This Week in FDA Regulation: Plan B Pills, Menthols, and E-Cigs
Regulation. The word itself sends chills down the spines of many. Fortunately, this past week’s Food and Drug Administration news isn’t exclusively restrictive. In fact, the pharmaceutical industry just got a jolt of good news with loosening of retractions on morning-after pills, though the new rules are indescribably complicated.
Meanwhile, five years after the FDA was granted the authority to regulate cigarettes, and four years after flavored cigarettes were banned, menthol may be the FDA’s next target. After that, it’s looking like the next target will be the exponentially-growing e-cigarette industry, which is currently virtually unregulated.
FDA's Plan C ... For Plan B
NPR reports that the FDA has now changed course again, and Plan B One-Step (the single pill version) will be available to women as young as 15 without a prescription. Plan B One-Step will gain three years of generic protection as well.
Oddly enough, thanks to the FDA handling the matter through numerous regulations, name brand Plan B One Step will be available to everyone, prescription-free, while the generic version, available in 2016, and which is $10 cheaper, may be available on retail shelves, but will only be available to those 17 years of age and older.
Meanwhile, the much cheaper two-pill version will remain behind the counter, with those under 17 not admitted without a prescription.
Confused yet? Us too. The short version is this: the cheaper the version, the harder it will be to obtain, especially for minors. Fun arguments like arbitrary, capricious, and regulations that serve no public interest whatsoever are sure to follow.
Menthol: Gateway Drug?
Lime, chocolate, and other fun flavors of cigarettes are banned, yet minty-Methol remains, and it may be more dangerous than even the candy-coated versions, according to a study cited by the FDA earlier this week.
Menthol is an analgesic that numbs and relieves pain. That's why it's used in cough drops. That also makes it more dangerous in cigarettes, as it reduces the perceived harshness from tobacco. The study showed that while the menthol cigarettes were not more or less harmful than regular variants, the reduced harshness made them more appealing to new smokers, reports Reuters.
NPR cites a number of interesting statistics, including that more than one-third of all cigarettes sold are menthols, 40 percent of new smokers prefer menthols, as do nearly three-quarters of African-American smokers. Are past advertising campaigns to blame for the racial disparity? The FDA is investigating any possible genetic connection.
The FDA also issued an advanced notice of public rulemaking, soliciting comments and describing the studies evaluated by the government agency.
E-Cigs Unregulated, For Now
You've probably seen those stupid-looking plastic cigarettes, which emit nicotine-laced vapor, yet are odorless and permissible under most smoking bans. According to CNBC, the e-cigarette industry is projected to reach $1 billion in sales, with about 250 different brands.
And all of it is unregulated. Unlike regular cigarettes, there are no restrictions on buyers' ages, advertising, Internet sales, fruity flavors. In other words, a five-year-old could hypothetically legally purchase and smoke a cherry nicotine-laced device after seeing a television ad during his cartoons.
Meanwhile, companies are racing for market share before the boom of regulation hits later this year. The FDA is expected to issue proposed rules in October, with notice-and-comment expected to take another 12 to 18 months.
One possibly disastrous regulation cited by CNBC would be an Internet sales ban. Such a regulation would all but hand the industry to Big Tobacco, which has existing retail sales and distribution channels.
Smoke 'em and sell 'em while you've got 'em, we guess.
- Monster Beverages Sues SF City Attny; Continues to Fight Regulation (FindLaw's In House Blog)
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- Off-Label Promotion Ruling Not a Free Pass for Pharma (FindLaw's In House Blog)