Ethical Issues in Dietary Supplements

The US FDA (Food and Drug Administration) Dietary Supplement Health and Education Act of 1994 (DSHEA) defines dietary supplements as products intended to supplement the diet.

The FDA is responsible for the safety of conventional foods, drugs and devices. The burden of proof for the safety and efficacy of dietary supplements has moved to the FTC (Federal Trade Commission). They are the watchdog working to remove “too good to be true” claims from interstate commerce.

DSHEA created the ODS (Office of Dietary Supplements) within the NIH, and generally allows manufacturers to use ingredients already present in the food supply or marketed as dietary supplements prior to 1994 in their dietary supplement products. If a dietary supplement contains a NDI (New Dietary Ingredient) the manufacturer must notify the FDA and include data to show the ingredient is reasonably expected to be safe and does not present a significant or unreasonable risk of illness or injury to most individuals under the typical conditions of use.

The Dietary Supplement Manufacturer (Company selling the OTC Supplement), not the FDA , remains responsible for ensuring the dietary supplement is safe and the labeling is truthful, not misleading, and has a fair balance of product benefits and risks, before the product is placed on the market. When enough negative data regarding a supplement reaches the FDA, it may be in jeopardy of loosing its GRAS (Generally Recognized As Safe) distinction. Until then, the safety and efficacy of the supplement go on unstudied! This is in distinction to prescription non-supplement drugs that have to go thru a ten year, one billion dollar drug study process to prove scientifically that they are safe and efficacious. And then comes the commercials with all the potential ADR’s (Adverse Drug Reactions). Curiously, no supplements advertise that they have any ADR’s. This is impossible as if you perform a drug study comparing placebo A to placebo B, you will get a long list of ADR’s.

Two supplements that were on the market and lost their GRAS designation include: Ephedra and Hydroxycut. If you recall their commercials said they were proven to be medically safe to help weight loss. Of course, this was not true. The supplements are not studied properly. After a large number of people getting hurt and dying, some of them complained to the FDA and that in turn led to their removal from the market. It is a shame that this occurs after the supplement-drug is on the market and that pre-release study of efficacy and safety are not mandated. Unlike real pharmaceutical drugs, the dietary supplement manufacturers do not need to register their products with the FDA nor get FDA approval prior to producing or selling their dietary supplements.

In conclusion, supplements are an unstudied wildcard. They can be useful at times. Their claims seem by and large too good and they lack the proper oversight to ensure their safety. Dietary supplement manufacturers are largely free to produce and sell their products without review or approval by the FDA or any other agency. This has led to many unique ethical considerations, especially since the lay public is generally unaware of the lack of oversight for dietary supplements. Most consumers incorrectly assume dietary supplements are regulated in a manner similar to other pharmaceutical products on US shelves.