Tell the FDA your thoughts about CBD- before September 13, 2017

The FDA wants to know your thoughts on CBD.

The Food and Drug Administration (FDA) has announced that it is taking comments on cannabidiol (CBD) and several other substances regarding their “abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes.” Comments will be accepted until September 13.

You may access the official FDA site by clicking HERE. If you have something to say about CBD now is the time.

I counsel clients in the hemp-based CBD industry on a daily basis. I’ve found that the biggest emerging obstacle to continued development of this sector is the FDA.

From the official site: “The Food and Drug Administration (FDA) is requesting interested persons to submit comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of 17 drug substances. These comments will be considered in preparing a response from the United States to the World Health Organization (WHO) regarding the abuse liability and diversion of these drugs. WHO will use this information to consider whether to recommend that certain international restrictions be placed on these drugs. This notice requesting comments is required by the Controlled Substances Act (the CSA).

 

Rod Kight is a lawyer based in Asheville, NC. He is licensed in North Carolina and Oregon and represents legal cannabis businesses. You can contact him by clicking here.

Posted 8-17-2017

17 thoughts on “Tell the FDA your thoughts about CBD- before September 13, 2017

  1. Carla Zacharanie

    This also has large implications for the recreational industry. If cbd oil (from hemp) loses this fight watch out rec industry! Public pressure is what is needed more than anything. GW Pharma (a foreign company) has a drug that is rumored to be on track to be approved June 2018. Preferably this should be settled before that drug is approved.

    Reply
  2. Drew Bodeen

    Not sure how a cbd oil from hemp could have been marketed as a dietary supplement when the DEA says it was illegal.
    There needs to be an exception in this case:
    1. CBD Oil from Hemp Flower per DEA is Illegal
    2. While it was illegal and IND was submitted for CBD Oil
    3. Then per the farm bill 2014 and possibly the upcoming Hemp Farming Bill CBD Oil from Hemp Flower is now legal per federal government after the IND was submitted.
    4. Now though because of the IND CBD Oil from Hemp Flower is illegal?
    5. Lets let a reasonable federal judge decide that thank you FDA.
    Not sure there is an precedence for this case.
    This is going to federal court or congress to be decided. No way the hemp cbd industry goes down without a fight.
    The little red yeast industry was a few folks. This effects a million people at least and the popularity is growing and people are not happy with the FDA currently.

    Reply
    1. Rod Kight Post author

      Thank you for your comment, Carl. You make a good point. CBD has never been scheduled on the Controlled Substances Act. However, as I have argued in a number of blogs, CBD is legal- or not- based on its source. If it is from lawfully cultivated hemp then it is legal. The problem is that hemp has only been legal to cultivate in the US since 2014, which is too late for the FDA dietary supplement rules. However, CBD from foreign sourced non-psychoactive hemp has been legal for over a decade.

      Reply
  3. Carl Hungus

    Regardless of the technicalities how can the FDA reasonably expect a company to market cbd oil from hemp flower when the dea has been sabre rattling hemp and hemp derivatives this entire time. They are still sabre rattling cbd oil from hemp as of this year and they still consider it a schedule one substance so there is no way a person or company should have been expected to stand up to a very powerful government agency who kicks doors down and market cbd oil from hemp flower before the ind and substancial clincial trials took place.

    Reply
  4. Carl Hungus

    Lets all meet up in federal court:

    How could CBD Oil from Hemp Flower have been marketed as a dietary supplement WHEN IT IS STILL ILLEGAL PER THE DEA’s OWN WORDS AS OF 2017? Is this a joke? So while it was illegal a foreign company can come in and claim an IND and have a monopoly on it? 1776

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  5. Carl Hungus

    The DEA made it impossible to market cbd oil from hemp flower as a dietary supplement. Who will be the lawyer who takes this landmark health freedom case to Federal Court?

    Reply
  6. Drew Bodeen

    This obstruction on free trade which gives a monopoly to one industry over another may be violation of United States of America Antitrust Laws.

    Reply
  7. Drew Bodeen

    The Sherman Antitrust Act (1890)

    Section 1. Trusts, etc., in restraint of trade illegal; penalty

    Every contract, combination in the form of trust or otherwise, or
    conspiracy, in restraint of trade or commerce among the several
    States, or with foreign nations, is declared to be illegal. Every
    person who shall make any contract or engage in any combination or
    conspiracy hereby declared to be illegal shall be deemed guilty of
    a felony, and, on conviction thereof, shall be punished by fine
    not exceeding $10,000,000 if a corporation, or, if any other
    person, $350,000, or by imprisonment not exceeding three years,
    or by both said punishments, in the discretion of the court.

    Section 2. Monopolizing trade a felony; penalty

    Every person who shall monopolize, or attempt to monopolize, or
    combine or conspire with any other person or persons, to monopolize
    any part of the trade or commerce among the several States, or with
    foreign nations, shall be deemed guilty of a felony, and, on
    conviction thereof, shall be punished by fine not exceeding
    $10,000,000 if a corporation, or, if any other person, $350,000, or
    by imprisonment not exceeding three years, or by both said
    punishments, in the discretion of the court.

