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  4.  » Dazed and Confused: The Minnesota Board of Pharmacy Rules Regarding  Hemp-Derived THC Contradict Statutory Law

Dazed and Confused: The Minnesota Board of Pharmacy Rules Regarding  Hemp-Derived THC Contradict Statutory Law

On Behalf of | Aug 26, 2022 | Slingshots

            On June 2, 2022,[1] Minnesota enacted a first-of-its-kind law legalizing products containing hemp-derived cannabinoids, including tetrahydrocannabinols (“THC”).[2] While hemp derivatives (including all cannabinoids) that contain less than 0.3 percent delta-9 THC by weight had already been legal federally under the 2018 “Farm Bill”[3], and legal in Minnesota since 2019,[4] the Minnesota Department of Agriculture did not permit hemp processors to add CBD or delta-9 THC to food or beverages for sale, given that these substances are currently active ingredients in pharmaceutical drugs, and consequently are not approved food additives by the U.S. Food and Drug Administration (“FDA”). The new law reversed Minnesota’s position, creating a new legal category of “edible cannabinoid products” in the state.[5] The Minnesota Board of Pharmacy (the “Board”) was appointed the responsibility to enforce the pertinent statute,[6] and unfortunately it has missed the mark in its attempt to interpret the statute.

            On July 22, 2022, the Board published a “Law Enforcement Hemp-Derived THC Inspection Checklist.”[7] The checklist does provide some helpful guidance on labeling and other requirements for hemp-derived THC products, but it is also likely incorrect on three of its interpretations of the statute: (1) that only edibles and beverages containing hemp-derived THC are allowed under state law (excluding raw industrial hemp and its non-edible cannabinoid product derivatives containing less than 0.3 percent THC that were already legal under both federal and Minnesota law)[8]; (2) that cannabinoids intended for health benefit or intoxication, other than THC and CBD, also remain illegal[9]; and (3) that the statement, “This product does not claim to diagnose, treat, cure, or prevent any disease and has not been evaluated or approved by the United States Food and Drug Administration (FDA),” must be printed on the product’s label[10] (negating the option under the statute to include that statement on a website only)[11].          

            First, the Board’s contention that hemp “flower, pre-rolls, tinctures, moonrocks, or topicals” constitute “unallowed” forms of THC in Minnesota ignores that each of those items are, in fact, legal to sell in Minnesota so long as they are hemp or are hemp-derived and contain less that 0.3 percent THC by weight.[12] Under federal and Minnesota law, hemp is defined as any part or derivative of the Cannabis sativa L. plant containing less than 0.3 percent THC, and hemp is not marijuana under either the federal or state Schedule of Controlled Substances.[13] The specific THC in hemp has also been explicitly removed from the Schedule of Controlled Substances.[14] Moreover, while there are additional requirements for edible cannabinoid products,[15] the sale of cannabinoids derived from hemp was already authorized without restriction as to the product’s form.[16] Indeed, it would be impossible to create hemp-derived THC that can be incorporated into edible cannabinoid products unless both the hemp itself and its derivatives were also independently legal. Moreover, while the Board has enforcement authority over edible cannabinoid products, it is the Minnesota Department of Agriculture that regulates hemp growers and processors.[17] The Board’s attempts to regulate non-edible products thus go beyond its powers. Therefore, we believe the Board’s interpretation that only edibles and beverages are allowed is completely unfounded.  Nevertheless, in an abundance of caution, sellers should be aware of the Board’s interpretation until its mischaracterization of the law is corrected.

            The legality of cannabinoids intended for health benefit or intoxication is more of a gray-area than the legality of hemp and its derivatives, but the Board’s position still demonstrates its confusion on the topic. As an example, the Board lists hexahydrocannabinol (“HHC”) as an unallowed cannabinoid for edible cannabinoid products.[18] It is unclear why. The law provides,

Notwithstanding any other section of this chapter, a product containing nonintoxicating cannabinoids, including an edible cannabinoid product, may be sold for human or animal consumption only if all of the requirements of this section are met, provided that a product sold for human or animal consumption does not contain more than 0.3 percent of any tetrahydrocannabinol and an edible cannabinoid product does not contain an amount of any tetrahydrocannabinol that exceeds the limits established in subdivision 5a, paragraph (f).[19]

 It continues:

No other substance extracted or otherwise derived from hemp may be sold for human consumption if the substance is intended: (1) for external or internal use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or other animals; or (2) to affect the structure or any function of the bodies of humans or other animals.[20]

 “Edible cannabinoid product,” in turn, means “any product that is intended to be eaten or consumed as a beverage by humans, contains a cannabinoid in combination with food ingredients, and is not a drug.”[21]

The first piece of the statute referenced above allows both (1) products containing “nonintoxicating cannabinoids” and (2) “edible cannabinoid products” for sale. Importantly, no part of the statute provides that edible cannabinoid products also containing intoxicating cannabinoids cannot be sold. The second excerpt applies only to “other substances,” meaning things that are neither nonintoxicating cannabinoids nor edible cannabinoid products.

