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This Week in FDA Regulations: Flavored Cigars, Pharmacies, and Deadlines

By William Peacock, Esq. on August 22, 2013 | Last updated on March 21, 2019

This week is more about the FDA being regulated (and empowered), rather than the agency regulating others, with the exception of their continuing crusade against tobacco use -- in any form. The recent trend began with e-cigarettes and menthols, continued with roll-your-own, and now, the FDA is eyeing flavored cigars, reports Fox News.

Meanwhile, a district court in California is keeping the pressure on the FDA to issue tardy food safety laws, while the Senate is moving to grant the FDA additional powers to help the agency oversee the operations of compounding pharmacies.

Tobacco + Flavor = Bad

Last week, we rhetorically asked what the difference is between filtered cigarettes and filtered cigarillos? After all, while flavored cigarettes have been banned since 2009, flavored mini-cigars still exist and sales are up 40 percent since 2008. Both have tobacco, candy-like flavoring, similar sizes and shapes, and have paper filters.

The only difference that we can think of, off the top of our heads, is that cigarettes have more additives and cost more. And they're more regulated and taxed.

While the 2009 Family Prevention and Tobacco Control Act only banned flavored cigarettes, the power to regulate cigars was transferred to the FDA. Now, four years later, the FDA is weighing possible regulations on flavored cigars, though they have provided not yet provided details on their plans, reports CBS.

Court Won't Relax Regulation Schedule

The Food Safety Modernization Act required the FDA to pass a batch of safety regulations by July 2012. That date came and went, and in response, the Center for Food Safety sued.

Since then, Judge Phyllis Hamilton has kept the pressure on the FDA, refusing further extensions of deadlines. To date, the agency has published proposed regulations for four of the seven areas mandated by the law, according to The Packer.

Currently, the court-imposed deadline is June 30, 2015. The FDA recently sought an extension to late 2017 for its regulation on intentional adulteration, but the court denied the extension on August 13. An appeal could follow.

Compounding Pharmacies Take a Pounding

After the fungal meningitis outbreak of last year, the Senate has introduced a bill that would grant the FDA increased power to regulate compounding pharmacies. Currently regulation of these entities, which produce custom dosages and delivery forms of medications, is split between states and the FDA.

The proposed bill would charge compounding pharmacies a registration fee, which would fund inspections. It is expected that, should the bill become law, it would take three years to inspect all large-scale compounding pharmacies, reports the Daily Press.

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