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  • Unauthorized claims for CBD products North Carolina USA

    Unauthorized claims for CBD products North Carolina USA

    Introduction

    Public interest in the use of cannabidiol (CBD), a non-intoxicating hemp derived compound, has become increasingly prominent in the United States (US). Demand for products containing CBD is growing as states legalize medicinal cannabis programs and companies promote health and medical applications of the compound.1,2 The rising relevance of CBD and its availability have followed the legalization of ingredients derived from hemp, including CBD, by the United States Congress,3 authorizing trade of hemp products and stimulating consumer participation in the market.

    Simultaneously, the Food and Drug Administration (FDA) has only approved a single CBD medication (Epidiolex) and cautions consumers about the claims made by cannabis companies based on little or low-quality evidence.4 Currently, only one prescription medication containing CBD is approved by the FDA; Epidiolex. While Epidiolex is marketed consistent with FDA regulations to treat seizure disorders,5–7 the FDA mandates that products containing CBD cannot be marketed for therapeutic purposes or benefits without prior approval from the FDA’s Center for Drug Evaluation and Research, use false and/or misleading information, or convey the product is approved or endorsed by the FDA without FDA approval. The FDA has not approved CBD as a dietary supplement and has prohibited addition of CBD to food products, thereby restricting advertisement regarding therapeutic properties or general health benefits.5 Resulting from the 2018 Farm Bill and state actions, the FDA has identified hemp/CBD dispensaries and shops are making medical claims that are both unproven and ambiguous. In accordance, FDA has indicated that actions will be taken when CBD-containing products are marketed using illegitimate unproven medical claims.5

    Currently, states across have varying regulations regarding cannabis products and their integration into the market for consumption.8 State laws range from excluding all marijuana access, legalization of high CBD and low delta-9-tetrahydrocannabinol (THC, the major intoxicating compound in cannabis) products, medical use of THC products, and recreational use of THC products.9 Interestingly, CBD products are available nearly nationwide in the US since only three states do not have any legal cannabis program as of February of 2022.10 In North Carolina (NC), delta-9-THC containing products or marijuana cultivation are illegal recreationally and medicinally but cultivation of hemp by licensed individuals was legalized in 2015.11 North Carolina serves as an example of a state with a program dedicated to the integration of hemp cultivation and medicinal CBD exclusively, containing a multitude of retailers selling it as a primary product. In fact, about half of growers in the state cultivate hemp for CBD production,12 demonstrating its increasing prominence and its role as a significant motivation for growing hemp.

    North Carolina defines industrial hemp as a cannabis plant containing 0.3{fe463f59fb70c5c01486843be1d66c13e664ed3ae921464fa884afebcc0ffe6c} THC or less, following the 2018 Farm Bill. Hemp is a rich source of raw materials and nutrients. Hemp fibers are used for clothing and paper, while seeds are used for cooking and cosmetic products. Importantly, CBD is extracted from the flower of the hemp plant and the seed oil can be used to dissolve the CBD extract, so hemp growers can use virtually all components of the plan, making it an attractive and profitable crop and commodity.1 There are no laws which restrict individuals to sell CBD products in NC if offered in an established business and an individual is approved to cultivate it. Notwithstanding, NC legislature complies with FDA rulings in the prohibition of CBD in food, medical claims of CBD, and labeling as a nutritional supplement.13 In parallel, the use of CBD for medical purposes is regulated in the state under the NC Epilepsy Alternative Treatment Act14 which serves to protect NC patients with epileptic disorders by reserving the ability to possess and administer hemp extract as an alternative form of treatment when traditional solutions have proven ineffective for an individual’s symptoms. Hemp extract is defined by the NC Department of Health and Human Services as an extract from a cannabis plant, or a mixture or preparation containing cannabis plant material that must be composed of less than 0.9{fe463f59fb70c5c01486843be1d66c13e664ed3ae921464fa884afebcc0ffe6c} THC by weight, at least 5{fe463f59fb70c5c01486843be1d66c13e664ed3ae921464fa884afebcc0ffe6c} CBD by weight, and may contain no other psychoactive substances.15 The hemp extract in possession must obey NC guidelines and patients and caregivers both undergo an approval process.14 This program in NC is not limited to the conditions by which Epidiolex is approved and therefore offers a potential treatment for other types of epilepsy. Whether this program offers advantages to NC patients with refractory epileptic syndromes over the FDA-approved CBD medication, Epidiolex, is unclear.

    Many companies are not compliant with marketing claim regulations, especially when promoting their products online. The FDA issued over thirty-nine warning letters to companies for noncompliance with their CBD products between the years 2015 and 2019 using online advertisement.4 These violations include falsely labeled CBD as a registered drug or as a dietary supplement or food, and marketing illegal therapeutic claims about CBD. The FDA revealed that twenty seven more letters have been released since then.4 We have analyzed the content of those FDA warning letters and uncovered that companies are targeting two major populations using online advertisements; healthy individuals (with products such as dietary supplements and food additives) and those suffering symptoms of chronic diseases (like cancer, diabetes, inflammation, pain, arthritis, anxiety, depression, and others).4

    Upon consideration of the development of the CBD industry and the history of government intervention across the country to protect consumers, we aim to characterize the online content of the NC CBD market by analyzing retailers’ websites to determine whether hemp/CBD shops comply with FDA regulations. Accordingly, we analyzed health and medical claims (eg, to preserve or enhance health or prevent or treat medical conditions) made by hemp/CBD shops and whether sensory traits (flavor, aroma, etc.) or psychoactive effects (sedation, relaxation, etc.) were included on their websites and for specific CBD products. Additionally, we aim to determine whether this analysis provides insight regarding the potential benefits of state CBD programs that offer alternative access to CBD for untreatable seizure disorders – as the NC program (and many other states) is designed for this purpose. Considering the availability of Epidiolex, it is plausible that legal CBD programs are conceived to offer a more accessible alternative in terms of mode of administration, potency, and/or price.

    Methods

    Selection of North Carolina Cities and CBD Retailers

    Retailers dedicated to sell CBD or hemp products (for simplicity, referred to as CBD retailers) were randomly selected from the ten most populated cities in North Carolina. Most populated cities were chosen based on their higher density of commercial establishments when compared to less populated areas. According to the World Population Review (which utilizes data from the 2020 Census), the most populated cities in North Carolina are the following, in descending order: Charlotte, Raleigh, Greensboro, Durham, Winston-Salem, Fayetteville, Cary, Wilmington, High Point, and Concord. We randomly selected three CBD dispensaries per city, for a total of 30 dispensaries across NC (Figure 1). This sample size is comparable to or more robust than other studies of cannabis dispensaries.16–18 Google Maps, which has been used successfully by our team and others to locate cannabis dispensaries19 or other type of retailers,20 was used to identify CBD retailers in the selected cities. We standardized the search criteria by using “CBD hemp cannabidiol dispensaries/shops in ‘city’ “NC” for each of the ten cities (ie, CBD hemp cannabidiol dispensaries in Charlotte NC). The basis of the order in which the retailers were listed by Google in the search results was unknown and inconsistent with distance, consumer rates, location within city limits, and other potential measures. Therefore, we randomly selected three CBD dispensaries per city. We obtained three numbers using an online random number generator (https://www.randomizer.org) and these numbers were used to select the three dispensaries from the Google search result list for each city. A dispensary selected by this method was included in the analysis only if its listed address was in the correct city or the website indicated it sold its products in the correct city. Thus, selected dispensaries that were not located in the proper city, did not have a physical address, or did not have a website were excluded from this selection process. If the dispensary chosen based on the obtained random number did not fit the criteria or was a dispensary already chosen in a different location, the succeeding dispensary that fit the criteria was selected from the result list. If unable to continue chronologically down the list, a preceding dispensary was chosen.

