Science and Law
5th December 2010

Dietary Supplements: Are they still good for consumers?

Consumers who use dietary supplements take comfort in the fact that they are taking a safe, natural and non-medical alternative to some prescription or over the counter (OTC) drugs to boost their health. However, the regulatory landscape for dietary supplements is changing and may seriously alter our perception of dietary supplements.

Dietary Supplements: Are they still good for consumers?

What’s happening?

Consumers who use dietary supplements take comfort in the fact that they are taking a safe, natural and non-medical alternative to some prescription or over the counter (OTC) drugs to boost their health. However, the regulatory landscape for dietary supplements is changing and may seriously alter our perception of dietary supplements.  With so many dietary supplement companies competing, the need for differentiated products and unique attributes is essential. However, this attempt to be innovative has led to questionable ingredients and processes being used and for dietary supplements to detract from their original allure of safe, natural, and non-medical products.  Dietary supplements have become the focus of increased safety scrutiny as academic researchers continue to study them and to publish sometimes alarming findings. For example, a recent study revealed that calcium, a tried and true dietary supplement used by thousands of women for managing osteoporosis and building strong bones, may be associated with increased cardiovascular risk [1]. This increased scrutiny of dietary supplements has recently translated into more regulation. Since DSHEA in 1994 [2], some of the major changes in this industry have only come in the past few years:

  • Required current good manufacturing practices (cGMP) for dietary supplements (2007) [3]
  • Required reporting of all serious dietary supplement related adverse events to the FDA (2007) [3]
  • Proposed legislation/guidance to heighten regulatory standards for dietary supplements (Institute of Medicine (IOM) 2010, Bills: S. 3002, S.510, and H.R. 4173) [456789]

What does it mean?

Regulators and lawmakers want to impose regulations and laws to make the process for getting dietary supplements on the market more rigorous (and therefore more safe for consumers) however, it is difficult to do so without creating barriers to access. The rise in regulation will create (if it hasn’t already) confusion as dietary supplements are treated more and more like drugs. With too much regulation, dietary supplements will become drug-like in rigor (which will be great for safety) but also drug-like in price (bad for everyone). Since natural products cannot be patented, there is no financial incentive for companies to continue to develop dietary supplements with the same rigor as drugs. Even if a company were to invest in pharmaceutical-scale clinical trials, costs would have to be recuperated by increasing prices to consumers. Would consumers want to pay the hiked up prices for products that no longer posses their original natural and non-medical appeal anymore? How do dietary supplement manufacturers navigate this new regulated environment while still staying true to what consumers want? I believe that we can achieve the goal of safer supplements on the market (without creating barriers to access) by enforcing a consistent scientific standard and review process that does not require the same capital as pharmaceutical clinical trials.

What can we do?

One very obvious approach is to go back to the roots of dietary supplements – keep the products truly natural and non-medical [10]. Companies should try to differentiate on the basis of quality ingredients and reliable scientific evidence (rather than obscure extracts from rare flowers tested on mice in China during a snowstorm in July). A more structured approach, however, may be to mandate a certification process that dietary supplements must pass in order to be classified as “natural” and to be marketed. This would be similar to how the U.S. Department of Agriculture (USDA) accredits private businesses, organizations, and state agencies to certify producers and handlers of agricultural products in order for those products to be considered “organic” [11]. A certification program for dietary supplements would require a third party to review the supplement and “certify” it against common standards. This would help consumers to choose products that have gone through a rigorous review and have been determined to be safe and natural. This would also help to ensure consistent standards from one dietary supplement to another. This process may also be improved if dietary supplements were required to be reviewed every year or couple of years in order to retain their certification – similar to renewing a driver’s license.  This would enforce a consistent scientific framework while supporting the industry (for both the health and financial benefit of the consumer). Whatever the approach, a need for standardization is apparent.

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