Monthly Archives: August 2016

Minnesota Medical Cannabis Program Explained

MDHThere has been lots of confusion on how a person can obtain medical cannabis products in Minnesota.  This is an attempt to help people understand the process.  This is certainly not an endorsement of the process either as it took several days of studying the various bits of information in order to get to this level of understanding.

First a patient must meet one of the qualifying conditions.  To find a list of the current qualifying conditions please follow this link – MDH-Conditions – .  If you have a qualifying condition you must be seen by your health care practitioner.

Any health care practitioner can register with the state of Minnesota.  So long as they are health care practitioner as defined by MN Law they can register with MDH to certify their patients.

“A health care practitioner is defined as a Minnesota-licensed doctor of medicine, a Minnesota-licensed physician assistant acting within the scope of authorized practice, or a Minnesota-licensed advanced practice registered nurse who has primary responsibility for care and treatment of the patient’s qualifying medical condition.” – MDH

MDH-1They are able to find more information and register with the state at this link – Health Provider Information Registration – MDH –  A doctor is not required to become registered with the state but in order to certify you meet the conditions they must register with the state.  It appears there is no fee to the health care provider.

A health care provider may refer a patient to another health care provider who can certify you.  The key is there needs to be a health care provider patient relationship.  As there are no threats of federal intrusion or state repercussions and no cost to your provider, every health care provider in Minnesota or with a Minnesota license should register to certify patients.  Medical practitioners are protected by the state of Minnesota for certification of patients.

Once your health care practitioner has certified you, or you have been certified by a health care practitioner, then you will get an email from the MDH.  In the email will be a link that allows you to register with the MDH and get your registration.  The fees are $200 and for some people as low as $50.  You can find out more about the fee structure at this link MDH-Costs to Register.

Once you have received your certification and registration with MDH you can visit one of the dispensaries located around the state.  They will probably need to set you up with an appointment to discuss your condition, medications and other things and then decide which of the preparations they have available will be the most help to you and your condition.  Then you will be allowed to purchase that product.

Once you are in the program there are some reporting requirements which aren’t yet clear, but should be pretty simple to complete.  The MDH and we also suggest you create a Email account that is not connected to you or as disconnected as possible as things change.

I hope this helps people looking to get into the terribly expensive and restrictive Minnesota Medical Cannabis Program such as it is.

 

9th Circuit Court of Appeals issues Decision on Medical Cannabis

9thYou haven’t heard about this with all the hoopla around the DEA’s decision about re-scheduling cannabis.  However there has been a ruling that clearly affects how DEA can operate in the states which have legalized medical use of cannabis.

In an appeal before the 9th Circuit Court of appeals, released Aug 16, 2016, the appellants wanted to halt their prosecution by the DOJ/DEA under the CSA as they were operating within state guidelines and that DOJ was not funded to prosecute them.  Many will remember that the DOJ/DEA were not funded to prosecute people working within state guidelines when it came to Marijuana.

In the United States vs McIntosh case the court consolidated 10 cases involving the same issue.  The issue before the court is pretty simple “decide whether criminal defendants may avoid prosecution for various federal marijuana offenses on the basis of a congressional appropriations rider that prohibits the United States Department of Justice from spending funds to prevent states’ implementation of their own medical marijuana laws.”

The defendants were being prosecuted for operating a number of “marijuana” stores in California and Washington State.  The defendants claimed that Congress had not appropriated any funds and specifically bared any funds be used to prosecute them and that their cases should be dismissed.

The court affirmed the defendants case showing that starting in Dec 2014 through the current budget there is no funding for DOJ/DEA to prosecute anyone involved in otherwise state legal activity with regards to Marijuana.

In the first part of it’s decision the court found that “In sum, § 542 prohibits DOJ from spending money on actions that prevent the Medical Marijuana States’ giving practical effect to their state laws that authorize the use, distribution, possession, or cultivation of medical marijuana.”

DEAAdding “DOJ, without taking any legal action against the Medical Marijuana States, prevents them from implementing their laws that authorize the use, distribution, possession, or cultivation of medical marijuana by prosecuting individuals for use, distribution, possession, or cultivation of medical marijuana that is authorized by such laws. By officially permitting certain conduct, state law provides for non-prosecution of individuals who engage in such conduct. If the federal government prosecutes such individuals, it has prevented the state from giving practical effect to its law providing for non-prosecution of individuals who engage in the permitted conduct.
We therefore conclude that, at a minimum, § 542prohibits DOJ from spending funds from relevant appropriations acts for the prosecution of individuals who engaged in conduct permitted by the State Medical Marijuana Laws and who fully complied with such laws.”

