Pseudoephedrine and Methamphetamine

The Combat Methamphetamine Epidemic Act of 2005 was incorporated into the Patriot Act and signed by George W. Bush in March 2006. The act bans OTC sales of cold medicines that contain the ingredient pseudoephedrine. The reason for the ban was that pseudoephedrine was used to make methamphetamine (AKA “meth”). While critics like Sullum and Balko took issue with the magnitude of the meth problem in the U.S., there was no debate about the devastation caused by meth addiction or the death and destruction that accompanies illegal drug trafficking. In the wake of the ban, manufacturers of OTC decongestants were forced to replace pseudoephedrine with phenylephrine.

What Is the Difference Between Pseudoephedrine and Phenylephrine?

The FDA ensures that medications available to American consumers are safe and effective, with safety being the top priority. While dietary supplements are often ineffective, the FDA does not regulate them. However, the agency will intervene to ban dangerous ingredients in otherwise unregulated products. For example, in 2004, the FDA banned ephedra, a stimulant found in many supplements.

Research indicated that pseudoephedrine was both safe and effective when taken as directed. OTC drugs containing pseudoephedrine effectively reduced nasal passage swelling with an acceptable side-effect profile. The FDA also deemed oral phenylephrine safe; however, the issue is that it doesn't work, as consumers quickly discovered.

Why a Proposal and Not an Outright Ban?

The FDA is in no hurry to ban oral phenylephrine, despite the fact that the medical and scientific community has known for decades that the drug is an ineffective decongestant. However, because safety is prioritized over efficacy, the FDA has been slower to act compared to its swift response against substances like ephedra.

Sourcesagree that the global decongestant market will exceed $21 billion in the coming years, with a growth rate of over 6%. As a result, manufacturers of OTC cold remedies have strong incentives to resist a ban on the only remaining decongestant ingredient in their products. Efforts to ban the substance will likely face significant pushback from the industry.

Do No Harm

Allowing consumers to use safe but ineffective medications can empower personal choice, supporting those who feel comforted or optimistic when taking them, even if it's purely due to the placebo effect. For some, the ritual of taking something to support their health or well-being provides psychological benefits, helping to reduce anxiety or stress, which can positively impact overall health. Safe but ineffective options offer an alternative for individuals hesitant about stronger, riskier medications. In cases where no effective options exist, these products can provide patients with a sense of control and hope, which is often crucial for mental and emotional resilience.

On the other hand, allowing consumers to use ineffective medications, even if they are safe, can have unintended consequences. First, it undermines trust in healthcare by promoting products that do not deliver tangible benefits. People who spend money on these medications may delay or avoid seeking effective treatments, potentially worsening their conditions. Additionally, the perception that these "safe but ineffective" products are helpful can contribute to misinformation, eroding the public’s ability to make informed health choices. Healthcare resources and consumer funds are better spent on evidence-based treatments that genuinely improve health outcomes, rather than perpetuating a cycle of wasted resources and false hope. For these reasons, doing no harm can sometimes be indirectly harmful.

No Phenylephrine, No Problem

Treating congestion from upper respiratory tract infections without OTC decongestants involves several natural remedies and lifestyle adjustments. One effective method is steam inhalation. Inhaling warm, moist air helps thin mucus and ease congestion. This can be done by taking a hot shower, using a humidifier, or creating a steam tent by placing a towel over the head while breathing in steam from a bowl of hot water. Adding eucalyptus or peppermint oil may enhance relief, as these oils can have mild decongestant effects.

Hydration is also crucial. Drinking plenty of fluids and hot teas with honey and lemon helps keep mucus thin, promoting faster drainage. Saline sprays or rinses can be beneficial as well, moisturizing nasal passages and helping flush out mucus and irritants.

Elevating the head while sleeping can promote sinus drainage and reduce congestion. Additionally, ginger tea and spicy foods, such as those containing chili peppers, may help temporarily clear nasal passages by stimulating mucus thinning and drainage.

Practicing breathing exercises or gentle yoga can also support respiratory health by promoting relaxed, open airways. Together, these natural approaches can provide relief without the need for OTC decongestants.

What To Do if You Have a Cold

Medical attention is usually unnecessary for most cold symptoms, such as mild congestion, cough, or a sore throat, as these typically improve with rest, hydration, and time. However, it is wise to consult a licensed healthcare provider if symptoms become severe—such as difficulty breathing, intense chest pain, or a persistent high fever. These could indicate complications like a sinus infection, bronchitis, or pneumonia, which may require professional treatment. Additionally, if symptoms last longer than ten days or worsen after initially improving, seeking medical guidance can help prevent further complications. Timely care ensures that a simple cold does not develop into a more serious condition.