Whistleblower Complaint Reveals Flaws in Assessing Harmful Tobacco Products

The Center for Tobacco Products (CTP) is part of the Food and Drug Administration.

The CTP is responsible for implementing the Family Smoking Prevention and Tobacco Control Act passed in 2009. The Tobacco Control Act gives the organization “broad authority to regulate the manufacturing, distribution, and marketing of tobacco products.”

The CTP makes decisions on whether new tobacco products and claims can be marketed—including reviewing and evaluating applications and claims before new products are allowed on the market. The CTP says its goals are:

• Preventing people from starting to use tobacco products
• Encouraging tobacco users to quit
• Reducing the harm caused by tobacco use

Whistleblower Complaint Leads to Investigation

According to a press release from the Office of Special Counsel (OSC), problems in assessing risk of some tobacco products have now been uncovered based on a complaint filed by a whistleblowing federal employee. According to the press release, the CTP has “relaxed its standards of review for certain tobacco products and stifled attempts by its scientists to raise concerns.”

The headline issued by OSC reads: “Unclear Standards for Scientific Review and Stifling of Scientific Dissent Resulted in Flawed FDA Process for Evaluating Potential Harm of Tobacco Products”.

A CTP toxicologist (the whistleblower) reported to OSC that a 2019 memorandum sent to CTP’s scientists revised the process for evaluating potentially harmful ingredients in “substantial equivalence applications” used for some tobacco products.

Allegation Agency Was “Eyeballing” Applications Instead of Using Scientific Data

According to the whistleblower, scientists were directed to stop using objective, quantitative data to evaluate applications. Instead, they were to use a less scientific approach similar to “eyeballing it”.

According to the whistleblower, the result of this approach was unclear review standards and less reliable decisions by the agency.

The whistleblower also contended flaws in the internal scientific dispute resolution process prevented several concerned scientists from raising issues within the CTP’s scientific evaluations—including consideration of whether some tobacco products authorized for sale were safe. The agency concluded the allegations were “not supported” and represented one point of view that did not take into account “the full range of regulatory considerations”.

The OSC referred the matter back to the FDA for another investigation. The FDA created an independent panel of scientific experts to evaluate the allegations.

Panel Largely Agrees With Allegations

The panel largely agreed with the issues raised by the whistleblower. It concluded the process lacked “quantifiable standards or criteria.” The expert panel made six recommendations, including a new process for resolving scientific discrepancies, which the agency largely adopted.

The panel’s scientists concluded “[t]he qualitative or semi-quantitative approach . . . lacks sufficient detail and guidance to be enacted as a scientific methodology in its current form”, including the lack of a methodology for assessing non-cancer chemical hazards.

The disagreement over the approach to be taken reverberated through the agency as a difference in the methodology to be used to measure risk. The whistleblower was in favor of a more definitive approach. The agency preferred a balanced approach depending on several factors. Using tobacco and the risk of cancer is obviously a concern to the public. The panel wrote:

When a difference between two products is apparent, such as toxicity to the heart versus toxicity to the liver, the above approaches yield the same decision. However, when the difference between two products is not apparent because they are similar, such as carcinogens of different potency, the quantitative approach can provide information on the amount of “risk of cancer” for the two products.

The difference in the “risk of cancer” between two products can be more (or less) then the expectation based on the qualitative assessment. It is important to specify the question about the chemical or compound under review.

CTP Defends Its Approach

The CTP Director responded to the allegations (see appendix 2). The position of the office was:

• The Office of Science did not err in changing the toxicological review process
• The best available science standard is subjective
• The Office of Science’s management team has a responsibility to use resources efficiently
• I support the decision of OS management

Public Health Considerations Emphasized

The panel concluded:

“[T]he process needs to have clear decision rules which guide the review and dictate the integration of the ‘qualitative or semi-quantitative evaluation with quantitative risk assessment. These decision rules should be added to the review process to ensure adequate protection of public health.”

• As a result, the Food and Drug Administration and CTP agreed action would be taken to make changes and to make the review process more transparent and straightforward.
• The agency will refine and clarify the stepwise, tiered process and revise the framing to better enable CTP staff to implement the memo in a more straightforward and consistent manner.
• FDA will take steps to improve and clarify the agency’s approach to scientific disagreements moving forward.
• A tiered approach—as it was intended to operate and would be reflected in revised procedures— is more protective of public health.

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