MOU 225-23-009

MEMORANDUM OF UNDERSTANDING BETWEEN
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
U.S. FOOD AND DRUG ADMINISTRATION CENTER FOR FOOD SAFETY AND APPLIED NUTRITION
AND
U.S. DEPARTMENT OF JUSTICE DRUG ENFORCEMENT ADMINISTRATION
DIVERSION CONTROL DIVISON

I. PREAMBLE

This Memorandum of Understanding (MOU) establishes procedures to facilitate the exchange of information between the Food and Drug Administration (FDA) Center for Food Safety and Applied Nutrition (CFSAN) and the Drug Enforcement Administration (DEA) Diversion Control Division (DC), (herein after referred to as “Federal Partners”) consistent with the agencies mutual interest in food products that may contain substances subject to the Controlled Substances Act, 21 U.S.C. §§ 801 et seq. All information exchanged between these Federal Partners will uphold distinct legislative mandates as defined by the Federal Food, Drug, and Cosmetic (FD&C) Act, 21 U.S.C. §§ 301 et seq., the Public Health Service Act, 42 U.S.C. §§ 201 et seq., and the Controlled Substances (CSA) Act, 21 U.S.C. §§ 801 et seq.

II. BACKGROUND

FDA is a regulatory agency responsible for promoting and protecting the public health by ensuring the safety of food, among other responsibilities. Pursuant to the FD&C Act, FDA has authority over food both domestic and imported. FDA can take action against food that is adulterated or misbranded under the FD&C Act. Among other things, a food is adulterated under section 402 of the FD&C Act if it was produced, packed, or held under insanitary conditions; if it contains any poisonous or deleterious substance which may render the food injurious to health; or if it contains an unapproved food or color additive. FDA has authority to initiate seizure of adulterated or misbranded foods, to seek to enjoin the introduction of such products into interstate commerce, and to refuse entry of imported foods that appear to be adulterated or misbranded.

DEA is a federal agency responsible for enforcing the CSA and DEA regulations implementing the CSA. Among its responsibilities, DEA coordinates and cooperates with federal, state, and local law enforcement officials on mutual drug enforcement efforts and investigates and prepares for the prosecution of major violators of controlled substance laws. Among its regulatory roles, DEA is responsible for domestic drug and chemical control, setting and implementing quotas for schedule I and II substances and certain listed chemicals, issuing DEA registrations to handle controlled substances, and preventing the diversion of controlled substances from the legitimate market. Under 21 U.S.C. § 873(a), the Attorney General is directed to cooperate with “local, State, tribal, and Federal agencies concerning traffic in controlled substances and in suppressing the abuse of controlled substances,” including through the exchange of information between government officials. This responsibility has been delegated to the Administrator of DEA in 28 C.F.R. § 0.100(b). Additionally, 28 C.F.R. §0.103(a)(1) authorizes the Administrator of DEA “[t]o release information obtained by DEA and DEA investigative reports to Federal . . . officials engaged in the enforcement of laws related to controlled substances.” Accordingly, DEA has clear regulatory authority to share information with FDA and other Federal entities, although DEA understands that nothing in this regulatory authority should be construed to contravene DEA’s agreement in this MOU section IV.A that it will not disclose information provided to it by CFSAN.

III. PURPOSE

This MOU is intended to create a mechanism to facilitate timely sharing of information and to build upon and establish additional collaborative efforts between the Federal Partners.

The goals of the partnership will be accomplished by undertaking the following activities:

(A) Effect a more efficient system of communication and exchange between FDA and DEA;

(B) Establish collaborations involving food that may contain controlled substances;

(C) Clarify and coordinate the responsibilities of each agency with respect to food that may be or contain controlled substances.

IV. RESPONSIBILITIES

A. Procedure Governing Information Exchanges.

In an effort to achieve the goals described above, the undersigned agree to the following procedure for exchanging information:

The undersigned agree that information exchanges between the Federal Partners are important to their ability to successfully carry out their statutory and regulatory responsibilities. Toward that end, this MOU is intended to provide a means for establishing and defining procedures by which information is to be exchanged between the Federal Partners and to enhance the Federal Partners’ collaboration.

DC and CFSAN may share information in writing (including in electronic form and e-mail) and verbally (whether in in-person meetings or by telephone, video conferencing or other electronic means).

To the extent any confidential or other non-public information is shared with DEA by FDA under this MOU, it will be shared under an information sharing agreement consistent with the requirements of 21 C.F.R. § 20.85. Parties can communicate, as needed, to establish an information sharing agreement.

