On America’s birthday in 1966, President Lyndon B. Johnson signed the Freedom of Information Act into law, commenting on that July 4, “I signed this measure with a deep sense of pride that the United States is an open society in which the people’s right to know is cherished and guarded.” To this day, the law—commonly referred to as FOIA (pronounced “foya”)—is an important tool that protects citizens’ “right to know” by allowing them to request information from the U.S. government, including the Food and Drug Administration and its Center for Tobacco Products (CTP), to shine a light on decisions and decision-making processes.
In conducting its work as an agency of the federal government, FDA creates and generates documents, and the public may request these written records under FOIA. At CTP, product applications, reports, and correspondence with manufacturers, retailers, and other stakeholders are among the documents created and collected as the center carries out its public health protection mission under the Family Smoking Prevention and Tobacco Control Act of 2009. FOIA empowers people to request these types of documents from the center.
“People are interested in the steps CTP is taking toward combating tobacco-related disease and death,” said CTP’s chief FOIA officer, Marqui Barnes, who leads a team of about 10 FOIA specialists. “It’s important that the center is accountable for its actions and provides transparency in its activities.” Center FOIA specialist Jennifer German added, “The FOIA team is a vital branch of CTP. We shine a light on activities happening throughout the center.”
To date, CTP has received more than 1,300 FOIA requests both simple and complex. In fiscal year 2019 alone, the center responded to 256 requests—the most ever since CTP was established 10 years ago. With e-cigarette use and related topics in news headlines, these subjects are a common focus of current requests for records, Barnes said.
While anyone is welcome to ask for records, members of the tobacco industry, media, and public interest groups are the most frequent requesters of CTP documents. Industry requesters, for example, often ask for reviews prepared by scientists across disciplines in authorizing or not authorizing a product. “The reviews can play a big role in helping requesters understand how we’ve reached the decisions we’ve made—for example, a decision relating to authorization to market a product,” said Barnes.
Requesting Records Under FOIA
Those considering submitting a FOIA request are encouraged to first check CTP’s website, including the CTP FOIA Electronic Reading Room page, in case information that is already publicly available can address the topics they are interested in. (See “CTP Website—A Wealth of Information.”)
CTP Website—A Wealth of Information
A great deal of information is already publicly available in the form of press releases, speeches, and congressional testimony, as well as documents such as:
- CTP-Issued Warning Letters (please check both FDA’s Warning Letters and CTP’s Tobacco Retailer Warning Letters webpages)
- CTP Letters to Industry
- Tobacco Product Problem Reports
- Substantial Equivalence (SE) Marketing Orders
- Reviewer Guides, Scientific Policy Memoranda About FDA Tobacco Product Reviews
“CTP’s website is easy to navigate and helpful for finding information,” said Barnes, who has specialized in FOIA for 16 years and led the CTP Freedom of Information team since 2017. “I’m very impressed with the amount of information CTP makes available online to help industry and others understand center decision-making.”
For those interested in submitting a FOIA request, the process is informal, although the request must be submitted in writing and contain certain basic information. FDA’s How to Make a FOIA Request webpage contains additional information about how to submit your request online using the FOIA request page, by fax, or via U.S. mail, and what information should be included. In some cases, FDA charges fees associated with the costs of responding to a request. Fees may be waived, however, for those who can show that disclosure of the requested information is likely to contribute significantly to the public’s understanding of the operations and activities of the government and is not primarily in the requester’s commercial interest.
When a tobacco-related FOIA request comes in, it is assigned to a FOIA analyst within Barnes’ team. To efficiently gather on-point records, the FOIA specialist will often seek support from a CTP program office, such as the Office of Science or the Office of Compliance and Enforcement, that is familiar with the subject matter and associated documents.
