[Dextromethorphan is an active ingredient in NyQuil. Image from raimund14/Adobe Stock]
The FDA’s drug listing process requires submitting information related to a drug product, including its name, active ingredients, dosage form, strength and labeling information. The agency asks that the information be submitted to its electronic Drug Registration and Listing System (eDRLS), an online application.
In its warning letter to Procter & Gamble, FDA noted that it sent a letter dated October 31, 2022 to the manufacturer with a list of deficiencies related to a type of Vicks Nyquil. The agency also sent the company a data removal email notification on December 15, 2022, informing you of a data removal action. As stated in this email, the agency concluded that continued deficiencies led it to remove the product from its Online NDC Directory. In the directory, the FDA explained that the listing for the drug was removed after the agency “found inaccuracy in the data submitted by the firm.” The agency said it would release data for publication after it receives “complete and accurate information.”
In addition to warning letters, failure to comply with the drug listing process can ultimately result in fines and penalties, product seizures, injunctions and, in extreme cases, criminal prosecution.
Background on the Nyquil problems
In its warning letter, FDA notes that it found inconsistencies in the drug listing information submitted by Procter & Gamble for Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion. In particular, the agency found discrepancies between the labeling and electronic listing file, amounting to a violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
The FDA had previously informed the firm about the observed deficiencies in the submitted information. Despite this, Procter & Gamble failed to solve the problems.
The crux of the problem lay in the mismatch between the active ingredients listed in the product’s labeling and the electronic listing file in Structured Product Labeling (SPL) format. The discrepancies between the two lists of active ingredients rendered the product misbranded under the FD&C Act and in violation of other related sections.
In February 2022, FDA sent a similar warning letter to ECI Pharmaceuticals for submitting incorrect information related to the active ingredients of two of its drug products, “esterified estrogens and methyltestosterone” (NDC 51293-639) and esterified estrogens and methyltestosterone (NDC 51293-640), to the agency’s electronic Drug Registration and Listing System (eDRLS). After reviewing the data, the agency FDA determined that the active ingredient information was incorrect.
Providing up-to-date drug listing information
FDA relies on accurate and up-to-date drug listing information to protect patient safety. The agency uses such information for a variety of purposes, including for inspections, supply chain security and post-market surveillance. Additionally, organizations outside of the FDA use drug registration and listing information for electronic prescribing, electronic health records, insurance reimbursement and patient education.
The FDA has urged Procter & Gamble to investigate the cause of the violations, correct them and ensure their product is in compliance with the FD&C Act. It gave the company 15 working days to respond to its communications with a detailed plan of action to address the violations and prevent their recurrence.
The case of Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion serves as a reminder of the importance of strict adherence to FDA’s drug listing regulations. Companies operating in the pharmaceutical industry must ensure the accuracy and consistency of their drug listing information to avoid potential legal consequences and, more importantly, protect patient safety. This case study highlights the importance of thorough compliance measures and proactive resolution efforts when discrepancies are discovered.
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