What's Worse Than Pot Staying Illegal? Pot As An FDA-Regulated Drug

[poledriver]

What's Worse Than Pot Staying Illegal? Pot As An FDA-Regulated Drug

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.

Right now, since marijuana is classified as an illegal drug with no medical benefits, the drug's prohibition is policed by the Drug Enforcement Administration and other law enforcement agencies. But if it is reclassified as a drug with medical benefits, the FDA would lead the charge in regulating its manufacture, distribution, sale, and use.

What's more, under the Schedule II classification, every cannabis-derived product would be subject to the kind of scrutiny typically reserved for drugs like Adderall and OxyContin. If, for instance, a brand says its Cannabidiol (CBD) oil cures seizures or Tetrahydrocannabinol edibles (THC) relieve pain, the products will be targeted for testing. If the claims turn out to be unproven, that company could be charged with criminal misbranding, says Ittleman. So rather than just going back to the drawing board, a company's operators might face prison time or fines. Further, if a company's manufacturing facilities aren't up to FDA standards, the products made in those facilities would be considered an "adulterated drug," or impure and unfit for consumption, under federal law, says Ittleman.

To be sure, ensuring your products are viable and safe for consumers is a worthy endeavor. There are, after all, a great many reasons why many regulations exist in the first place. Additionally, this new classification could give marijuana something of a credibility boost--that is, it puts the drug in the same league as legal, but controlled substances that are regulated by the government, prescribed by degree-holding doctors, and dispensed by licensed pharmacists.

The trouble is, the marijuana industry as it exists today simply isn't prepared for the rigors of transforming into a pharmaceutical industry.

If marijuana becomes a Schedule II drug, the FDA would subject companies to intense inspections and testing. Companies would need to get their packaging and labeling approved by the FDA; the Federal Trade Commission would be there to ensure companies don't sink to unfair or deceptive marketing and advertising practices. If marijuana was de-scheduled, and placed into the same category of alcohol and tobacco, it would fall under the purview of the Bureau of Alcohol, Tobacco, Firearms, and Explosives. That has its own maw of legal hoops to maneuver.

"If the FDA came out and said we are making cannabis Schedule II and the entire industry didn't change, the whole industry would be illegally trafficking a Schedule II substance," says Hank Levy, a CPA for marijuana companies, including Harborside, one of the largest dispensaries in the nation. Simply put, the industry as it stands today would not be legal under a whole set of other laws.

"I don't see Schedule II as being any help here for the existing cannabis industry at all," says Ittleman, who notes that the changes likely open the door to big pharmaceutical companies that have the experience manufacturing Schedule II controlled substances. "This is the red carpet for Purdue Pharma and Pfizer to enter the industry," adds Ittleman.

Even so, marijuana entrepreneurs remain undeterred. The cannabis industry is a $40 billion dollar market regardless of federal law and it's not going away.

Last December at a Meetup group event in New York City called High NY, marijuana entrepreneur Steve DeAngelo, the founder of Oakland, California-based Harborside, took questions from the audience regarding the future of the industry. DeAngelo, who started as an activist in Washington, D.C., now runs a $30 million a year dispensary. DeAngelo has battled federal law enforcement to successfully avoid commercial forfeiture and is currently battling the IRS in an effort to change tax code 280e.

One audience member asked: What happens if the industry loses the war? What if a new president comes in and orders the DEA to drop out of black helicopters and arrest every entrepreneur in all 24 states where some form of the marijuana economy enjoys state law protections? What if the DEA and FDA do the same thing to marijuana as they did with opium and outlaw the actual plant and only permit pharmaceutical pills? What would the marijuana industry do if suddenly pot was only legal in pill form?

DeAngelo smiled and said the marijuana plant cannot be stopped by a government, a new president, or a cadre of agencies.

"We'll take to the hills, like we always have," said DeAngelo, explaining that farmers in northern California have been growing in the isolated foothills of the Emerald Triangle since the 1960s. "It's a plant and it can grow anywhere. The only way they can take it away from us is if we give it to them."

http://www.inc.com/will-yakowicz/nightmare-of-schedule-ii-cannabis.html

 

[neversickanymore]

The thought of big pharma oozing into the industry made me throw up in my mouth.

 

[herbavore]

Ironically it was my own kids that brought this up to me years ago when I was doggedly pushing for legalization. But here is where my optimism comes in (as quoted in the article):

"We'll take to the hills, like we always have," said DeAngelo, explaining that farmers in northern California have been growing in the isolated foothills of the Emerald Triangle since the 1960s. "It's a plant and it can grow anywhere. The only way they can take it away from us is if we give it to them."

Uruguay remains my ideal but their model would never work here--different culture, different relationship to weed.

I worry about the laws, I worry about the Monsantos of the world and the Pfizers but we just have to remain vigilant. The prohibition does have to end; about that I am unequivocal. But we need to be as active as we were to end the prohibition by helping to craft local policies and be watchdogs concerning all legislation at the federal and state levels. Around here I see a lot of greedy growers with dollar signs in their eyes wanting not just to work with big business but to become big business. That makes me sad. I don't have any problem with someone making a very decent living (like anything with plants, it's hard work and there are lots of variables that make it as risky as any other farming), but I see moguls in their private helicopters that can shuttle them between their many grow warehouses and I know those guys are not thinking about pure products, good wages and benefits and not filling the streams with more chemical fertilizers and fungicides--they are thinking about money.

