Review your content's performance and reach.

Become your target audience’s go-to resource for today’s hottest topics.

Understand your clients’ strategies and the most pressing issues they are facing.

Keep a step ahead of your key competitors and benchmark against them.

Questions? Please contact [email protected]

“FDA Approved” claims are often used, and misused, in the advertising and marketing of a number of FDA-regulated products. In recognition of this issue, on May 10, 2022, the FDA issued a consumer advisory providing insight into the scope of the agency’s pre-market approval process.1

The consumer advisory explains that only a subset of products regulated by FDA are approved and reviewed by FDA for safety, quality, and effectiveness prior to their sale to consumers (referred to herein as “Formal Premarket Approval”). In addition to and distinct from Formal Premarket Approval, in some circumstances FDA requires notification, review, or certification prior to a product’s sale.

However, claims of “FDA Approved” should not be used on or about any products that do not undergo Formal Premarket Approval. Doing so is sufficient grounds for a misbranding violation in some contexts. See 21 U.S.C. § 352; see, e.g., 21 C.F.R. 807.98 (by regulation, device is deemed misbranded if there is any “impression of official approval of a device because of complying with the premarket notification regulations”).

FDA’s consumer advisory provides additional context and specific clarification regarding the boundaries between products, facilities, labels, and claims that require Formal Premarket Approval, and those that do not.

No Formal Premarket Approval required

Some FDA review prior to market release, but no Formal Premarket Approval required

If you would like to learn how Lexology can drive your content marketing strategy forward, please email [email protected] .

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