16 May 20225 minute read

FDA premarket approval and the use of “FDA Approved” claims

“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.

Formal Premarket Approval required

  • New drugs and biological products for human use such as prescription drug products, vaccines, allergenic products, cellular and gene therapies, and products manufactured from plasma
  • Class III medical devices such as mechanical heart valves and implantable infusion pumps
  • Certain human cells, tissues, and cellular and tissue-based products that “pose an additional risk because of their processing or use”
  • New food additives (substances added intentionally to food and substances that migrate to food from food contact products) for human consumption
  • Color additives used in food, dietary supplements, drugs, cosmetics, and some medical devices (except coal-tar hair dyes).

No Formal Premarket Approval required

  • Healthcare facilities including health care providers, physician offices, and laboratories
  • Manufacturing facilities and contract manufacturers
  • Compounded drugs
  • Class I medical devices such as elastic bandages, tongue depressors, and exam gloves
  • Existing tobacco products
  • Certain food ingredients that are considered generally recognized as safe (GRAS) for their intended conditions of use
  • Cosmetic products, ingredients, and their labeling. This includes products such as perfumes, makeup, moisturizers, shampoos, hair dyes, face and body cleansers, and shaving preparations
  • Medical foods intended for dietary management of a disease or condition with distinctive nutritional requirements
  • Infant formula
  • Dietary supplements2
  • Labels for food products, including nutrition fact labels
  • Structure-function claims on dietary supplements and foods (claims that “describe the role of a nutrient or dietary ingredient intended to affect [or maintain] the normal structure or function of the human body”3) such as the claim that calcium builds strong bones.

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

  • Some owners and operators of facilities must register with FDA prior to selling or distributing products in the US, including owners and operators of domestic or foreign food and drug facilities (and most device facilities) and owners and operators of establishments that manufacture blood products or cells, tissues, and cellular and tissue-based products
  • Mammography facilities must be FDA certified prior to operation
  • Cosmetic companies are not required to, but may, register their products or facilities with FDA
  • Some Class I and II medical devices may require FDA premarket clearance based on a demonstration that the device is substantially equivalent to a legally marketed predicate device
  • New tobacco products must receive authorization from FDA prior to introduction to the market through either submission of a premarket tobacco product application or substantial equivalence application, or exemption from substantial equivalence requests
  • Manufacturers of infant formula must register with FDA and provide the agency with an infant formula submission before marketing a new formula
  • For dietary supplements containing “new dietary ingredients,” meaning ingredients that were not marketed in the US before October 15, 1994, dietary supplement companies must submit a premarket safety notification to FDA at least 75 days before marketing the product.

To learn more about the implications of this guidance for your business, please contact any of the authors or your usual DLA Piper relationship attorney.

1 See FDA Consumer Updates, “Is It Really ‘FDA Approved’?,” May 10, 2022, available at https://www.fda.gov/consumers/consumer-updates/it-really-fda-approved?utm_medium=email&utm_source=govdelivery.

2 However, “companies are required to submit a premarket safety notification to the FDA at least 75 days before marketing dietary supplements containing “new dietary ingredients” that were not marketed in the U.S. before October 15, 1994

3 See FDA’s Food Labeling & Nutrition Page, “Structure/Function Claims,” March 7, 2022, available at https://www.fda.gov/food/food-labeling-nutrition/structurefunction-claims.