    Figure 1 Study flow chart.

    Presence of Claims, Warnings, and Disclaimers

    We searched on the home page, hovered over a tab, or navigated to a non-product related page containing other information to identify whether the studied websites make general health claims, general medical claims, presence of safety health warnings, and FDA disclaimers (or references to uncertain/unguaranteeable/not yet proven benefits of CBD with FDA references). We quantified the number and percent of CBD retailers that made these claims somewhere on their website.

    Featured Product Categories

    Once the websites of selected retailers were visited, the main menu was located to determine the type of products offered and the order in which these product categories appeared in the menu. We focused on consumable products and excluded textiles, basketry, cordage, and other non-consumable product. Product types were given a score related to their order of appearance, 1 for the type of product that was listed first, 2 for the second, and so forth to chronologically list the order in which each website presented its product categories, as we have previously described.21 We also quantified the number of dispensaries featuring each type of product in their menus to determine their frequency of appearance.

    Product Characterization

    Two products from each of the major product categories (edibles, oral, inhalable, and topical) were selected in each included dispensary (Figure 1). We defined a priori that the first two CBD products in these categories were going to be selected to collect information. A CBD product was defined as a product claimed to contain CBD as one of its ingredients. Products that contain only THC or with no content of CBD were skipped (excluded). Products that contain other hemp or cannabis derived products in combination with CBD were considered CBD products and were included (ie, products with Delta-8 and CBD). Some selected dispensaries only displayed a photo of their products and did not provide any other product information (CBD content, price, chemovar, or claims); therefore, these dispensaries were excluded from the study at this time (Figure 1).

    We evaluated whether these products had descriptions that included health claims (defined as non-medical attributes referred to a general state of wellbeing or health improvement not related to a disease), medical claims (defined as any mention of a disease, symptom, or therapeutic property or effect), sensory traits (defined as flavor, taste, smell, or aroma), and psychoactive effect claims (defined as subjective or psychotropic effects). First, we recorded the description of each studied product and then input the information verbatim into an online word counter (databasic.io/en/wordcounter). We obtained single word, bigram, or trigram frequencies. Two independent investigators extracted medical related terms, health-related terms, sensory trait terms, and psychoactive related terms. A third senior investigator reconciled discrepancies (ranged between 5{fe463f59fb70c5c01486843be1d66c13e664ed3ae921464fa884afebcc0ffe6c} and 25{fe463f59fb70c5c01486843be1d66c13e664ed3ae921464fa884afebcc0ffe6c}). The resulting extracted information was further analyzed by the three investigators and only unanimously selected terms were included in the final results. The data were organized to reflect the most frequent words, bigram, or trigram terms per category.

    We recorded the total content of CBD and the price of the studied products when available. Then, we calculated the price per 300 mg of CBD per product category. This concentration was chosen since it seems the minimal clinically relevant concentration of CBD based on studies on epileptic syndromes22 or anxiety.23

    Analysis and Statistics

    Frequencies (in the form of percentages) were calculated for each type of claim, and for the presence and rank of different types of product categories in menus. Average or median values for CBD content (in mg) and product prices were calculated and compared among product categories using one-way ANOVA and Tukey’s multiple comparisons test. Correlation analyses for CBD content and price were conducted using Pearson correlation coefficients. GraphPad Prism 9 software was used for statistical analysis.

    Results

    Featured Product Categories

    We first determined products’ rank location in the filter menus or their frequency in dispensary menus. Figure 2A depicts the order in which CBD products most likely appear in website menus. Notably, when present, beverages are consistently featured at the top of the menus, followed by oral oils, flower/preroll, edibles, tinctures, etc. Figure 2B depicts the frequency in which different product types appear in website menus (out of 25 included dispensaries). In this case, topicals were more frequently featured in menus, followed by edibles, flower/preroll, tinctures, vaping products, etc.

    Figure 2 Characterization of product types in website menus. Product rank in menu and number of dispensaries featuring product types in their menu; data presented as median (black lines) and 95{fe463f59fb70c5c01486843be1d66c13e664ed3ae921464fa884afebcc0ffe6c} CI (dotted gray lines); (A). Frequency of product type menu appearances in dispensaries (B). Percent of products found in dispensary menus (C).

    We noticed that different types of products belong to a similar category based on form of consumption or administration, except for non-CBD products such as Delta 8. Thus, we grouped oral oils, dietary supplements, and tinctures into “oral category”, edibles and beverages into “edible category”, and concentrate to inhale, vape and herbal products into “inhalable category”. We found that the frequency of these categories, inhalable, edible, topical, and oral, was similar, and Delta 8 products were slightly less frequent (Figure 2C).

    Claims in Websites

    First, we analyzed retailer websites. We observed that 39.4{fe463f59fb70c5c01486843be1d66c13e664ed3ae921464fa884afebcc0ffe6c} of the included retailer websites (25 included retailers) featured general medical claims, 35.7{fe463f59fb70c5c01486843be1d66c13e664ed3ae921464fa884afebcc0ffe6c} included health claims, 10.7{fe463f59fb70c5c01486843be1d66c13e664ed3ae921464fa884afebcc0ffe6c} claimed CBD as food supplement, and 7.1{fe463f59fb70c5c01486843be1d66c13e664ed3ae921464fa884afebcc0ffe6c} displayed safety or health warnings.

    Claims in Products

    Second, we analyzed the descriptions of selected products. Word analysis for medical related terms using product descriptions (from 21 dispensaries featuring product descriptions) uncovered that the most frequent single word was “pain” (including pain and pains), followed distantly by “inflammation” (including “inflammation and anti-inflammatory”), “anxiety”, “stress”, and “aches/achy” (Figure 3A). Based on the available scientific evidence about CBD’s medical effects, we found remarkable “epilepsy” was found only two times in the evaluated product descriptions. The most frequent bigrams for medical related terms revealed a similar trend, with “pain relief/pain management”, “anti-inflammatory properties” (including also “reduce inflammation” and “for inflammation”), and “sore muscles/achy muscles” (Figure 3B). The most frequent trigrams for medical related terms were “under the/your tongue”, “water soluble CBD”, “into the skin”, “muscle and joints”, and “aches and pain” (Figure 3C).

    Figure 3 Product description word analysis for medical-related terms. Frequency of medical-related single words (A), bigrams (B), and trigrams (C).

    Word analysis for health-related terms uncovered that the most frequent single word was “organic” (including organic and organically), followed by “natural” (including “natural”, “naturally”, “all-natural”), “help”, “benefits”, and “health/healthy” (Figure 4A). The most frequent bigrams for health-related terms revealed a similar trend, with “organic hemp” (including “organic hemp”, “organically grown”, “finest organic”, “pure organic” and “organic ingredients”), “all natural” (including “all natural”, “natural ingredients”, “naturally occurring”, and “naturally flavored”) (Figure 4B). The most frequent trigrams for health-related terms were “pure hemp botanicals”, “all natural ingredients”, and “from organic hemp” (Figure 4C).

    Figure 4 Product description word analysis for health-related terms. Frequency of health-related single words (A), bigrams (B), and trigrams (C).

    For sensorial trait related terms, we found that the most frequent individual word was “flavor”; (including “flavor”, “flavors”, and “flavored”), “cool/cooling”, “lavender”, and “taste/tasting” (Figure 5A). For psychoactive related terms, we found that the most frequent individual word was “Relax”; (including “relax”, “relaxing”, “relaxation”, and “relaxed”), “sooth/soothing”, “enjoy”, and “discomfort” (Figure 5B).

