Monthly Archives: August 2016

Response To FDA Petition

FDAWe have offered some ideas on ways people can comment against the petition before the FDA to label cannabis products.  Here is our submitted  as it is filed wrong.

Docket: FDA-2015-P-3991

Posted: 10/30/2015 ID: FDA-2015-P-3991-0001

commentThis is a public comment in response to the Citizen Petition to the FDA filed by the Take Back America Campaign, Frederick S. Mayer, Ron Allen, Scott Chipman, et al., submitted 10/18/2015.

For the following reasons, the Commissioner of the FDA should immediately deny and remove the petitioners’ request for hearings and/or any other actions:

1). The petitioner filed the petition with the wrong federal agency. FDA has no jurisdiction to hold hearings or provide any relief to the petitioners. The petition asks that “the FDA Commissioner hold public hearings to establish standards for “medical” and recreational marijuana currently being marketed to the general public in the various states.” The law does not support directing a request of this type to FDA.

2). Petitioners appear to be petitioning the FDA to establish regulations contravening governing statutory law, i.e., 21 U.S.C. Chapter 13 Subchapter I, Part B (§ 811 et seq.), 21 U.S.C. § 82, 21 U.S.C. § 825, and 21 U.S.C. § 871 et seq; and applicable Executive Orders.

DEAA). Under law, exclusive jurisdiction and enforcement of Marijuana, a Schedule I substance, to the Attorney General (AG), Department of Justice (DOJ) and also to the Drug Enforcement Agency (DEA).

B). Under law, the DEA is charged with enforcement of and control through licensing the production, importation, sale, distribution, packaging, labeling and standards for Marijuana a substance on Schedule I.

C). Authorized by law, the DEA creates standards, labeling and packaging for Marijuana. See Exhibit A 1-5 Pictures of Federally Licensed Marijuana Cigarettes provided to people involved in research involving Marijuana.

A13). Marijuana is a substance listed in the Controlled Substances Act (CSA) as a Schedule I substance. Under 21 U.S.C. § 13 I, and Parts B, C, and E, FDA’s role for Schedule I substances is advisory to Health and Human Services (HHS) and the DEA. Through its licensing process and other federal rules the DEA has exclusive control over production quotas, production, packaging, labeling, sales, use, and who is licensed to conduct research on Marijuana.

4). The Schedule I substance Marijuana, as defined by the petitioners petition, is not being sold legally under federal law, the CSA, in the various states. This includes other items made from or with Marijuana for sale in the various states. Petitioners have failed to provide any information that the sale of Marijuana in the various states is being done in accordance with the CSA. Furthermore, in the attached supporting documents. Exhibit B, obtained from the DEA in June of 2016 through the Freedom of Information Act request and is on file with the DEA, the FDA will find that none of the producers, sellers or users of Marijuana that the petitioners either identify by name or otherwise indicate in their petition, in the various states are registered with the DEA and in compliance with the CSA.

5). No section or part of the FDC act, or the CSA, gives FDA jurisdiction over substances on Schedule I of the CSA outside that the limited role specified in the CSA. The FDCA does not contain provisions that would allow FDA to create any rules, regulations or requirements for Marijuana, a Schedule I substance. That authority is vested solely in the DEA whose jurisdiction over these substances is listed in 21 U.S.C. § 821, § 825, and §871.

6). The FDA does not have jurisdiction to change the rules and regulations as promulgated by the AG/DOJ/DEA Under 21 U.S.C. Chapter 13 Subchapter I; Parts B, C, and E, which includes setting standards, labeling and packaging of Substances on CSA Schedule I, which includes Marijuana.

7). Currently no drugs made from Marijuana have been approved by the FDA. No drugs made from Marijuana are currently involved in Investigative New Drug (IND) or New Drug Approval (NDA) trials under the FDA. As there are no substances made from Marijuana under FDA jurisdiction there is no basis for the Commissioner to take any action requested by the petitioners.

8). Petitioners petition has failed the burden of proof requirement as defined in 5 U.S.C. Subchapter II d. Also, the petition included material that is irrelevant, immaterial and is unduly repetitious in nature. It is argued that the petitioners knowingly filed an insufficient petition, which the FDA should dismiss.

In Summary:

1). The petition was filed with the wrong agency. The Attorney General, DOJ and DEA have exclusive jurisdiction. The law gives authority to DEA for control and licensing of marijuana, a Schedule I substance under the CSA.

2). The FDA lacks statutory jurisdiction to undertake the action requested by petitioners.

3). In May 2016 as a part of Docket Federal Register Docket 2016-11867 the FDA stated in response to comments for THC and Cannabinoid Content being a part of food labeling “labeling requirements of products containing THC and/or marijuana edibles is outside the scope of this rule. Therefore, we are making no changes in response to this comment.”