Because HHC is a cannabinoid, if it were combined with food ingredients and the final product was intended to be eaten or consumed as a beverage by humans, that final product would appear to necessarily fall within the definition of “edible cannabinoid product” under the law, thus exempting it from requirements regarding other substances that could be extracted from hemp. The only qualifier might be that an edible cannabinoid product cannot be “a drug”—and this is where some amount of legal gray area may exist.

Still, the statute clearly contemplates that edible cannabinoid products containing THC are not drugs because THC thresholds are set for edible cannabinoid products, namely that these products cannot contain more than 0.3 percent THC by weight, that each serving size cannot contain more than 5 mg THC, and each package cannot contain more than 50 mg THC.[22] Similarly, in issuing its checklist, the Board itself counts products containing CBD and/or THC only as edible cannabinoid products, again suggesting that these products are not drugs, even if CBD or THC by themselves are used separately in some pharmaceutical drugs. Based upon this analysis, food ingredients combined with the cannabinoid HHC should also be considered “edible cannabinoid products” under the statute and be permitted for sale.

Finally, the Board is incorrect in its requirement that words to the effect of “This product does not claim to diagnose, treat, cure, or prevent any disease and has not been evaluated or approved by the United States Food and Drug Administration (FDA),” must be included on the product’s label.[23] While Minn. Stat. 151.72, subd. 5(d) does provide such a requirement, section (e) of the same subdivision allows that “[t]he information required to be on the label by this subdivision must be prominently and conspicuously placed and on the label or displayed on the website in terms that can be easily read and understood by the consumer.”[24] It thus appears that the Board has failed to consider the entirety of the law in its interpretation. To be safe, we recommend that suppliers place an FDA label on the packaging for the time being, but this requirement is ripe for legal challenge.

If you have questions about the legalization of hemp-derived cannabinoids in Minnesota, please contact the experienced attorneys at Eckland & Blando LLP.


[1]             Research and drafting assistance provided by Robby Dube, associate at Eckland & Blando, and Adrian Kipp, law clerk at Eckland & Blando LLP.

[2]             HF 4065, Third Engrossment, 92nd Sess. (Minn. 2022).

[3]             Pub. L. No. 115-334, 132 Stat. 4908 (2018) §§ 10113, 12619.

[4]             See Minn. Stat. § 18K.02, subd. 3.

[5]             See generally HF 4065, Third Engrossment, 92nd Sess. (Minn. 2022).

[6]             Minn. Stat. § 151.72 subd. 6(c) (2022).

[7]             Minnesota Board of Pharmacy, Law Enforcement Hemp-Derived THC Inspection Checklist at 1 (July 22, 2022).

[8]             Id. at 2.

[9]             Id.

[10]            Minnesota Board of Pharmacy, supra n. 4.

[11]            Minn. Stat. § 151.72 subd. 5(d) (2022) (“the product does not claim to diagnose, treat, cure, or prevent any disease and has not been evaluated or approved by the United States Food and Drug Administration (FDA)”).

[12]            Minnesota Board of Pharmacy, supra n. 4 at 2.

[13]            Minn. Stat. §§ 151.72 subd. 1 (d) (2022), 18K.02 subd. 3 (2021); Pub. L. 115-334 (2018).

[14]            Id. at § 151.02 subd. 2(h)(2) (2022).

[15]            Id. at § 151.72 subd. 5a (2022).

[16]            Id. at subd. 3.

[17]            Minn. Stat. 18K.02 subd. 2, 18K.04 (2021)

[18]            Minnesota Board of Pharmacy, supra n. 4 at 2.

[19]            Minn. Stat. § 151.72, subd. 3 (emphasis added).

[20]            Id. (emphasis added).

[21]            Minn. Stat. § 151.72, subd. 1.

[22]            Minn. Stat. § 151.72, subd. 3, 5a.

[23]            Minn. Stat. § 151.72 subd. 5(d) (2022).

[24]            Emphasis added.

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