    Figure 5 Product description word analysis for sensory traits and psychotropic effects-related terms. Frequency of sensory trait single words (A) and psychotropic effect single words (B).

    CBD Content

    We observed that the concentration of CBD products is consistently given as the total amount of CBD in the entire product content rather than per serving, with the exception of inhalable products that is given in percent of total product weight. To make herbal CBD concentrations comparable to other types of products, we converted the percent of CBD to mg in inhalable products when information was available. Even though we did not find a statistical difference in CBD concentrations among edibles (median 300 mg; 150–750 mg 95{fe463f59fb70c5c01486843be1d66c13e664ed3ae921464fa884afebcc0ffe6c} CI), oral (750 mg; 500–1000 mg), topical (500 mg; 200–600 mg) or inhalable (625 mg; 200–600 mg), we observed that oral products have the largest range of concentrations and the category with the highest amount of CBD (Figure 6A). Most products, regardless of category, contain less than 1500 mg (101/117; 86{fe463f59fb70c5c01486843be1d66c13e664ed3ae921464fa884afebcc0ffe6c}) in total, and the majority of products contain less than 1000 mg (71/117; 61{fe463f59fb70c5c01486843be1d66c13e664ed3ae921464fa884afebcc0ffe6c}; Figure 6B). Products with less than 500 mg constituted 29{fe463f59fb70c5c01486843be1d66c13e664ed3ae921464fa884afebcc0ffe6c} (34/118) of the total studied products (Figure 6B). These findings contrast with the minimal clinically relevant dose of CBD, 300 mg.24,25

    Figure 6 CBD claimed concentration. Total CBD claimed concentration of product per category (median and 95{fe463f59fb70c5c01486843be1d66c13e664ed3ae921464fa884afebcc0ffe6c} CI; (A)), and CBD claimed concentration frequency distribution (B).

    Price of Products

    We normalized the price per product in relation to 300 mg as a clinically meaningful dose.22,23,26 Even though we did not find statistical differences in the price of products among edibles (median $26; $18–50, 95{fe463f59fb70c5c01486843be1d66c13e664ed3ae921464fa884afebcc0ffe6c} CI), oral ($25.48; $18–30), topical ($30; $24–36.40) or inhalable ($15.33; $2.12–23.56), we observed that inhalable products are more likely sold within the lower price range (Figure 7A). We found a significant positive correlation between CBD content and price per product when all studied products were analyzed (Figure 7B). A similar positive correlation was found when CBD and price were analyzed by type of product (Figure 8).

    Figure 7 Product price and price correlation to CBD concentration. Price per 300 mg of product per category (median and 95{fe463f59fb70c5c01486843be1d66c13e664ed3ae921464fa884afebcc0ffe6c} CI); one-way ANOVA + Tukey’s post test (no significant differences; (A) correlation of price and CBD concentration; P < 0.001 by Pearson correlation coefficient (B).

    Figure 8 Product price correlation to CBD concentration per type of product. Price per 300 mg of product and its correlation to price in edibles (A), oral (B), topicals (C) and inhalables (D); P values by Pearson correlation coefficient.

    Discussion

    The major findings of our study are, first, that NC dispensaries advertise their CBD products online using unauthorized medical claims, therefore NC retailers do not comply with FDA regulations; and second, that the online advertised CBD products in NC have a low potency and are expensive, indicating that the NC CBD market does not offer an advantage over the only available FDA approved CBD product, Epidiolex. Notably, the out-of-pocket cost of Epidiolex is $123527 (100 mL of 100 mg/mL), which represents a similar cost of a given CBD product found in the NC market. The low concentration of the NC CBD products contrasts with the consistency and clinically adequate concentration of Epidiolex.

    Our results show that the CBD online marketing strategy in NC encompasses the pattern of claims that FDA has identified nationwide in the US,4 CBD products are offered using unsubstantiated medical and health-related claims. Similarly, this pattern has been uncovered in Canada.28 It is worth noting that these pervasive violations currently occur in NC despite the historic and increasing FDA pressure through warning letters since 2015.4 This persistent lack of compliance demonstrates that the current FDA approach has been unsuccessful, and it is insufficient to stop this problem. Notably, therapeutic benefits for pain, inflammation, and anxiety (see bigram medical claim analysis) were the top medical claims in the NC online CBD marketplace. This is consistent with the conditions for which CBD is advertised online in Canada28 and what FDA warning letters have included as more frequent violations in the US CBD online marketing.4 Alarmingly, epilepsy, the only conditions for which CBD has been approved to treat,6,7,22 does not seem to be within the scope of the NC CBD market despite the presence of the NC Epilepsy Alternative Treatment Act.

    Our study demonstrates that CBD is marketed with medical and health-related claims for conditions that afflict a large segment of the population (ie, pain, inflammation, and anxiety). Chronic pain affects approximately 10{fe463f59fb70c5c01486843be1d66c13e664ed3ae921464fa884afebcc0ffe6c} of the general population, a condition that is often presented and complicated with depression and anxiety that leads to increase disability rates.29,30 Our study shows that musculoskeletal pain conditions seem paramount as “sore/achy muscles” was among the most frequent in our bigrams. However, the evidence for CBD for treating pain is limited and negative, or derived from sub-quality studies (ie, small sample sizes and lack of prospective, blinded, randomized, placebo control studies).31–35 Similarly, 11{fe463f59fb70c5c01486843be1d66c13e664ed3ae921464fa884afebcc0ffe6c} of adult Americans regularly had feelings of worry, nervousness, or anxiety.36 Despite the frequency of marketing CBD for the treatment of depression and anxiety, the evidence for CBD treatment anxiety is also mixed.23 Despite the lack of scientific evidence that CBD could treat pain, inflammation, or anxiety this online marketing strategy seems to be effective as reflected in popular interest and online testimonials about the uses of CBD by the general population that rate these conditions as primary reasons of CBD use.37 Accordingly, online searches for CBD products have sustainably and pronouncedly increase in all American states during the last decade,38 indicating that online marketing is an effective strategy to reach out consumers and potentially spur interest and influence their decision on CBD use. In fact, searching and examining online information is associated with positive attitudes towards medicinal cannabis and its legalization.39 Of note, dispensaries of medical cannabis are rated more favorably than other sources (friend, grower, Health Canada, etc.) in terms of product reliability, quality, and safety.40 Thus, providing misleading information about CBD products via online dispensaries represents a high risk for public health.

    Medical cannabis consumers consider CBD as the most important attribute that influences their willingness to buy cannabis products,41 signaling they perceive CBD to possess therapeutic benefits. The lack of effective medications for medical conditions, as is the case for pain, chronic inflammation, and anxiety/depression, can encourage patients to seek alternative therapies, including cannabis and CBD.42 Certainly, a significant portion of consumers state their purpose for CBD use is pain, arthritis, self-perceived mental health problems like anxiety and depression, among others.43–45 Intriguingly, epilepsy does not appear in the major reasons for CBD use in the available literature. Furthermore, this attitude towards CBD could drive patients to substitute CBD for their prescribed medication,42 which possesses multiple risks. For example, the major public health risk for non-FDA approved CBD products is the fact that their content and concentration is inaccurately labeled. They might possess undisclosed THC at various intoxicating levels and display lower or larger CBD concentrations than their actual content.2 Furthermore, CBD products have been reported to be contaminated with synthetic cannabinoids or other substances that caused mass poisonings,46 or lung injury outbreaks due to CBD e-cigarette or vaping products.47

    Notably, the concentrations of CBD products advertised in the online NC dispensaries are significantly lower than the known therapeutic doses for CBD and likely not clinically relevant. This apparent low potency together with inaccuracies in content information and the potential of adulterations and contaminants make these products not risk-free, especially when an FDA approved CBD drug is available. Furthermore, and despite their low CBD content, CBD products are expensive, namely $15–30 per 300 mg and the cost increases as CBD content increases.

