- The FDA said it would seek public input before withdrawing phenylephrine.
- The ingredient, found in medications such as Sudafed, was deemed ineffective.
- READ MORE: FDA rules Benadryl and Sudafed ingredient doesn’t work
The Food and Drug Administration (FDA) will seek public input before making a decision to remove an ingredient from over-the-counter (OTC) drugs like Sudafed and Benadryl that doesn’t work.
The agency announced the clarification Thursday after a panel of outside experts voted unanimously that the ingredient phenylephrine, which is widely used in cold and cough syrups, is ineffective.
If the FDA agrees with the panel’s opinion, it will propose removing phenylephrine from the list of permitted ingredients in over-the-counter medications and will seek public comment on the matter.
The ingredient phenylephrine is common on pharmacy shelves and has received the FDA’s designation of generally recognized as safe. But losing that designation could mean that big players in the over-the-counter drug field pull their products from shelves or reformulate them.
After considering the comments, if the FDA continues to conclude that phenylephrine is not effective, the agency would issue a final order on the matter and work with manufacturers to reformulate products to effectively treat cold or allergy symptoms.
Meanwhile, a lawsuit has been filed against Johnson & Johnson (JNJ.N) and Procter & Gamble (PG.N), which makes Vicks NyQuil, accusing the companies of misleading consumers about decongestant cold medications.
Kenvue’s Tylenol (KVUE.N) and GSK’s Advil (GSK.L) are among the most prominent cough and cold syrups containing phenylephrine sold in the United States. Johnson & Johnson spun off its consumer healthcare unit as Kenvue this year.
In addition to cough syrup, phenylephrine is also an ingredient used in nasal sprays, but the agency said its order would only relate to oral medications and not the aerosol form.
Medications that could be withdrawn from the market
- Colrex Compound
- Tylenol Severe cold and flu day and night
- Codral Cold and Flu + Cough Day and Night
- Alka-Seltzer Plus Severe Cold and Flu Formula Effervescent Tablets
- XL-3 Cold Medicine
- Robitussin Peak Overnight Nasal Cold Relief
- Tylenol Sinus congestion and pain at night
- Norel SR
- Trital SR
- Vicky Sinex
- Benadryl Allergy Plus Congestion
- Mucinex Products
- Advil Allergy and Congestion Relief
- Vicks Nyquil Severe Cold and Flu