Monday, January 28, 2013

Dietary Supplements are Food

[Note: a client asked me for my professional opinion regarding the status of Dietary Supplements for people in nursing homes who are experiencing cognitive issues.]

January 28, 2013

In my opinion… to whom it may concern:


          The law is clear. Dietary Supplements are foods. The Dietary Supplement Health and Education Act of 1994 (DSHEA) says

§3. Definitions.  (a) Definition of Certain Foods as Dietary Supplements. Section 201 (21 U.S.C. 321) is amended by adding at the end the following: (ff) The term "dietary supplement" - (1) means a product ...intended to supplement the diet that bears or contains one or more of the following dietary ingredients: (A) a vitamin; (B) a mineral; (C) an herb or other botanical; (D) an amino acid; (E) a dietary substance... or (F) a concentrate, metabolite, constituent, extract, or combination of [same].

          As food, dietary supplements are manufactured under cGMPs patterned after food cGMPs and are sold with labeling that provides information about their nutrient content.

In its FAQ page about Medical Foods, FDA indicates that Dietary Supplements can fit in that category and can therefore be offered for the dietary management of health conditions, such as cognitive decline associated with aging.  One health claim approved by FDA reads:

 “Consumption of phosphatidylserine may reduce the risk of cognitive dysfunction in the elderly.”

          Under these circumstances, it is my professional opinion, to a reasonable degree of certainty, upon which you may rely, that individuals may choose to achieve and maintain a healthy status through the use of food substances, including dietary supplements. Every person has the fundamental human right to choose what means that person will use for that purpose.

Respectfully submitted,
Ralph Fucetola JD

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