“Given this context and the restriction of the relevant laws to those that authorize conduct, we conclude that § 542 prohibits the federal government only from preventing the implementation of those specific rules of state law that authorize the use, distribution, possession, or cultivation of medical marijuana. DOJ does not prevent the implementation of rules authorizing conduct when it prosecutes individuals who engage in conduct unauthorized under state medical marijuana laws. Individuals who do not strictly comply with all state-law conditions regarding the use, distribution,possession, and cultivation of medical marijuana have engaged in conduct that is unauthorized, and prosecuting such individuals does not violate § 542. ”

“The government had authority to initiate criminal proceedings, and it merely lost funds to continue them. DOJ is currently prohibited from spending funds from specific appropriations acts for prosecutions of those who complied with state law. But Congress could appropriate funds for such prosecutions tomorrow”

“For the foregoing reasons, we vacate the orders of the district courts and remand with instructions to conduct an evidentiary hearing to determine whether Appellants have complied with state law”

Here is a copy of the decision 15-10117

Here is a link to the Decision – US v McIntosh

DEA Hands Us A Win In Disguise

DEA Hands Us A Win In DisguiseDEA

by Richard Rose

I may be the only one happy about DEA’s recent failure to De-Schedule Cannabis from Schedule 1. Why do I consider it a win? This is why:

1) One of the most difficult phenomenon to battle in activism is that of complacency. If they went to S2, most of the public will think “med pot is legal, hurray we won,” when in fact very little would have changed, except loss of public support and momentum towards doing something better, like Bernie’s S2237 legalizing it all at the federal level. By remaining in a profoundly unpopular status (89% support med pot), the continuing unconstitutionality of S1 is laid bare.

FDA2) If FDA gets involved at all, it should only be on a limited, narrow, proof-of-need basis, such as approved medicines for Medicare and insurance reimbursement, traditional food safety roles, and safety of imports. FDA is completely unable to grasp two-molecule medicines, let alone a plant, let alone a plant with 420 active compounds. Therefore jamming the square Cannabis peg in the round FDA hole will have natural and massive conflict. Better for FDA to ignore the parallel gray market, and for intRAstate medicines it has no choice.

USDA3) As the FDA and USDA guidelines released this week reveal, ingestible hemp products (CBD, viable seed, hempseed for food, hempseed oil and protein, hemp flowers, hemp foods) still need to get legal in the eyes of FDA, and the best way would be a new hemp bill legalizing all of the plant, not just fiber and seed like HR525. Re-scheduling takes some of that wind from our sails. We still need “our DSHEA,” and fewer “Neville Chamberlains” advocating appeasement with the enemy (quoting them, pushing baby steps and lousy hemp bills, etc).

hemp4) For hemp, S2 would have done nothing for viable seed interstate transport, University research-only mandates, or needing a DEA 225 permit. For hempsters, NOTHING would have changed, not banking, seed, imports, exports, state laws, etc.

5) All options for legalization are still on the table now, it can remain a campaign issue, and DEA can always de-Schedule to 2 at any time merely by enforcing S1 as written and per Congressional intent.

All in all, I think S2 would have been a huge Machiavellian blow to the movement, helping only Big Pharma and hurting us substantially. Find the good in the bad, and that’s it: we live to fight a bigger battle another day, with far more upside. The worst thing DEA could have done to us is to de-Schedule to 2. Hallelujah for short-sighted bureaucrats.

Richard Rose,

Medicinal Hemp Association

www.the-mha.org

FDA is the problem that DEA relies on

FDADEAWhen the petitions get filed before the DEA the DEA is required to get information from HHS and the FDA.  Not that they are required to listen to it, they do have to get it from them.  This is where DEA has decided that in order to re-schedule Cannabis it must listen to the report from the FDA.  The DEA interprets the law to mean they must listen but that isn’t what is written.  The DEA does have discretion in this area and others.

