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P             roducts containing cannabidiol (CBD)   were measured several times during the public speak-


                                                                 ing exercise. Patients who were pretreated with CBD
                                seem to be everywhere, from corner
                                                                 showed significantly less anxiety, cognitive impair-
                                stores to mail-order giants. Consum-
                                ers can pick from supplements and
                                                                 ment, and discomfort during the simulation.
                                                                   Janice Newell Bissex, MS, RDN, FAND, a holis-
                                sprays to balms and brownies as they
                                seek the serenity promised by this
                                cannabis derivative. Cannabis bever-  tic cannabis practitioner, culinary nutritionist, and
                                                                 owner of Jannabis Wellness in Melrose, Massachusetts,
                   ages are particularly appealing to consumers. Accord-  says, “We are beginning to learn about the variety of
                   ing to a survey by High Yield Insights, 17% of current   health benefits of CBD to help alleviate pain, anxi-
                   CBD respondents, led by men aged 21–34, reported con-  ety, insomnia, muscle spasms, inflammation, depres-
                   suming CBD beverages, and 30% of nonusers reported   sion, and possibly autism. It isn’t a cure-all, but it can
                   interest.  With a projected average annual growth in   improve or relieve a lot of conditions in a more natu-
                         1
                   the United States of 75%, from 2018 to 2023, the emerg-  ral way. Some of my clients have been able to decrease
                   ing category of CBD beverages is hard to ignore.   their use of antianxiety and pain medications after
                                                                 adding cannabis to their regimen.”
                   Overview of CBD                                 Questions remain, however, regarding the safety of
                   Of the Cannabis sativa plant, marijuana and hemp are   CBD, including the effects of long-term use and using
                   the best-known strains; CBD and tetrahydrocannabi-  multiple CBD-containing products simultaneously. CBD
                   nol (THC) are the best-known bioactive compounds.   use has been associated with liver toxicity, extreme
                   More than 80 phytocannabinoid compounds have been   sleepiness, interaction with certain medications, and
                   identified in the Cannabis sativa plant alone.  CBD is the   potential harm to a fetus or breast-fed baby. More
                                                     2
                   nonintoxicating cannabinoid associated with health   research is needed to better understand the benefits and
                   benefits, including analgesic properties. THC, the intoxi-  drawbacks of CBD and to increase knowledge about the
                   cating compound, features prominently in marijuana   endocannabinoid system, its potential modulators, and
                   but is present at less than 0.3% in hemp; therefore, hemp   its impact on various conditions.
                   is the source of choice for CBD.
                     A quick scan of the available research demonstrates   Regulatory Status in Flux
                   broad interest in the functions and health-supporting   The 2018 Farm Bill removed hemp from the list of
                   roles of the body’s endocannabinoid system, includ-  Schedule 1 narcotics (where it previously was catego-
                   ing mental and physical health, as well as disease treat-  rized with marijuana) and legalized its cultivation,
                   ment and prevention. Plant-derived cannabinoids (ie,   opening the door for production of topical and other
                   phytocannabinoids) have been researched as potential   products containing CBD. The Farm Bill retains FDA’s
                   therapeutic options because of their modulation of the   authority to regulate the sale and marketing of CBD-
                                      2
                   endocannabinoid system.                       containing foods. However, under the federal Food,
                     In her FNCE® 2019 presentation, “CBD is Every-  Drug, and Cosmetic (FD&C) Act, because CBD is an
                   where! Navigating the MNT and Its Role in the Mar-  active pharmaceutical ingredient in an approved drug,
                   ketplace,” Laura Lagano, MS, RDN, CDN, highlighted   Epidiolex, food (or beverage) products containing CBD
                   more than two dozen conditions CBD usage can help   can’t be introduced into interstate commerce, that is,
                   alleviate. She noted that CBD acts by impacting sero-  manufactured in one state and sold in another, accord-
                   tonin, opioid, dopamine, and other receptors located   ing to the FDA.   6
                   throughout the body.                            The FDA issued warning letters in late November
                     Studies suggest the effects of CBD on the activity of   2019 to companies regarding CBD in their food and
                   the endocannabinoid system have the potential to ben-  beverage products and for higher amounts of THC
                   efit treatment for a broad range of conditions, including   than are stated on labels or legally permitted. In a
                   neurodegenerative, cardiovascular, and inflammatory   November 26, 2019, consumer notice, the FDA stated
                   disorders; obesity and metabolic syndrome; cachexia;   that “under the FD&C Act, it’s illegal to introduce
                   chemotherapy-induced nausea and vomiting; and tissue   into interstate commerce any human or animal food
                   injury and pain.  Clinical trials, however, have focused   to which certain drug ingredients, such as CBD, have
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                   primarily on THC and its targets, CB1 receptors. To date,   been added. In addition, the FDA isn’t aware of any
                   CBD studies are limited to preclinical and pilot studies   basis to conclude that CBD is GRAS [generally rec-
                   that elucidate its anti-inflammatory, antioxidative, and   ognized as safe] among qualified experts for its use
                   neuroprotective effects.   4                  in human or animal food. There also is no food addi-
                     One preliminary study published in 2011 com-  tive regulation which authorizes the use of CBD as
                   pared the effects of simulated public speaking on   an ingredient in human food or animal food, and the
                   healthy control patients, patients with diagnosed but   agency is not aware of any other exemption from the
                   untreated social anxiety who received a single 600-mg   food additive definition that would apply to CBD. CBD
                   dose of CBD, and patients with diagnosed speaker   is therefore an unapproved food additive and its use
                                            5
                   anxiety who received a placebo.  Subjective mood   in human or animal food violates the FD&C Act for
                   and self-deprecation tests and physiological tests   reasons that are independent of its status as a drug
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