FDA Halts Hangover Claims
It’s not uncommon for new businesses to apply for exhibition at Natural Products Expos with “hangover” treatments, either as beverages or more commonly, dietary supplements. Typically, the labeling includes claims that the products minimize and sometimes prevent hangovers. Applicants can be surprised to learn these claims fall outside Expo Standards.
In late July, FDA issued warning letters to seven companies marketing “hangover” products saying the claims on these products, all labeled as dietary supplements, established them as drugs because they were intended for use in the cure, mitigation, treatment, or prevention of disease. The most common reaction from our exhibitors eager to market products like these is that they don’t consider hangover a disease. Steve Mister, President and CEO of the Council for Responsible Nutrition (CRN), reflects that sentiment in a Natural Products Insider article written by Josh Long: “[m]any in the industry have disagreed with FDA for years about the characterization of hangover claims as a disease claim. It is not like you are saying ‘alcoholism’ and it’s hard to … argue that a hangover is a disease.’”
FDA, however, asserts that alcohol intoxication is the disease and hangover the sign or symptom of that disease. By regulation, statements that a product has an effect on the characteristic signs or symptoms of a disease, like relieving or preventing a hangover, are considered disease claims by FDA. Alcohol intoxication like other types of poisonings, FDA explains, “causes dose-related dysfunctioning and damage, ranging from mild impairments to death.” It is alcohol intoxication, which “causes temporary damage to brain function, causing impairments of judgement, attention, reflexes, and coordination,” that meets the regulatory definition of disease.
Often, exhibitors point out that their products never claim to prevent hangovers. Instead, they simply help metabolize alcohol more quickly, or detoxify with herbs. Manufacturers, however, will want to consider the kinds of claims cited by FDA in its warning letter to LES Labs: “DETOXX FOR HANGOVERS,” “…helps reduce hangover symptoms,” “natural ingredients … helping to metabolize the toxins that cause hangover symptoms.” Because products that treat the symptoms of disease are considered disease statements themselves, even these kinds of claims are objectionable.
In its July 29th Constituent Update, FDA stressed its particular concern that young adults might believe using a “hangover” product could substitute for drinking in moderation and could prevent or minimize health problems associated with excessive alcohol use. Products marketed to young adults will likely draw increased scrutiny from FDA.