In an alliance to keep plant medications off the market the FDA has in place a number of rules that it falls on to decide if a item has medical value.  First is it currently approved by the FDA.  Next is it in a IND program for clinical trials.  There are a variety of other things they can fall back on but for Cannabis the fact there are no approved FDA medications and there are no IND’s for Cannabis it fails to meet their definition of “accepted medical use”.  Again FDA is not required to give this result as they could look at medical use in other places in the world. They could also state they simply do not know if there is accepted medical use.  There are many responses the FDA can give as this is an area of ambiguity and open for interpretation.

In order to bring a new drug to market we are all well aware of the expense for a Pharmaceutical company goes through.  This has been compounded by the lack of ability for private industry to even work with Cannabis in it’s raw form.  This falls on the heads of the DEA and their interpretation of the CSA and the associated Treaties they claim say Schedule I substances are for Federal Research.

marijuana-001Recently Senator Gillibrand got clarification from the State Department that DEA’s interpretation wasn’t correct.  This forced DEA to make a statement that they would allow additional manufacturers to make “medical grade” cannabis. Released in the Federal Register the DEA said that it would, if the producer meets the requirements they set forth, expand production.  They didn’t announce who the new manufactures would be or that they would approve anyone, just that rather than summarily dismiss their application they would consider it.

This now opens a new box, what is “Medical Grade” cannabis when the FDA says there isn’t accepted medical use.  Who is going to decide on what “Medical Grade” cannabis is?  Well that is currently a determination that is made by NIH, NIDA and the University of Mississippi Farm.

There is a lot of interpretation of the federal jumble of laws/rules/regulations regarding cannabis.  When agencies are able to weasel around by their own interpretations of the laws or until someone figures it out and brings the right petitions before the proper agencies/courts the state of Cannabis will remain in complete confusion.

Statement of Principles on Industrial Hemp

USDAUSDA, DEA and FDA reach agreement on Industrial Hemp.  Today the USDA announced in the Federal Register a “Statement of Principles on Industrial Hemp” it has reached with the DEA and FDA. 2016-19146

SUMMARY: The U.S. Department of Agriculture, in consultation with the U.S. Drug Enforcement Administration and the U.S. Food and Drug Administration, has developed a Statement of Principles on Industrial Hemp to inform the public how Federal law applies to activities associated with industrial hemp that is grown and cultivated in accordance with Section 7606 of the Agricultural Act of 2014. The purpose of this notice is to set forth the statement in its entirety.
Because the law didn’t specify a US agency the USDA they took it on with the help of DEA and FDA.  “Section 7606 authorized State departments of agriculture to promulgate regulations to carry out these pilot programs but did not provide a specific delegation to the U.S. Department of Agriculture (USDA) or any other agency to implement the program.  As well, the statute left open many questions regarding the continuing application of Federal drug control statutes to the growth, cultivation,manufacture, and distribution of industrial hempproducts, as well as the extent to which growth by private parties and sale of industrial hemp products are permissible. Section 7606 did not remove industrial hemp from the controlled substances list.  Therefore, Federal law continues to restrict hemp-related activities, to the extent that those activities have not been legalized under section 7606.”
Even though the USDA, DEA, and FDA were not given authority they define what Industrial Hemp means they did so anyways “industrial hemp” includes the plant Cannabis sativa L. and any part or derivative of such plant, including seeds of such plant, whether growing or not, that is used exclusively for industrial purposes (fiber and seed) with a tetrahydrocannabinols concentration of not more than 0.3 percent on a dry weight basis.  The term “tetrahydrocannabinols” includes all isomers, acids, salts, and salts of isomers of tetrahydrocannabinols.”
This statement of principles in the words of the USDA, “does not establish any binding legal requirements.”

DEA to Allow More Manufacturers of Cannabis

DEAOn Friday Aug 12, 2016 the DEA will announce that it is going to increase the number of legal manufacturers of Cannabis.  – Federal Register – or here 2016-17955

In response to increased need for Medical Grade Cannabis the DEA is set to allow others to manufacture medical grade cannabis.  In a release to the Federal Register set for Friday the DEA will announce the following:

“To facilitate research involving marijuana and its chemical constituents, DEA is adopting a new policy that is designed to increase the number of entities registered under the Controlled Substances Act (CSA) to grow (manufacture) marijuana to supply legitimate researchers in the United States.”

