Nicotine Research Cigarettes Drug Supply Program

What We Do:

The National Institute on Drug Abuse (NIDA) Drug Supply Program (Drug Supply Program (DSP)) provides a variety of research chemicals, controlled substances, and marijuana cigarettes for research purposes to investigators working in the area of drug abuse, addiction, and related disciplines. Research investigators with primary assignments in academia, public and private research laboratories are encouraged to request these supplies in support of their research. The availability of controlled substances is regulated by the United States Drug Enforcement Administration, Department of Justice under the Control Substances Act, and Psychotropic Convention. These substances include hallucinogens, stimulants, sedatives and hypnotics, narcotics, designer drugs, cannabinoids, marijuana and other miscellaneous category of drugs.

More recently, the NIDA DSP has also taken steps to provide a variety of nicotine research cigarettes (NRCs) to research investigators. For more information on the types of NRCs available, please see the Table of available NRCs types and descriptions below:

Available NIDA DSP Nicotine Research Cigarette Types and Descriptions

TPMF	Type	Description	Nicotine content (mg/g nicotine)	Nicotine Yield/cig	Tar Yield/cig
NRC100	RN-HV	Reduced Nicotine-High Ventilation	0.47 ± 0.02	0.02 ± 0.01	3 ± 1.5
NRC101	RN-HV-Men	Reduced Nicotine-High Ventilation-Menthol	0.47 ± 0.01	0.02 ± 0.01	3 ± 1.5
NRC102	RN	Reduced Nicotine	0.42 ± 0.01	0.03 ± 0.01	9 ± 1.5
NRC103	RN-Men	Reduced Nicotine-Menthol	0.44 ± 0.01	0.03 ± 0.01	9 ± 1.5
NRC104	RN-HT	Reduced Nicotine-High Tar	0.51 ± 0.00	0.04 ± 0.02	13 ± 2
NRC105	RN-HT-Men	Reduced Nicotine-High Tar-Menthol	0.46 ± 0.01	0.07 ± 0.02	9 ± 1.5
NRC200	RN	Reduced Nicotine	1.40 ± 0.03	0.07 ± 0.02	9 ± 1.5
NRC201	RN-Men	Reduced Nicotine-Menthol	1.34 ± 0.07	0.07 ± 0.02	9 ± 1.5
NRC300	RN	Reduced Nicotine	2.53 ± 0.04	0.12 ± 0.03	9 ± 1.5
NRC301	RN-Men	Reduced Nicotine-Menthol	2.54 ± 0.05	0.12 ± 0.03	9 ± 1.5
NRC302	RN-HT-Men	Reduced Nicotine-High Tar-Menthol	2.50 ± 0.04	0.16 ± 0.03	13±2
NRC400	RN	Reduced Nicotine	5.62 ± 0.18	0.26 ± 0.06	9 ± 1.5
NRC401	RN-Men	Reduced Nicotine-Menthol	5.54 ± 0.27	0.26 ± 0.06	9 ± 1.5
NRC402	RN-HT	Reduced Nicotine-High Tar	6.03 ± 0.18	0.33 ± 0.06	13 ± 2
NRC404	RN-HT	Reduced Nicotine-High Tar	8.08 ± 0.15	0.60 ± 0.12	13 ± 2
NRC405	RN-HT-Men	Reduced Nicotine-High Tar-Menthol	5.96 ± 0.21	0.40 ± 0.08	13 ± 2
NRC406	RN-HT	Reduced Nicotine-High Tar		0.40 ± 0.08	13 ± 2
RNC500	RN-HT	Reduced Nicotine-High Tar	12.06 ±0.41	0.70 ± 0.15	13 ± 2
NRC501	RN-Men	Reduced Nicotine-Menthol	11.26 ±0.11	0.60 ± 0.12	9 ± 1.5
NRC600	CN	Conventional Nicotine	17.36 ±0.28	0.80 ± 0.15	10.5 ± 1.5
NRC601	CN-Men	Conventional Nicotine	16.50 ±0.17	0.80 ± 0.15	10.5 ± 1.5
NRC602	CN-HT-Men	Conventional Nicotine-High Tar-Menthol	16.10 ±0.52	1.10 ± 0.2	16 ± 2
NRC700	LTNR-HT	Low Tar Nicotine Ratio-High Tar	25.94 ±0.65	1.6 ± 0.3	16 ± 2
NRC701	LTNR-Men	Low Tar Nicotine Ratio-Menthol	25.83 ±0.48	1.2 ± 0.2	12 ± 2

To obtain NRCs from the National Institute on Drug Abuse Drug Supply Program, all research investigators will need to prepare a Request Package. For more detailed information about the Request Package, please see: Ordering Guidelines for Nicotine Research Cigarettes.

