Since the FDA generally classifies the products it regulates based on the intended use and ingredients found therein, an initial stage in determining how a product is regulated is by looking to the intended use thereof. One way that the FDA determines the intended use of a product is based on statements, called “claims,” made about a product, i.e., what the marketer states that a product can do for the consumer. By developing marketing content that is compliant with FDA regulations and federal law, a FDA regulatory attorney can help you avoid making claims that would cause your product to be regulated more strictly.

FDA Regulations and Marketing Content

Because in today’s information age, there are a number of ways to market and sell FDA-regulated products, including brochures, telemarketing, infomercials, etc., it is important to consider how statements made about a product through these various mediums may impact how a product is regulated by the FDA. In fact, the FDA considers statements made about a product through various media to constitute part of the overall “labeling” of a product, rendering any statements made through these means to reflect on the product itself. Accordingly, it is critical to ensure none of your marketing materials contain impermissible product claims, inasmuch as these claims have the potential to cause your product to be subject to heightened regulation. More information about the FDA’s regulation of claims and product labeling may be accessed here.

Reviews of Marketing Content

At Shehadeh Giannamore, PLLC, a FDA regulatory attorney can help you develop marketing content and achieve FDA compliance by:

  • Reviewing your marketing materials to ensure that no impermissible claims are being made;
  • Providing guidance with respect to any changes that must be made to your marketing content in order for you to achieve FDA compliance;
  • Suggesting alternative language that reduces the risk of FDA enforcement action, should you have problematic claims in any of your marketing materials, and
  • Conducting reviews of final marketing content to ensure FDA compliance.