    Our online marketing analysis shows that CBD dispensaries also use language to signal healthy products. The use of words like “organic”, “natural”, “help”, “healthy” indicates that dispensaries also target a non-medical population interested in general wellbeing. Similarly, the uncovered psychoactive descriptors (ie, relaxing, soothing, enjoy, calm, energy, mind, asleep.) support the interest of retailers in a segment of the population that uses products associated with a healthy lifestyle and reportedly consume CBD products.37 The taste references related to pleasant flavors or sensations (ie, cool, lavender, delicious, honey, menthol) resemble the strategies used for tobacco, including cigarettes and e-cigarette products designed to attract youth users,48 one of the most vulnerable demographic groups that notoriously suffers in larger proportions from anxiety and depression.49

    Our study provides valuable information about how the NC market is promoting CBD products in the context of the local epilepsy program. One of its limitations is that we did not directly compare the NC market with other states or other programs. For example, it is not clear whether the dynamic of the NC program and market extrapolates to states where medical cannabis or recreational cannabis coexist with CBD programs. However, the existing data from Canada and the analysis of the FDA warning letters sent to CBD retailers suggest that our results depict what is happening in other markets regardless of the availability of other cannabis products. Although beyond the scope of this study, another limitation is that we did not study whether this online information is in line with actual products in physical CBD shops. In any case, it is unlikely that retailers offer online products and information that is different from their physical shop menus. Regardless of its accuracy, online information is widely utilized by consumers, which could help form their preferences and perceptions towards CBD.37–39 We recognize that retailer websites are not the only source of information for CBD consumers seeking therapeutic benefits. In fact, in addition to self-directed research websites, trusted care providers and anecdotal experience of another are also informational sources that form the decision of CBD use for medical purposes.50

    Conclusions

    In conclusion, our study demonstrates that, 1) the NC CBD market promotes products online making unsubstantiated medical claims, a strategy that opposes FDA and NC regulations; 2) NC CBD retailers use their websites to primarily target patients suffering from pain, inflammatory conditions, and anxiety in conjunction with a healthy population interested in general wellness; 3) The products offered online by NC CBD shops do not represent a favorable alternative to the only FDA CBD medication, Epidiolex ($1235 per 100 mL, 100 mg/mL; $37 per 300 mg),27 as they are labeled with sub-clinical CBD concentrations and a high price. The latter shows a paradoxical disconnect between the NC CBD market and the NC Epilepsy Alternative Treatment Act that is intended to broaden the access of CBD to other epileptic conditions. Altogether, our data highlight the need of a more efficient strategy to enforce FDA and local regulations. The risk of providing online misleading information to vulnerable populations that often seek an alternative therapeutic option for their condition51 should spur scientific journals to gain online presence for the general population and warrants a change in the current policies to limit the access of non-pharmaceutical grade CBD products and their online promotion. Efforts to educate health-care providers, and, if possible, increase their online activity52 should also be part of the policy changes that are required to provide a safer environment to patients where CBD or cannabis programs are available.

    Abbreviations

    CBD, Cannabidiol; FDA, Food and Drug Administration; NC, North Carolina; US, United States; THC, Delta-9-tetrahydrocannabinol.

    Data Sharing Statement

    Data could be shared upon request to corresponding senior author, Dr. E. Alfonso Romero-Sandoval.

    Ethics Approval and Informed Consent

    This study is not an animal or human research study.

    Acknowledgments

    Department of Anesthesiology, Department of Biostatistics and Data Science, Department of Social Sciences and Health Policy, and Center for Addiction Research at Wake Forest University School of Medicine. The abstract of this paper was presented at the 2022 US Association for the Study of Pain (USASP) Conference in Cincinnatti, as a poster presentation and a conference talk with interim findings. The poster’s abstract was published in “The Journal of Pain”, Volume 23, Issue 5, Supplement, May 2022, Page 61; https://doi.org/10.1016/j.jpain.2022.03.228.

    Author Contributions

    All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.

    Funding

    Funding provided by the Department of Anesthesiology and Pilot Research Award by the Center for Addiction Research, Wake Forest University School of Medicine (ER-S), and National Institutes of Health, NIDA grants R01DA053209 (BR) and R01DA051542 (KW).

    Disclosure

    Dr E Alfonso Romero-Sandoval reports grants from Center for Addiction Research, Wake Forest University School of Medicine, NIDA, during the conduct of the study; personal fees from American Chronic Pain Association, Governor’s Institute, Addiction Medicine Conference, Swedish Medical Center Continuing Medical Education, Wake Forest University Graduate School Addictions Research and Clinical Health, International Academy on the Science and Impact of Cannabis, Massachusetts School of Pharmacy, Colorado State University, Covenant Health, and University of Connecticut, outside the submitted work. All authors declare no other competing interests in this work.

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    16. Cavazos-Rehg PA, Krauss MJ, Cahn E, et al. Marijuana promotion online: an investigation of dispensary practices. Prev Sci. 2019;20(2):280–290. doi:10.1007/s11121-018-0889-2

    17. Firth CL, Davenport S, Smart R, Dilley JA. How high: differences in the developments of cannabis markets in two legalized states. Int J Drug Policy. 2020;75:102611. doi:10.1016/j.drugpo.2019.102611

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    20. Ali SH, Imbruce VM, Russo RG, et al. Evaluating closures of fresh fruit and vegetable vendors during the COVID-19 pandemic: methodology and preliminary results using omnidirectional street view imagery. JMIR Form Res. 2021;5(2):e23870. doi:10.2196/23870

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    22. Devinsky O, Verducci C, Thiele EA, et al. Open-label use of highly purified CBD (Epidiolex®) in patients with CDKL5 deficiency disorder and Aicardi, Dup15q, and Doose syndromes. Epilepsy Behav. 2018;86:131–137. doi:10.1016/j.yebeh.2018.05.013

    23. Larsen C, Shahinas J. Dosage, efficacy and safety of cannabidiol administration in adults: a systematic review of human trials. J Clin Med Res. 2020;12(3):129–141. doi:10.14740/jocmr4090

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    26. Hurd YL, Spriggs S, Alishayev J, et al. Cannabidiol for the reduction of cue-induced craving and anxiety in drug-abstinent individuals with heroin use disorder: a double-blind randomized placebo-controlled trial. Am J Psychiatry. 2019;176(11):911–922. doi:10.1176/appi.ajp.2019.18101191

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    29. Colloca L, Ludman T, Bouhassira D, et al. Neuropathic pain. Nat Rev Dis Primers. 2017;3:17002. doi:10.1038/nrdp.2017.2

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    31. Capano A, Weaver R, Burkman E. Evaluation of the effects of CBD hemp extract on opioid use and quality of life indicators in chronic pain patients: a prospective cohort study. Postgrad Med. 2020;132(1):56–61. doi:10.1080/00325481.2019.1685298

    32. Cunetti L, Manzo L, Peyraube R, Arnaiz J, Curi L, Orihuela S. Chronic pain treatment with cannabidiol in kidney transplant patients in Uruguay. Transplant Proc. 2018;50(2):461–464. doi:10.1016/j.transproceed.2017.12.042

    33. Notcutt W, Price M, Miller R, et al. Initial experiences with medicinal extracts of cannabis for chronic pain: results from 34 ‘N of 1’ studies. Anaesthesia. 2004;59(5):440–452. doi:10.1111/j.1365-2044.2004.03674.x

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    35. Xu DH, Cullen BD, Tang M, Fang Y. The effectiveness of topical cannabidiol oil in symptomatic relief of peripheral neuropathy of the lower extremities. Curr Pharm Biotechnol. 2020;21(5):390–402. doi:10.2174/1389201020666191202111534

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  • Sick at school? – North Carolina Health News

    Sick at school? – North Carolina Health News

    By Michelle Crouch

    Co-published with Charlotte Ledger

    One morning last month, Ben Jacobs, a senior at Myers Park High School, woke up feeling nauseated with a terrible headache. He ran to the bathroom and vomited. Then he pulled himself together and hustled to school before the end of first period.

