FDA Released a Draft Guideline in Labeling of Dietary Supplement
The Dietary Supplement and Non-prescription Drug Consumer Protection Act which is an amendment to the ‘Federal Food, Drug and Cosmetic (FFD&C) Act’ had been signed by the President on December 22, 2006. The law amends the former Act with respect to adverse event reporting and recordkeeping for dietary supplements and non-prescription drugs marketed without an approval application.
The draft labeling guidance note for dietary supplement is for comment within 60 days
Until December 2007, FDA had issue a guidance document regarding the new labeling requirement of Non-prescription drug (e.g. Dietary Supplements). The guidance document is treated as a supplementary document to the law of Dietary Supplement and Non-prescription Drug Consumer Protection.
The draft guidance document is intended to further assist the cosmetic and food industries to comply with the labeling requirements prescribed for manufacturers, packers and distributors as required in the law.
What is being included in the guidance document?
The Guidance covers the following topics:
what “domestic address” means for purpose of the dietary supplement labeling requirements in section 403(y) of the FFD&C Act FDA’s recommendation for the use of an introductory statement on the product label under section 403(y) when FDA intends to begin enforcing the labeling requirements of section 403(y) This guidance document itself does not establish legally enforceable responsibilities. The purpose of the document is to provide a clear picture on how the label should be prepared and enable any serious adverse event report reaching the responsible person.
Without the required information, dietary supplement & non-prescription drug even cosmetic products are classified as misbranded.
The labeling requirement for the dietary supplement, non-prescription products was effective on December 22, 2007. However, since the guidance is just being issued, the FDA will exercise enforcement discretion until January 1, 2009.
For more information:
FDA Guidance for Industry: Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act
Being your quality insurance partner, SGS aims at providing all-round services to our customers. Our team is now offering the best services for Dietary Supplement ranging from contaminant testing to assay testing as required in your daily in-process control. Please contact us for offerings!
Thomas Lee (Life Science)
T + 852 2609 9611
F + 852 2603 7577
SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 75,000 employees, SGS operates a network of over 1,500 offices and laboratories around the world.