Should Congress Repeal DSHEA?

A recent opinion piece prominently featured on the front page of www.cnn.com calls for repeal of the Dietary Supplement Health and Education Act of 1994 (DSHEA).

This is just one of many warning shots being fired over the bow of those who would like to maintain their freedom to make their own health related decisions. For anyone in the least interested in determining the course of their own healthcare, here’s what the DSHEA is and why calls for its repeal is cause for concern.

Under the DSHEA, a dietary supplement is defined as a dietary ingredient intended to supplement a diet. According to the FDA, these include vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites which are taken orally.

Prior to passage and President Clinton’s signing the DSHEA into law, supplements were regulated by the FDA just like drugs. Now dietary supplements are treated by the FDA as foods, not drugs. This makes sense as there is a distinct difference between these naturally occurring and extracted supplements and synthesized drugs marketed by pharmaceutical companies.

So why the fuss about repealing the DSHEA? The crux of the issue for detractors is manufacturers of drugs are required to prove drug effectiveness and safety prior to marketing while there is no similar burden of proof on supplement manufacturers.

On its face, this sounds like a reasonable argument. Why shouldn’t supplement manufacturers prove their products are safe and effective? Here are just a few reasons.

Supplements cannot be patented
Although manufacturing methods, like specific extraction processes, can be patented, naturally occurring substances themselves cannot. You cannot patent turmeric, for example. This leaves considerably less incentive for companies to invest millions of dollars in clinical trials and studies needed to meet the same burden of proof.

If DSHEA were repealed, promising supplements would take many more years (if at all) to come to market due to lack of research funding while pharmaceutical companies continue raking in billions with their patent-protected drugs. Instead of more options to proactively protect their health through proper nutrition and supplements they would be at the mercy of drugs and their frequent hazardous side effects.

Supplements really are safer than most pharmaceutical drugs
The overwhelming majority of purported health risks for supplements actually revolve around their impact on conventional medical treatments. Ginkgo biloba and Vitamin E are both known to act as blood thinners. So are aspirin and prescription Coumadin. Take a combination of any of these and effects can be compounded. One should always inform their doctor of any supplements, over the counter drugs, or prescriptions used when discussing any medical treatment options. This is simple good prudence.

On the other hand, many prescription drugs come from the pharmacy with a page or more of warnings listing all the potential adverse reactions. DSHEA critics warn that’s because of higher scrutiny. That’s more of a half-truth than fact. Advertised side-effects on drug labels are potential for use in recommended dosages, while most supplements are safe unless used far above recommended dosages.

It should be noted that manufacturers remain responsible for supplement quality and safety, including truthful labeling. The FDA is still tasked with removing any unsafe products from market and taking action against any manufacturer who fails to abide by standards such as following Good Manufacturing Practices (GMP) just like the rest of the food industry.

Manufacturers who include a new ingredient (such as an extract) in supplements that are not present in regular food must also provide a statement to the FDA 75 days before marketing their product. This statement must detail why the new ingredient should be considered safe. This means supplements still have to meet a high safety requirement before ever reaching consumer hands.

Supplements work only when you take them
Perhaps the simplest reason to keep the DSHEA is it means less government regulation. Less regulation allows the marketplace to continue making safe supplements available to the American public.

Americans have – and should keep – the right to make their own health choices. The foods and supplements we eat are one of those. The DSHEA helps keep safe supplements widely available by minimizing government red tape interfering with consumers choosing natural means to stay healthy… instead of being forced to rely upon modern medicine to heal them after health has already declined.

It’s a fact that natural health practitioners have helped many people get better and stay healthy using supplements and other non-invasive, non-pharmaceutical means. In spite of barbs like those used by the opinion piece author on CNN equating “natural healers” with shamans and astrologers. Rather than name calling, this author simply believes consumers deserve to make their own educated choices instead of relying upon the government to make those choices for them.