FDA lifts restrictions on OTC nicotine replacement therapies
In a truly stunning announcement, last week, the U.S. Food and Drug Administration announced its intention to lift many restrictions on labeling of over-the-counter Nicotine Replacement Therapy drugs; allow multiple NRT products to be used concurrently, and concurrently with cigarettes; and to substitute the current firm limitation of 8 to 12 weeks with a squishier recommendation that, if needed for longer durations, the user should consult his or her physician.
This was in response to citizen petitions from Tobacco Free Kids, the State of New York and multiple other parties alleging the safety of these proposed changes and that such action would enhance the efficacy of NRT products in curbing cigarette smoking. Even though the FDA found the referenced studies weak, inconclusive or technically flawed,it accepted the major recommendations of these citizen petitions on the basis of “30 years of experience” with these products.
If I understand the response correctly, these products are now to be available basically without warnings or restrictions, and, as they have been in the past, with no age restrictions for purchase or prohibitions on TV or other media advertising.
In addition, the FDA approved their being made available at much lower cost in single-day packaging without considering how this might be seen by teens attracted to possible nicotine use.
While I agree in general with the thrust of the citizen petitions and the steps taken by the FDA with regard to the labeling requirements on these products, I wonder if the practical effect is to move these products into the realm of recreational drug use. Certain elements of their action may be worthy of reconsideration.
The other aspect of this is what it implies for manufacturers and vendors of e-cigarettes and other smoke-free, relatively low risk tobacco products. Should they all submit drug applications, or will FDA use this opportunity to rethink the provisions of the tobacco control law that prohibit these manufacturers and vendors from advising current smokers and others about the difference in risk posed by these products, as compared to cigarettes?
