FDA Approved Meaning

FDA Approved Meaning

One of the most frequently asked questions by clients and the public alike is what FDA approved means. The difficulty is there is no single answer. Typically, what someone is trying to say or imply is that their invidual product or formula was subject to some type of review where the FDA agreed the product or formula is safe and/or effective. That is only true for a small number of products. Below are some quick notes on what the term may mean for different products. As a consumer, be cautious when you see the term and remember no label is ever authorized to use the FDA logo.

Foods or Dietary Supplements: The term FDA approved carries little significance for these products. There is no general process for the FDA to review each food or dietary supplement. Only products with new or novel ingredients, which is a very small group, would file a GRAS (Generally Recognized as Safe) or NDI (New Dietary Ingredient) submission for clearance to use a specific ingredient. No label for a food or dietary supplement can claim FDA approved.

Cosmetics: There is no process for the FDA to review cosmetics or ingredients in cosmetics. The one exception is certified color additives, those that begin with FD&C. No label for a cosmetic can claim FDA approved.

Medical Devices: Class I, low risk devices, are exempt from filing a pre-market application that would evaluate safety or efficacy. This type of medical device can state “FDA Registered.” Class II, moderate risk, and Class III, high risk, medical devices are subject to a pre-market application like a 510(k), De Novo or PMA. These devices can claim “FDA Cleared” or “510(k) Cleared” but should refrain from stating they’re FDA approved.

Drugs: Like Class I medical devices OTC FDA Monographed drugs (like sunscreens) and Homeopathic drugs are exempt from filing a pre-market application that would evaluate safety or efficacy. These drugs can state “FDA Registered.” Pioneer and Generic drugs are subject to lengthy and expensive applications and often do appropriately claim FDA approved.

The term FDA approved has many means that should be carefully evaluated and approached with some caution.

What does FDA Approved
Mean?

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Marc is dedicated to helping his clients navigate the complex world of FDA and USDA legislation. He represents FDA-regulated companies in the food, dietary supplement, beverage, cosmetic, medical device, and drug industries.

Marc is the author of two textbooks and a lecturer at Northeastern University. He is a member of the Washington State Bar Association and the D.C. Bar Association.

2 Comments

  1. Elton Parker-Calderon on March 14, 2019 at 6:44 pm

    Hello,
    I am not sure if this is the correct place to ask but doesn’t hurt to ask. If a company is FDA approved and they ship into Australia do they need to register with the TGA?

    • Marc Sanchez on March 15, 2019 at 9:04 am

      Thank you for the comment, Elton. My firm only works on FDA regulations, a TGA consultant may be better able to assist you. Generally speaking, every nation has its own independent regulatory system.

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