Petition leaves FDA Confused

In AFDAug of 2015 The Take Back America Campaign, an organization made up of Drug Free America people, filed a petition with the FDA to require labeling of Cannabis products.  The petition asked the FDA to “establish standards for “Medical” and “recreational” cannabis products.

The petition further states what they would like to see on the label and why.

They argue that CBD is a beneficial component and is known to mitigate the euphoria associated with THC.  However genetic manipulation of the plant by growers has increased the concentration of THC from 2.17% to almost 10% and the concentration of CBD has decreased from .24% to .008%  The potency has continue to climb dramatically since 2008.  Stating that “medical” marijuana sold in the normal range of 20% to as high as 37% in smoked form and as high as 96% as an extract or Oil.

NIDAThey further argue that Marijuana causes Physical and Mental problems including Cancer.  Relying on NIDA studies they also claim that Cannabis can cause: cancer of the Head, Neck, Bladder, Brain and Testis; cause chronic bronchitis and other respiratory problems and elevates the risk of heart attack.  They also claim it it is a major cause of strokes as well.  They further claim that Marijuana causes DNA damage resulting in mutations and chromosomal abnormalities that can affect future generations.  The list of things all debunked by science is long and if you wish to read it you can in the attached document.  Citizen_Petition_from_The_Take_Back_America_Campaign

They claim that there is “ample amount of scientific evidence and information available to request the FDA Commissioner to hold Public Hearings and open up a Federal Registry to establish standards and oversight of Marijuana, currently being marketed as a drug and food.”

imagesThey falsely claim there is no economic impact involved with the petition.  This is blatantly false, there would be significant economic impact if the purposed labeling requirements are implemented.  in order to determine what they are asking the FDA to require would be expensive for the existing businesses and people involved in the industry.  There would be further impact if they get the FDA to enforce the CSA, which is the domain of the DEA.

They are asking the FDA to:

  1. 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 dispensaries that are selling marijuana products for medicine or recreation that do not comply with safe standards.
  4. Enforce federal CSA laws in all the states and bring them into compliance with federal law.

The FDA is not very happy with this petition and expresses it rightly in it’s reply to the Petitioners.  A copy of the FDA response is here – Citizen_Petition_Interim_Response_from_FDA_OP_to_Roger_Morgan,_Frederick_Mayer,_Ron_Allen,_Scott_Chipman

In it’s interim reply, of April 2016, they state that the “FDA has not yet resolved the issue raised in the citizen petition.”   The FDA reason why they have not been able to resolve the issue.  “it raises numerous and complex issues requiring extensive review and analysis by Agency officials.”

This is obvious that it raises “numerous and complex issues” for the FDA.  If the FDA determines that there needs to be standards for packaging, labeling, contents of marijuana, they are making a statement about Marijuana.  If they require dosage and potency to be in the label they are calling Marijuana a recognized drug.  If they attempt to bring people into compliance with the CSA they are stepping into the area that is controlled by the DEA.

The public, members of the industry and others are encouraged to comment on the petition at the following link.

****NOON UPDATE****

PLEASE THINK CAREFULLY BEFORE RESPONDING TO THE PETITION.

There are upsides to having FDA recognize that Cannabis is a product and require labeling.

There are also downsides to having FDA labeling.  Especially if those that are asked for in the petition are given.  It would be likely that IF FDA were to decide to require labeling that some sort of middle ground would be met.

http://www.regulations.gov/docket?D=FDA-2015-P-3991