a.30 (AHP standards) ■ NoneNo mandatory testing. No lab accreditation required. No contaminant screening. Products may contain residual solvents, heavy metals, or unknown chemical byproducts from synthesis.FDA: products "have not been evaluated or approved for safe use in any context"
Tracking ■ Seed-to-SaleMandatory electronic tracking system — every plant, transfer, and sale recorded in real time. Monthly inventory reviews. Annual comprehensive inventories. Transport manifests for all transfers.35 P.S. § 10231.701; 28 Pa. Code §§ 1151a.30, 1161a.32 ■ NoneNo tracking. No supply chain documentation. No manifests. No audits. Product origin is unverifiable.No federal or PA tracking framework for hemp-derived consumables
Labeling ■ StrictMust list: THC %, CBD %, individual terpenes and %, all other cannabinoids, dose count, medical warnings, child safety language. Original container required.28 Pa. Code § 1161a.28 ■ NoneNo labeling requirements. FDA found products routinely mislabeled. Some mimic children's snack brands — Skittles, Sour Patch Kids, Flamin' Hot Cheetos.FDA/FTC joint warning letters, July 2024
Age Gate ■ 18+ with IDQualifying medical condition required. Practitioner certification. State-issued patient ID card. Identity verified in-person at dispensary.35 P.S. § 10231.801; 28 Pa. Code § 1161a.23 ■ NoneNo age restriction in PA. No ID check. Available online with no age gate. Available at gas stations with zero purchase restrictions.No PA statute addresses age minimums for hemp-derived THC
Potency ■ ControlledPharmacist determines form, dosage, quantity per patient. 90-day supply limit. Cannabinoid content verified by independent lab.35 P.S. § 10231.801; 28 Pa. Code § 1161a.24 ■ NoneNo potency limits. No dosing guidance. No max serving. Concentrated delta-8 distillate far exceeds naturally occurring hemp levels.FDA: "likely expose consumers to much higher levels than naturally occurring"
Facility ■ InspectedIndoor, enclosed, secure. Electronic locking and surveillance. Sanitation protocols. Pesticide use governed by PA Pesticide Control Act. Every application documented.28 Pa. Code §§ 1151a.23, 1151a.26, 1151a.27 ■ NoneNo manufacturing standards. Delta-8 synthesized from CBD using chemical catalysts — FDA flags use of "potentially unsafe household chemicals." No inspections.FDA consumer update: delta-8 THC
Recall ■ MandatoryWritten recall procedures. Adverse event reporting. Failed tests trigger investigation, root cause analysis, potential destruction. Ongoing DOH enforcement.28 Pa. Code §§ 1161a.38, 1171a.31(c) ■ NoneNo recall mechanism. No adverse event reporting. FDA enforcement limited to warning letters. FDA has stated it lacks statutory authority for comprehensive regulation.FDA has urged Congress to act
03

THE LEGISLATION BEHIND THE GAP

PA Medical Marijuana Act (Act 16 of 2016)
35 P.S. §§ 10231.101–10231.2110 · Senate Bill 3

Created Pennsylvania's medical cannabis program with comprehensive regulatory infrastructure: licensed grower/processors and dispensaries, electronic seed-to-sale tracking, mandatory independent lab testing, practitioner certification, patient registries, and ongoing Department of Health oversight.

Created oversight
Agriculture Improvement Act of 2018 (Farm Bill)
P.L. 115-334 · 7 U.S.C. § 1639o

Defined hemp as cannabis with ≤0.3% delta-9 THC by dry weight. Removed hemp from the CSA. By referencing only delta-9 THC, it left delta-8, delta-10, THCA, HHC, and all other intoxicating cannabinoids outside federal scheduling — so long as they were hemp-derived. No consumer safety framework was created because no intoxicant market was anticipated.

Created the gap
PA Industrial Hemp Act
3 Pa.C.S. Chapter 15 · Senate Bill 335 / House Bill 967

Aligned Pennsylvania's hemp definition with the federal Farm Bill. Legalized hemp-derived products including cannabinoids, extracts, and derivatives — but established no consumer safety framework, no testing requirements, and no licensing for consumable products. PA Dept. of Agriculture oversees hemp growing but has no jurisdiction over retail products.

Extended the gap to PA
AK Futures LLC v. Boyd St. Distro (9th Circuit, 2022)
U.S. Court of Appeals for the Ninth Circuit

Held that hemp-derived delta-8 products are legal under the Farm Bill regardless of method of manufacture — effectively ruling that the source of the product (hemp vs. non-cannabis), not the process used, determines legality. This cemented the loophole in federal court.

Cemented the loophole
FY2026 Agriculture Appropriations Act (Nov 2025)
P.L. 119-37, Section 781 · Effective November 12, 2026

Redefined hemp using a "total THC" standard (including THCA, delta-8). Capped finished products at 0.4mg total THC per container. Expressly excluded synthetically derived cannabinoids. Closes the loophole — but doesn't take effect until November 2026, and creates no alternative regulatory framework. Products currently on the market at 2.5–10mg per serving will become federally illegal with no transition pathway.

Closes loophole — creates new gap
Executive Order 14370 (December 2025)
President Trump · "Increasing Medical Marijuana and Cannabidiol Research"

Directed federal agencies to accelerate Schedule III reclassification, expand research, and develop a regulatory framework for hemp-derived cannabinoid products. Acknowledged risks of inaccurate labeling and inconsistent quality control. Does not itself change any law — it directs agencies to work toward changes. No rescheduling has occurred.

