Article by: Will Yakowicz, Inc.
A lawyer who helps companies gain regulatory approval says getting reclassified as a legal, but controlled substance could kill the industry.
The end of marijuana prohibition is coming. But how the federal policies will change could have a dramatic effect on the nation’s burgeoning legal marijuana businesses, which could fall victim to the same scourge that has hampered so many other nascent industries: regulations.
At the end of this month, the Food and Drug Administration and the Drug Enforcement Administration will announce their decision whether or not to reclassify marijuana under the Controlled Substances Act. The agencies did not give a hint as to which way they are leaning, but there are a number of moves they could take–the plant could be de-scheduled completely like alcohol or tobacco; it could remain as a Schedule I drug (it’s current classification) or some of the plant’s active chemicals could be rescheduled while the whole plant could remain illegal.
The real concern among those in the industry is what happens if the FDA and DEA reschedule marijuana as a Schedule II drug. FDA regulation experts say if pot is placed in the same category as legal pharmaceutical formulations of opioids like oxycodone and stimulants like amphetamine the burden of keeping up with regulatory compliance might be too costly for many of today’s small marijuana companies.
“Schedule II would be a nightmare for the cannabis industry,” says Andrew Ittleman, a lawyer and partner at Fuerst Ittleman David & Joseph in Miami. His firm helps companies navigate FDA’s laws and regulations.