“FDA Proposes Sweeping Restrictions on Menthol, Other Flavored Tobacco Products.” That should have been the headline when the FDA Center for Tobacco Products issued the final deeming rule last month. Newly released documents reveal that the FDA intended to boldly use its enforcement discretion to take newly-deemed products with any flavor other than tobacco off the market – including menthol. This would have included all flavored cigars and e-cigarette liquids.
The policy as the FDA wrote it would have been a monumental event in tobacco control in the United States. Unfortunately, the final rule did not limit flavored products at all - this incredibly important attempt to protect public health was deleted prior to the release of the rule by the White House Office of Management and Budget (OMB).
The “redline” draft of the final rule, released last week, illustrates which provisions were proposed by the FDA as well as the changes made by OMB. The draft reveals that the FDA intended to treat newly-covered flavored products differently than those without a characterizing flavor. However, OMB deleted this policy, opting to keep these youth-attractive, flavored products on the market.
As a part of the federal rulemaking process, so-called “major” rules, those that have a large impact on the economy, must be reviewed by OMB. Although it is staffed mostly by economists who review a rule’s impact on the national economy, this office has broad authority to require agencies to change their rules, and these changes can have significant impacts on public health, safety, and welfare.
The FDA was not actually proposing to prohibit flavors in tobacco products, but instead suggested using its enforcement discretion to remove all newly-deemed tobacco products with characterizing flavors from the market.
Currently, all regulated tobacco products must be compliant with the Tobacco Control Act and the deeming rule on the date that the deeming rule takes effect, which is August 8, 2016. Because it is logistically impossible for many of the requirements of the Act to be satisfied by that date, the deeming rule delays enforcement of many of the Act’s requirements. One of the most important requirements in the Act is that all products marketed after February 15, 2007, be reviewed by the agency before they can enter the market. The deeming rule phases this process in over the next three years, allowing manufacturers to submit applications and the FDA to review them before the products are ordered to come off of the market.
The redline draft of the deeming rule discloses that the FDA intended to provide this industry-friendly enforcement schedule only to those products that are non-flavored or tobacco-flavored. For all products with a characterizing flavor, including menthol, the FDA intended to order those products off of the market by November 6, 2016. To market a flavored product after that date, a manufacturer would have to receive a marketing order from the FDA first. To receive such an order, a manufacturer must prove to the FDA that the marketing of a product actually benefits public health, a high bar for products with flavors that are known to attract youth.
If the deeming rule had been finalized as the FDA had written it, all varieties of flavored e-cigarette liquids and flavored cigars clearly meant to target youth would have disappeared from stores on November 6. Only smokeless tobacco would have been allowed to be sold with a characterizing flavor. Scientific research indicates the public health impact of this policy would have been significant.
OMB’s changes to the deeming rule also wiped out the FDA’s strongest statement to date on menthol, including this language that was ultimately deleted by OMB:
“FDA expects that the tobacco flavor in a tobacco product need not be naturally inherent to the product in order for a manufacturer to fall within the compliance policy described here, but rather may result from the addition of ingredients or other measures by the manufacturer to result in the presence of tobacco as a characterizing flavor. However, menthol flavored products will be treated the same as products with characterizing flavors other than tobacco for the purpose of this policy, because when it is used as a characterizing flavor, menthol has a similar impact on a product’s appeal to youth and young adults as such other characterizing flavors. We note that newly-deemed flavored tobacco products that are not grandfathered may still need to address the public health implications of any added flavors, including tobacco flavor, in their pre-market review submissions.”
While the FDA has yet to act to prohibit menthol in cigarettes, the language above indicates that the agency recognizes the public health danger posed by menthol tobacco products. Unfortunately, excitement over the FDA’s attempt to act is squelched by the simultaneous revelation that the White House itself prevented the agency from taking action on the most harmful of all flavor additives in tobacco products.
The good news for the public health community is that our thousands of comments on the proposed deeming rule, supported by scientific evidence, influenced the FDA’s thinking on the regulation. The FDA’s Center for Tobacco Products agrees that the evidence shows that menthol is just as harmful as other flavors in tobacco products. We must continue to support the FDA with our comments to its proposed rules, guidance documents, and information collections. At the same time, advocates must urge the White House to fulfill the promise of the Tobacco Control Act by supporting the FDA to enact strong regulations that best protect public health.
June 2, 2016