    Jacobs, who had already missed some school because of a medical issue, said he didn’t want to risk another absence in light of Charlotte-Mecklenburg Schools’ attendance policy – one of the strictest in the state, according to an informal analysis by The Charlotte Ledger/ NC Health News.

    The CMS policy says a high school student who misses more than 10 days of any class – whether the absence is excused or unexcused – will fail the course. To avoid a failing grade, a student must get a special medical waiver or make up the time through a process called “attendance recovery.”

    Although the rule has been in place since 1970, CMS is aggressively enforcing it this year as it tries to get students back on track after the pandemic, when absences soared and school performance tanked.

    Research shows excess absences – missing 10 percent or more of school days – is strongly linked to lower academic achievement.

    The policy is sparking controversy among parents and students who say it encourages students to go to school sick at a time when respiratory illnesses are surging. In addition to the ongoing threat of COVID – which triggers a five-day quarantine under CMS rules – respiratory syncytial virus (RSV) and flu are also on the rise.

    “It’s ridiculous,” said Erin Garvey, whose daughter is a sophomore at Hough High. “Ten days is not a lot when we have all sorts of illnesses spreading like wildfire. I know absenteeism has gotten out of hand with some kids. But there’s a big difference between kids who are just skipping and a straight-A student whose family says, ‘My kid was sick.’”  

    The goal: keep kids in school

    Matthew Hayes, CMS deputy superintendent for academic services, said emphatically that CMS does not want sick kids to come to school. At the same time, the district wants to send the message that families need to make school a priority and try to schedule vacations and appointments outside of school time.

    Chronic absenteeism leads to lower grades and test scores, less engagement in school and higher dropout rates, research shows.

    “If students are not in the classroom, they are missing instruction,” Hayes said. “Even if it’s an excused absence, it still is going to create a gap in the continuation of a student’s learning.”

    The CMS policy allows students who are absent for an extended amount of time for medical reasons to apply for a medical waiver with documentation. In addition, missing class for a school-sponsored activity such as a field trip or an athletic competition doesn’t count toward a student’s total absences.

    Hayes noted that absences skyrocketed during the pandemic when CMS suspended its attendance rule. About 29 percent of CMS students were “chronically absent” in the 2021-2022 school year – that’s twice as many as before the pandemic. CMS considers students chronically absent if they miss at least 10  percent of days in a school year – or about 18 days.

    Since the board reinstated the policy this school year, absences have dropped. In a Nov. 11 Charlotte Observer article, outgoing interim superintendent Hugh Hattabaugh listed better student attendance as one of his accomplishments, noting that chronic absenteeism is down to about 15 percent today.

    Hayes said the attendance policy is not intended to penalize students: “It’s about making sure they have the resources and the knowledge they need in order to be successful, not just for the course they are currently in but also for future courses.”

    One CMS high school teacher said he’s glad the district is cracking down. “I had students last year with 30-plus absences. I cannot do my job like that,” he said.

    The teacher said he did not want to be named because he feared retribution from school administrators – or from angry parents. “I’ve already been asked by parents to ignore the policy, falsify the recovery of time or allow students to make up the remediation work on their own time,” he said.  

    “A really wrong-headed idea”

    Although CMS may want sick kids to stay home, students and families said that’s not always what happens.

    Jacobs said he recently sat next to a student in class who admitted to having a fever, but who said she was there because of the attendance policy. And Garvey said her daughter returned to school early when she had a cold earlier this year.

    “She felt like garbage but went back, and I know she was not the only one. She has several friends who have gone back prematurely because they felt the pressure,” Garvey said.

    Meanwhile, some psychologists have another concern: they say the policy is creating unnecessary anxiety among teens with mental health issues, and it’s making kids opt out of getting therapy they need, because they can’t get appointments outside of school hours.

    “Our kids are in crisis,” said Kristin Daley, a psychologist at Base Cognitive Behavioral Therapy in Charlotte. “With all of the isolation during the pandemic, referrals are through the roof. Ideally, of course, we would love for all of these kids to be seen outside of school hours, but it’s just not feasible.”

    Daley said the CMS attendance policy came up at a recent staff meeting in her office, and it has also been a frequent complaint on a Facebook page of Charlotte area counselors, therapists and psychologists. There was even discussion about publishing an open letter urging the district to reconsider the policy, Daley said.

    “It just feels like a really wrong-headed idea,” Daley said. “It’s causing families to prioritize compliance to school over their physical health and mental health. Increasing anxiety is not going to improve test scores.”

    Other districts more lenient

    The Ledger/NC Health News reviewed the attendance policies of other large N.C. school districts as well as the ones immediately surrounding Charlotte and found that the CMS policy is among the toughest.

    • In Wake County, for example, high school students are “referred to the school-based attendance team” if they exceed 20 excused or unexcused absences – double the number that CMS allows. The team will then consider “appropriate interventions to improve the student’s attendance,” according to the district’s policy manual.
    • Cabarrus County schools call for a review (not an automatic failing grade) if a student exceeds eight absences in a semester. The review should consider the circumstances of the absences, other measures of academic achievement and the extent to which the student completed missed work, according to the district’s policy.
    • In Asheville, the Buncombe County school board voted to loosen its policy earlier this year, allowing high school students to miss 14 days of a year-long class, rather than the 10-absence limit it imposed before, said spokeswoman Stacia Harris. “We know that we must give grace and work with families as much as possible,” Harris said in an email.

    5-day limit in handbook not being enforced

    The CMS 2022-2023 parent-student handbook actually differentiates between students in year-long and semester-long classes. The handbook says students in a semester-long class will receive a grade of “F” for the course once they exceed  five absences.

    Hayes told the Ledger that CMS is not enforcing that five-absence limit and is focusing instead on students who exceed 10 absences total.

    He also noted that CMS counselors and teachers reach out to families long before they hit the 11th day.

    “When we see students with consecutive days out, teachers are speaking to counselors, and counselors making phone calls home: Is this a transportation issue? Is there something else keeping a student from getting to school? We want to solve for that.”  

    No state guidelines mandating failure

    The state Department of Public Instruction offers no specific guidelines requiring districts to fail students who miss a lot of school, said Rob Taylor, deputy state superintendent for district and school support services. 

    Years ago, the state required a certain amount of seat time before a student could earn course credit. That policy was eventually eliminated in favor of a focus on content mastery, but it may be why some districts still tie excess absences to failure, Taylor said in an email. 

  • Should North Carolina operate its Medicaid oral health program as fee-for-service or transition to managed care?

