Twenty years ago, it became clear that Congress intended to curb the illegal production of methamphetamine by restricting access to pseudoephedrine, a meth precursor that was also widely used as a decongestant in cold and allergy medications such as Sudafed. Pfizer, the manufacturer of Sudafed products, responded by announcing it would sell alternatives that contain a different active ingredient: phenylephrine.
What is the difference between pseudoephedrine and phenylephrine? “SUDAFED products containing phenylephrine are available without restrictions,” explains Johnson & Johnson, which acquired the brand from Pfizer in 2006, while “products containing pseudoephedrine as the active ingredient are restricted.” Johnson & Johnson makes no mention of another distinction that might be of interest to consumers: Pseudoephedrine works, while phenylephrine does not. A unanimous panel of experts recommended this to the Food and Drug Administration (FDA) on Tuesday.
The biggest problem with phenylephrine: When taken orally, it is so thoroughly metabolized in the intestines that almost none of it enters the bloodstream. “The new data seem convincing that the monographic dosage of oral [phenylephrine] does not result in meaningful systemic exposure or evidence of efficacy,” according to an FDA briefing document submitted to the advisory committee. “Additionally, the review suggests that higher doses… have also failed to demonstrate efficacy. These findings are supported by in vitro and in vivo clinical pharmacology data demonstrating that orally administered phenylephrine undergoes high first-pass metabolism, resulting in a bioavailability of less than 1%.”
In short, legal restrictions on the sale of pseudoephedrine have given us reformulated products, including pseudo-Sudafed, that not only don’t work as well, but apparently don’t work at all, as you may have discovered after trying them. But at least those ineffective products are easy to buy.
In contrast, legal restrictions on pseudoephedrine have taken it off the shelves and behind the pharmacy counter, where it can only be picked up under certain conditions. Thanks to the Combat Methamphetamine Epidemic Act of 2005, Johnson & Johnson notes, “There are limits on the amount of pseudoephedrine that can be purchased at one time within a month. Buyers will generally be required to provide a valid photo ID to make purchases. these products, and the pharmacy is obliged to record purchases for a maximum of two years.”
The federal purchase limit is 3.6 milligrams of pseudoephedrine base in one day and nine milligrams in one month. The monthly limit should be enough to keep you covered during allergy season (for example, two 12-hour Sudafed pills per day). But the daily limit means you have to make repeated trips to the pharmacy to get your monthly allotment. And if there are two or more people in your household who need relief from allergies or colds at the same time, each should buy pills separately. Don’t think you can get pills yourself And for your partner or your child. Inter-store and interstate databases will deter you from making such a suspicious transaction, marking you as a likely meth cook or smurfer.
Each state has its own rules for purchasing pseudoephedrine, which may be stricter than federal regulations. In Oregon and Mississippi, for example, you can legally obtain the decongestant only with a prescription.
This policy has caused no small amount of discomfort, snooping and inconvenience to innocent people with allergies or colds, while treating them like potential criminals. It has pushed many of them to choose less restrictive alternatives that, as it turns out, are nothing but placebos. What benefits can be weighed against these costs?
Restrictions on pseudoephedrine affected the illegal methamphetamine trade, primarily by shifting production from small-scale U.S. operations to large-scale Mexican traffickers. But that has by no means limited the supply. By 2010, The New York Times reported that meth had “reached the highest purity and lowest price in the United States since 2005,” when Congress set pseudoephedrine limits.
The number of illicit meth users in the United States more than doubled between 2009 and 2021, according to survey data. And according to a 2023 study American pharmacist According to the report, “the age-adjusted drug overdose death rate per 100,000 population for psychostimulants with abuse potential (primarily methamphetamine) increased from 0.2 in 1999 to 5.0 in 2019.” It appears that the restrictions on pseudoephedrine have been about as effective as the phenylephrine pills.