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10,28;,? <br />2 04 eM '.u IF- about D , P Intra- dmem rabmol <br />Je¢a-B?NC� <br />FDA <br />• One pediatric case was coded with a medical outcome of death. <br />3. Delta -8 THC has psychoactive and intoxicating effects. <br />Delta -8111C has psychoactive and intoxicating effects, similar to delta -q THC (i.e., the <br />component responsible for the "high' people may experience from using cannabis). The IDA is <br />aware of media reports of delta -8 THC products getting consumers "high." The FDA is also <br />concerned that delta -8111C products likely expose consumers to much higher levels of the <br />substance than arc naturally occurring in hemp cannabis raw extracts.'Ficus, historical use of <br />cannabis cannot be relied upon in establishing a level of safety for these products in humans <br />4. Delta -8 THC products often involve use of potentially <br />harmful chemicals to create the concentrations of delta -8 <br />THC claimed in the marketplace. <br />"Phe natural amount of delta -8 TRC in hemp is very low, and additional chemicals are needed to <br />convert other cannabinoids in hemp, like CBD, into delta-811IC (i -e, synthetic conversion). <br />Concerns with this process include: <br />• Some manufacturers may use pote:itialiy unsafe household chemicals to make delta -8 <br />THC through this chemical synthesis process. Additional chemicals may be, used to change <br />the color of the final product. The final delta 8IC. product may have potentially harmful <br />by-products (contammants; due to the chemicals used in the process, and there is <br />uncertainty with respect to other potential contaminants that may be present or produced <br />depending on the composition of the starting raw material. If consumed or inhaled, these <br />chemicals, including some iced to make (synthesize) delta -8 tHC and the by-products <br />created during syuihesis, can be harmful. <br />• Manufacturing of delta -8 THC products mayoccur iu uncontrolled or unsanitary settings, <br />which may lead to the presence of unsate contaminants or other potentially harmful <br />substances. <br />5. Delta -8 THC products should be kept out of the reach of <br />children and pets. <br />Manufacturers are packaging and I a h e 1 i n g these. products iu ways that may appeal to children <br />(gummies, chocolates, cookies, candies, etc.). These. products may be purchased online, as well <br />as at a variety of retailers, including convenience stores and gas stations, where there may not be <br />age limits on who can purchase these products. As discussed Chose, there have been numerous <br />poison control center alerts :iivolving pediatric patients who were expos( d to delta -8 I ITC <br />h" X11W D, YDNCC S➢ la 0 =u - "L ,♦ "14 ii r 1, r 1 , I I n i", , '01i181,1 VS <br />