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.