Contractors of the Federal Partners who will receive access to the information shared under this MOU must sign the non-disclosure agreement included in Appendix A. Each Federal Partner will maintain on file non-disclosure agreements signed by its contractors.

B. Periodic Meetings.

Representatives of CFSAN and DC will meet periodically for the purpose of discussing information exchange, to plan or establish collaborative between the Federal Partners. The frequency of these meetings will occur as needed and agreed upon by both entities. And the agencies agree to abide by agreed upon timeframes and to work in good faith in implementing the terms of this MOU.

Meeting notices, announcements, and any agendas for such meetings will include the following language: “Information shared during this meeting will be pursuant to the FDA CFSAN- DC Memorandum of Understanding for the Sharing of Information. Such information may not be further disclosed or shared in any manner without the express written consent of the originating agency or, if such disclosure is required by law, without advance notice to the originating agency.”

C. Timely Sharing of Information.

Federal Partners will respond in a timely manner to requests for information pursuant to this MOU, considering agency priorities and resources.

The undersigned acknowledge that each Federal Partner may be limited in its ability to share information or expertise in response to a particular request for several reasons, for example: agency priorities, resources, and statutory or regulatory prohibitions.

D. Freedom of Information Request

If an agency that has received information under this MOU receives a Freedom of Information Act (FOIA) request for which there are responsive records that originated with the other agency, to the extent practicable, it will refer that request to the other agency for it to respond directly to the requestor regarding the releasability of the information. In such cases, the agency making the referral will notify the requestor that a referral has been made and that a response will issue directly from the other agency.

The undersigned recognize that information exchanged that contains any of the following types of information must be protected from unauthorized use and disclosure:

(1) confidential commercial information, such as the information that would be protected from public disclosure pursuant to Exemption 4 of the FOIA;

(2) personal privacy information, such as the information that would be protected from public disclosure pursuant to Exemption 6 or 7(c) of the FOIA;

(3) information compiled for law enforcement purposes, such as information that would be protected from public disclosure pursuant to Exemption 7 of the FOIA; or

(4) information that is otherwise protected from public disclosure by Federal statutes and their implementing regulations (e.g., Trade Secrets Act (18 U.S.C. § 1905), the Privacy Act of 1974 (5 U.S.C. § 552a), other FOIA exemptions not mentioned above (5 U.S.C. § 552(b)), the FD&C Act, and the Health Insurance Portability and Accountability Act (HIPAA), Pub. L. 104-191), or other legally recognized privileges or bases for nondisclosure.

Proper safeguards shall include the adoption of policies and procedures to ensure that the information shared under this MOU shall be used consistent with the Trade Secrets Act, the FD&C Act, the Privacy Act of 1974, as amended, the FOIA, and any other applicable Federal law and their implementing regulations. Pursuant to section 301(j) of the FD&C Act (21 U.S.C. § 331(j)), FDA will not reveal to DEA any method or process which is entitled to protection as a trade secret. DEA will not disclose individual manufacturing and procurement quotas or other registrant information to FDA that DEA deems to be entitled to protection as a trade secret.

E. Disclosure Pursuant to Legal Process.

Should information shared pursuant to this MOU be subpoenaed or otherwise ordered through a legal process, the Federal Partner to whom the subpoena or order is directed will notify an MOU Point of Contact of the other Federal Partner immediately to provide an opportunity to seek to intervene and block the disclosure. To the extent permitted by law, the receiving party will assert any privileges against disclosure if requested by the originating agency.

F. Continuing Obligation to Protect Information from Disclosure.

Termination of this MOU or any related agreement for exchange of information between the parties does not relieve either of the Federal Partners of their obligation to safeguard, protect, and limit access to the shared information under this MOU.

G. Mitigation of Prohibited Exchanges & Disclosures.

The undersigned agree that disclosure of confidential and other non-public information directly or indirectly through verbal or written communication, conduct, or any other means that is not disclosed in accordance with applicable laws, regulations, policy, and this MOU may be detrimental to agency activities and may interfere with the Federal Partners’ ability to protect personal privacy, confidential, and/or trade secret information. Accordingly, if a Federal Partner becomes aware of a prohibited exchange or disclosure, whether made to the other Federal Partner or to a third party, it will immediately notify the MOU Point of Contact of the Federal Partner, providing the content of the prohibited exchange or disclosure, the identity of the person by whom it was made, the identity of the person to whom it was made, and the date on which it occurred. The Federal Partners will work with one another to develop and implement a plan to remedy the prohibited exchange or disclosure, taking into consideration the Federal Partners’ responsibility to preserve documents and records in accordance with applicable law or legal process.