Based on the aforementioned, The FDA should deny and dismiss the petitioners’ petition as being improperly filed and beyond the scope of legal authority of the FDA.

I reserve my right to add to my further comments to this petition.

Minnesota Medical Cannabis, How To

mn-largemapThe Minnesota Medical Cannabis program is an interesting program with lots of confusion about how it works.  We followed a patient with intractable pain through the process.

First it took considerable amounts of research on the MDH website for information on the program.  But once it’s understood it’s really not that hard provided your Health Care Practitioner is ok with the medical use of Cannabis.  You can find more about this part of the process in our other article – Link

People will probably be surprised if they discuss this with their Health Care Practitioner.  It’s always best if you good relationship with your Care provider and are able to talk openly with them.  It seems that there are a very limited number of Health Care Practitioners in the state or anywhere that aren’t willing to give something new a try, even Cannabis.  It’s very easy for any Care provider to register with the state to certify people, there is also protections in place for Providers to keep their names out of the hands of everyone.

Our patient said,  “With the support of my Doctor I was able to find someone who was in my health care system and able to fast-track me to a doctor (that) was in the state registry and could certify me.”  For this patient it was a regular referral and covered by insurance.

Certification is an instant process once your entered into the system  “After that consultation I was entered into the state registry and certified almost instantly from the state.  Then I completed the registration process with the state and was approved.  It was then a matter of setting up an initial consultation with the dispensary”

01We followed the patient through the registration process.  It started with an email from the MDH with a link back to their website and introduces you.  It also shows some of the information you are going to need when the patient registers with the program.  We suggest you have copies of your state picture id and also any documents about being eligible for the reduced registration fee.

As you go through the registration process it will ask you for various things and verify your information in the system to create an account.

04Once your account is created you are given a ID number and fill in some demographic information.  After that you will need to upload a scan or picture of your state identification and also documents that show you might be part of the reduced cost to register.06-1

Then you verify all of your information to make sure that it’s correct and your ready to submit your payment with a credit card.13

 

There is a verification process that does take a few minutes to confirm that you are entered properly but appears to be very quickly.  Our patient completed the registration online in the afternoon on a Friday and was certified, registered and verified within a very short period of time.15

The next step is to contact a dispensary and set up an appointment.  “I was kinda surprised when I set up my consultation with the dispensary that they were busier than I expected.  But not so that I had to wait a long time to see them.”

It does take about an hour for your initial appointment as they go through all your medications, medical conditions.  “In many ways the visit to the dispensary was similar to any other pharmacy, they asked a number of questions about my medical history and medications I was taking.”

During the initial consultation at the dispensary they determine if your aware of the various affects of cannabis products, the different formulations they offer.  Our patient said “the individual who went over the various formulations they had available and we openly discussed the use of marijuana.”  adding “I liked that the individual I worked with was very knowledgeable about the products they had and the effectiveness of the different delivery methods.  All in all they were very professional and answered any questions I had and were very through.”

The cost of the medication will not be covered by any insurance plan, however the expense really depends on what formulation you need.  Our patient had pain which is best treated with higher concentrations of THC, which is cheaper.  “I was surprised at the cost of my medication.  I thought it would be more expensive than I had heard.

While it is true that some of the formulations are more expensive that has to do with the concentrations of THC to the other Cannabinoids and other biologics in the extracted compounds.

There is extreme flexibility in dosage.  It’s very well documented that THC and the other cannabinoids have a very high LD-50 level so the products are easy to figure out a dosage and start someplace and then increase to what finally gives you the relief you seek without any fear of an accidental overdoes.

The dispensary our patient went to is using whole plant extracts.  Using a very safe and proven CO2 method of extraction they not only extract the THC but all the other beneficial plant elements that would be found in smoked cannabis.  They have taken great care in attempting to provide what will be the most effective formulations for the individual patient.   There is nothing to keep a patient from mixing the various formulations to find what it is that works best for them.  The program in it’s operation and dispensing of medication is very flexible to fit the patient.

While we are not impressed with the variety of products, number of companies allowed, and dispensary locations are few and far between in out-state MN we are impressed with what they are doing now.  It’s not that hard for a patient to be certified, it’s very easy for Care providers to register with the state to certify people, it’s a start in the right direction.

New Marijuana Manufacturers?

DEAAccording to the federal register within 8 days of the DEA deciding it’s ok for others to manufacture cannabis 3 companies applied for licenses.  2 Applied for manufacturer and another for importer.

It’s probably just because they are handling synthetic THC but within 8 days of the DEA decision to expand production of Cannabis beyond the U of Miss farm 3 companies applied for licenses about Marihuana.

