W/ DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration Silver Spring, MD 20993 September 26, 2016 Pete O°Neil Chief Executive Officer Empire Cannabis Brands, LLC 555 Fayetteville Street Raleigh, NC 27601 Dear Mr. O'Neil, ‘Thank you for your email dated July 19, 2016, addressed to Dr. Robert Califf, Commissioner of the Food and Drug Administration (FDA or Agency). Dr. Califf asked that I respond to your email, in which you offer to work with FDA to establish federal standards for the cannabis, (marijuana) industry. We are aware that a number of states have passed laws that remove state restrictions on the medical and/or recreational uses of marijuana or are considering doing so. However, as noted in your email, marijuana is currenily conteolled by the Drug Enforcement Administration as a Schedule i substance under the Controlled Substances Act. Schedule I substances are defined as those ‘with a high risk of abuse and no currently accepted medical use in treatment in the United States In addition, to date, the FDA has not approved a marketing application for marijuana for any indication, This means that the FDA has not found any such product to be safe or effective for the treatment of any disease or condition. However, the FDA has approved Marinol and Syndros for therapeutic uses in the United States, including for the treatment of anorexia associated with weight loss in AIDS patients. Marinol and Syndros include the active ingredient dronabinol, a synthetic delta-9- tetrahydrocannabinol (THC) which is considered the primary psychoactive component of marijuana, Another FDA-approved drug, Cesamet, contains the active ingredient nabilone, which has a chemical structure similar to THC and is synthetically derived. One of FDA’s roles, as laid out in the Federal Food, Drug, and Cosmetic (FD&C) Act, is to review data submitted to the Agency in a marketing application for approval. Prior to approving a drug product for marketing, FDA assures that the product meets the statutory standards for approval. FDA's Guidance for Industry: Botanical Drug Products (available at hitp://www. fa. gov/downloads/drugs/euidancecomplianceregulatorvinformation/guidances/uem (070491 pdf) explains FDA’s current thinking on the chemistry, manufacturing, controls, and other characteristics of drug products that are derived from botanicals, such as marijuana,Page 2 ~ Pete O°Neil The FD&C Act authorizes FDA to review and authorize applications for clinical research with investigational new drugs (INDs). FDA has already authorized dozens of clinical trials on marijuana and marijuana-derived products, FDA believes that scientifically valid research conducted under an IND application is the best way to determine whether patients could benefit from the use of drugs derived from marijuana. Your email requests that the Ageney review the Orphan Drug Act of 1983, because you believe itallows for approval of clinical studies regarding marijuana, and it also allows marijuana to be regulated in a similar manner as tobacco and alcoholic beverages. We disagree that the Orphan Drug Act provides a pathway for recreational marijuana to be regulated in a similar way to tobacco and alcohol. The Orphan Drug Act allows FDA to grant a so-called “orphan” designation to a particular drug for a rare disease or condition, A sponsor or manufacturer may request an orphan designation for a drug prior to submission of an application under section 505(b) of the FD&C Act, or for a biological product, prior to the submission of an application for licensing under section 351 of the Public Health Service Act. An orphan designation qualifies the sponsor of a drug for various development incentives, including tax credits and waivers of certain user fees. It does not relate to recreational uses of products, such as tobacco or alcoholic beverages: Your email also refers to FDA’s statutory authority to regulate tobacco products. The Family Smoking Prevention and Tobacco Control Act, signed into law on June 22, 2009, gives FDA authority to regulate the manufacture, distribution, and marketing of tobacco products. We note that FDA’s authority to regulate tobacco products does not extend to products containing ‘marijuana that are not made or derived from tobacco. The Agency cannot comment on the role of the Aleohol and Tobacco Tax Bureau in collecting taxes for alcohol, tobacco, or marijuana. Finally, your email states that the marijuana industry would like the opportunity to comment on any rules that FDA might promulgate regarding marijuana products. Although FDA has not published any regulations that are specific to marijuana, as a general matter, FDA welcomes public comment on its rulemakings. Similarly, FDA does not have current plans to hold an Advisory Committee meeting to discuss the marijuana industry, but all FDA Advisory Committee meetings are open to the public. Peter Lurie, M.D., M.P.H.