Over-the-Counter Meds Are Coming Clean

“We’ve seen and continue to see consumers be hyper-focused on ingredient transparency, efficacy, and clean labels across food, beauty, and more,” says David Johnson, co-founder of “clean” medicine brand Genexa. Now, this consumer scrutiny is being applied to medicines: A 2022 Nielsen report identified clean-label OTC (defined as products free from added sugar, GMOs, and artificial colors, flavors, preservatives, and sweeteners) as a factor driving growth among direct-to-consumer health-care brands.

Johnson was inspired to launch Genexa in 2016 with co-founder Max Spielberg after spotting the long list of fillers he didn’t recognize in his kids’ medicine. “When we looked at the OTC aisle, we were shocked to find that nearly every medicine contained these artificial inactive ingredients, yet no one was doing anything to create clean options,” he says. So, he and Spielberg took things into their own hands, stripping cough suppressants, laxatives, allergy meds, antacids, and more of an “Ex List” of 39 excipients used by legacy OTC brands and generics, while retaining the actives and rebuilding the drugs with natural fillers like rice extract, agave fiber, and vegetable cellulose. Last year, Genexa raised a $60 million Series A. This year, the brand more than doubled its retail presence to a total of 60,000 stores, including Walmart, CVS, Rite Aid, and Walgreens, and released four new products (bringing its total to 31).

While they’re considered “inactive” because they do not have a therapeutic effect, excipients can potentially impact your body like anything else you might consume. 

Another brand to watch in this space is Welly, which launched a line of OTC medications and supplements in August. Its 13 products treat everyday ailments like cough, cold, pain, and indigestion with actives used in existing drugs but formulated into soft liquid-gel capsules to avoid the need for artificial dyes and flavors, talc, and parabens. Also this fall, KinderFarms, a line of organic protein shakes and electrolyte solutions for kids, expanded into pharma with the launch of KinderMed. The new line, available in more than 19,000 stores nationwide, includes four liquid OTC products for kids and infants that use the actives from Tylenol and Triaminic but swap artificial sweeteners for organic agave syrup, organic flavors, and citric acid.

Also in 2022, new pharmaceutical brand Wonderbelly launched with a stripped-down take on TUMS chewable antacids that includes just the active (calcium carbonate) and five plant-based excipients: sucrose, natural flavors derived from fruit and vegetable extract, maize starch, vegetable cellulose, and vegetable magnesium stearate. Wonderbelly raised a $3.4 million seed round this summer, which co-founders Noah and Lucas Kraft, Well+Good 2023 Trends Advisors, say will be put toward becoming a full-fledged “clean pharma gut-health brand.” Up next in the company’s pipeline for 2023 are other digestive-health products like a gas-relief medicine, a laxative, and a multi-symptom product utilizing the same active as Pepto-Bismol, all formulated without artificial dyes, sweeteners, or flavors, or talc or titanium dioxide.

These new launches are reflective of clear consumer demand. Whether they represent a health necessity, however, is murky. In order for any OTC drug to get approved by the Food and Drug Administration (FDA), all of its ingredients, including the inactive ones, have to be determined “safe in the amounts administered.” That said, the lack of a proven safety issue doesn’t necessarily make an ingredient a good thing to consume or mean it’s recommended to do so long-term. An example? Titanium dioxide (TiO2), used in many legacy OTC products, is currently an FDA-approved food additive but was banned in the European Union in 2021 after a study by an EU food agency found that regular consumption of it may have the potential to damage DNA over time. (As of now, Petco and Dunkin’ Donuts ban TiO2, and Mars is currently being sued for the ingredient’s inclusion in Skittles.)

In the same realm, there are a few other ingredients often used as fillers in OTC drugs that have raised red flags among the wellness-minded for their inclusion in other items. For instance, parabens were once a common preservative in shampoos and moisturizers, but have since been axed by many major beauty brands and drug stores because exposure to them may be linked to breast cancer (though there isn’t yet sufficient evidence to prove this claim). And talc, which can contain asbestos, has been linked to ovarian and lung cancer, leading Johnson & Johnson to remove it this year from its baby powder after billions of dollars in lawsuits. But again, this isn't definitive evidence that these ingredients, or others noted above, are bound to cause damage when consumed in medications, or that they need to be eliminated from your medicine cabinet.

Where new clean OTC options can play an essential role, however, is for people with allergies and sensitivities. In building their new excipient profiles, the folks at Genexa, Wonderbelly, and KinderMed also opted for ingredients free from gluten, dairy, lactose, and other common allergens—which is a rarity for medication. A 2019 study on excipients found that nearly 93 percent of oral solid medications contain common allergens like peanut oil, lactose, and dyes, and almost all have compounds that some people can’t tolerate, like gluten and certain types of sugars. Indeed, over 1,200 reports for “allergic reaction to excipient” were filed to the FDA between 2017 (the earliest data is available) and 2022 by consumers, health-care providers, and drug manufacturers—though the number of people actually reacting is likely larger, since people may not connect the dots between a reaction and the “inactives” of a drug, says gastroenterologist Giovanni Traverso, MD, lead author on the study.

“Drugs aren’t required to use warnings like ‘contains gluten’ or ‘contains dairy’ or to list quantities of these allergens." Giovanni Traverso, MD

Drug companies don’t need to disclose anything about inactive ingredients beyond their names (compare this to the food industry, where the FDA requires nutrition labels list all ingredients by order of weight). This makes it very hard to tell from the label alone if a drug contains a potential allergen, which might be just a component of an ingredient with another name. “Drugs aren’t required to use warnings like ‘contains gluten’ or ‘contains dairy’ or to list quantities of these allergens,” says Dr. Traverso. He initially became interested in the topic after a patient with celiac disease reacted poorly to the acid-reducer omeprazole. As it turned out, the particular drug this patient took contained gluten, but Dr. Traverso only learned this after reaching out to the manufacturer for more information.

The fact that different versions of a single OTC medication (say, Advil versus store-brand ibuprofen) can include different inactive ingredients just complicates things further for folks with allergies and intolerances. If one contains lactose and the other doesn’t, that has implications for someone who’s lactose-intolerant—but the products are sold interchangeably. By contrast, Wonderbelly, Genexa, and KinderMed take a page from the food industry and widely advertise their products as free from the full slate of common allergens.

This kind of transparency is groundbreaking for OTC medications given how little scrutiny the drug-manufacturing industry has traditionally received. “People often confuse the FDA’s drug approval process with drug manufacturing processes,” says David Light, CEO and co-founder of Valisure, a laboratory that offers third-party testing for pharmaceutical and personal-care products. “To get any drug approved, OTC or prescription, does require huge clinical trials and tons of FDA oversight. But once a drug is approved and is being manufactured, the end product is not being tested by the FDA. That’s just being done by the manufacturers and self-reported to the FDA—but as it’s produced batch by batch, the final product can change from what was approved.” This is why, on average, 4,500 drugs and devices are recalled in the U.S. every year, including OTC drugs like ranitidine (Zantac), a common antacid recalled in 2020 after tests discovered it contained unacceptable amounts of the known carcinogen N-nitrosodimethylamine (NDMA).