The first was Chemtos, we have known of them for some time they have been in the DEA listing we got earlier this year.  But they are supposedly going to manufacture marijuana – LINK

The next to apply was Noramco Inc, they plan to make synthetic Marijuana.  How you make a synthetic plant is beyond us but it might be a rule of the DEA because they make THC?  – link

The last is Cerilliant Corp is very interesting as it appears that they plan to import Cannabidiol. – LINK

 

FDA No Jurisdiction Over Labeling of Cannabis Foods

FDARecently, May of 2016, the FDA looked at and made changes to Food Labeling.  In it’s decision and response to Comments it appears that some commented on THC in certain foods.  The FDA responded to those comments.

The FDA in it’s response to the comments that THC needed to be included on any labels says that it is outside the scope of this rule.

Food Labeling: revision of the Nutrition and Supplement Facts Labels.  Makes changes to how foods are labeled under the FDA.  Federal Register Docket 2016-11867

In the FDA’s publication it should be noted that they got “Some comments asked that we require the declaration of cannabinoid content, nutritional values, and/or health risks pertaining to the consumption of tetrahydrocannabinol (THC) and/or marijuana edibles for all consumers, in particular, children under the age of 4 years as well as pregnant and lactating women.”

In the response to this they stated “We note that section 403(q)(2)(A) of the FD&C Act ….” General labeling requirements of products containing THC and/or marijuana edibles is outside the scope of this rule. Therefore, we are making no changes in response to this comment.”

This could easily be used as an argument against the FDA petition to establish labeling standards for Cannabis products Docket Number FDA-2015-P-3991

If the requirement of adding it to a label was outside the scope of the FDA’s authority in May of 2016 then it certainly must be outside the scope of their authority still as there has been no change in authority.

MN Open for Comment on New Conditions and Delivery Options

MDHMinnesota Department of Health has been petitioned to add new conditions and delivery methods for the Medical Cannabis program.   The comment period and also hearings are starting in the next month.

Important Dates and places for meetings are at:

Thursday, August 25, 2016   1-4 p.m.
The Wellstone Center  179 Robie St. E   St. Paul, MN 55107
Public comment will not be available during this meeting.

Thursday, September 8, 2016   1-5 p.m.
The Wellstone Center  179 Robie St. E   St. Paul, MN 55107
Limited public comment will be available during this meeting.

Thursday September 22, 2016   1-5 p.m.
The Wellstone Center  179 Robie St. E  St. Paul, MN 55107
Limited public comment will be available during this meeting.

Additional public comment can be sent to Health.Cannabis.AddMedicalCondition@state.mn.us. Comments must be received by Tuesday, September 20, 2016.

Among the conditions being considered:

Acquired absence of limb, Arthritis,  Autism, Autism Spectrum Disorder, Depression, Treatment-resistant, Diabetes, Ehlers Danlos Syndrome, Insomnia, PTSD, Post Traumatic Stress Disorder, Schizophrenia

Petitions proposing an additional delivery method/approved form of medical cannabis are:

Edibles, Topicals, Use of the plant, Vaporization of Cannabis Flower

More information can be found at   MN Medical Cannabis Rulemaking

Some ways to Respond to FDA Petition

If you have been following you know the FDA has a petition, Docket Number FDA-2015-P-3991 , to hold hearings, to determine standards for packaging, labeling, dosage, contents and potency of marijuana produced as medicine and food,  Create and implement an educational awareness program for all members of the public about the side effects and harms of marijuana, Shut down or bring into compliance marijuana companies that do not comply with the safe standards brought about by the FDA, Enforce federal CSA laws in all state to bring them into compliance with Federal Law.

There are a number of ways to comment on the purposed hearings.  One way is to make a general comment like those that have already been published.  Another is to attack the petition itself and the many flaws it contains.

Flaw #1 Definition of the word Drug.  The petitioners have given a definition of a drug from a dictionary.  They don’t even name which dictionary they took the definition from.  Was it Webster’s or just something off the net?  No one knows as they didn’t cite it.  Luckily the term is already been defined by the Food, Drug and Cosmetics Act which is in 21 USC 321(g)(1)

“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.”

Clearly the petitioners definition of a drug isn’t legally correct or in compliance with federal law.

Flaw #2 Irrelevant and repetitive content in the petition.  This petition before the FDA asks them to do specific things, primarily hold hearings.  Items #2 and #4-17 are irrelevant to what the petitioners are asking for, a hearing to determine the labeling.  They shouldn’t have been filed in the petitioners petition they should have been brought as evidence before the hearing administrator at the time of the hearing.