The law sets a 20-day time limit for CTP’s response, and the center is committed to responding within this time frame when feasible. Barnes recommends giving careful consideration to how requests are framed to help direct CTP’s identification of relevant records. A specific-as-possible request can ease the process of identifying the proper documents, whereas a fishing expedition for “all information” on a specific topic falls on the other side of the spectrum and can present obstacles to a timely response, Barnes noted. When refining a request could help CTP zero in on useful records, the FOIA specialist may seek clarification from those who submitted it. “A request is not entering a black hole when it arrives in our office,” Barnes emphasized. “We really engage with our requesters so they can help us help them.”
Limits Under the Law
In responding to a request, CTP supplies relevant documents as allowed under FOIA, but the center is not required to create new records, conduct research or analyze data, collect information FDA does not have, or answer written questions.
While information is generally presumed to be releasable, FOIA sets forth nine exemptions that protect specific information from the requirement of disclosure to the public. If a document contains sensitive portions, sometimes redacting these parts—that is, blocking them out so they cannot be read—can allow a document to be provided in response to a FOIA request.
Reasons for Not Releasing Records
The Center for Tobacco Products withholds certain information, in keeping with the FOIA law—most commonly, records that fall within these relevant exemption categories:
- Trade secrets and privileged or confidential commercial information
- Legally privileged memoranda or letters within the agency or between agencies
- Personnel, medical, and similar files whose disclosure constitutes an invasion of personal privacy
- Information compiled for law enforcement purposes
- Classified information based on national defense and foreign policy
- Internal personnel rules and practices
- Records that are exempt under other laws
Information relating to the public availability of FDA records is found in 21 CFR Part 20 of the agency’s regulations. If a request for records is denied, a letter of explanation will be sent to the requester, who has the right to appeal the denial.
CTP receives a large amount of sensitive commercial information, such as specifics contained in a company’s application to market its tobacco product. Public release of this type of information could cause harm, Barnes stated, and the center will not release it to an outside party, in keeping with the FOIA exemption protecting trade secrets and privileged or confidential commercial information.
Barnes also highlighted another example of an exemption, “Exemption 5,” which relates to certain communications within an agency or between agencies and includes the “deliberative process privilege” designed to protect certain decision-making processes of an agency and avoid harming the quality of its decisions. In a nutshell, the purposes of this privilege include encouraging frank discussions within the agency on policy matters, and avoiding confusion from disclosing information that was not ultimately used as a basis for an agency action.
Take the brainstorming process as an example, Barnes explained: “When we’re taught to brainstorm, we are encouraged to open our minds to all possibilities—reach for the moon—even if an idea seems far-fetched.” In CTP’s work, preliminary ideas are ultimately narrowed down looking for concurrence on a policy decision. To the extent that back-and-forth toward concurrence remains in house, records are in draft format, and recommendations are not ultimately adopted, this type of deliberative information may be protected against disclosure. May, Barnes pointed out, because the decision on what to release is discretionary where this privilege is concerned, meaning information may be released or withheld based on all relevant factors, including whether or not disclosing records could have a chilling effect on the types of agency dialogue that commonly precede a final decision. “In our decision whether to release documents on these types of matters related to agency decision-making, our team acts as an advocate for the requester as well as for CTP,” Barnes said. “It is important to protect the agency’s science-based decision-making, and transparency is very important, as well.”
Balancing Right to Know, Potential Injury
The bottom-line aim, Barnes summed up, is to provide maximum information to the public while protecting information as required under the law. “We look at information very closely, reviewing documents line by line to identify whether and where any exemption applies and determine what can be released under the law.”
CTP’s FOIA office is committed to protecting citizens’ right to know when it comes to FDA’s tobacco regulatory decisions and the rationales for these decisions. The office operates in the spirit of these additional words from LBJ in signing FOIA into law more than 50 years ago: “No one should be able to pull the curtains of secrecy around decisions which can be revealed without injury.”
More Information About FOIA
Resources related to FOIA are available online: FDA’s Freedom of Information webpage is a helpful starting point for reaching various materials, including FDA’s FOIA regulations.
You may also reach out to CTP for help by mail or phone.
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Document Control Center
Building 71, Room G335
Silver Spring, MD 20993-0002
Contact: Marqui Barnes