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  5. Dietary Supplements Guidance Documents & Regulatory Information
  1. Guidance Documents & Regulatory Information by Topic (Food and Dietary Supplements)

Dietary Supplements Guidance Documents & Regulatory Information

FDA develops regulations based on the laws set forth in the Federal Food, Drug, and Cosmetic Act or other laws under which FDA operates.

To further support the public health goals of the Dietary Supplements Health and Education Act (DSHEA), FDA also issues guidance documents containing nonbinding recommendations to help industry understand and comply with all regulations and the law. You can access guidance and other regulatory documents by clicking on the links below.

We solicit information and comments, announced in the Federal Register and posted in dockets on Regulations.gov, from concerned citizens, industry, and organizations on a wide range of issues related to the implementation of DSHEA.

For additional information, see the Dietary Supplements webpage.


Current Good Manufacturing Practice (CGMP)

New Dietary Ingredients

Warnings Letters and Safety Information

Labeling and Claims

To view structure/function claim notifications submitted to FDA before 2012, please visit regulations.gov and type “FDA-1997-S-0039” in the search box.

Structure/function claim notifications submitted to FDA after 2012 are separated by year. To view those submissions, please include the 4-digit year in the following search term:  FDA-YEAR-S-0024. Therefore, if you are looking for submissions made in 2018, you would type “FDA-2018-S-0024” in the search box.

FDA’s courtesy letters responding to such notifications can be found by typing “FDA-1997-S-0006” in the search box on regulations.gov.

Adverse Event Reporting and Recordkeeping

General Compliance and Inspection Information for Industry

Special Issues/Miscellaneous Items

Archived Items of Interest



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