According to FDA rules about a petition there are several things that are required.  They are defined in 21 CFR 10.30

In this section, (3) Petition format .  When you look at the petition it is not formatted properly.

In section C there needs to be an environmental impact statement.  In the petition there is none.  Even though there probably isn’t an environmental impact it does need to be addressed and isn’t in any manner.

In Section D the petitioners stated that there would be no Economic Impact.  Clearly adding labels whatever their format costs money so there would be an economic impact.

These are not the only things that a person can submit comments on just a few idea’s.

 

Is the DEA wrong about marijuana’s medical value?

We love to publish the work of as many as is possible.  This submission by Carl Olsen from IA is exceedingly excellent.  Carl has been working on cannabis legalization for many decades and has insight that many don’t see or understand.

Is the DEA wrong about marijuana’s medical value?

by Carl Olsen

The Question Presented

I’ve been asked to explain the U.S. Drug Enforcement Administration (DEA) decision on July 19, 2016, not to accept the Marijuana Rescheduling Petition filed by the states of Washington and Rhode Island on November 30, 2011.  See Page 53688 of the Federal Register, Vol. 81, No. 156, Friday, August 12, 2016.

My Background

I have special expertise because I was one of the petitioners in the Marijuana Rescheduling Petition filed by the National Organization for the Reform of Marijuana Laws (NORML) in 1972 (I joined that case in 1985 and my name is on the cover of the Administrative Law Judge’s Ruling on September 6, 1988), and finally resolved in the U.S. Court of Appeals in 1994 (I did not participate in that appeal).  Alliance for Cannabis Therapeutics v. DEA, 930 F.2d 936 (D.C. Cir. 1991); Alliance for Cannabis Therapeutics v. DEA, 15 F.3d 1131 (D.C. Cir. 1994).  I was also one of the original petitioners in the Marijuana Rescheduling Petition filed by the Coalition for Cannabis Rescheduling in 2002, and finally resolved in the U.S Court of Appeals in 2013 (I did participate in that appeal, and I filed my own Petition for Writ of Certiorari in the U.S. Supreme Court).  Americans for Safe Access v. DEA, 706 F.3d 438 (D.C. Cir. 2013).  The five part test that was developed in the first petition and applied in the second is the same test that was just recently applied again by the DEA in the most recent petition filed by the states of Washington and Rhode Island.

Dividing the Question

So, there are two questions we need to ask.  First, the question most people are asking, did the DEA apply the five part test correctly?  The second question is one you won’t hear from anyone but me, and that is whether the five part test is even valid.  I’m not going to address the first question, because I don’t think its relevant whether DEA applied the five part test correctly.  I’m going to divide the second question further and ask whether the five part test was ever valid at all, and then, if it was valid, I’m going to ask if the five part test is still valid today.

The Five-Part Test

On Page 938, Alliance for Cannabis Therapeutics, 930 F.2d 936 (D.C. Cir. 1991), the court explains the difference between schedule 1 and schedule 2, “is whether a drug has ‘no currently accepted medical use in treatment in the United States.’  This case turns on the appropriate definition and application of that phrase.”

On Page 938, the court goes on to explain, “In a prior proceeding, the Administrator had employed an additional eight factor test to further elaborate the characteristics of a drug that he thought had a ‘currently accepted medical use’:”

  1. Scientifically determined and accepted knowledge of its chemistry;
  2. The toxicology and pharmacology of the substance in animals;
  3. Establishment of its effectiveness in humans through scientifically designed clinical trials;
  4. General availability of the substance and information regarding the substance and its use;
  5. Recognition of its clinical use in generally accepted pharmacopeia, medical references, journals or textbooks;
  6. Specific indications for the treatment of recognized disorders;
  7. Recognition of the use of the substance by organizations or associations of physicians; and
  8. Recognition and use of the substance by a substantial segment of the medical practitioners in the United States.

53 Fed. Reg. 5,156 (1988).

On Page 939, Alliance for Cannabis Therapeutics v. DEA, 930 F.2d 936 (D.C. Cir. 1991), explains why the DEA is creating tests for determining “currently accepted medical use.”  “The difficulty we find in petitioners’ argument is that neither the statute nor its legislative history precisely defines the term ‘currently accepted medical use’; therefore, we are obliged to defer to the Administrator’s interpretation of that phrase if reasonable.” So, the DEA is trying to define a term used in the statute that Congress did not define.

What is important to note is the the eight-part test was the result of a previous test that was found invalid.  In Grinspoon v. DEA, 828 F.2d 881, 891 (1st Cir. 1987), the court found that the Administrator applied an incorrect standard in determining the meaning of the phrase “currently accepted medical use in treatment in the United States.”  53 Fed. Reg. 5,156 (1988).  The DEA has had a difficult time creating a valid interpretation of the language used in the statute.