While giving positive reasons for allowing more manufacture of cannabis “There is growing public interest in exploring the possibility that marijuana or its chemical constituents may be used as potential treatments for certain medical conditions.” it continues with the following “no drug product made from marijuana has yet been shown to be safe and effective in such clinical trials”.  Makes one wonder why some forms of Cannabinoids are in Schedule III and also unscheduled according to Sigma-Aldrich (a company that makes and distributes all of the various cannabinoid analogs so far known).

Giving more we are happy to help comments like “one of the ways DEA can help to facilitate research involving marijuana is to take steps, within the framework of the CSA and U.S. treaty obligations, to increase the lawful supply of marijuana available to researchers.”

DEA States that it had relied on a single supplier to supply only Federal Funded studies on Cannabis.  However “under the new approach explained in this policy statement, persons may become registered with DEA to grow marijuana not only to supply federally funded or other academic researchers, but also for strictly commercial endeavors funded by the private sector and aimed at drug product development. Likewise, under the new approach, should the state of scientific knowledge advance in the future such that a marijuana-derived drug is shown to be safe and effective for medical use, pharmaceutical firms will have a legal means of producing such drugs in the United States—independent of the NIDA contract process.”

So how will they do this?  Well they explain it out like this:

“DEA is obligated to register only the number of bulk manufacturers of a given schedule I or II controlled substance that is necessary to “produce an adequate and uninterrupted supply of these substances under adequately competitive conditions for legitimate medical, scientific, research, and industrial purposes.”  So how many bulk manufacturers are needed? it doesn’t specify leaving open the door that the single producer can make as much as is necessary.

“DEA will evaluate each application it receives to determine whether adding such applicant to the list of registered growers is necessary to provide an adequate and uninterrupted supply of marijuana (including extracts and other derivatives thereof) to researchers in the United States.”

Unfortunately the next section just about eliminates all those that have a great deal of experience with the plant DEA states  “among the factors to be considered are whether the applicant has previous experience handling controlled substances in a lawful manner and whether the applicant has engaged in illegal activity involving controlled substances. In this context, illegal activity includes any activity in violation of the CSA (regardless of whether such activity is permissible under State law) as well as activity in violation of State or local law.”

Applicants will be subject to abnormally high scrutinty “applicants will be asked to provide a written explanation of how they believe they would be able to augment the nation’s supply of research-grade marijuana within the meaning of subsection 823(a)(1). Applicants may be asked to provide additional written support for their application and other information that DEA deems relevant in evaluating the application under section 823(a).”

In order to comply with International Treaty DEA is changing it’s model from NIDA owned Cannabis to Cannabis not owned by NIDA “DEA believes it would be consistent with the purposes of articles 23 and 28 of the Single Convention for DEA to register marijuana growers outside of the NIDA-contract system to supply researchers, provided the growers agree that they may only distribute marijuana with prior, written approval from DEA.  In other words, in lieu of requiring the growers to operate under a contract with NIDA, a registered grower will be permitted to operate independently, provided the grower agrees (through a written memorandum of agreement with DEA) that it will only distribute marijuana with prior, written approval from DEA.”

How does one apply?  “Persons interested in applying for a registration to become a bulk manufacturer of marijuana to supply legitimate researchers can find instructions and the application form by going to the DEA Office of Diversion Control website registration page at www.deadiversion.usdoj.gov/drugreg/index.html#regapps. Applicants will need to submit Form 225.”

Finally a note of This MIGHT BE the way we do things at the DEA they add “While this document reflects how DEA intends to implement the relevant statutory and regulatory provisions, it does not establish a rule that is binding on any member of the public.”

 

DEA Denies 2 Cannabis Petitions

DEAIt is not yet official but will be tomorrow when the DEA publishes in the Federal Register that they are denying Re-scheduling petitions by Mr. Krumm and also Ms. Raimondo and Mr. Inslee, The Honorable Lincoln D. Chafee and The Honorable Christine O. Gregoire. Here are the notices to be published 2016-17960 and 2016-17954

In Nov of 2011 Raimondo & Inslee filed a petition with the DEA, in July of 2016 Mr Krumm filed a similar petition.  The petitions asked the DEA to once again consider re-scheduling Cannabis into another schedule of the CSA.  “and “related items” removed from Schedule I of the CSA and rescheduled as medical cannabis in Schedule II” and also “Removed from schedule I of the CSA and rescheduled in any schedule other than schedule I of the CSA.”

