According to FDA regulation, conventional food and dietary supplements are allowed to make three categories of claims: health claims, nutrient content claims, and structure/function claims. The FDA tightly regulates the use of these types of claims, with significant penalties for manufacturers who do not comply fully and properly. Nonetheless, many manufacturers, either out of misunderstanding of the regulations or general disregard, run afoul of these regulations. This post will focus on health claims that can be made by conventional foods.
Conventional food and dietary supplement health claims are defined as a relationship between a food substance and reduced risk of a disease or health-related condition. They are limited to claims of disease risk reduction and cannot contain language insinuating that the food substance can diagnose, cure, mitigate, or treat a disease. To determine if a claim qualifies as a health claim, the FDA uses the 1990 Nutrition Labeling and Education Act (NLEA), the 1997 Food and Drug Administration Modernization Act (FDAMA), and petitions for qualified health claims.
There are two types of health claims: “authorized” health claims and “qualified” health claims. Authorized health claims require significant scientific agreement from relevant experts that the claim is fully supported by the publicly available scientific evidence. The FDA has outlined the process for petitioning an authorized health claim. Since 1990, the FDA has approved only twelve (12) health claims. One example is “low sodium diets may reduce the risk of high blood pressure”.
Qualified health claims are supported by some scientific evidence, but do not meet the same agreement standard as authorized health claims. Therefore, qualified health claims are required to include a disclaimer or qualifying language that accurately communicates the available level of supporting evidence. For example, on June 19, 2019, the FDA granted approval to Global Organization for EPA and DHA Omega-3s’ (GOED) petition for qualified health claims related to Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) and reduction of blood pressure in the general population. The FDA authorized the use of a number of claims including the following:
“Consuming EPA and DHA combined may help lower blood pressure in the general population and reduce the risk of hypertension. However, FDA has concluded that the evidence is inconsistent and inconclusive. One serving of [name of the food or dietary supplement] provides [ ] gram(s) of EPA and DHA.”
All conventional food health claims require pre-market review by the FDA. ISS has over two decades worth of experience petitioning the FDA and helping clients write claims that meet FDA requirements. Contact us today to discuss how we can help.
This is the first in a series that will cover structure-function claims, GRAS Notification, medical food, and much more.