Posted: 10/30/2015 ID: FDA-2015-P-3991-0001
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.
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.
3). 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.
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.