The Biden administration is preparing to issue highly anticipated standards targeting menthol cigarettes despite heavy opposition from small business, civil rights, law enforcement and free market consumer groups.

The regulations, which would broadly ban the product, were first proposed by the Food and Drug Administration (FDA) two years ago and have sparked a contentious debate between health advocates and civil liberties and business groups. The FDA has repeatedly missed target dates for finalizing the proposed ban, the latest of which was earlier this week.

"The FDA remains committed to issuing the tobacco product standards for menthol in cigarettes and characterizing flavors in cigars as expeditiously as possible; these rules have been submitted to the [Office of Management and Budget] for review, which is the final step in the rulemaking process," an FDA spokesperson told Fox News Digital. "As we’ve made clear, these product standards remain at the top of our priorities."

The spokesperson said the agency, which handed the regulations off to the White House Office of Management and Budget (OMB) for final approval months ago, is limited from discussing the process further since the proposal remains pending. White House spokesperson Kelly Scully declined to comment, also noting the rulemaking process is ongoing.

BIDEN ADMIN FACING CONGRESSIONAL PROBE OVER PROPOSED BAN ON MENTHOL CIGARETTES

Biden and menthol cigarettes

The Food and Drug Administration initially proposed rules prohibiting menthol cigarettes and flavored cigars in April 2022 to "prevent children from becoming the next generation of smokers" and to "help adult smokers quit." (Getty Images)

But the Biden administration's continued delays in finalizing the regulations has caused angst among proponents of banning menthol cigarettes, many of whom have argued such an action is vital for achieving goals laid out in President Biden's "Cancer Moonshot" initiative. The administration was first expected to finalize the ban in August 2023, meaning its delays have stretched more than seven months.

"This continued inaction is a shocking deference to the tobacco industry, which has repeatedly demonstrated its willingness to profit from products that result in death," said Karen Knudsen, the CEO of the American Cancer Society and its affiliate Cancer Action Network.

CONSERVATIVE GROUP UNLEASHES 6-FIGURE AD CAMPAIGN TARGETING BIDEN'S MENTHOL CIGARETTE BAN

Opponents of the ban expressed optimism that their advocacy has resonated with White House officials, potentially prompting them to reconsider the ban. Associations representing convenience stores, police, consumers and minority groups have warned a ban on menthol cigarettes could foster a black market while punishing small business owners and minorities who are the largest consumers of the product.

According to OMB filings, the White House and the FDA have convened a flurry of meetings on the proposal with a wide range of stakeholders, including proponents, such as the American Cancer Society's Cancer Action Network and American Lung Association, and opponents, such as the National Association of Convenience Stores (NACS), National Organization of Black Law Enforcement and National Action Network.

Smoking cigarette

Tobacco smoking remains the leading cause of preventable death nationwide, according to the FDA. But opponents of a ban on menthol cigarettes say it would create a black market and disproportionally harm small businesses and minorities. (iStock)

"The proposed ban would have the exact opposite results that proponents have championed," NACS said in a statement to Fox News Digital. "We hope that FDA is reconsidering its policy in light of the evidence that these types of bans simply don’t work."

"The proposed ban, while well-intentioned, could have had far-reaching economic consequences for convenience stores by cutting 30% of sales and the livelihoods of over 600,000 workers," said Javier Palomarez, the president and CEO of the U.S. Hispanic Business Council (USHBC).

BIDEN ADMIN'S PROPOSED MENTHOL CIGARETTE BAN COULD BECOME LIABILITY IN 2024: 'UNINTENDED CONSEQUENCES'

NACS, USHBC and other opponents of the regulations have pointed to data from states that have banned menthol cigarettes, arguing such policies don't work.

According to NACS, the rule would lead to a reduction of $72,285 a year in non-tobacco sundry sales and $160,107 a year in tobacco product sales for the typical convenience store nationwide. The organization claims the convenience store industry could collectively lose $2.16 billion in sales because of the new regulations. 

Commissioner of the FDA Dr. Robert Califf testifies during a Senate Committee on Health, Education, Labor and Pensions hearing on Capitol Hill, Sept. 14, 2022 in Washington, D.C.

FDA Commissioner Robert Califf testifies during a Senate Committee on Health, Education, Labor and Pensions hearing in September 2022. (Drew Angerer/Getty Images)

Groups representing minorities, like the National Organization of Black Law Enforcement and the nonprofit National Action Network, the latter of which was founded by civil rights leader Rev. Al Sharpton, argue that banning menthol cigarettes while not restricting non-menthol cigarettes "puts a microscope on minority communities." They say it could increase the probability of negative interactions between police and minorities.

The National Organization of Black Law Enforcement, National Action Network, National Newspaper Publishers Association and civil rights attorney Benjamin Crump met with Health and Human Services Secretary Xavier Becerra, FDA Commissioner Robert Califf and White House domestic policy adviser Neera Tanden to discuss the proposal in November.

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The FDA first issued the product standards to prohibit menthol as a characterizing flavor in cigarettes and prohibit all characterizing flavors other than tobacco in cigars in April 2022. The agency said the move would reduce disease and death from tobacco product use by reducing youth experimentation and addiction, while increasing the number of smokers that might quit.

Tobacco smoking remains the leading cause of preventable death nationwide, according to the FDA. In proposing the rules, the FDA cited its congressional authority to adopt tobacco product standards.

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