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Half-Baked — The Retail Promotion of Marijuana Edibles — NEJM

A striking feature of the rollout of the state-legalized retail sales of marijuana has been the tremendous popularity of edible marijuana products. Marijuana brownies have long been a staple of cannabis coffee shops in the Netherlands, but the new products are quite different. They are skillfully produced and packaged to closely mimic popular candies and other sweets (see photoEarly Examples of Prepackaged Marijuana Edibles.). These products can now be purchased legally in four states; retail stores are operating in Colorado and Washington State, and voters recently approved retail sales in Alaska and Oregon.The new edibles raise public health concerns, including a risk of consumption by children. Although the states that have legalized recreational use of marijuana have only partially addressed these risks, many others — including Arizona, California, Maine, Massachusetts, Missouri, Nevada, and Vermont — are likely to move legalization proposals forward, developments that may amplify the problem.Marijuana is associated with a long history of public misinformation and anxiety, and many observers will therefore view concerns about edibles with skepticism. Still, edibles that resemble sugary snacks pose several clear risks. One is overintoxication. Whereas consumers commonly assume that a candy bar constitutes a single serving, some of these products contain four or more times the level of tetrahydrocannabinol (THC) that is considered to be a safe dose. (Colorado, for instance, set a standard size for an edible serving at no more than 10 mg of THC.) At high doses, THC can produce serious anxiety attacks and psychotic-like symptoms. This problem is augmented by differences in the pharmacokinetic and metabolic effects of marijuana when it is ingested rather than smoked.1 In addition, case reports document respiratory insufficiency in young children who have ingested marijuana.2Although the use of marijuana remains illegal everywhere for people under 21 years of age, today’s edibles are likely to appeal to children and young people. Even if consumption by minors is not intended by manufacturers, the packaging of edibles brings to mind the tort-law concept of the “attractive nuisance”: a hazardous condition that is foreseeably likely to attract children who are unable to appreciate the risk involved. It also evokes tobacco companies’ use of advertising campaigns with youth appeal, such as the long-running campaign featuring Joe Camel.3Whether through deliberate acquisition or unknowing consumption, these child-friendly edibles increase minors’ risk of exposure to and experimentation with marijuana.4 A recent study showed that the proportion of ingestion-related emergency department visits by young children in Colorado that were attributable to marijuana ingestion increased after legal restrictions were eased and that the majority of identified sources of the marijuana involved were edibles.5 Accidental exposures are not the only reason for concern, however. Plausibly, the availability of child-friendly edibles could increase the probability of initiation to marijuana use, reduce the average age of initiation, and increase the frequency and intensity of use among users of all ages.Why have new kinds of marijuana edibles proliferated? The answer is simple: they appeal to consumers, and the ballot propositions that legalized marijuana use did not include rules prohibiting edibles in formulations and packages that appeal to children. In the face of intense lobbying from the new industry, Colorado and Washington State subsequently adopted fairly modest regulations for edibles. Both states require child-resistant packaging, a warning to “keep out of the reach of children,” and labeling describing a standard serving size. Neither requires warnings that ingested marijuana can have different effects from smoked marijuana. Both states prohibit packaging and advertising that specifically target children, but neither requires formulation or packaging that is clearly distinguishable from ordinary food products.The federal government does not regulate marijuana edibles. Marijuana remains a Schedule I controlled substance under the federal Controlled Substances Act (CSA), which means that it’s considered to have high potential for abuse, is not recognized as having any accepted medical use, and is not considered safe to administer even under medical supervision. As long as it remains on Schedule I — a determination that has been periodically reconsidered — it is outside the purview of the Food and Drug Administration (FDA) to regulate as a drug, except in the context of research studies. The FDA could determine that marijuana edibles qualify as a food under the federal Food, Drug, and Cosmetic Act (FDCA) and seek to enforce regulations concerning food adulteration. Under the FDCA, foods must not contain additives that the FDA has not approved or that are not “generally recognized as safe.” Marijuana arguably fails that standard