A category in chaos
U.S. adults get an average of two to four colds per year, according to the Chicago-based American Lung Association. And between 5% and 20% of Americans come down with the
flu annually.
It should come as no surprise, therefore, that treatment of coughing, congestion and other symptoms associated with those respiratory ailments translates into big business. In fact, New York-based IBISWorld valued the U.S. over-the-counter cough and cold medicine manufacturing industry at $11 billion in 2022, based on revenues.
But the industry has been sailing in rough waters of late. Back in September 2023, the U.S. Food and Drug Administration’s Non-prescription Drug Advisory Committee concluded that “current scientific data do not support that the recommended dosage of orally administered phenylephrine is effective as a nasal decongestant.”
Phenylephrine replaced pseudoephedrine in hundreds of OTC cold, flu and allergy formulations after pseudoephedrine was moved behind pharmacy counters in 2006, thanks to concerns tied to methamphetamine manufacturing.
Many multi-symptom products now contain phenylephrine, noted Fraidy Maltz, B.S., Pharm.D., BCAP. She is director of student engagement, developmental portfolios and co-curricular learning and associate professor of Pharmacy Practice at Touro College of Pharmacy, New York. She predicts that such products will be either reformulated without decongestants or contain pseudoephedrine (and be sold behind the pharmacy counter).
“Interestingly, allergy products such as Claritin-D, Zyrtec-D and Allegra-D all contain pseudoephedrine as the ‘D’ decongestant and were not reformulated with phenylephrine due to its questionable efficacy,” Maltz said. “For nasal congestion symptoms related to the common cold, I usually recommend immediate-release (30-mg) pseudoephedrine for daytime use and oxymetazoline nasal spray for nighttime use, as pseudoephedrine may cause insomnia due to its stimulant effects. It is important for consumers to be aware that all decongestants may increase blood pressure and affect other health conditions such as benign prostatic hyperplasia and narrow angle glaucoma.”
Not a safety issue
The conclusions of FDA’s committee certainly stirred up the industry. A number of class-action lawsuits were quickly filed, targeting the makers and sellers of many phenylephrine-containing products. And at least one retail drug chain, Woonsocket, R.I.-based CVS Health, announced plans to remove certain phenylephrine-containing products from store shelves, CNN reported.
[Read more: Something old, something new]
But it is important that consumers and retail drug stores understand that safety is not an issue here. “Neither FDA nor the committee raised concerns about safety issues with the use of oral phenylephrine at the recommended dose,” FDA noted in a Sept. 14 statement. “FDA will consider the input of this advisory committee, and the evidence, before taking any action on the status of oral phenylephrine.” Phallon Obomanu, senior director, self-care customer strategy for Skillman, N.J.- headquartered Kenvue Inc.—a spinoff of New Brunswick, N.J.-based Johnson & Johnson—also emphasized that FDA made it clear that the committee review was not about the safety of phenylephrine.
“They have not made a determination about oral phenylephrine in the monograph, nor have they advised consumers to discontinue use,” Obomanu said. “While we have not seen a shift in shopping behavior to date, we will work with the agency and our retail partners to ensure that we continue to offer a variety of science-backed options, oftentimes multi-ingredient solutions, of both OTC and behind-the-counter solutions to serve the needs of our consumers.”
Kenvue’s “robust portfolio” of existing self-care products for both the allergy and cough, cold and flu categories is designed to treat several of the symptoms that consumers experience, Obomanu noted.
“The majority of our portfolio of products are multi-ingredient, which means they are specifically formulated to relieve several symptoms at once,” she pointed out. “We formulate this way because we understand that cough, fever, aches and pains, congestion, runny noses and sneezing can present oftentimes concurrently during the same sickness.”
But Maltz called for caution when it comes to recommending multi-symptom products to patients with cold or flu symptoms. “Consumers are not always aware of hidden ingredients such as acetaminophen, which is often contained in these products,” she said. “Patients might be taking acetaminophen for fever or pain along with these products that could result in an overdose and ultimately may lead to serious adverse outcomes such as liver failure.”
It is important for consumers to have the background and education they need to choose the right ingredient or ingredients to treat their specific symptom or symptoms, Obomanu said. For its part, Kenvue provides tools and resources related to ingredients, dosing and more through Health in Hand, a nonprofit supported by the Consumer Healthcare Products Association) Educational Foundation.
Like Kenvue, Weybridge, England-based Haleon is awaiting FDA’s guidance related to oral phenylephrine’s status in the OTC monograph.
