The U.S. Food and Drug Administration said on Thursday it would seek public opinion before finalizing its decision to remove a decongestant widely used in cough syrups from the agency’s list of ingredients for over-the-counter (OTC) use.
The FDA’s clarification follows a unanimous vote by its panel of outside experts on Tuesday against the effectiveness of oral OTC medicines made with phenylephrine, an ingredient widely used in cold and cough syrups.
If the FDA concurs with the panel’s view, it will first issue a proposed order removing phenylephrine from the list of ingredients that are allowed in OTC drugs, and seek public comment on it.
After considering the comments, if the FDA continues to conclude phenylephrine is not effective, the agency would issue a final order on it and work with manufacturers to reformulate products to effectively treat symptoms of cold or allergies.
Why are they reporting it this way. The Administrative Procedures Act literally requires them to have a comment period on these executive rule changes.
By the way, they seldom modify anything about the proposed actions even if the comments are overwhelmingly negative. Reference all the recent ATF “rule changes” that essentially amounted to executive fiat gun control. In those rule changes the comments were 90% negative and the positive comments were obviously astroturfed form letters, and they proceeded with the changes anyway.