Disclaimer: This is not legal advice. Laws may vary. Please consult an attorney or check local regulations to ensure compliance.

Effective March 12, 2025, the Florida Department of Agriculture and Consumer Services (FDACS) began enforcing a revised version of Rule 5K-4.034 (Hemp Extract For Human Consumption Child-Resistant Packaging). This rule outlines specific legal requirements for the sale of hemp extract products within the state. Retailers, distributors, and manufacturers operating in Florida must now comply with detailed standards related to packaging, labeling, testing, and ingredient composition. Failure to meet these standards may result in stop-sale orders, fines, or product removal. The following is a clear summary of the most important provisions currently in effect.

Florida has issued public enforcement notices about label compliance. See the official FDACS Press Release.

Here’s a quick breakdown of the most important changes now in effect under Rule 5K-4.034 for Hemp Extract Products in Florida
(Vapes, edibles, oils, capsules, topicals, flower)

1. Packaging & Safety

  • Child-resistant packaging required (ASTM compliant)

  • No packaging that appears attractive to children (cartoons, candy-style fonts, bright colors)

Expanded Notes for Retailers and Inhalable Products:

Child-resistant, tamper-evident packaging now applies across all product categories. This includes pre-rolls and loose hemp intended for inhalation. Retailers should verify that all items for sale meet ASTM D3475 child-resistance standards. Examples include resealable mylar bags with locking strips, rigid containers with certified closures, and push-and-turn lids.

Avoid packaging designs that use:

  • Animated or childlike imagery

  • Bright or candy-associated color schemes

  • Fonts that mimic candy branding or toy labels

These requirements are designed to prevent unintended use by minors and are subject to enforcement.

2. Labeling

  • QR code linking to a valid COA

  • Batch number and expiration date

  • Manufacturer name and contact

  • Cannabinoid content per serving and per container

  • Statement that product contains no more than 0.3% total Delta‑9 THC by dry weight

Expanded Notes for Retailers and All Hemp Formats:

All hemp products must carry clear and legible batch-specific information. For example:

  • A QR code that links directly to a current Certificate of Analysis (COA)

  • Printed batch and lot numbers

  • Date of packaging and expiration

  • Full company name, contact address, and phone or web contact

  • Cannabinoid profile per unit and per package

  • Compliance statement verifying adherence to the 0.3% Delta-9 THC threshold

Pre-packaged hemp intended for inhalation must also indicate its total cannabinoid concentration per gram and per container (e.g., “CBD 12.1%, Δ9-THC 0.25%, THCA 0.22%”).

3. Testing

  • Batch-tested by a Certified Testing Laboratory (CTL)

  • COAs must confirm:

    • THC compliance using this formula: (%THCA × 0.877) + %Δ9‑THC ≤ 0.3%

    • No unsafe levels of heavy metals, solvents, mycotoxins, or pesticides

Expanded Notes for Retailers and Extract Products:

Every product, including raw plant material, must be tested through an FDACS-recognized Certified Testing Laboratory. Each COA must verify:

  • Total THC calculation using the approved conversion formula

  • Absence of heavy metals, including arsenic, cadmium, mercury, and lead

  • No detectable mycotoxins or mold spores

  • No residual solvents or pesticide contaminants

Retailers should confirm that the vendor provides these reports per batch and that they are easily accessible through the QR code.

4. Ingredient Restrictions

37 Fully Banned Color Additives:

FD&C Blue No. 1, FD&C Blue No. 2, FD&C Green No. 3, Orange B, Citrus Red No. 2, FD&C Red No. 3, FD&C Red No. 40, Cochineal Extract, Carmine, FD&C Yellow No. 5, FD&C Yellow No. 6, FD&C Green No. 1, FD&C Green No. 2, FD&C Red No. 1, FD&C Red No. 2 (Amaranth), FD&C Red No. 4 (Ponceau SX), FD&C Violet No. 1, Azorubine Carmoisine, Ponceau 4R (Cochineal Red A), Patent Blue V, Green S, Brilliant Black BN (Black PN), Brown FK, Brown HT (Chocolate Brown), Cuttlefish Black, Cuttle Black, Alkanet (Alkane), Carbon Black (Vegetable Carbon), Charcoal-NF XI, Cudbear, Ferric Chloride, Ferrous Sulfate, Logwood (Chip & Extract), FD&C Yellow No. 10, Yellow 2G, Mica-Based Pearlescent Pigments.

⚠️ 29 Additives Banned When Used as Colorants:

Annatto Extract, Dehydrated Beets (Beet Powder), Butterfly Pea Flower Extract, Calcium Carbonate, Canthaxanthin, Caramel, β-Apo-8'-Carotenal, β-Carotene, Sodium Copper Chlorophyllin, Toasted Partially Defatted Cooked Cottonseed Flour, Ferrous Gluconate, Ferrous Lactate, Grape Color Extract, Grape Skin Extract (Enocianina), Synthetic Iron Oxide, Fruit Juice, Vegetable Juice, Carrot Oil, Paprika, Paprika Oleoresin, Riboflavin, Saffron, Soy Leghemoglobin, Spirulina Extract, Titanium Dioxide, Tomato Lycopene Extract, Tomato Lycopene Concentrate, Turmeric, Turmeric Oleoresin.

Expanded Notes:

Retailers must ensure that ingredient panels on hemp edibles, tinctures, and other ingestible goods do not include banned colorants. These prohibitions apply regardless of whether the additive is synthetic or naturally derived. This includes infused inhalable items like flavored pre-rolls or visually enhanced oils.

5. Inhalation-Specific Prohibitions

The following are banned in all inhalable hemp products:

  • Vitamin E Acetate

  • Diacetyl (2,3-butanedione)

  • Myclobutanil

Expanded Notes:

These substances are known respiratory hazards and may not appear in any product meant for inhalation. This includes cartridges, infused biomass, and pre-rolls. Verify with the supplier that these compounds are entirely absent and confirm this through a current COA.

6. Vape Labeling

All hemp-derived vapes must now include the label:

“NOT FOR HUMAN CONSUMPTION”

Expanded Notes:

This warning is mandatory for all inhalable devices sold in Florida. It must be prominently printed on both primary and secondary packaging. Absence of this warning is grounds for stop-sale action by inspectors.

7. Labeling of Proprietary Blends

FDACS now enforces strict requirements for accurate ingredient disclosure. Any ingestible product (such as chocolates, capsules, tinctures, or functional gummies) that uses general blend terminology must be reformulated or relabeled.

  • Phrases like “proprietary blend,” “adaptogen complex,” or “nootropic matrix” are not sufficient.

  • Each active ingredient must be listed individually, with an exact quantity in milligrams or a measurable unit.

View Compliant Products for Retailers

To support retail buyers, we offer a curated list of hemp extract products that fully meet the latest Florida compliance standards. These include tested, labeled, and packaged SKUs suitable for immediate distribution.

 Click here to view Mega Distributions’ Florida-compliant product examples

This collection may include verified pre-rolls, hemp flower, compliant edibles, and regulated vapes, all supported with current batch-level documentation and QR-linked COAs.

For more resources about Rule 5K-4.034, Hemp Extract for Human Consumption Child-Resistant Packaging, click here.

Disclaimer:
The information provided on this page is for general informational purposes only and does not constitute legal advice. We are not attorneys, and this content should not be relied upon as a substitute for legal counsel. Regulations may vary and change over time, so we strongly recommend consulting with a qualified attorney or regulatory expert to verify compliance with all applicable federal, state, and local laws.

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