In Alliance for Cannabis Therapeutics v. DEA, 15 F.3d 1131, 1135 (D.C. Cir. 1994), the DEA’s “Final Order discards the earlier formulation and applies a new five-part test for determining whether a drug is in ‘currently accepted medical use’:”

  1. The drug’s chemistry must be known and reproducible;
  2. there must be adequate safety studies;
  3. there must be adequate and well-controlled studies proving efficacy;
  4. the drug must be accepted by qualified experts; and
  5. the scientific evidence must be widely available.

57 Fed. Reg. 10,506 (1992).

So, the five-part test is the third time the DEA has tried to define a term that Congress did not define in the statute, “currently accepted medical use in treatment in the United States.” We should be asking ourselves if the DEA got it right on the third try.

Federalism

So, this brings us up to 1994 and the final ruling from the courts is that the five part test is a valid interpretation of the language used in the statute. What happens in 1996 is that California becomes the first state to enact a law accepting the medical use of marijuana. We now have a total of twenty-six (26) states that have accepted the medical use of marijuana, and an additional sixteen (16) states that have accepted the medical use of a marijuana extract. Let’s do a little review here. In 1987, the DEA’s interpretation of “currently accepted medical use in treatment in the United States” was found to be invalid. In 1991, the DEA’s interpretation of “currently accepted medical use” was found to be invalid. Notice how the words got truncated to completely ignore “in treatment in the United States.” Then, in 1994, the DEA’s interpretation of “currently accepted medical use” was found to be valid. So, why did the words “in treatment in the United States” get left out? In 1994, there were no states that had accepted the medical use of marijuana.

A couple of graphics illustrate the point.

States with Medical Marijuana laws (1994)

States with Medical Marijuana laws (2016)

Did the DEA apply the five-part test correctly?

Yes, under the five-part test, no plant could ever be approved for medical use by the DEA, which makes perfect sense.  DEA has never rescheduled a plant.  All the plants are in the same schedule Congress originally put them in.  Doctors are not writing prescriptions for plants in schedule 2.  If opium plants and coca plants had to pass the DEA’s five-part test, they would fail the same way marijuana does.  So, the test is being applied correctly, the same way it would be applied to any other plant.  Congress did not give the DEA the any directions on what to do if a plant is in the wrong schedule.  Because schedule 1 prevents their medical use, these plants will remain without medical use until Congress removes them from schedule 1.

Was the five-part test valid in 1994?

It’s hard to say whether a test for medical use of a plant in schedule 1 could ever be valid, because schedule 1 prevents them from being used for medicine.  However, the court did approve this test, so it was valid from that perspective.  The five-part test was not contested, so it was valid from that perspective.  In 1994, there were no states that had accepted the medical use of marijuana, and there were no states that had accepted the medical use of marijuana in 1970 when the law was written.  So, there wasn’t a better interpretation of “currently accepted medical use” in 1994.  Apparently, nobody wanted to state the obvious, a test for medical use of a plant in schedule 1 is an oxymoron.  Accepted medical use in a state is a state decision, but there were none in 1994 or in 1970.

Is the five-part test valid in August of 2016?

The problem with the petition filed by the states of Washington and Rhode Island is that it cedes state sovereignty to a federal administrative agency by accepting the DEA’s ability to interpret the meaning of “accepted medical use in treatment in the United States” without regard to state laws defining marijuana as medicine  If the DEA is going to interpret the meaning of “accepted medical use in treatment in the United States” without considering state laws on the matter then the five-part test is the only approved test for making that determination.  Both the states of Washington and Rhode Island classify marijuana as a schedule 1 substance with no accepted medical use in treatment in the United States in their own state drug laws, in clear violation of the Full Faith and Credit Clause of the U.S. Constitution.  Revised Code of Washington §§ 69.50.203(a)(2) and 69.50.204(c)(22) (2016); State of Rhode Island General Laws, §§ 21-28-2.03(2) and 21-28-2.08(d)(10) (2016).  The states of Washington and Rhode Island will not appeal from the DEA’s denial of their petition, because they have no grounds on which to appeal (they have 30 days from the date of publication in the Federal Register to appeal), thereby proving they knew they had no valid legal argument when they filed their petition.

So, the question is why the DEA is still being asked to interpret the meaning of “accepted medical use in treatment in the United States” when we have forty-two states as of August of 2016 that have accepted it for medical use.  One explanation is that the states of Washington and Rhode Island have marijuana classified as having no accepted medical use in the United States in their own state drug laws, despite the fact both states have defined marijuana as medicine in those same state drug laws.  How could a state act against its own interests in this way?

