Politics of Healthcare (Part 3): Dietary Supplements and DSHEA

President Bill Clinton

President Bill Clinton

For the 3rd installment of my “Politics of Healthcare” series we return to the Clinton years and a significant piece of legislation that has been controversial to say the least.  The Dietary Supplement Health and Education Act of 1994 (DSHEA) was signed into law by President Clinton on October 25, 1994, changing the regulatory environment for dietary supplements in the United States.  Over the course of the 20th century, the United States had made great strides in regulating the things Americans put in their mouths since the creation of the Pure Food and Drugs Act in 1906 (See the significant dates throughout the history US Food & Drug law).  While today it makes sense that we should test products before they are released to the masses to reduce the number of “Snake Oil” salesmen, these regulatory additions didn’t happen overnight.  It took half a century from the Pure Food and Drugs Act to reach the Kefauver-Harris Drug Amendments in the early 1960’s, following the thalidomide debacle, for the United States require both safety AND efficacy of drugs to be approved.  Then somehow 30 years post-thalidomide, the United States decided to go in a different direction on policy related to “dietary supplement” regulation.  So let us review some of the key components of DSHEA and I’ll share a few opinions:

Dietary Supplement Health and Education Act of 1994 (DSHEA)

  • Signed by Democratic President Bill Clinton on October 25, 1994
  • Introduced by Senator Orrin Hatch (R-Utah) in 1994 (he introduced similar legislation in 1992 called the “Health Freedom Act”)
  • Prior to DSHEA, it appeared that the FDA was working to regulate many of the supplements out of business after passage of the Nutritional Labeling and Education Act (NLEA) in 1990, so DSHEA was considered a compromise that saved the supplement industry (Wholefoods Magazine, March 2014)
  • Doesn’t appear to be a Democrat vs. Republican issue

Impact on Healthcare

  • Under DSHEA, manufacturers and distributors are prohibited from marketing products that are adulterated or misbranded (it is their responsibility to ensure their products meet the safety and labeling requirements)
  • Companies must register with the FDA, but their products do NOT require pre-approval from the FDA. In other words, companies can start marketing and selling the product and the burden of proving unsafe falls on the FDA (very different than a prescription drug that requires drug companies to go through expensive and lengthy drug approval process of Phase I, II and III trials).
  • The FDA may remove a product from market if they show that it produces a significant or unreasonable risk
  • Labeling disclaimer added to any structure/function claims by the supplement manufacturer: “This statement has not been evaluated by FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.”
  • “Dietary supplements” include: vitamins, minerals, herbs, botanicals, amino acids, enzymes, or extract.

My Thoughts on DSHEA

  • This is not a progressive piece of legislation and Democrats should be more critical of the POTUS and all congressional Democrats who supported it (it passed by pretty wide margins).
  • DSHEA was supposedly accompanied by a huge “grassroots” campaign, demonstrating the power of flooding your Congressman with phone calls and letters.  The dietary supplement industry had a lot to lose and there wasn’t really a well-armed opponent trying to stop it.
  • While DSHEA is an example of Republicans and Democrats compromising on regulation/deregulation principles, it is really more of an example on politicians going along with a powerful lobbying campaign from a particular industry.
  • We must be mindful that this industry isn’t tightly regulated and products can be on the shelf without approval from a regulatory body (FYI – this can also be said about the food industry but I’ll save that for another day).
  • Does that mean supplements are bad? No. It just means they are not regulated to the same standard as pharmaceutical products and neither have to proven safe or effective prior to marketing.
  • I personally use dietary supplements (I like using protein powder to make shakes), so I obviously don’t think dietary companies are evil or anything like that.  I just know that the protein powder I buy may or may not have 100% of the ingredients listed on the label since it is not tested rigorously by a third party (some supplements do actually submit their products to independent companies for testing).
  • A product may be unsafe but the burden of proof is on the FDA, so the product could be on the shelf for years until the FDA has the resources/studies necessary to remove the product.
  • As a pharmacist, it is my duty to explain to patients that these products may or may not be helpful/harmful.  Evidence may support the use of a certain ingredient for a disease state, but the actual product the patient purchases may or may not actually contain the dose on the label (and studies of individual products do show that there is a great variance depending on the manufacturer).  Hypothetical example: 100mg daily of Vitamin X (not a real vitamin) is found to reduce the risk of heart attack. A patient comes to the pharmacy and finds 3 different manufactured products of 100mg tablets of Vitamin X.  The patient buys all three and sends to a lab only to find out that 2 of the products contain only 50mg of Vitamin X and 1 product contains 125mg in each tablet.
  • There are independent testing organizations, such as NSF, that can test the purity of a supplement.  As a consumer, looking at the labels before you purchase a supplement to see if they submit to voluntary testing may be a good idea.  If you own a pharmacy, try to stock your nutritional supplement section with products from reputable manufacturers.

 

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Joey
Joey Mattingly, PharmD, MBA is an assistant professor at the University of Maryland School of Pharmacy located in Baltimore, Maryland. Joey has managed retail and long-term care pharmacy operations in Kentucky, Illinois and Indiana. Leading Over The Counter is a blog of Joey's views and opinions on the topics of pharmacy leadership and management and do not represent the University of Maryland, Baltimore. Joey can be followed on Twitter @joeymattingly.

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