Because the FDA generally classifies the products it regulates based on intended use and ingredients found therein, among other considerations, an initial stage in determining how a product will be regulated is by looking to the intended use. The FDA generally determines the intended use of a product based on statements, called “claims,” made about a product, i.e., what the marketer claims the product can do. By understanding the types of claims under FDA regulations and federal law, we can help you avoid making disease claims that may cause your products to inadvertently be regulated as drugs.
Disease Claims and FDA Regulations
While there are different types of claims, i.e., health claims, disease claims, structure-function claims, some claims may cause a product to be subject to heightened regulation. For example, if a product is otherwise classified as a food but its labeling contains disease claims, the FDA will classify this product as a drug. On the other hand, certain claims, called structure-function claims, may be made about dietary supplement products and, if done correctly, will not cause these products to be subject to heightened regulation. More information about disease claims in FDA regulations may be accessed here. Thus, when marketing a FDA-regulated product, it is critical to understand what types of claims may be used for your particular product and to ensure that these claims are properly worded.
Disease Claims and Label Reviews
At Shehadeh Giannamore, PLLC, a FDA regulatory attorney can assist you with establishing FDA compliance by:
- Reviewing your product labeling, including your actual product labels, websites, and other marketing materials, to determine whether your claims are in compliance with FDA regulations;
- Providing guidance with respect to any changes to your claims that must be made in order for you to remain compliant with the laws and regulations enforced by the FDA, and
- Suggesting alternative language to reduce the risk of FDA enforcement action, should you have problematic claims in your product labeling that may result in FDA action.