“We are committed to working closely with our retail partners before, during and after FDA makes a formal decision on oral phenylephrine to minimize any disruption to their operations and ensure consumers have continued access to trusted OTC solutions,” said Lisa Paley, president, North America for the company.
In defense of phenylephrine
Paley maintained that the removal of oral phenylephrine’s availability “as a therapeutic choice” would limit choices and access to quality care on the part of consumers. More consumers, for example, might seek care from doctors, pharmacists or clinics.
“Consumers indicate that they may delay or forgo treatment in this case, which could lead to worse outcomes and increase demand for doctor and clinic visits in the long run,” Paley said. “If consumers shift to behind-the-counter ingredient options, it could put further pressure on pharmacy resources as well.”
In a Sept. 15 statement, Scott Melville, president and CEO of Washington-based CHPA, also weighed in on the topic. “We encourage FDA, before making any regulatory determination, to be mindful of the totality of the evidence supporting this long-standing OTC ingredient, as well as the significantly negative unintended consequences associated with any potential change in oral [phenylephrine’s] regulatory status,” Melville said. “While we respect the scientific and public process that allows new science to influence health policy and regulations, we are concerned about previous clinical evidence being inappropriately dismissed and discounted. We look forward to working with FDA in the coming days to further discuss how to best move forward in the interest of patients and consumers.”
Plenty of innovation
It’s not all doom and gloom within the cough and cold remedy space, of course. In fact, Paley is excited at the pace of innovation.
“Consumers have more choices than ever available to them to treat symptoms, across a variety of formats that align with their preferences,” she noted. “For example, last cold and flu season, we launched a new line of products: Theraflu Flu Relief Max Strength, available in different formats and flavors such as hot liquids, syrups and caplets. With this launch, we knew not only was it important to provide a science-based max-strength product to consumers, but also options that cater to consumer preferences.”
And a number of other innovative products made their debut this year. One such product, Robitussin Medi-Soother Lozenges from Haleon, targets cough sufferers.
[Read more: CVS to remove certain cold medicines from shelves]
“Unlike other cough drops, Robitussin Medi-Soothers are medicated and made with real honey or elderberry and provide fast, powerful relief for up to four hours,” Paley noted “These dual-action lozenges soothe both cough and sore throat pain.”
For its part, Atlanta-based Genexa recently introduced two “clean” OTC kids’ medicines in an organic blueberry flavor. Genexa Kids’ Multi-Symptom Cold & Flu oral suspension helps to relieve symptoms such as fever, sore throat, body aches and cough and chest congestion in children ages 4 and up, the company noted. The non-drowsy formula contains 5 mg of dextromethorphan HBr (cough suppressant), 100 mg of the expectorant guaifenesin and 320 mg of acetaminophen per 10-ml dose.
Genexa Kids’ Daytime + Nighttime Cough Relief, meanwhile, is a day and night value pack for children ages six and up. It is free from artificial fillers such as FD&C red No. 40, propylene glycol and sucralose, the company said. The daytime product is a non-drowsy oral suspension with 5 mg of dextromethorphan HBr and 100 mg of guaifenesin per 5-ml dose. The nighttime product is a new oral suspension containing 15 mg of dextromethorphan HBr and 2 mg of chlorpheniramine maleate per 10-ml dose for up to eight hours of effective cough relief; it also temporarily relieves sneezing and runny nose.
“Parents who are committed to clean products will have effective and clean medicine options to turn to this winter,” said David Johnson and Max Spielberg, Genexa co-founders, in a press release issued at the time of launch.
And Vicks, a licensed brand of Marlborough, Mass.-based Helen of Troy, launched a new formula for its VapoPad scent humidifier accessory, VapoPads Sinus, this fall. The product is made with a blend of menthol, chamomile and citrus oils to soothe discomfort from irritated sinus and throat passages, providing up to eight hours of soothing relief, the company noted.
Designed to work with most Vicks humidifiers and vaporizers, Vicks VapoPads Sinus also pairs with the Vicks Sinus Inhaler for targeted, natural symptomatic relief from congestion and irritation.
“One in seven adults suffers from diagnosed sinus issues—and this doesn’t even include those undiagnosed sufferers,” said Megan Dristilaris, director of marketing, Beauty & Wellness. “It’s our hope that VapoPads Sinus will enhance their inhaler and humidification experience just in time for the upcoming cold and flu season.”
Meanwhile, On/Go, part of Miami Beach, Fla.-based Intrivo, debuted its Sniffles product in November. The product is said to be an “all-in-one solution” that combines $75 worth of cough/cold/flu remedies, medications and devices, as well as telehealth services, for $39.
