On October 25th, 2014 we will mark the 20th anniversary of DSHEA (Dietary Supplement Health and Education Act), which has been responsible for revolutionizing the way we market dietary supplement in the U.S. DSHEA was signed into law on October 25th, 1994 by President Bill Clinton and upon signing Clinton stated that “After several years of intense efforts, manufacturers, experts in nutrition, and legislators, acting in a conscientious alliance with consumers at the grassroots level, have moved successfully to bring common sense to the treatment of dietary supplements under regulation and law.”
This Act defined the term “dietary supplement” in Section 3 of the Act, as:
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 supplement used by man to supplement the diet by increasing the total dietary intake; or
(F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C), (D), or (E).
Also, a dietary supplement is a product that is labeled as a dietary supplement and is not represented for use as a conventional food or as a sole item of a meal or the diet.
The Act has placed the responsibility for ensuring dietary supplement safety on manufacturers, identified how literature may be used in connection with sales, specified types of statements of nutritional support that may be made on labels (i.e. structure/function statements), specified certain labeling requirements, and provided for the establishment of regulations for current Good Manufacturing Practices (cGMPs).
Finally, the Act created the Office of Dietary Supplements (ODS) in the National Institutes of Health (NIH), with a mandate to coordinate scientific research relating to dietary supplements within NIH and to advise Federal agencies on issues relating to dietary supplements.
20 years later we now ask ourselves, are we upholding and complying with DSHEA? It is working for our industry? Should the Act be updated to reflect our current industry? Will the Act permit further innovation and development based on the rapid growth our industry has seen over the past 20 years?
Only time will tell how much our industry will further grow, but we owe our thanks to the founding members who established this Act to bring safe, affordable, and effective dietary supplements to the market.
dicentra can assist with guidance on dietary supplement regulations as well as food, cosmetics, and OTC products.