Discussion topics from week seven

FDA Regulations

The FDA is responsible for the regulation of both dietary supplements and dietary ingredients. They are not regulated as food products, but are governed by the Dietary Supplement Health and Education Act of 1994 (DSHEA). The companies that market these products are responsible for ensuring that they are correctly branded and that they are unadulterated. However, the FDA does not regulate them as drugs (FDA, 2014).

I believe that this approach is adequate. I do not believe that supplements should be regulated in the same way that drugs are. There are several reasons for this. The major reason is the cost-benefit. The FDA exists to protect the public. The cost of the new drug approval process is tremendous -- it can take years and millions to bring a new drug to market, and the costs to the FDA are not inconsequential. With pharmaceuticals, this is a necessary process because they are more complex, and often have a very strong impact on the body. This is not typically the case with supplements. As the risk to humans for supplements is not much different than the risk posed by food, the regulatory cost should also not differ much.

A second reason is rooted in the fundamental difference between supplements and drugs. A supplement is something that is optional -- consumers need not take any -- and thus the consumption of supplements is more similar to that of foods. Indeed, supplements are typically made from ingredients such as animal parts, algae, yeasts, fungus and other food extracts. Typical supplements are merely minerals and vitamins. Examples are amino acids, enzymes, energy bars and liquid food supplements. These do not have medicinal value, and there is almost no risk posed to public health of unregulated consumption of such supplements (ACS, 2015).

Supplements are also limited in their ability to make medical claims. They can make the same general claims that any food product can -- remember there are many foods marketed specifically on their health benefits. So, too, do supplements have that right. They are not generally allowed to promote anything other than general health benefit. A supplement cannot, for example, claim to cure cancer. The FDA has provisions that ensure that only approved drugs can make claims about treating specific conditions, as they have proven their claims in studies. The FDA is strict about off-label uses on drugs, and likewise is strict about supplements or foods attempting to make such claims.

As such, the current regulatory regime regarding supplements is sufficient for the risks that these products pose to society. If there are concerns about overdose, the reality is one can overdose on many things, including water. Anecdotes are not the same as proven evidence, even when they provide an intense narrative about excess. If there are concerns about efficacy, remember that efficacy claims are limited under current law. There are interests -- pharmaceutical companies -- who may prefer not to have supplements that may challenge their market shares, but the reality is that these are complementary products. Supplements are not a replacement for medicine, except to people who are making unwise choices.