 

[neversickanymore]

The thought of having to pay some clueless doctor for a permission slip to buy grass from big pharma marketed through some pharmacy chain makes me throw up on the floor.

 

[Erikmen]

Uruguay remains my ideal but their model would never work here--different culture, different relationship to weed.

Would that be because they don't smoke as much as in US? I get the culture difference issue, not really sure why that wouldn't work in US.
Uruguay is a very small country. Not that many criminal problems, but this is soon going to be a touristic weed place. Something like that.

 

[Clocktower]

Yeah, I won't be happy until the DEA is gone completely. The entire scheduling system is a blatantly unscientific waste of money, so having drugs in one schedule or another doesn't make much of a difference. IF lowering Cannabis to Schedule II means lighter prison sentences for nonviolent drug offenders, then that's good, but that's about all the good I can see in it.

 

[manboychef]

The thought of having to pay some clueless doctor for a permission slip to buy grass from big pharma marketed through some pharmacy chain makes me throw up on the floor.

QFT. If this is the model we end up with, it means that it will still be illegal to grow it, and having bootleg marijuana will be considered a federal offense. I look at growing marijuana like growing corn. Everyone should be allowed to do it.

 

[Erikmen]

Just like the bad choice we have for food the world was totally drug free for ages until 80 years ago more or less.The government could not tell what you could or could not use, the same principal used for food. They were not even interesting to know. It would be as if people would get in jail for eating bacon for instance.

This all started due to the opium trade by the Chinese communities, and the thousands of addicts and ODs. I watched a documentary showing samples of heroin being sold for cough medicine, morphine to wives with kids, etc. It's difficult to believe but it took decades to make laws out of drugs' use or marketing.

 

[neversickanymore]

This will not have an overall positive effect if its enforced. It will ruin businesses people have worked hard and invested a ton of time and money into. It will fire back up the black market harder and stronger than ever. Millions and millions in tax revenue will be lost. Safety measures like testing for harmful pesticides will no longer be present in the black market. Many many people will take an economic hit. Owners, growers, bud tenders, trimmers, warehouse owners, CO2 companies and workers, Hvac and air conditioner people, officers at the MED, grow stores and their workers, canibus product testing labs and their workers, and piss tests labs and all the people who these groups spent money with.

It will mean that law enforcement can once again fire up mass incarceration so the DEA and police mob, prison workers, and lawyers will benefit monetarily. It also means that big pharma will cash in a little bit on the edibles or whatever shit product they put out. Then the doctors who write out your hall pass will also benefit. Canibus pill mill doctors are assured as its a fucking joke and everyone knows it.

 

[manboychef]

This will not have an overall positive effect if its enforced. It will ruin businesses people have worked hard and invested a ton of time and money into. It will fire back up the black market harder and stronger than ever. Millions and millions in tax revenue will be lost. Safety measures like testing for harmful pesticides will no longer be present in the black market. Many many people will take an economic hit. Owners, growers, bud tenders, trimmers, warehouse owners, CO2 companies and workers, Hvac and air conditioner people, officers at the MED, grow stores and their workers, canibus product testing labs and their workers, and piss tests labs and all the people who these groups spent money with.

It will mean that law enforcement can once again fire up mass incarceration so the DEA and police mob, prison workers, and lawyers will benefit monetarily. It also means that big pharma will cash in a little bit on the edibles or whatever shit product they put out. Then the doctors who write out your hall pass will also benefit. Canibus pill mill doctors are assured as its a fucking joke and everyone knows it.

This is exactly what I was thinking about. Instead of jobs being created by the market, the jobs will be made by so called "job creators" and if history is evidence (which it always is) these will be low wage, non benefit, non union work that is just as soul crushing as most of the jobs out there these days. The black market and bootleg marijuana will become rampant as these companies will be setting quality standards and price. Think about the fact that the most consumed beer in america is cheap swill....this will take away the boutique industry that marijuana provides and make something of a business model like beer. The most common weed will be swag. Innovation will be regional and stifled due to the lobbying power of big business. It is angering to see this happening. The DEA will still be justified, but now they will be enforcing tax code, and enforcing it in the same brutal manner they enforce drug policy today.

I've been watching a lot of "future movies" (Scanner darkly, brazil, etc) lately and I'm just simply shocked at how exact these dystopian futures line up with our own. It's evidenced by shit like this and that NY heroin user hold. We see it a lot in the drug scene, but I think it's getting worse. Crazy hard times to be alive, just like all the others I suppose!

The secret to subjugating a nation and taking away their rights is that it must be done slowly, so as to not be nearly recognizable. If you take a lot of rights away immediately the people will revolt...however if you do it in a slow insidious manner, us john workaday sixpacks will be left squatting in our crappy apartments wondering what happened.