Stepwise Procedure (in brief)

1. A Request Package for NRCs is submitted to the NIDA Drug Supply Program.
   • Note that researchers conducting studies with human participants will need to determine if an Investigational Tobacco Product (ITP) application is necessary prior to submitting their NRC order. For more information about the ITP process, please refer to the Ordering Guidelines for Nicotine Research Cigarettes.
2. Once all request package materials are received, the NIDA Drug Supply Program reviews request package for completeness.
3. Materials are reviewed by NRC Staff and the assigned NIH Program Officer.
   • For non-NIH Grantees, the NRC Staff refers to an external Scientific Expert Committee (SEC) for further review. Members of the SEC includes subject matter experts, identified by the NIDA Drug Supply Program.
4. Once reviewed, the Program Officer or the SEC provides a recommendation to the NIDA Drug Supply Program Director for approval.
5. Once approved, if there is adequate inventory of nicotine research cigarettes, the NIDA Drug Supply Program Director issues shipment authorization.

Investigational Tobacco Product (ITP) application

Researchers conducting studies with human participants will need to determine if an ITP is necessary prior to submitting their Nicotine Research Cigarette (NRC) order.  If uncertain, inquiries may be directed to the FDA CTP at: CTP-OS-ITP@fda.hhs.gov.

The email should:

• Clearly and uniquely identify the Nicotine Research Cigarette product(s) you wish to study by brand and sub-brand—including the type or category of tobacco product (e.g., TPMF code and Menthol).
• Provide additional available information such as packaging type, package quantity, and/or characterizing flavor that may help answer the specific question(s)

Once the FDA CTP receives the email, they will make every effort to respond via email within 2 weeks.

It is the PIs responsibility to determine the need for an ITP for their project. Please contact CTP to verify if your proposal requires an ITP.l]

If an ITP is determined to be necessary, an Investigational Tobacco Product (ITP) authorization must first be obtained from the FDA.  Guidance on how to file an ITP can be found here: https://www.fda.gov/downloads/tobaccoproducts/labeling/rulesregulationsguidance/ucm463953.pdf

1. When filing the ITP application, you will need to include a Letter of Authorization (LOA) from the NIDA Drug Supply Program. Request the LOA by emailing NIDANRCSupply@mail.nih.gov
2. The LOA indicates that your application has NIDA’s permission to cross-reference the SPECTRUM Tobacco Product Master File, which is on file with The FDA Center for Tobacco Products.
3. Submit the ITP application to:

   
   Center for Tobacco Products
   Food and Drug Administration
   Attn: Document Control Center
   10903 New Hampshire Avenue
   Building 71, Room 0335
   Silver Spring, MD 20993-002

The FDA will respond with a (Advice/Information Request) letter which must be included in the NRC Request Packet. Below are helpful notes to assist with the ITP application process.  Please be consistent and as specific as possible throughout your ITP application.  If not, applications may be considered incomplete and delayed until corrected.

• If applicable, include date(s) of previously submitted ITPs for cross-reference.
• Reference the actual Tobacco Product Master File (TPMF) code name for the requested nicotine research cigarette (NRC) (e.g., NRC 300, RN).
• Provide the specific grant number (e.g., R01DA123456), grant title (where appropriate), project and/or protocol number and title, and the name of the PI for the study.
• Please provide the study sponsor. Note the distinction between “sponsor” and “investigator:” Sponsors are typically considered to be the awarded institution (for NIH grants) to which the funding will be designated. Investigators are the primary research contact who conducts the research at that particular institution.
• Please be sure that the title of SPECTRUM cigarettes should be in all caps and consistent throughout your ITP application.

All inquiries and requests for the Investigational Tobacco Product application should be forwarded to the:

Food and Drug Administration
Center for Tobacco Products
Document Control Center
Building 71, Room G335
10903 New Hampshire Avenue
Silver Spring, MD  20993-0002
CTP-OS-ITP@fda.hhs.gov

Application Process Overview:

Note that a completed request packet may include an ITP. See ordering guidelines page

Points of Contact:

All NRC requests/questions should be addressed to:

NIDANRCSupply@mail.nih.gov