Florida’s Kratom “Consumer Protection” Bill Conflicts With Florida Law

This Week 8 Special is written in a statutory, enforcement-focused tone for lawmakers, regulators, and journalists. It is policy criticism and opinion grounded in existing law and the structure of SB 994.

Florida lawmakers are considering SB 994, titled the Florida Kratom Consumer Protection Act. The bill is presented as a consumer safety measure. In reality, it conflicts directly with Florida’s own Food, Drug, and Cosmetic Act and weakens existing public-health protections.

Florida already prohibits the sale of adulterated, misbranded, and unapproved drug products. SB 994 does not strengthen those protections. It bypasses them.

Florida Already Prohibits the Sale of Unapproved Drug Products

Under Florida’s Food, Drug, and Cosmetic Act, a product is unlawful if it is:

• An unapproved drug
• Adulterated
• Misbranded
• Marketed with therapeutic or drug-like claims without approval

These provisions mirror federal law and give Florida clear authority to remove unsafe products from commerce.

Kratom products are routinely marketed for pain relief, anxiety, mood enhancement, and opioid withdrawal. Those are drug claims. Kratom is not approved as a drug, dietary supplement, or food additive.

Under existing Florida law, that alone is enough to make kratom products unlawful.

SB 994 does not dispute this. It simply ignores it.

Specific Florida Statutes SB 994 Conflicts With

Unapproved New Drugs

Florida law prohibits the sale of any new drug unless it has been approved for safety and effectiveness.

Kratom contains pharmacologically active compounds that act on opioid receptors and are sold for therapeutic effects. No kratom product has been approved. SB 994 attempts to regulate these products instead of enforcing their removal.

Adulterated Drugs

Florida law deems a drug adulterated if its strength, quality, or purity differs from what it is represented to be or if it contains unsafe ingredients.

Kratom products frequently vary widely in alkaloid content, potency, and contamination. SB 994 allows these products to remain on the market as long as basic manufacturing requirements are met.

Misbranded Drugs

Florida law prohibits products whose labeling is false or misleading or which fail to include adequate directions for safe use.

There is no medically recognized safe dose of kratom. Labels cannot provide adequate directions for safe use of an unapproved psychoactive drug. SB 994 permits labeling instead of acknowledging that lawful labeling is impossible.

Permits Do Not Replace Drug Approval

SB 994 requires kratom to be manufactured by a processor holding a permit from the Florida Department of Agriculture and Consumer Services.

Permits do not establish safety.
Permits do not determine appropriate dosing.
Permits do not substitute for drug approval.

This creates a false impression that kratom has been reviewed for safety when it has not.

SB 994 Facilitates Interstate Distribution of Illegal Products

The bill explicitly allows kratom products manufactured in Florida to be shipped outside the state.

Florida cannot authorize the interstate distribution of unapproved drug products. Allowing in-state manufacturing for out-of-state sale places Florida in direct conflict with federal law and exposes the state to legal risk.

The “Controlled Substance” Clause Is a Loophole

SB 994 states that a processor violates the act if kratom products contain a controlled substance or other prohibited substances.

This does not address the real issue.

Kratom itself is an unapproved drug under Florida law. The absence of additional controlled substances does not make an illegal product lawful.

The Wrong Agency for a Drug Enforcement Problem

SB 994 assigns oversight to agricultural and consumer services regulators rather than public-health or drug-safety authorities.

Florida’s Food, Drug, and Cosmetic Act already provides the proper enforcement framework. SB 994 diverts enforcement away from it.

Public Funds Are Used to Normalize an Illegal Market

The bill includes an appropriation of more than $3.7 million to implement the regulatory program.

Those funds are not allocated to treatment, surveillance, or enforcement. They are used to build a compliance system for products that Florida law already prohibits.

The Bottom Line

Florida does not need a kratom consumer protection act.

Florida already has a Food, Drug, and Cosmetic Act that prohibits the sale of unapproved, adulterated, and misbranded drug products.

SB 994 weakens those protections by replacing enforcement with accommodation. It conflicts with existing law, legitimizes an unapproved drug, and uses public funds to stabilize a market that should not exist.

Consumer protection does not mean regulating illegal products.
It means removing them from the shelf.

What Else Is Wrong With SB 994 (Beyond the Chapter 499 Conflict)

1. It treats drug safety as a retail compliance problem

SB 994 rewrites a pharmacologically active drug issue into a consumer product checklist: labeling, age restrictions, permits, and basic standards. Drug safety is not determined by retail conditions. It is determined by approval, safety data, and risk-benefit analysis. SB 994 avoids all three.

2. It creates a de facto safe harbor

Once the state builds a regulatory program, retailers point to compliance as legitimacy. Regulators hesitate to act outside the new framework. Courts receive mixed signals. Even without explicit legalization language, SB 994 functions as insulation.

3. It shifts the burden of proof onto the public

SB 994 does not require proof of safety before products reach consumers. It assumes acceptability unless contamination or mislabeling is proven later. That reverses the basic logic of drug law.

4. It misleads consumers by signaling safety

A “consumer protection act” tells the public the state has reviewed a product. SB 994 does not do that. It creates regulatory signaling without safety.

5. It ignores interaction risk and predictable ER patterns

SB 994 does not address medication interactions, poly-drug use, or contraindications. Emergency events are frequently driven by combinations, not single substances. The bill pretends this problem does not exist.

6. It assumes enforcement capacity Florida has not demonstrated

Florida retailers continue to sell many products that are already unlawful under existing federal food and drug restrictions. Under the FDA Tobacco Control Act, unauthorized flavored disposable vaping products without PMTA have been illegal for years, yet they remain widely available in retail settings. If Florida cannot meaningfully remove clearly illegal products under existing federal law, SB 994 raises an obvious question: how will the state enforce a more complex regime for unapproved psychoactive substances?

7. It is reactive by design: compliance is not tested until after harm

SB 994 does not require premarket safety review or independent evaluation before products reach consumers. In practice, testing and enforcement occur only after a complaint, an inspection, or an adverse event.

That means the first meaningful “test” is a human being.

8. It makes injury or death the enforcement trigger

When the system waits for ER visits, poison control calls, seizures, overdoses, or deaths to identify a product problem, enforcement has already failed. A framework that detects danger after irreversible harm is not consumer protection.

9. It expands obligations without guaranteeing proactive testing

SB 994 references testing and standards but does not guarantee routine batch testing, random surveillance, independent verification, or timely public reporting. Without guaranteed, preventive testing, compliance remains theoretical.