    Should North Carolina operate its Medicaid oral health program as fee-for-service or transition to managed care?

    By Anne Blythe

    As lawmakers ponder whether to expand Medicaid to add some 600,000 more people to the rolls, the North Carolina Oral Health Collaborative is looking at a different aspect of the federal- and state-sponsored insurance program.

    Nearly a year ago, North Carolina transformed its Medicaid program from a fee-for-service-based plan to a system managed by private insurers.

    The oral health portion of the program, however, was not part of the Medicaid transformation. It is still managed by the state.

    Zachary Brian, director of the North Carolina Oral Health Collaborative and vice president of impact, strategy and programs at the Foundation for Health Leadership and Innovation, said recently in a telephone interview that his organization has partnered with the North Carolina Institute of Medicine and The Duke Endowment to launch the Oral Health Transformation Initiative. (Disclosure: The Duke Endowment is a NC Health News sponsor).

    In July, a task force with members from diverse vantages in oral health care delivery will begin a year-long process in which members consider whether oral health care provided through Medicaid should remain a fee-for-service program or be overseen by private insurers.

    “The traditional fee-for-service payment system incentivizes costly, more invasive procedures,” Brian contended while announcing the joint initiative.

    “Nationally, we see a movement in remodeling our health care delivery system in many ways,” Michelle Ries, associate director of the North Carolina Institute of Medicine, added in the same video announcing the initiative. “As North Carolina has moved to managed care for primary health care and behavioral health services, we believe we owe it to the consumer and provider communities to thoroughly look at the current landscape for oral health and make recommendations based on an analysis of what other states are doing and lessons learned from the rollout of Medicaid managed care so far in North Carolina.”

    Whole-body care

    For too long, many public health advocates say, oral health care has been in a silo, of sorts, the mouth separated from the body. This is increasingly out of step with the systemic “whole-body” approach being advocated for more recently.

    A look into someone’s mouth can reveal evidence of heart disease, cancer, autoimmune syndromes, viruses, diabetes and gastrointestinal problems.

    Public health advocates say that integrating oral health care with primary care could not only make many communities and populations healthier but also reduce costs. People who do not have routine access to dental care often end up in emergency rooms with toothaches or infections in the oral cavity. Those visits can be far more costly for the patient, the provider and the insurer.

    Many communities in North Carolina face challenges accessing “optimal oral health care,” according to the Oral Health Collaborative.

    Four counties in North Carolina do not have a regularly practicing dentist, according to data collected from 2020 by the Cecil G. Sheps Center for Health Services Research. They’re in the northeastern tip of the state — Camden, Gates, Hyde and Tyrrell counties.

    Will more dentists participate?

    The collaborative says roughly 35 percent of the dentists in North Carolina participate in Medicaid or the Children’s Health Insurance Program, or CHIP as it’s often called.

    Dave Richard, head of Medicaid at the state Department of Health and Human Services, said his office puts that number closer to 40 percent. 

    Nonetheless, that number can pose a challenge for children and adults in need of care, often in the state’s rural reaches, public health care advocates note. Only 18 percent of adult Medicaid recipients in North Carolina use the dental care option, according to the collaborative’s statistics.

    Richard said that in 2021, the state’s fee-for-service Medicaid oral health program paid $24 million in claims for children in the CHIP program. The program paid $300 million for children ages 6 to 20 in the Medicaid program, and $104 million for adults 21 and older.

    Richard took no stance on whether it would be better to shift the oral health program to managed care or keep it as a fee-for-service program.

    Instead, he posed several questions.

    “What value add would you bring if you move to managed care?” Richard asked. He also wondered whether the state would lose or gain more dentists through such a shift.

    That’s what the task force plans to study over the next year with hopes of delivering a report and potential series of recommendations for a reimagined oral health care system. Their goal is to get something that policymakers and lawmakers can have to review in time to decide whether the state should make the shift before the next contracts are negotiated in 2024.

    “So often we don’t have the opportunity to really slow down and take a year, 18 months and dig in and engage with other states and engage with experts and really bring people to the table,” Stacy Warren, program officer for The Duke Endowment, said when the initiative was announced. 

    “We can’t just fund a lot of programs,” she said, although she said that’s actually happening. “We fund school-based oral health programs. We fund medical-dental integration programs, but what we’ve learned and the North Carolina Oral Health Collaborative has certainly helped teach us this over the years, is that these programs can’t exist successfully in isolation of true systems change.”

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    by Anne Blythe, North Carolina Health News
    June 14, 2022

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  • CBD, hemp legalization rolls to North Carolina Gov. Roy Cooper’s office after OK by NC House

    CBD, hemp legalization rolls to North Carolina Gov. Roy Cooper’s office after OK by NC House

    RALEIGH, N.C. (WGHP) – The legislation that would make hemp and CBD authorized in North Carolina is headed for the desk of Gov. Roy Cooper.

    Senate Invoice 455 was handed by the condition Property on Wednesday following unanimous approval in the Senate.

    The invoice would allow for farmers to go on to expand hemp as a basis for the fiber discovered in rope and clothes and other goods but also for the CBD merchandise, such as oils, vapes and other consumables. The difference is that these goods are very small in intoxicants, these types of as THC, and provide much more to soothe folks than to make them large.

    It is also a precursor to a go by the Senate to approve professional medical cannabis. That measure cleared its final committee on Wednesday and could get a comprehensive vote in the Senate as shortly as currently. Really should that take place, potential customers for its getting reviewed by the House in this session are trim.

    The Property also was not totally behind the hemp bill that handed by a vote of 86-25. Among the these 25 Republicans voting nay have been Household Speaker Professional Tempore Rep. Sarah Stevens, who represents Surry, Wilkes and Alleghany counties, Rep. John Faircloth of Guilford County, Pat Hurley of Randolph County and Ben Moss of Montgomery County.

    WGHP achieved out via e-mail to every of those reps to talk to what prompted their votes, but most did not reply quickly.

    Faircloth responded with a cellphone get in touch with to say that he supports clinical cannabis but he imagined the hemp invoice was far too advanced and “tried to do as well a lot of points. This is these types of a complex invoice,” he stated. “I was not satisfied with the way it defined marijuana and hemp and that it guarded individuals.”

    Some others may perhaps have been involved that the decriminalization of hemp was a worry between regulation enforcement brokers – Faircloth, for a single, was a lifelong law enforcement officer and explained that was a little bit of a component – but that was unclear.

    N.C. Rep. Jon Hardister (R-Guilford County) (Courtesy of Jon Hardister)
    N.C. Rep. Jon Hardister (R-Guilford County) (Courtesy of Jon Hardister)

    Point out Rep. Jon Hardister (R-Whitsett) explained on the Household floor that the sheriff’s association and state agriculture section experienced no objection to the invoice.

    “I’ve not read from any other regulation enforcement businesses,” WRAL quoted Hardister as saying even though speaking about the monthly bill.

    Law enforcement officers had opposed this regulation, seeking hemp and cannabis to stay illegal, but Eddie Caldwell of the North Carolina Sheriffs’ Affiliation, which has extended led the opposition, explained to WRAL Tv set that his team does not have a posture on the regulation.

    “We will be next it and consulting with the affiliation management if it continues moving by the legislative procedure,” Caldwell reported.

    A WGHP/The Hill/Emerson University Poll discovered that a vast majority of North Carolinians help some variety of legalized marijuana. That poll, performed in April among registered voters, discovered that 68{fe463f59fb70c5c01486843be1d66c13e664ed3ae921464fa884afebcc0ffe6c} of respondents aid the legalization of health care cannabis, and 19{fe463f59fb70c5c01486843be1d66c13e664ed3ae921464fa884afebcc0ffe6c} mentioned it ought to not be lawful. North Carolina is one particular of only 6 states that never allow clinical marijuana.

