The marketplace for over-the-counter cold and congestion remedies is undergoing a significant change following a re-evaluation of common product ingredients. Consumers may notice certain familiar decongestant pills and liquids are being voluntarily removed from shelves or reformulated by manufacturers. This shift stems from new scientific scrutiny regarding the effectiveness of a widely used component in many multi-symptom cold and flu formulas. The goal is to ensure that nonprescription products provide the relief they promise.
The Scientific Rationale for Regulatory Action
The regulatory scrutiny centers on the ingredient phenylephrine, or PE, when it is taken by mouth. In September 2023, the Nonprescription Drugs Advisory Committee, an independent panel that advises the Food and Drug Administration, discussed new data on this ingredient’s effectiveness as an oral decongestant. The committee unanimously concluded that scientific data do not support the effectiveness of oral phenylephrine at the recommended dosage. This finding suggests that oral formulations are no more effective at relieving nasal congestion than a placebo.
The lack of efficacy is attributed to how the body processes the medication when swallowed. A significant amount of the drug is inactivated in the gut and during the first pass through the liver before it can reach the bloodstream. Up to 99% of the parent drug is metabolized, meaning very little reaches the nasal passages to constrict blood vessels and reduce swelling.
This ineffectiveness only applies to the oral form of the medication. Phenylephrine is still effective when applied directly to the nasal passages, such as in nasal sprays or drops. Direct application avoids the extensive metabolism that occurs in the digestive system and liver. The advisory committee did not raise concerns about the safety of oral phenylephrine, indicating the issue is one of efficacy, not immediate toxicity.
Identifying Affected Oral Cold Products
The conclusion that oral phenylephrine is ineffective has led to a market shift, though it is not a mandatory recall. Manufacturers and retailers are proactively removing or reformulating products to comply with the findings. The ingredient is a common nasal decongestant found in hundreds of over-the-counter products, including single-ingredient tablets and capsules, as well as multi-symptom formulas.
Multi-symptom cold, flu, and allergy formulas are particularly affected, as they often contain phenylephrine alongside pain relievers or antihistamines. To determine if a product contains the affected ingredient, consumers must check the “Active Ingredients” section on the drug facts label. Look for “phenylephrine” or “phenylephrine hydrochloride,” often listed under Nasal Decongestant. If the product is a tablet, capsule, or oral liquid, it is impacted by the advisory committee’s findings.
Consumer Guidance for Existing Medications
Consumers who have medications containing oral phenylephrine should understand the context of the regulatory action. Since the issue is a lack of efficacy, not a safety concern, these products are not considered dangerous when taken as directed. However, continuing to use them for congestion relief is unlikely to provide any benefit beyond a placebo effect.
For disposal, the best option is to use a drug take-back program, available at local pharmacies or through periodic events hosted by law enforcement. If a take-back program is unavailable, the medication can be discarded with household trash. To prevent accidental ingestion by children or pets, follow these steps:
- Mix the medicine with an unappealing substance like used coffee grounds or cat litter.
- Place the mixture in a sealed plastic bag or container before throwing it into the trash.
- Scratch out or remove any personal information on the empty packaging before disposal.
- Avoid flushing most medications down the toilet due to environmental concerns, unless the packaging specifically instructs otherwise.
Effective Alternatives for Symptom Relief
For individuals seeking an effective oral decongestant, pseudoephedrine remains a proven alternative for temporary nasal congestion relief. This ingredient is available over-the-counter but is kept behind the pharmacy counter due to regulations concerning its use in the illegal manufacture of other substances. Consumers who purchase pseudoephedrine must show identification and comply with limits on the amount they can buy.
Nasal sprays that contain decongestants, such as phenylephrine or oxymetazoline, are also highly effective alternatives. Since these medications are applied directly to the nasal lining, they bypass the gut and liver metabolism, allowing them to work as intended. Other options include nasal steroid sprays, which are effective for allergy-related congestion, and antihistamines, which can help if the stuffiness is caused by an allergic reaction.
There are also several non-pharmacological methods that can provide meaningful relief for a stuffy nose. Saline nasal sprays or nasal rinses, administered using a neti pot or similar device, can help clear mucus and reduce congestion. Using a humidifier in the bedroom can add moisture to the air, which soothes irritated nasal passages. Staying well-hydrated is also important, as it helps to thin mucus, making it easier to clear from the system.