Update: FDA Regulation of Marijuana “Medibles” Presents Challenges and Uncertainty for Marijuana-based Food Manufacturers and Distributors
As we recently reported, federal regulators have continued to take measures aimed at stymieing the growth of the marijuana industry. Medical marijuana is now legal in over 18 states and, in November 2012, voters in Colorado and Washington legalized the sale of recreational marijuana to adults age 21 or older. However, possessing, cultivating, and distributing marijuana remains illegal under federal law, despite state laws to the contrary, and the federal government has aggressively pursued medical marijuana dispensaries for violating federal laws. (For more information about the federal government’s crackdown on medical marijuana dispensaries, please read our previous posts here, here, and here.). As Colorado and Washington’s marijuana laws go into effect, the federal government is faced with new questions regarding the manufacture and sale of “medibles,” food and beverages infused with marijuana. Of particular concern for medibles manufacturers is how, if at all, edible marijuana products implicate regulation by the U.S. Food and Drug Administration (“FDA”). (For more coverage regarding edible marijuana products, please read NBC’s article here.)
The FDA, the federal agency primarily responsible for the safety of the nation’s food supply, has specific regulations regarding the manufacture, quality, and labeling of food products. Under 21 U.S.C. § 321(f) of the federal Food, Drug, and Cosmetics Act (“FDCA”), a “food” is loosely defined as “an article used for food or drink.” Products that are intended to be consumed as foods or are otherwise labeled or represented as food products must comport with the FDA’s regulations. Pursuant to the FDA’s regulations, food manufacturers must register their establishments with the FDA and operate in accordance with current good manufacturing practices (“cGMPs”). (Generally speaking, cGMPs are a series of regulations, found at 21 C.F.R. Part 110, designed to ensure that food products are prepared, packaged, and stored in sanitary conditions.).
In addition, food manufacturers must also ensure that food products do not contain any unapproved substances or additives and that the ingredients contained in food products are generally recognized as safe (“GRAS”). As described by the FDA:
GRAS is an acronym for the phrase Generally Recognized As Safe. Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the Act), any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excluded from the definition of a food additive.
More information on GRAS requirements can be found on the FDA’s website here.
Moreover, food products must bear correct food labeling, including a Nutrition Facts panel and appropriate food claims. Manufacturers that fail to meet cGMPs or use ingredients that are not GRAS in their food products could be subject to enforcement action under the misbranding or adulterated food provisions of the FDCA.
With marijuana legalization, commercial retailers in Colorado and Washington have started developing various “medible” products. However, as of now these manufacturers have been operating in a void of regulations because marijuana remains illegal under federal law. As a result, FDA has not developed GRAS regulations for marijuana and has not publicly commented on the applicability of cGMPs to medible manufacturers.
Although the FDA has not released an official position on whether or how it intends to regulate medible products, medibles likely could trigger heightened FDA scrutiny. An initial question which must be evaluated by the FDA is whether medibles qualify as foods at all, or whether their intended uses would qualify these products as drugs under the FDCA. (21 U.S.C. § 321(g) defines the term “drug” in part to mean “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.”).
If the FDA deems medibles to be foods, medibles would then be required to be manufactured using good manufacturing practices and product labeling compliant with FDCA regulation of foods. However, even if cGMPs and labeling requirements are satisfied, manufacturers, distributors, and sellers of marijuana medibles could still face liability under the FDCA because the FDA has not approved marijuana as a food ingredient or food additive and has not deemed marijuana to be GRAS. Generally speaking, products which contain food additives and ingredients that are not GRAS are considered adulterated under the FDCA. Thus, if the FDA were to assert jurisdiction and begin regulating medibles as foods, under the current regulatory regime FDA would likely allege that medibles are adulterated.
Manufacturers and distributors of marijuana medibles face the possibility of several FDCA violations should marijuana medibles be considered adulterated food products. These include: 1) the adulteration of a food product in interstate commerce; 2) introduction or delivery for introduction into interstate commerce of an adulterated food product; and 3) the receipt in interstate commerce of any food that is adulterated, and the delivery or proffered delivery thereof for pay or otherwise. See 21 U.S.C. § 331 (a), (c). The penalties and punishments associated with these crimes are governed by 21 U.S.C. § 333 and depend on whether the government charges the defendant with committing a violation “with the intent to defraud or mislead.” Each of these penalties is available regardless of whether marijuana is legal under State law.
Regardless of how FDA regulates medibles, the federal government has made clear that marijuana is still classified as a Schedule I drug under the Controlled Substances Act (“CSA”). Accordingly, distributors face the risk of additional criminal penalties beyond those prescribed within the FDCA. 21 U.S.C. § 841 prohibits the manufacture and distribution of a controlled substance expect as permitted under the CSA. Unlike the FDCA where first offenders convicted of adulteration violations face a maximum of three years imprisonment, first time offenders under the CSA face a minimum of five with a possibility of a maximum of forty years imprisonment. Because the production of medibles is not permitted under the CSA, criminal indictments under this separate regulatory regime are still possible. Such indictments would be similar to those of three medicinal marijuana dispensary operators late in 2012. (More information on those indictments can be read in our previous report here.).
Due to the federal government’s apparently unwavering position on marijuana products, some Congressional lawmakers have introduced legislation that restricts federal involvement in regulating the sale and use of marijuana. On March 7, 2013, Representative Dana Rohrabacher proposed a new bill to Congress entitled the “Respect State Marijuana Laws Act of 2013″ (H.R. 1523). The proposed bill protects both marijuana businesses and individual marijuana users from federal or criminal prosecution so long as their acts comply with existing state laws. Specifically, the Respect State Marijuana Laws Act of 2013 proposes to add the following language to the Controlled Substances Act (21 USC 801 et seq.): “Notwithstanding any other provision of law, the provisions of this subchapter related to marihuana shall not apply to any person acting in compliance with State laws relating to the production, possession, distribution, dispensation, administration, or delivery of marihuana.” Congress has yet to vote on this bill.
Unless and until the federal government begins to respect state laws governing marijuana, marijuana growers and commercial manufacturers should be aware of the potential issues that will continually arise due to the conflict between state and federal law.
The attorneys at Fuerst Ittleman David & Joseph, PL have extensive experience in the areas of administrative law, constitutional law, regulatory compliance, white collar criminal defense and litigating against the U.S. Department of Justice. You can reach an attorney by emailing us at email@example.com or by calling us at 305.350.5690.
This entry was posted on Monday, May 20th, 2013 at 1:49 pm and is filed under FDA.
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