FDAIn it’s final response the DEA states  “Based on the HHS evaluation and all other relevant data, the DEA has concluded that there is no substantial evidence that marijuana should be removed from Schedule I. A document prepared by the DEA addressing these materials in detail also is enclosed. In short, marijuana continues to meet the criteria for Schedule I control under the CSA ”

Adding “Based on the established five-part test for making such determination, marijuana has no “currently accepted medical use” because: As detailed in the HHS evaluation, the drug’s chemistry is not known and reproducible; there are no adequate safety studies; there are no adequate and well-controlled studies proving efficacy; the drug is not accepted by qualified experts; and the scientific evidence is not widely available.”

Further adding “At present, there are no marijuana products approved by the U.S. Food and Drug Administration (FDA), nor is marijuana under a New Drug Application (NDA) evaluation at the FDA for any indication. The HHS evaluation states that marijuana does not have a currently accepted medical use in treatment in the United States or a currently accepted medical use with severe restrictions. At this time, the known risks of marijuana use have not been shown to be outweighed by specific benefits in well-controlled clinical trials that scientifically evaluate safety and efficacy.”

Finally stating once again that ” in view of United States obligations under international drug control treaties, marijuana cannot be placed in a schedule less restrictive than schedule II.”

 

 

FDA Labeling Petition

FDACurrently there is a petition before the FDA to require labels on Cannabis Products.  This petition originally filed by the Take Back America Campaign in 2015 has put the FDA and the Cannabis Community in an interesting position.  For the Cannabis Community there is the question of do you agree and get a federal agency to recognize medical cannabis, or do you oppose it and the potential label requirements that might be imposed by the FDA.

The Petition FDA Docket Number FDA-2015-P-3991 asks the FDA to do 4 things.

1). hold hearings to determine standards for packaging, labeling, dosage, contents and potency of marijuana produced as medicine and food.

2). Create and implement an educational awareness program for all members of the public about the side effects and harms of marijuana.

3). Shut down or bring into compliance marijuana companies that do not comply with the safe standards brought about by the FDA regarding item #1.

4). Enforce federal CSA laws in all state to bring them into compliance with Federal Law.

It’s far easier to dismiss #2 and #4 so through the process of elimination we are left with a debate about item #1

#2 – The FDA doesn’t create or implement educational awareness programs for all members of the public about anything.  This isn’t within their legislated mandate, further it would require specific funding from Congress to implement.  Since it isn’t within their mandate, or funding ability it can be dismissed.

DEA#4. – DOJ and the DEA are charged with enforcement of the Controlled Substances Act.  This is already codified in law.  The FDA has no authority to enforce any provision of the CSA.  Again it would take an act of Congress and Funding for the FDA to take on the authority to enforce the CSA, even if it were only in regard to Cannabis.  The DEA is likely going to complain a great deal should they loose the funding for Cannabis law enforcement.

So we are left with item #1  Should the FDA hold hearings and determine standards for Packaging, Labeling, Dosage, Contents, and Potency of Cannabis products produced for Medicine, Recreational and Food use?

Should a person decide that it is in the interests of forcing the DEA to re-schedule, or even de-schedule, cannabis then it is important to have the FDA on your side.  The DEA under the CSA is required to obtain a report from the FDA on the “medical value” of a product that is scheduled.  Currently DEA has Cannabis in Schedule I which states it has “no recognized medical value”.  If the FDA does require labeling of medical cannabis products as sold in the various states it would appear that the FDA is admitting that there is medical value that is recognized by them.  This would be a first for a Federal Agency.

That alone would allow other petitions before the DEA to proceed beyond the initial stage at which they are shut down.  As I said the DEA is required to get a report from the FDA on various things, one of which is “recognized medical value”.  The FDA is required to use the definition of a drug to make that determination.

