Trying to avoid making express or implied disease claims when marketing an immune product is tricky. Consumers take immune products to both shore up the body’s defenses year-round and to counteract periods of heightened risk of illness, such as during cold and flu season. The very job of the immune system is to identify potentially harmful substances, called pathogens, and either keep them out of the body or get rid of them once they infiltrate and multiply.
As approved health claims are rare, especially for immune health, most marketers have target allowances for structure-function claims, which don’t get pre-approved by the agencies. Still, claims must be substantiated by science, which in the modern FDA and FTC era means controlled and randomized clinical research. Much research focuses on disease or related endpoints, but given the safest immune claims may be in the area of general immune support, substantiation science may need to focus more on markers of immune function.
Marketers and manufacturers often seek out attorneys, consultants and other regulatory specialists experienced in natural products regulations to help keep any immune claims within the confines of the law, but they also turn to suppliers of key immune ingredients, many of whom have invested vast resources into research on the ingredient. These suppliers can provide guidance on safe claims for their ingredients based on their substantiation files.
Another great resource is FDA’s library of warning letters. These can show the agency’s thinking on specific aspects of immune marketing, such as what constitutes an implied claim and what kind of substantiation is sufficient for certain types of structure-function claims.
Read more about the complexities of marketing immune products in “Healthy Marketing: Immune Products Vulnerable to Regulatory Scrutiny," a part of INSIDER’s Immune Health Digital Issue.