Back to Federalism

Notice how the phrase “accepted medical use in treatment in the United States” is interpreted by the court in Grinspoon v. DEA, 828 F.2d 881, 886 (1st Cir. 1987):

We add, moreover, that the Administrator’s clever argument conveniently omits any reference to the fact that the pertinent phrase in section 812(b)(1)(B) reads “in the United States,” (emphasis supplied).  We find this language to be further evidence that the Congress did not intend “accepted medical use in treatment in the United States” to require a finding of recognized medical use in every state or, as the Administrator contends, approval for interstate marketing of the substance.

And, notice in that case the phrase is not truncated to only say “currently accepted medical use.”  Grinspoon v. DEA, 828 F.2d 881, 887 (1st Cir. 1987):

Unlike the CSA scheduling restrictions, the FDCA interstate marketing provisions do not apply to drugs manufactured and marketed wholly intrastate.  Compare 21 U.S.C. § 801(5) with 21 U.S.C. § 321 (b), 331, 355(a).  Thus, it is possible that a substance may have both an accepted medical use and safety for use under medical supervision, even though no one has deemed it necessary to seek approval for interstate marketing.

So, the DEA’s five-part test, just like approval for interstate marketing, does not take into account individual states.  The five-part test is for “every state,” just like the approval for interstate marketing, because it would require a finding of recognized medical use in every state.  This leaves absolutely no doubt, the five-part test is no longer valid.

This is not the first time state officials in states such as Washington and Rhode Island have acted against the interests of the people who elected them.  In New York v. United States, 505 U.S. 144, 181-182 (1992), the U.S. Supreme Court asked, “How can a federal statute be found an unconstitutional infringement of state sovereignty when state officials consented to the statute’s enactment?”  The context was different in that case, but the idea is the same as it is here.  State officials in the states of Washington and Rhode Island have consented to the DEA interpreting a statute in a manner that infringes on their own state sovereignty.

What the states of Washington and Rhode Island should have done is tell the DEA it has no business interpreting a term Congress has not defined (“medical use”) when the state has a law that defines the “medical use” of marijuana.  See, Gonzales v. Oregon, 546 U.S. 243 (2006), for an example of how this works.  Gonzales v. Oregon, 546 U.S. 243, 258 (2006):

The Attorney General has rulemaking power to fulfill his duties under the CSA.  The specific respects in which he is authorized to make rules, however, instruct us that he is not authorized to make a rule declaring illegitimate a medical standard for care and treatment of patients that is specifically authorized under state law.

DEA is the federal agency that acts for the U.S. Department of Justice in making scheduling decisions.  In Gonzales v. Oregon, the Attorney General tried to tell the state of Oregon that the use of controlled substances to assist in suicide was not a lawful “medical use” of controlled substances, but the court disagreed and said the state has the authority to decide what is “accepted for medical use” because Congress did not make those decisions in the federal statute.  The court said Congress could make decision on “medical use,” but hasn’t.  Gonzales v. Oregon, 546 U.S. 243, 271-272 (2006):

Even though regulation of health and safety is “primarily, and historically, a matter of local concern,” Hillsborough County v. Automated Medical Laboratories, Inc., 471 U.S. 707, 719, 105 S. Ct. 2371, 85 L. Ed. 2d 714 (1985), there is no question that the Federal Government can set uniform national standards in these areas.  See Raich, supra, at 9, 125 S. Ct. 2195, 162 L. Ed. 2d 1. In connection to the CSA, however, we find only one area in which Congress set general, uniform standards of medical practice.  Title I of the Comprehensive Drug Abuse Prevention and Control Act of 1970, of which the CSA was Title II, provides that

“[The Secretary], after consultation with the Attorney General and with national organizations representative of persons with knowledge and experience in the treatment of narcotic addicts, shall determine the appropriate methods of professional practice in the medical treatment of the narcotic addiction of various classes of narcotic addicts, and shall report thereon from time to time to the Congress.”  § 4, 84 Stat. 1241, codified at 42 U.S.C. § 290bb-2a.

This provision strengthens the understanding of the CSA as a statute combating recreational drug abuse, and also indicates that when Congress wants to regulate medical practice in the given scheme, it does so by explicit language in the statute.

It’s clear that Congress never intended to tell states what they can accept for medical use within their own borders.  But, we have states telling the DEA it’s a federal decision when it’s not.  The DEA simply refuses to budge until someone gives them a valid legal argument for removing marijuana from schedule 1.