The definition of what is a drug is open for interpretation.  However it appears that the FDA has choose, with regard to Cannabis, the tightest of interpretations.  The legal definiton of a drug is found in Title 21, Chapter 9, Subchapter II  § 321(g) (1)  which states:

“The term “drug” means (A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and
(B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and
(C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and
(D) articles intended for use as a component of any article specified in clause (A), (B), or (C).
A food or dietary supplement for which a claim, subject to sections 343(r)(1)(B) and 343(r)(3) of this title or sections 343(r)(1)(B) and 343(r)(5)(D) of this title, is made in accordance with the requirements of section 343(r) of this title is not a drug solely because the label or the labeling contains such a claim. A food, dietary ingredient, or dietary supplement for which a truthful and not misleading statement is made in accordance with section 343(r)(6) of this title is not a drug under clause (C) solely because the label or the labeling contains such a statement.

The operative word in the definition of a drug is the word and.  For most substances the FDA appears to use the more liberal interpretation that the word And could be Or as well.  However in the case of Cannabis and their responses to the DEA when it has been asked to re-schedule cannabis they seem to be stuck at item (A).  Since Cannabis isn’t in the United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary,  It doesn’t have recognized medical value.

Again, this is open for interpretation.  I have had a lawyer give two different opinions.  He believes that in this instance the word AND also means the word OR.  However agencies generally take the strict interpretation and the word is AND which means it must meat all the requirements to be a “drug” under the Federal definition.

The other problem with the Petition before the FDA is the Economic Impact.  They claim that there would be NONE.  Well this is blatantly false as any pharmacy will tell you that it costs money to make the various labels that are required by the FDA that they put on prescription medications. Saying there would be no economic impact is simply untrue and could come into conflict with the various states and their labeling requirements.

There are arguments in favor of having the FDA require labeling, there are arguments against having the FDA get involved with Cannabis products.  It is likely that eventually the FDA will become involved, especially when there becomes inter-state commerce, like the Iowa purposed borrow medical cannabis from Minnesota law they attempted in 2016.  So if it is inevitable anyway, do you go ahead and get ahead of the game?

DEA Had No Plans For Cannabis

marijuana-001It’s pretty clear that the DEA has no plans to re-schedule or de-schedule Cannabis in the CSA.  Further there is no evidence that DEA is doing anything other than business as usual.

For those unfamiliar with the changing of a schedule for a substance there are certain steps that DEA must do if it wishes to add or change the schedule of a substance.  Essentially DEA must make a public announcement in the Federal Register, which it hasn’t done.  It then must ask HHS for it’s recommendation, which it hasn’t done.  If any of this had been done there would be a clear paper trail that any reporter worth their salt could follow.  We certainly have not found any documentation that DEA plans to do anything.

It appears that this may have been nothing more than a Hoax.  First reported in a news outlet with an Article about a supposed DEA Lawyer talking to a informant and his attorney. That in and of itself sounds fishy and should have set off alarms, which it did.  However it appears that others then had information supposedly from various other government officials from the Senate to the White House confirming that there would be a decision by mid year.

DEAWell mid-year has come and gone and there is nothing showing up anywhere.  Nothing in the Federal Register has been published other than the usual report about annual production needs.  No request has been made to HHS by the DEA since the last petition to have cannabis was filed.  There are no official letters from the DEA to congress or from the White House to DOJ/DEA.

Even according to Snopes.com there is no evidence that DEA will do anything regarding Marijuana re-scheduling by Aug 1 and that this is a hoax.

“The CSA places each controlled substance—drug or other substance—into one of five schedules based on the substance’s medical use, potential for abuse, and safety or dependence liability. The Act also allows substance to be added to or removed from a schedule, and to be rescheduled or transferred from one schedule to another.”  After a lengthy process involving HHS, FDA, and other government agencies and eventually public hearings the DEA can if it desires change the schedule of a substance.

Cannais-ConcDEA retains such a strict control over Cannabis that it is unlikely that without direction from Congress that the DEA is going to change the law that congress passed back in 1971.  That is generally not the job of federal agencies, even though they do it all the time, especially when they get funded by congress to do their job.  It is pretty clear that DEA likes the funding it gets from congress to enforce Federal anti-cannabis laws that it will likely consider any change to be the job of congress.

Would love to be proven wrong and find that DEA has asked HHS, that HHS has asked FDA and others for input.  That their input has been positive but there is no evidence to support this.  Actually it’s pretty clear that the FDA is still considering the Citizens Petition by Take Back America and what sort of actions it should take.  In their response of April 2016 to the petitioners and the open docket item that they have nothing from DEA about cannabis.