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)
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
principal display panel
identity(established name of drug product, general pharmacological category or the principal intended actions)
net quantity of contents
Cosmetic Label Requirements
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)
name and place of business of the manufacturer, packer, or distributor
domestic U.S contact number and mailing address
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.
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If you have any questions about FDA regulation of Medical Device, OTC Drugs, Cosmetic, Dietary Supplement Registration and labeling compliance... , please CONTACT US.