    Section 3. Trusts in Territories or District of Columbia illegal;
    combination a felony

    Every contract, combination in form of trust or otherwise, or
    conspiracy, in restraint of trade or commerce in any Territory of
    the United States or of the District of Columbia, or in restraint
    of trade or commerce between any such Territory and another, or
    between any such Territory or Territories and any State or States
    or the District of Columbia, or with foreign nations, or between
    the District of Columbia and any State or States or foreign
    nations, is declared illegal. Every person who shall make any such
    contract or engage in any such combination or conspiracy, shall be
    deemed guilty of a felony, and, on conviction thereof, shall be
    punished by fine not exceeding $10,000,000 if a corporation, or,
    if any other person, $350,000, or by imprisonment not exceeding
    three years, or both said punishments, in the discretion of the
    court.

    Reply
  8. Drew Bodeen

    I hereby find the HHS; DEA; FDA and GW Pharma in violation of section one sentence one of the Sherman Antitrust Act of 1890 which states the following:

    “Every contract, combination in the form of trust or otherwise, or
    conspiracy, in restraint of trade or commerce among the several
    States, or with foreign nations, is declared to be illegal.”

    I recommend that the Secretary of HHS to immeditaly sign a waiver that allows all products from hemp flower to be used by the American citizens as a dietary supplement and furthermore I recommend that all interested parties urge the HHS to act on this.

    Reply
  9. Drew Bodeen

    As explained by the U.S. Supreme Court in Spectrum Sports, Inc. v. McQuillan 506 U.S. 447 (1993):

    The purpose of the [Sherman] Act is not to protect businesses from the working of the market; it is to protect the public from the failure of the market. The law directs itself not against conduct which is competitive, even severely so, but against conduct which unfairly tends to destroy competition itself.[9]

    Reply
  10. Drew Bodeen

    In regards to the FDA obstructing cbd oil from hemp flower from the definition of a dietary supplement and through combination allowing one industry a monopoly over another:

    I hereby find the HHS; DEA; FDA and GW Pharma in violation of section one sentence one of the Sherman Antitrust Act of 1890 which states the following:

    “Every contract, combination in the form of trust or otherwise, or
    conspiracy, in restraint of trade or commerce among the several
    States, or with foreign nations, is declared to be illegal.”

    I recommend that the Secretary of HHS immediately sign a waiver that allows all products from hemp flower to be used by the American citizens as a dietary supplement and furthermore I recommend that all interested parties urge the HHS to act on this.

    As explained by the U.S. Supreme Court in Spectrum Sports, Inc. v. McQuillan 506 U.S. 447 (1993):

    The purpose of the [Sherman] Act is not to protect businesses from the working of the market; it is to protect the public from the failure of the market. The law directs itself not against conduct which is competitive, even severely so, but against conduct which unfairly tends to destroy competition itself.

    If it was impossible for cbd oil from hemp flower to have been marketed as a dietary supplment it should have been impossible for the pharmaceutical industry to be granted a monopoly by the FDA.

    Reply
  11. Carl Hungus

    In regards to the FDA obstructing cbd oil from hemp flower from the definition of a dietary supplement and through a combination allowing one industry a monopoly over another:

    I hereby find the HHS; DEA; FDA and GW Pharma in violation of section one sentence one of the Sherman Antitrust Act of 1890 which states the following:

    “Every contract, combination in the form of trust or otherwise, or
    conspiracy, in restraint of trade or commerce among the several
    States, or with foreign nations, is declared to be illegal.”

    I recommend that the Secretary of HHS immediately sign a waiver that allows all products from hemp flower to be used by the American citizens as a dietary supplement and furthermore I recommend that all interested parties urge the HHS to act on this.

    As explained by the U.S. Supreme Court in Spectrum Sports, Inc. v. McQuillan 506 U.S. 447 (1993):

    “The purpose of the [Sherman] Act is not to protect businesses from the working of the market; it is to protect the public from the failure of the market. The law directs itself not against conduct which is competitive, even severely so, but against conduct which unfairly tends to destroy competition itself.”

    If it was impossible for cbd oil from hemp flower to have been marketed as a dietary supplement it should have been impossible for the pharmaceutical industry to be granted a monopoly by the FDA.

    Furthermore the conclusion of the USA Court of Appeals for the Ninth Circuit in HIA vs. DEA filed February 6, 2004:

    “The DEA’s Final Rules purport to regulate foodstuffs containing “natural and synthetic THC.” And so they can: in keeping with the definitions of drugs controlled under Schedule I of the CSA, the Final Rules can regulate foodstuffs containing
    natural THC if it is contained within marijuana, and can regulate synthetic THC of any kind. But they cannot regulate
    naturally-occurring THC not contained within or derived from marijuana—i.e., non-psychoactive hemp products—because non-psychoactive hemp is not included in Schedule I. The DEA has no authority to regulate drugs that are not
    scheduled, and it has not followed procedures required to schedule a substance.”

    The court clearly states non-psychoactive hemp is not included in the schedule I CSA classification for marijuana so therefore the DEA was sabre rattling an entire country as to prevent the public from any access to a potential superfood and obvious dietary supplement and aided the FDA to clear the way for one industry to have a monopoly over another industry.

    Reply

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