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FDA Compliance Label Review, How vital is it?

Feburary 08 2023

The U.S. Food and Drug Administration (FDA) develops and administers regulations under authority granted by laws passed by Congress that apply to food, drugs, cosmetics, biologics, radiation-emitting electronic products, and medical devices.

The FDA Labeling Regulations must strictly be adhered to; it is the law.

Labels that are not compliant with the FDA regulations can be detained at customs. Claims that are irrelevant with the product or are exaggerated can cause legal issues.

Non-compliant product labels are subjected to warning letters and recalls upon the random inspections by the FDA.

Medical Device Label Requirements

  • name and place of business of manufacturer, packer, or distributor(including street address, city, state, and zip code)

  • intended Use

  • Adequate directions for use

- statements of all purposes for which and conditions under which the device can be used

- quantity of dose for each use and usual quantities for persons of different ages and physical conditions

- frequency of administration

- duration of application

- time of administration in relation to other factors

- route or method of application

- any preparation necessary for use

OTC Drugs Label Requirements

  • name and place of business of manufacturer, packer, or distributor

  • adequate directions for use

  • location of expiration date

  • control numbers

  • principal display panel

  • identity(established name of drug product, general pharmacological category or the principal intended actions)

  • net quantity of contents

  • pregnancy/breast-feeding warnings

  • tamper-evident labeling

Cosmetic Label Requirements

  • ingredient labeling

  • name of the product

  • identify by descriptive name or illustration the nature or use of the product

  • net quantity of contents(weight, measure, numerical count, or a combination of numerical count and weight or measure

  • name and place of the firm marketing the product(street address, city, state, and zip code)

Dietary Supplement Label Requirements

You must place all required label statements either on the front label panel(the principal display panel) or on the information panel(usually the label panel immediately to the right of the principal display panel, as seen by the consumer when facing the product), unless otherwise specified by regulation.

  • identity(name of the dietary supplement)

  • net quantity of contents(amount of the dietary supplement)

  • nutrition labeling

  • ingredient list

  • name and place of business of the manufacturer, packer, or distributor

  • domestic U.S contact number and mailing address

  • supplement facts

Prevent Your Product Recall

FDA may initiate legal action including facility inspections and warning letters, as well as administrative or import bans, injunctions, seizures, and criminal prosecution. For recalls, FDA may suspend a firm’s registration of a facility, and suspension continues until the relevant compliance problem has been resolved and proven to the FDA.

We will streamline the regulatory processes so that our clients can utilize

their time and money most efficiently.

Experience the best FDA approval directions and solutions!

If you have any questions about FDA regulation of Medical Device, OTC Drugs, Cosmetic, Dietary Supplement Registration and labeling compliance... , please CONTACT US.

Office 1-909-493-3276


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