Advertising & Promotion

Improper Advertising and Promotion can Change the Regulatory Status of your Product

Advertising and promoting your device, diagnostic product, genetic or genomic test, wellness product, or digital health product with certain claims or images may lead FDA to deem your product to be “misbranded.” Improper claims may also lead your product to be held to a higher regulatory standard than it should be, based on its risk profile. Your product could even be considered a different type of product. For example, if promoted with improper claims, a wellness product can be subject to regulation as a device.

Is Device Advertising Regulated like Drug Advertising?

FDA has extensive regulations, guidance, and policies regarding advertising and promotion for drug products. But under FDA’s governing statute, the Federal Food, Drug, and Cosmetic Act (FDCA), the agency can only regulate the advertising of “restricted devices,” which are sold, distributed, or used under a prescription, or other conditions specified by regulation.

For all other devices, the FDA’s authority over advertising and promotion stems from the general “misbranding” provision in the FDCA. Under the statute, a “drug or device shall be deemed to be misbranded. . . [i]f its labeling is false or misleading in any particular.” The FDCA defines labeling as including “written, printed, or graphic matter” (1) upon the product itself, its immediate or other “containers or wrappers,” or (2) “accompanying such article.”

Additionally, the FTC has regulatory authority over the advertising of non-restricted medical devices. FTC’s regulations and enforcement standards are not entirely consistent with FDA’s.

To FDA, “Labeling” is not Limited to the Label

FDA has interpreted “written, printed, or graphic matter . . . accompanying” a product to go far beyond what most manufacturers and consumers consider to be a product’s label. In recent years, websites and printed material distributed at scientific conferences have been considered device labeling. This material must therefore not be false or misleading, and must only make claims that are consistent with the product’s intended use.  

Is Your Advertising and Promotion Compliant with FDA and FTC Requirements?

It is important to have experienced counsel review all claims that you plan to make about your product, as well as all advertising and promotional material. This includes websites, press releases, and any speeches or presentations. Christine P. Bump has extensive experience drafting and reviewing claims, as well as reviewing advertising and promotional material. Penn Avenue Law & Policy can work with you to make your advertising and promotion compliant with regulations, guidance, and policies from both FDA and the FTC.

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