A Brief History of Supplement Regulation and Why It Matters

People frequently ask, “Are supplements regulated?” As a maker of and a user of nutritional supplements, it troubles me to think that people may not know the answer to this question, because the FDA does much to ensure the health and well-being of U.S. citizens.

For example, in 1994 congress passed the Dietary Supplement Health and Education Act (DSHEA).  The purpose of this new law was, “To amend the Federal Food, Drug, and Cosmetic Act to establish standards with respect to dietary supplements, and for other purposes.”[1] DSHEA was the first time the federal government outlined what a supplement was. It was an important first step, because now the FDA had a definition that could separate a food from a supplement.[2] This gave the FDA something to regulate.

One of the regulations that DSHEA began to initiate was regulation of ingredients of dietary supplements. It determined that, “The dietary supplement contains only dietary ingredients which have been present in the food supply as an article used for food in a form in which the food has not been chemically altered.”[3] In other words, reputable companies who produced dietary supplements with ingredients that were already in the diet did not have to produce new evidence for those ingredients.

Another provision for ingredients provided by DSHEA was, “There is a history of use or other evidence of safety establishing that the dietary ingredient when used under the conditions recommended or suggested in the labeling of the dietary supplement will reasonably be expected to be safe and, at least 75 days before being introduced or delivered for introduction into interstate commerce, the manufacturer or distributor of the dietary ingredient or dietary supplement provides the Secretary with information, including any citation to published articles, which is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe.”[4]

Essentially, the new law had checks and balances—because at some point in the future the FDA was expected to create a series of new regulations just for dietary supplements. DSHEA had several other parts as well—ranging from how the ingredients were listed, to what advertising claims could and could not be made.

Now fast forward to 2001 when the FDA developed its next major regulation—the New Dietary Ingredient notification or NDI. This regulation required manufactures to notify the FDA a minimum of 75 days before selling a supplement, if that supplement contained an ingredient that was not on the market prior to 1994.[5] While this regulation seemed good, it did cause a great deal of confusion because the FDA had not yet published a list of old dietary ingredients (ODI). It was up to the providers of ingredients to do the research and find out if an ingredient had been sold prior to 1994 or face penalties. The law stated:

“The term “new dietary ingredient” means a dietary ingredient that was not marketed in the United States in a dietary supplement before October 15, 1994. (See section 413(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 350b(d)). There is no authoritative list of dietary ingredients that were marketed in dietary supplements before October 15, 1994. Therefore, manufacturers and distributors (you) are responsible for determining if an ingredient is a “new dietary ingredient” and, if not, for documenting either that a dietary supplement that contained the dietary ingredient was marketed before October 15, 1994, or that the dietary ingredient was marketed for use in dietary supplements before that date.”[6]

To further complicate things, the FDA had the right to reject an NDI if it determined that a risk to consumers was possible. Needless to say, manufacturers made great efforts to ensure that their products didn’t have NDIs that had not been filed with the FDA.

Finally, in 2007 the FDA released the regulation we had been waiting for—the cGMPs. These new regulations initiated guidelines for manufacturers to follow regarding how supplements are made and further defined what could be said on a dietary supplement label. One of the main objectives of the cGMP for supplements was to give the FDA the tools needed to ensure that consumers were getting what a manufacturer claimed on the label. In addition, the cGMPs outlined that raw material identity must be tested and known before the ingredient could be used in a finished product. Then, the finished product was to be regularly tested to ensure that identity and potencies match labels claims.

As the FDA worked with manufacturers of dietary supplements to ensure compliance with the new regulations, it soon became apparent that a division would not be sufficient to oversee the mounting work. So, in December of 2015 the FDA announced the formation of a new office called Office of Dietary Supplement Programs. This office’s mandate is to ensure enforcement with all regulations applying to dietary supplements and the public safety of those supplements.

In conclusion, this brief history of the regulation of dietary supplements demonstrates how the FDA has been very proactive in protecting consumers and providing guidelines that have been flexible over time as needed. However, it is also apparent that reputable dietary supplement companies have been in the forefront in not only complying with these regulations—but also far exceeding them with extra diligence and care for our customers.

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