    Due to the fact Hemp farming turned lawful less than federal regulation in 2014, there are about 1,500 hemp growers and much more than 1,200 processors in North Carolina registered beneath the USDA Domestic Hemp Output Rule. But North Carolina has seemed at this as a pilot software, which was scheduled to stop in June. Given that January all individuals producers had to be registered under that USDA rule.

    The 2022 Farm Act redefines the difference involving hemp and cannabis. Hemp is described as becoming cannabis that has .3{fe463f59fb70c5c01486843be1d66c13e664ed3ae921464fa884afebcc0ffe6c} fewer Delta-9, which is the chemical that would make a cannabis user higher. Hemp would be eradicated completely from the state’s list of controlled substances. There are 31 other states in which hemp is decriminalized, as North Carolina does for now.

  • North Carolina Legislature Faces Decisions on Medical Cannabis, Hemp, and CBD | Parker Poe Adams & Bernstein LLP

    North Carolina Legislature Faces Decisions on Medical Cannabis, Hemp, and CBD | Parker Poe Adams & Bernstein LLP

    The North Carolina Common Assembly returns to Raleigh on May well 18 for its once-a-year short session. Customers are anticipating to tackle several important challenges even though they are in city. Between the pending matters is laws to legalize healthcare hashish and a decision on what to do with hemp and CBD items when present legal guidelines expire.

    The North Carolina Compassionate Treatment Act

    More than the past decade, a number of states have handed regulations allowing for the use of hashish for clinical needs. North Carolina could quickly be amongst them, as major legislation is pending right before the state legislature. Senate Bill 711, the North Carolina Compassionate Care Act, will “provide for the sale of hashish and cannabis-infused merchandise to capable clients with a debilitating medical affliction by means of a regulated healthcare hashish offer system” if signed into law. Sponsors of the laws involve both of those Democrats and Republicans, with the key sponsor getting the Chair of the Senate Policies Committee.

    The invoice passed both of those the Senate Judiciary and Finance Committees through last year’s session. The legislation now sits in the Senate Guidelines Committee, awaiting a flooring vote. Senate leaders have indicated that they will probable revisit the bill in May possibly, as it has relatively broad bipartisan assistance. It will then be up to the Dwelling to determine if the invoice goes forward this 12 months.

    Currently, North Carolina has stringent cannabis statutory limitations. G.S. § 90-95 prohibits the sale, manufacture, possession, or supply of Timetable VI controlled substances, including cannabis and THC. Senate Bill 711 would let individuals suffering experienced ailments or disorders to use professional medical hashish, as regulated by the regulation. Certified health-related situations incorporate cancer, epilepsy, HIV/AIDS, amyotrophic lateral sclerosis (ALS), Crohn’s disorder, sickle mobile anemia, Parkinson’s illness, and a number of sclerosis. The laws also will make provisions for homebound or bedridden clients to use health care cannabis. Additionally, write-up-traumatic worry disorder (PTSD) would be regarded as a qualifying affliction, furnished there is ample proof that the affected person has expert a traumatic celebration.

    This final provision has garnered guidance from some fight veterans. North Carolina veterans suffering from PTSD and other injuries have testified in advance of Senate committees that cannabis has assisted their therapy. Immediately after listening to from these veterans, the monthly bill sponsors included a provision for them.

    The legislation establishes an advisory committee under the North Carolina Office of Wellbeing and Human Solutions and a commission charged with overseeing the state’s clinical hashish business. The fee would award 10 licenses to clinical cannabis suppliers. The monthly bill would also need each and every licensed provider to open up at the very least just one retail outlet in a county labeled as a “tier 1 county,” a list of North Carolina’s poorest counties.

    Under the proposed legislation, sufferers ought to use for and get a health-related cannabis identification card to be permitted to order cannabis. Nevertheless, cardholders would not be permitted to smoke or vape hashish in a community position.

    This legislation has the opportunity to crank out a new earnings stream in North Carolina. The professional medical cannabis firms accepted by the commission would shell out a month to month fee to the North Carolina Division of Earnings of 10 per cent of the gross profits derived from the sale of cannabis. That income would be dispersed to the fee, the North Carolina Hashish Investigation System, and the Common Fund.

    If the laws passes the Senate, it will be the farthest to make it in North Carolina. House leaders from the two get-togethers have expressed their help, but there is no indicator of exactly where the bill is ranked in Property priorities for the limited session. Supporters hope that a bipartisan thrust could be plenty of to make North Carolina the 37th state where professional medical hashish is authorized.

    Standing of Hemp and CBD Items Right after July 1 Is Mysterious

    CBD products derived from hemp keep on being authorized in most states. North Carolina is no exception. Having said that, the state’s hemp farming legal guidelines expire on June 30, and some dread that hemp will come to be unlawful in North Carolina.

    Hemp-derived solutions in North Carolina should contain fewer than .3 percent delta-9 THC. This mirrors language in federal law that states hashish sativa is deemed legal hemp as long as it doesn’t exceed .3 per cent THC by dry quantity. This exemption has led to the progress of a broad selection of hemp-based mostly solutions sold by specialty suppliers, markets, and even pet suppliers.

    The Standard Assembly can increase the hemp exemption when it returns in May perhaps. Legislative has not indicated when they may possibly acquire action on this concern. IN the past, the exemption alone has not been controversial. The discussion has been centered on the styles of solutions that really should be authorized, such as smokable hemp flower. Legislation enforcement groups have traditionally lobbied versus smokable hemp but have mainly stayed out of the common debate on hemp farming in North Carolina.

    We will proceed to watch equally of these subject areas this 12 months. Stay tuned for updates.

    [View source.]

  • South Carolina Senate Approves Medical Marijuana Bill On Initial Vote After Weeks Of Debate

    South Carolina Senate Approves Medical Marijuana Bill On Initial Vote After Weeks Of Debate

    South Carolina’s Senate gave preliminary approval to a medical marijuana legalization bill on Wednesday.

    If the legislation clears a forthcoming third reading vote for final passage, which is expected on Thursday, it will formally proceed to the House of Representatives.

    Senators, who spent weeks debating the legislation and considering dozens of proposed amendments, voted 28-15 on second reading passage Wednesday evening.

    Gov. Henry McMaster (R) said earlier this week that it was too early to comment on the proposal, as changes were still being made by lawmakers. “This is one that’s going to depend on a lot of things,” he told a local FOX station, adding that he’ll wait to see the final version before deciding whether he would potentially sign or veto the bill if if were to arrive on his desk.

    The Compassionate Care Act was prefiled in late 2020 and passed out of the Senate Medical Affairs Committee last March, but a lone senator blocked it from reaching the chamber floor in 2021. Since then, the bill’s sponsor, Sen. Tom Davis (R), has redoubled his efforts to get the bill across the finish line, arguing that South Carolina voters are ready what he’s repeatedly called “the most conservative medical cannabis bill in the country.”.

    Davis said last month that House Speaker Jay Lucas (R) has agreed to “allow the bill to go through the House process” if it advances through the Senate, but a spokesperson for Lucas later told the Charleston Post and Courier that “Sen. Davis doesn’t speak for Speaker Lucas.”

    The bill, S. 150, in its current form would allow patients with qualifying conditions to possess and purchase cannabis products from licensed dispensaries. Smokable products, as well as home cultivation of cannabis by patients or their caretakers, would be forbidden. Merely possessing the plant form of cannabis could be punished as a misdemeanor.

