Global Nicotine: Key takeaways from our call with Will Woodlee

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Global Nicotine: Key takeaways from our call with Will Woodlee

blueberry flavours, albeit under tighter restrictions. But for fruit/candy/sweet flavours, a

practical hurdle still remains.

Litigation risk is more likely to come from tobacco control groups than from industry: Mr.

Woodlee was not aware of significant industry momentum to challenge the May guidance. By

contrast, tobacco control groups have previously challenged the FDA when they viewed the

agency as being too lenient, including around PMTA deadlines. While FDA can argue this is only

guidance and largely formalises existing enforcement discretion, Mr. Woodlee did not rule out a

successful challenge. That said, FDA appears to have drafted the policy with litigation risk in

mind.

“High” nicotine content is slightly ambiguous, creating uncertainty around the scope of

the guidance: The FDA has said it will exclude “high nicotine content” products from its

enforcement discretion, but it does not clearly define what “high” means. This creates

ambiguity for manufacturers, particularly in nicotine pouches where labelled strength does not

necessarily equate to nicotine delivery: pH adjusters, nicotine salt formulations, release profile

and other ingredients can all affect how much nicotine is actually delivered. Mr. Woodlee

expects manufacturers to stay close to nicotine strengths in products that have already been

approved, until FDA provides more clarity.

Policy durability is questionable given its format and upcoming mid-term elections: Note

that because it is guidance that has been published, rather than new agency rules, the FDA

could revise or withdraw the guidance relatively easily from a procedural standpoint. A future

administration could adopt a tougher stance towards tobacco products, but Mr.