On October 10, 2021, Claudia Lewis and Todd Harrison were quoted in Beverage Business Insights on important issues for food and beverage manufacturers to consider, including the risk of using immune support claims.
According to the article, the pandemic period has seen an influx of beverages boasting elderberry, zinc, and other immunity-enhancing ingredients keyed to consumers’ deepened interest in protecting themselves. But tying these items to COVID-19 – even in a very subtle way – is risky, given heightened vigilance by the FDA and the FTC. And it doesn’t have to be an overt pitch to bring the wrath of an agency down upon you, Lewis and Harrison warned.
“In the FDA context, any Covid-19 claim will render your product an unapproved new drug or device (unless it was approved by the FDA for that purpose), and its sale federally illegal,” Harrison and Lewis said. “In the FTC context, virtually no Covid-19 claim about a product can be substantiated.” The FTC, sometimes in conjunction with the FDA, has sent nearly 500 warning letters on this issue, and has sued several companies.
Obviously, use of words like “COVID,” “corona,” and “SARS” can be a red flag to an agency that you’re overstepping bounds. But, Lewis noted, so can more neutral immunity language if there’s a picture of the coronavirus or a respirator in the background. Even a reference to a speaking engagement of a beverage company executive on coronavirus can be an issue. Regulators also are monitoring meta-tags and search phrases. Use of a phrase like “maintaining your immune system is more important now than ever” can tip the scales from a normal immune-support claim into a disease claim.