There are three ways that could happen: (1) an executive order declaring marijuana has accepted medical use in the United States as a matter of law would clarify that the DEA has no authority to keep marijuana in schedule 1; (2) a ruling from a court declaring marijuana has accepted medical use in the United States as a matter of law would clarify that the DEA has no authority to keep marijuana in schedule 1; and, finally (3) a clarification from Congress explaining that state laws are accepted medical use in the United States as a matter of law would clarify that the DEA has no authority to keep marijuana in schedule 1.  There are some bills pending in Congress (S. 683 and H.R. 1538, for example) that would do this, but they are not as clean as simply enforcing the existing law (they would place marijuana into another schedule, which an executive or judicial ruling would not do, for the best example).

Congress has withheld funding for enforcement of federal schedule 1 against medical use of marijuana in states that have accepted it.  See United States v. Marin Alliance, 3:98-cv-00086-CRB (N.D. Cal., 12/18/2015); and United States v. Steve McIntosh, No. 15-10117 (9th Cir., 8/16/2016).  These cases demonstrate the difficulty imposed on the federal courts, because the court has to determine if the defendant was in compliance with a state medical marijuana law, and then has to determine if the money being appropriated for the prosecution of the case falls within the time period that Congress has forbidden the appropriation of such funds for such purposes.  Wow!

International Law

Finally, the DEA ruling published in the Federal Register on August 12, 2016, relies on international treaty obligations.  If a schedule is required by an international treaty, then the DEA is precluded from applying some or all of the scheduling criteria.  21 U.S.C. § 811(d)(1).  The courts have previously determined that international treaty obligations prevent marijuana from being scheduled any lower than schedule 2.  NORML v. DEA, 559 F.2d 735, 751 (D.C. Cir. 1977).  Because the abuse potential for schedule 1 and schedule 2 is the same, the only relevant question then is whether marijuana has “currently accepted medical use in treatment in the United States.”  Abuse potential is not relevant, because the international treaties prevent the DEA from considering it.

Because the states of Washington and Rhode Island ceded the authority to define “medical use” to a federal administrative agency, they also limited the choices to schedule 1 or schedule 2, regardless of whether marijuana actually belongs in either of those classifications.

But, the international treaties themselves provide the answer.  Only one of the treaties is specifically mentioned, the Single Convention on Narcotic Drugs, 1961 (As amended by the 1972 Protocol), but all of the treaties use the same language in their enforcement sections:

Article 36(2) “Subject to the constitutional limitations of a Party, its legal system and domestic law, . . .”

The treaty does not apply if there is a domestic law that allows the activity.  A domestic law would be intrastate and solely within the borders of a state.  State medical marijuana laws are exempt from the international treaties.

The states of Washington and Rhode Island have not only ceded their state sovereignty to a federal administrative agency, but they have also ceded their state sovereignty to an international administrative agency, the United Nations Commission on Narcotic Drugs.  This is treachery of the highest magnitude.

FDA Publishes Comments on Petition

FDAAs reported earlier, the FDA has been petitioned to hold hearings on labeling, packaging and a variety of things regarding Cannabis.  The comment period is open right now as the FDA takes public comments.  So far two comments have been publicly posted.

Comments from Benjamin Cassidy says  “The unnecessary and irrelevant regulation and burden that this petition brings to discussion is 100% ridiculous to anyone who is actually involved in the current industry or benefits from it. There will be unnecessary regulatory costs and burden placed upon the manufacturer of products which will be then be passed along to the consumers in both the recreational and medical markets. In the end this piece of legislation does nothing to progress its own agenda and is obviously written by a group who does not understand the industry or the challenges that people in and out of it face.”

The other, by Tammy Page, is longer and more a treatise on Drug Prohibition than a comment “I am asking for the research on Marijuana, especially Medical Marijuana. I have researched history over and over again concerning why Marijuana is still in need of more research. Why Marijuana is listed by the Federal Government as a non medical use drug, classified in the Schedule 1 controlled Substance Act? My History research has lead me to believe that Marijuana was suppose to have been researched as to why Marijuana is a MIRACLE drug (herb is actually what it is) and has actually helped more people then not.

According to the Marijuana Tax Act of 1937 and President Nixon Shafer Commission, we the citizens of THE UNITED STATES OF AMERICA and not THE DIVIDED STATES OF AMERICA should be able to understand why Marijuana isn’t being researched for the pro’s instead of research of Marijuana being researched for the con’s.

As History repeats itself usually then realistically Marijuana will always stay at the Federal Governments Schedule 1 controlled Substance Act. I as well as other citizens feel like this is so unjust.

I used THE UNITED STATES OF AMERICA versus THE DIVIDED STATES OF AMERICA as an example because of each State being allowed to vote for making Marijuana legal or not. This is VERY UNFAIR, why? I would love to respond by saying that since each State can decide for itself, then why not my State? I also can answer by saying that whomever is in office such as the Governor of the State amongst legislatures, etc. being the people that can make this decision and not the people who happen to live in that particular State.

