How to make immunity claims without FDA or FTC warning about COVID-19
Here are a few tips from savvy supplements companies about how to substantiate claims that resonate with consumers.
Starting with televangelist Jim Bakker on March 6, 2020, the FDA and FTC have issued nearly 200 warning letters to companies selling supplements and other products claiming to prevent, cure or treat COVID-19.
So how does a company create immune-support claims for supplements that will not run afoul of structure/function claims and drug/disease claims per the governing Dietary Supplements Health and Education Act?
In the U.S., savvy companies know that warning letters are a worst-case scenario and work to prevent that regulatory action in the first place.
One of the key points when it comes to substantiation of claims is to start the process early on internally within the company.
“Start the dialog between whatever departments—in our case it’s R&D and legal—with what type of evidence do we have and what types of claims do we want to make,” said Julian Peterson, corporate counsel at Traditional Medicinals, a tea and supplements company, at a SupplySide West conference session held by the American Herbal Products Association on Oct. 30. “The dialog goes back and forth throughout formulation so we can feel confident we can make those claims. You don’t want to find out when the product is on shelf that you’ve got a problem.”
Claimsmaking then has to go beyond R&D and legal and flow also to the marketing department. There, too, due diligence before products go to market seems to be the best way to prevent problems after a product has been launched.
“You want to know before you market, not after,” said Kyle Garner, CEO of Matys Organic & All Natural, a supplements and OTC company. “We test wide-ranging claims before we launch. Otherwise, it could be devastating.”
Garner said that Matys tests not only claims with consumers before a product launches, but also makes sure claims are substantiated to dosage levels found in products.