V. Effect on Existing Statutes and Regulations.

Each Federal Partner will take actions under this collaboration that are consistent with existing laws, regulations, and policies, and nothing in the MOU shall be construed as changing the current requirements under the statutes and regulations administered and enforced by the Federal Partners including but not limited to: Titles 21 and 42 of the United States Code, the Public Health Service Act, and the FD&C Act. Further, nothing contained in this MOU constitutes a mandate or a requirement that is additional to the mandates or requirements imposed on the Federal Partners by Federal statutes, regulations, and policies.

VI. MZOU POINT OF CONTACTS

A. For FDA:

Jesse Lunzer, Biologist
Center for Food Safety and Applied Nutrition/Office of Food Safety/Division of Plant Products and Beverages
Jesse.Lunzer@fda.hhs.gov
240-402-2879

Nicholas Long, Consumer Safety Officer
Center for Food Safety and Applied Nutrition/Office of Compliance/Division of Enforcement
Nicholas.long@fda.hhs.gov
240-402-1612

Katherine Vierk, Division Director
Center for Food Safety and Applied Nutrition/Office of Analytics and Outreach/Division of Public Health Informatics & Analytics
Katherine.Vierk@fda.hhs.gov
240-402-2122

B. For DEA:

Matthew Strait, Deputy Assistant Administrator
matthew.j.strait@dea.gov
202-423-8648

Stacy Harper-Avilla, Section Chief UN Reporting and Quota
stacy.harper-avilla@dea.gov
202-487-9463

Terry Boos, Section Chief Drug and Chemical Evaluation
Terrence.L.Boos@dea.gov
571-362-8207

VII. EFFECTIVE DATE, TERMINATION, AND MODIFICATION

This MOU will become effective on the date of the last signatory to the agreement. This agreement may be modified or terminated by mutual written consent by the Federal Partners or may be terminated by either Federal Partner upon a 30 day advance written notice to the other. The parties will review this MOU every 5 years to determine whether it should be revised, renewed, or cancelled.

APPROVED AND ACCEPTED BY:
U.S. FOOD AND DRUG ADMINISTRATION

/s/ 
Douglas Stearn, Deputy Director for Regulatory Affairs
Center for Food Safety and Applied Nutrition
Date: 06/09/2023

APPROVED AND ACCEPTED BY:
DRUG ENFORCEMENT ADMINISTRATION

/s/
Matthew Strait, Deputy Assistant Administrator
Diversion Control Division
Date: 06/19/2023

APPENDIX A

Non-Disclosure Agreement for Contractors
Access to information shared under the 2022 FDA CFSAN-DEA DC Memorandum of Understanding ("MOU" or "Agreement"), between the Center for Food Safety and Applied Nutrition ("CFSAN"), as part of the Food and Drug Administration ("FDA") within the Department of Health and Human Services ("DHHS"), and the Diversion Control Division (“DC”) of the Drug Enforcement Administration ("DEA"), as part of the Department of Justice ("DOJ''), dated [insert date], is required to perform my official duties under the contractual agreement with my employer, in accordance with the uses of information as authorized by the MOU. I am an authorized contractor of FDA or DEA. I recognize that information exchanged that contains any of the following types of information must be protected from unauthorized use and disclosure:

1. confidential commercial information, such as the information that would be protected from public disclosure pursuant to Exemption 4 of the Freedom of Information Act (FOIA);
2. personal privacy information, such as the information that would be protected from public disclosure pursuant to Exemption 6 or7(C) of the FOIA;
3. information compiled for law enforcement purposes, such as information that would be protected from public disclosure pursuant to Exemption 7 of the FOIA; or
4. information that is otherwise protected from public disclosure by federal statutes and their implementing regulations (e.g., Trade Secrets Act (18 U.S.C. § 1905), the Privacy Act (5 U.S.C. § 552a), other Freedom of Information Act exemptions not mentioned above (5 U.S.C. § 552(b)), the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 301 et seq.), and the Health Insurance Portability and Accountability Act (HIPAA), Pub. L. 104-191). I have been advised of (1) the necessity to safeguard and limit access to the information, and (2) the administrative, civil, and criminal penalties for noncompliance contained in applicable Federal laws. I, on this day of   , 20   , hereby agree that I shall not further release, publish, or disclose information shared under this MOU without the express written consent of the originating agency or, if such disclosure is required by law, without advance notice to the originating agency. I shall protect such information in accordance with applicable laws and regulations governing the confidentiality of non- public information.

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