I am on disability for a variety of health issues. Since the DEA has yet once again interfered with Professional Skilled Pain Specialist deciding on what is best for there patients concerning therapy, injections, Medications, etc. being used by the Professional Skilled Pain Specialist then this really brings up a HUGE PROBLEM FOR PEOPLE WHOM HAVE HEALTH ISSUES..

We the citizens even though we may be disabled for many, many reasons as to how we became disabled still should have the right to live our life to the best way we can without being in pain 24/7,Depression, Nausea, etc. The “WAR ON DRUGS” has failed for so many years now, why not do the research of the pro’s of using Marijuana and allow anyone that has MAJOR health problems ( Yet again brings up the question of weather the DEA is qualified to determine how badly the MAJOR health problems are with each individual) to be able to have the choice of what to use (within reason) to help control the Pain, Depression, Anxiety, Lack of Sleep, Nausea, PTSD that unfortunately people suffer from.

Just imagine how much the Federal Government would save on overcrowding of prisons and the up keep of each prisoner that has been arrested or still serving time ( since Marijuana is so harmful to people causing people to commit violence, theft, harder drugs, murder, resisting arrest, etc. that some people belong in prison if they are trafficking Marijuana. (Not really, BUT FOR THE SAKE OF TOTAL EMBARRASSMENT ON THE LAW OFFICIALS THAT HAVE  ARRESTED THESE INDIVIDUALS.) and also making it almost impossible to get a job with a felony hanging over your head even after serving the time in jail or prison.

Yes, I was being a little sarcastic about Marijuana causing people to commit violence, rape, murder, etc. with the exception of Marijuana being laced with something off the streets. That my friend is just another point I feel should be made. No one that has a medical card receiving Medical Marijuana from a Marijuana dispensary should not worry at all that the Marijuana has been laced or has anything in it that possibly could put someone in danger.

To make ABSOLUTELY POSITIVE that the Marijuana being dispensed is not tampered with in any way then that’s another reason for the Federal Gov’t to legalize Marijuana or at least de classify Marijuana until further research can be done as it should have been since the Marijuana Tax Act of 1937 and President Nixon Shafer Commission.

One last thought, people have said that younger children could possibly get ahold of Marijuana causing death, well unfortunately younger children can get ahold of Guns, Tylenol lying around on a dresser, alcohol, etc. it all depends on the safety that you provide for any younger child. I would much rather prefer should any child (God Forbid) get into something dangerous that it would be Marijuana versus these other examples given.

Thank you for taking the time to read just SOME examples that hopefully can be used or at least thought of when it actually comes down to ending the failing “WAR ON DRUGS” and realizing that Marijuana is a NATURAL HERB that God even saw fit to grow on this earth that we live in to help people.”

A Unique Treatment for Glaucoma

Prof West at the University of the West Indies in Jamaica developed a product that has been used by thousands in Jamaica and people around the world.  The product made from the Cannabis plant is a eye drop that treats glaucoma in unique ways.

Most glaucoma medications are taken orally, by injection or smoking cannabis.  This causes an unfortunate affect that both eyes are affected equally by the drug.  However in many instances only one eye is a problem.  Canasol is a solution to this problem.  In studies done by Dr West and others, they have seen that Canasol only affects the eye it is placed in, that is it’s more a topical medication.

This is highly preferred to other medications for glaucoma.  It’s pretty obvious that this medication is superiour to most others in many ways.  It’s a sterile solution that is dropped into the eye and within about 2 minutes pressure has dropped.  It also works for multiple kinds of glaucoma as well.

Here is a copy of the report from the late Dr West – the-use-of-certain-cannabis-derivatives-canasol-in-glaucomathe-use-of-certain-cannabis-derivatives-canasol-in-glaucoma

Here is a link to the article if it still exists in this location – LINK

New Conditions and Delivery Methods to be Considered in MN

MDHWhile researching the MN Medical Program for a potential patient discovered The MN Department of Health has released with very little fanfare the following on their website

 

Petition to Add Qualifying Medical Condition or Approved Delivery Method

You may petition the Department of Health to add a qualifying medical condition or an approved medical cannabis delivery method/approved form of medical cannabis. The department accepts petitions from June 1 to July 31 each year. Petitions received outside this window will not be considered.

For 2016, petitions must be postmarked by August 1. Petitions received as of July 15, 2017 proposing an additional qualifying medical condition are:

Petitions received as of July 15, 2017 proposing an additional delivery method/approved form of medical cannabis are:

To comment on a proposed delivery method/approved form of medical cannabis, send an email to Health.Cannabis.AddDeliveryMethod@state.mn.us. Comments must be received by September 15, 2016 to be considered.