Directive — no force of law yet
04

THE CONSEQUENCES ARE ALREADY HERE

2,362
Delta-8 exposure cases reported
to U.S. poison control in
14 months (Jan '21–Feb '22)
41%
Of those exposure cases
involved patients
under 18 years old
82%
Of unintentional exposures
involved children — often from
candy-mimicking packaging
55%
Of FDA-reported adverse events
required emergency intervention
or hospitalization
$28.4B
Estimated intoxicating hemp sector
market value by 2025 —
zero federal safety framework
39
State attorneys general —
including PA's Dave Sunday — called
to close the loophole (Nov '25)

In Pennsylvania, PA AG Dave Sunday called these products "rampantly available," noting that businesses profit from selling "super-potent, hemp-derived THC products that are often packaged to attract children." The FDA issued a warning letter to a Pennsylvania company (Hippy Mood) for selling delta-8 products in packaging mimicking children's cereal and candy brands.

Meanwhile, the PA Hemp & Cannabis Guild — representing the state's legitimate hemp businesses — has been pushing Harrisburg for the same regulations their own members already follow voluntarily: age-21 sales restrictions, advertising limits, and mandatory product testing. The rules they're asking for are less strict than what PA dispensaries already comply with. The state hasn't acted.

05

HOW WE GOT HERE

1970
Controlled Substances Act places all cannabis — including hemp — under Schedule I.
April 2016
Governor Wolf signs PA SB 3 — the Medical Marijuana Act — creating one of the most tightly regulated medical cannabis programs in the country.
December 2018
The Farm Bill removes hemp from the CSA. Defines it solely by delta-9 THC. Unintentionally opens the door for intoxicating hemp-derived products.
2020–2021
Delta-8 products proliferate nationwide. Gas stations, vape shops, online. Poison control cases surge — disproportionately involving children.
May 2022
Ninth Circuit rules in AK Futures v. Boyd St. Distro that hemp-derived delta-8 is legal under the Farm Bill. The loophole is cemented in federal court.
July 2024
FDA and FTC jointly issue warning letters for "copycat" delta-8 products — including one PA company — packaging mimicking Skittles, Cap'n Crunch, and Flamin' Hot Cheetos.
November 2025
PA AG Dave Sunday joins 38 state AGs calling on Congress to close the loophole. Products called "rampantly available" and "often packaged to attract children."
November 2025
P.L. 119-37 redefines hemp using total THC. Bans most intoxicating hemp products — effective November 12, 2026. No regulatory framework created as alternative.
December 2025
Executive Order 14370 directs Schedule III reclassification and a regulatory framework for hemp-derived products. No force of law.
06

WHERE WE STAND

Regulate, don't just ban.

Prohibition without a regulatory alternative doesn't eliminate demand — it pushes it underground. The November 2026 ban creates a cliff with no bridge. Congress should establish a federal framework with mandatory testing, labeling, potency limits, and age restrictions — the same protections patients already receive in regulated state programs.

Close the gap — in both directions.

The solution isn't only tighter rules for hemp-derived products. It's also removing the federal barriers that prevent the plant from being studied. Cannabis remains Schedule I. The research blockade remains intact. We are regulating by assumption instead of by evidence because the system prevents the evidence from being gathered.

Protect functional access.

The goal should never be to restrict access for patients and responsible adults. It should be to ensure that what they access is safe, accurately labeled, honestly marketed, and produced under accountable conditions. Pennsylvania's medical program — for all its cost and complexity — proves rigorous oversight and patient access can coexist.

Protect kids by protecting standards — not by demonizing the plant.

Children aren't being harmed by Cannabis sativa. They're being harmed by the absence of rules: no age checks, no child-resistant packaging, no restrictions on marketing products that look like candy. That's a regulatory failure, not a plant problem.


Sources & References
  1. PA Medical Marijuana Act — 35 P.S. §§ 10231.101–10231.2110 (SB 3, signed April 17, 2016)
  2. 28 Pa. Code Chapters 1141a, 1151a, 1161a, 1171a — PA medical cannabis regulations
  3. Agriculture Improvement Act of 2018 — P.L. 115-334, 7 U.S.C. § 1639o
  4. DEA Interim Final Rule — 85 FR 51639 (August 2020)
  5. AK Futures LLC v. Boyd St. Distro, LLC — 9th Circuit, 2022
  6. FDA, "5 Things to Know about Delta-8 THC" — fda.gov
  7. FDA/FTC Joint Warning Letters — copycat delta-8 products, July 2024
  8. CRS, "The 2018 Farm Bill's Hemp Definition" — R48637
  9. CRS, "Changes to the Statutory Definition of Hemp" — IF13136
  10. FY2026 Agriculture Appropriations Act — P.L. 119-37, Section 781 (Nov 2025)
  11. Executive Order 14370 (December 18, 2025)
  12. PA Capital-Star — AG Sunday / 39-state AG letter (Nov 2025)
  13. WHYY — PA Hemp & Cannabis Guild (September 2025)
  14. PA Dept. of Agriculture, Hemp Program FAQs — pa.gov
  15. Progressive Policy Institute — "The Farm Bill High" (October 2025)
  16. Cannabinoid Safety and Regulation Act (CSRA) — Wyden/Merkley, December 2025