FDA Labeling Petition

Currently 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.

#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?