Because the FDA typically regulates products based on both their intended use and ingredients found therein, an initial stage in determining how a product is regulated is by looking to the intended use. The FDA gleans 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. These claims may be made on product labels, through infomercials or other marketing materials and on product websites.
FDA Regulations and Website Reviews
Because it is increasingly common to market and sell FDA-regulated products via online websites, it is important to consider how statements made on a product website may impact how a product is regulated by the FDA. In fact, the FDA considers websites to constitute part of the overall “labeling” of a product, rendering any statements made on a product website to reflect on the product itself. Accordingly, it is critical to ensure that your website does not contain impermissible product claims, as these claims may cause your product to be subject to heightened regulation by the FDA. Thus, a FDA regulatory attorney can help you by conducting website reviews to ensure that your website does not cause your product to be targeted by the FDA.
Our Services: Website Reviews
At Shehadeh Giannamore, PLLC, a FDA regulatory attorney can conduct website reviews to ensure FDA compliance by providing the following:
- Conducting product website reviews including all websites linked thereto, to ensure that no impermissible claims are being made;
- Providing guidance with respect to the changes that must be made in order for you to remain compliant with the laws and regulations enforced by the FDA, and
- Suggesting alternative language that reduces the risk of FDA enforcement action, should you have problematic claims on your website that may negatively affect your business operations.