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Food and Drug Branch (FDB)

 FDB Home Page

 Contact

Main Telephone:

(800) 495-3232

 

Email:

FDBinfo@cdph.ca.gov

 

Address (Courier Delivery):

California Department of Public Health - Food and Drug Branch

1500 Capitol Ave, MS 7602

Sacramento, CA 95814

 

Address (Non-Courier Delivery):

California Department of Public Health - Food and Drug Branch

P.O. Box 997435, MS 7602

Sacramento, CA 95899

Dietary Supplements

​A dietary supplement is defined in the California Code of Regulations as an article (other than tobacco) intended to supplement the diet, and contains specified dietary ingredients.  A dietary supplement is labeled as such, and is intended to be ingested in a pill, capsule, tablet or liquid form, and is not represented for use as a conventional food or as the sole item of a meal or diet.

The federal definition further states, “A dietary supplement is a product taken by mouth that contains a "dietary ingredient" intended to supplement the diet. The "dietary ingredients" in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Dietary supplements can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, soft gels, gel caps, liquids, or powders. They can also be in other forms, such as a bar, but if they are, information on their label must not represent the product as a conventional food or a sole item of a meal or diet.”

Whatever their form may be, dietary supplements are required to be clearly labeled as dietary supplements, herbal supplements or with a similar term.  Dietary supplements are not drugs.  Any person that engages in the manufacture, packing, or holding of dietary supplements in California must have a valid Processed Food Registration (see link below).

Because of their unique qualities and safety concerns, dietary supplements are regulated differently than conventional foods. 

The Current Good Manufacturing Practice (cGMP) for manufacturing, packaging, labeling, and holding operations for dietary supplements are found in Title 21 of the Code of Federal Regulations Part 111 (21 CFR Part 111). 

Dietary Supplements must be labeled according to the Dietary Supplement Health and Education Act (DSHEA).  Under DSHEA, a dietary supplement can make certain structure function claims, but cannot be sold for the treatment, prevention, mitigation, or cure of diseases or conditions associated with known diseases.  Such claims render the products unapproved drugs, and it is illegal to manufacture and sell unapproved drugs.

DSHEA requires manufacturers to provide a “disclaimer” statement indicating that the FDA has not evaluated the accuracy of the claim being made, when an allowable structure function claim is made. 

In addition, California has specific regulations that require a warning statement on the labels of dietary supplements that contain stimulant laxative ingredients, such as senna, cascara sagrada, aloe latex, buckthorn, frangula, and rhubarb root. 

If a dietary supplement is labeled or advertised as “certified organic” or bears the USDA organic seal, the product must meet the “food” standards set by the National Organic Program (NOP); including certification by an accredited agency.  The processor or handler must also possess an Organic Processed Products Registration, issued by CDPH.

If you would like to file a complaint regarding a dietary supplement, please contact our toll free complaint line at (800) 495-3232. 

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