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.