    While more qualifying conditions could be added in the future, the bill specifies cancer, multiple sclerosis, epilepsy and other neurological disorders, glaucoma, Crohn’s disease, sickle cell anemia, ulcerative colitis, cachexia or wasting syndrome, autism, nausea in homebound or end-of-life patients, muscle spasms and post-traumatic stress disorder (PTSD) provided a patient can establish they experienced one or more traumatic events. Patients diagnosed with less than one year to live could also qualify.

    —
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    The bill would also allow access among patients with “any chronic or debilitating disease or medical condition for which an opioid is currently or could be prescribed by a physician based on generally accepted standards of care,” for example severe or persistent pain.

    Medical marijuana would be subject to the state’s 6 percent sales tax. Local governments were initially prohibited from adding further taxes of their own, but an amendment from Sen. Sandy Senn (R) removed that restriction.

    Senators spent most of Tuesday and Wednesday’s floor sessions discussing dozens of amendments to the legislation, taking action on some while tabling or carrying over others.

    Davis successfully urged rejection of some of the more hostile proposals, though he embraced other restrictions in the name of getting the bill passed. Under one amendment approved Tuesday with the sponsor’s support, for example, the medical marijuana law would sunset entirely at the end 2028. Lawmakers would have to take affirmative action for the program to continue into the next year.

    Among other new restrictions adopted in amendments, senators altered the bill’s language around medical marijuana and driving to clarify that DUI laws still apply and add a provision that patients who refuse to submit to a blood test if suspected of impaired driving would lose their license for six months. It would also be a misdemeanor for patients and caretakers to have an open container of cannabis in a vehicle unless it’s in the trunk, glove compartment or other sealed section.

    Further changes did away with dispensaries under the bill’s language and instead creating so-called cannabis pharmacies. The facilities would need to have a pharmacist on site at all times, and the South Carolina Board of Pharmacy would promulgate business regulations.

    That sweeping amendment, which Davis eventually backed, also revised the bill such that only physicians could recommend cannabis, rather than physician assistants and some nurses as allowed in previous versions of the legislation. A later amendment specified that retired law enforcement, former military or another qualified agency provide security to cannabis pharmacies.

    Other new restrictions say that doctors who recommend cannabis would need to independently verify the qualifying diagnosis with the patient’s treating physician, and that cannabis cultivation centers could not be multi-level facilities. People with felony-level drug convictions would also be prevented from participating in the new industry for a period of 10 years.

    Another change, dubbed the South Carolina First amendment, would give in-state businesses extra points in the state’s cannabis licensing process in an effort to prioritize them over larger, multi-state businesses that supporters said might otherwise dominate the market. Yet another amendment would clarify that state-licensed cannabis businesses could obtain cannabis only from other in-state businesses.

    Lawmakers held a lengthy debate on an amendment that would have replaced the main patient access provisions of the bill with a limited program of clinical trials on medical cannabis’s effects, but it was tabled. A revised version of the amendment was reintroduced later to create a complementary system of clinical trials that would exist alongside the general program, a change senators approved.

    Other adopted changes adjusted the makeup of the program advisory board, removed qualified immunity for doctors who recommend cannabis, restricted certain shapes of edibles in an effort to reduce their appeal to children, required cannabis businesses require liability coverage of at least $1 million and mandate that the state annually publish details on qualified patients by age group and type of debilitating condition. Another prohibits members of the General Assembly who vote on the cannabis bill, as well as their direct family members, from owning or benefiting financially from a medical marijuana business.

    Amendments to the bill made last year in committee, meanwhile, were formally adopted on the Senate floor late last month. Those made a number of small changes to the proposal, for example allowing visiting patients with medical marijuana cards from other states to access South Carolina dispensaries. Another clarified that legalization would not require health plans to cover cannabis.

    Revenue allocation would also change slightly as the result of recent amendments. Under the amended bill, 75 percent of tax revenue after expenditures would go to the state’s general fund, with another 10 percent going to drug use disorder treatment service providers, 5 percent going to state law enforcement, and the remainder going to cannabis research and drug education.

    For the initial rollout, regulators would approve 15 cannabis cultivators, 30 processing facilities, a cannabis pharmacy for every 20 pharmacies in the state, five testing laboratories and four cannabis transporters. The bill initially allowed state regulators to add other license types, but an amendment adopted Wednesday made it so only elected lawmakers could do that.

    The bill initially allowed state regulators to add other license types, but an amendment adopted Wednesday made it so only elected lawmakers could do that.

    Local governments could ban medical cannabis businesses from operating in their jurisdictions under the amended bill, but otherwise the it says that local land use and zoning burdens “should be no greater for a cannabis-based business than for any other similar business.”

    The state Department of Health and Environmental Control would oversee licensing and other regulations of the new industry. A newly established Medical Cannabis Advisory Board would be in charge of adding or removing qualifying conditions. Under amendments adopted this week, it would meet at least once per year and be led by a governor-appointed chairperson.

    Davis has championed medical marijuana in South Carolina since 2014 and at a rally last week brought out a binder that he said contained eight years of research into the issue. He said he would use the information to “take on every single argument that has been raised in opposition to this bill, and I’m going to show that they cannot stand in the way of facts and evidence.”

    He’s also continued to push back against opposition to cannabis legalization from his own party, for example calling out an attack ad that was paid for by the state GOP.

    The state Republican organization separately slammed a federal legalization bill from U.S. Rep. Nancy Mace, a Republican who represents South Carolina in Congress. And last month cannabis opponents sent a mailer accusing Davis of wanting to turn the state into “one big pot party.”

    A former White House chief of staff under President Donald Trump also recently calling out his home state South Carolina Republican Party for opposing the medical marijuana bill medical marijuana. Mick Mulvaney, Trump’s top aide for more than a year and a former congressman, called the legislation “something that merits discussion and reasoned analysis,” even if it’s not a proposal that is conventionally considered a conservative priority.

    Davis referred to the maneuvers by his own party as “the elephant in the room” on the Senate floor as debate on the floor kicked off last week, saying he was offended by the misinformation and planned to rebut every misleading claim the group made.

    “I’m going to go through every single legal argument that’s been put up there—lack of medical evidence, unintended social consequences—and take them all up and discuss them and refute them,” the senator said.

    A poll released last February found that South Carolina voters support legalizing medical marijuana by a five-to-one ratio. But the state does not have a citizen-led initiative process that has empowered voters in other states to get the policy change enacted.

    Support for medical marijuana legalization among South Carolina residents has been notably stable, as a 2018 Benchmark Research poll similarly found 72 percent support for the reform, including nearly two-thirds (63 percent) of Republicans. Davis said last year that if the legislature didn’t advance the reform, he’d propose a bill to put the question of medical marijuana legalization to voters through a referendum.

    Also in 2018, 82 percent of voters in the state’s Democratic primary election voted in favor of medical cannabis legalization in a nonbinding ballot advisory vote.

    Lawmakers prefiled four marijuana measures for the 2019 session, but they did not advance.

    As debate on the bill kicked off in the Senate this session, Davis said that after years of effort, even seeing his bill advance to the chamber floor was a victory.

    “If you pound at the door long enough, if you make your case, if the public is asking for something, the state Senate owes a debate,” he told the Charleston Post and Courier. “The people of South Carolina deserve to know where their elected officials stand on this issue.”

    Congress Briefed On Federal Courts’ Diverging Opinions On Medical Marijuana Protection Rider

    Photo courtesy of Mike Latimer.

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