Editor's Letter | Are Supplements Safe?

by Stephen Adele, Editor-in-Chief

How safe are supplements, really? Which ones are potentially safer than others? Does anyone regulate supplements? Who? And, what's the difference between a drug and a supplement anyway?

These are all very good questions, and ones I plan to answer. In fact, I bet there's a good chance they're answers you need to know anyway, especially if you're using supplements right now.

First, this subject is not as complicated as it appears; however, at the root of this debate lies some very confusing information, often passed on by the mass media. Over the years, the media's inability to grasp the truth surrounding these issues has brought on a mound of misinformation, which has caused a great deal of unnecessary fear and confusion for the public.

The media have been quick to criticize the use of dietary supplements. Clearly, they have not researched their subject thoroughly, instead just spreading the type of information that makes good headlines.

Here are some straightforward facts that should help set the record straight:

#1 Drug vs. Supplement

A drug, by definition of Taber's Cyclopedic Medical Dictionary, is any substance that, when taken into a living organism, may modify one or more of its functions. Such a substance, adds the Physicians' Desk Reference, is recognized by the U.S. Food, Drug, and Cosmetic Act, used in the diagnosis, treatment, or prevention of a disease or as a component of a medication.

Supplements, as defined by the Dietary Supplement Health & Education Act (DSHEA), are "vitamins, minerals, herbs, and other botanicals (except tobacco), amino acids, any dietary substance for use by man to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent, extract, or combination of any of the above-listed ingredients."

Drugs must always be prescribed by a doctor (or physician) or purchased over-the-counter and are typically used to treat or relieve symptoms of particular health ailments, such as arthritis, allergies, heart problems, diabetes, and so on. It's a well-known fact that certain drugs save the lives of hundreds of thousands of people each year, thanks to pharmaceutical advancements.

Supplements, on the other hand, are designed by nature to promote health (which may prevent some diseases in the first place) and, more recently, have gained immense popularity by being shown to give athletes and active people an "extra" edge in their performance (e.g., strength, speed, endurance) or in their ability to reduce bodyfat or increase fat-free mass (i.e., muscle).

Classified as "dietary supplements" by DSHEA in 1994, supplements like creatine and the amino acid glutamine (which are both naturally produced in the human body and are found naturally in certain foods we eat), and even natural herbal extracts like goldenseal, Echinacea, and ginseng have become extremely popular and can be purchased at your local grocer, health-food store on the internet, or at the gym.

#2 FDA Regulation

Prior to a drug company starting its marketing of a brand-name drug it has developed, the company applies for a patent for the drug (on the actual process of manufacturing a synthetic compound). This also means, for a defined time, the company has the sole right to manufacture and sell that particular drug.

Before a drug can be prescribed (and sold) to the public, it must first pass federal regulations set forth by the New Drug Application (NDA). Since 1938, every new drug has been the subject of an approved NDA before U.S. commercialization. The NDA application is the vehicle drug sponsors use to formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S.

The data gathered during the animal studies and human clinical trials of a new drug become part of the NDA, which are to provide enough information (e.g., safety, effectiveness, labeling, accompanying information, etc.) to permit the FDA to approve or disapprove the drug.

Despite what many people think, and what hoards of media writers have unintelligently spouted, dietary supplements are, in fact, regulated by the FDA as well. The FDA has the direct authority to ensure that supplements available on the market are accurately labeled, and, much like the regulation of drugs, ensure that manufacturers meet certain criteria called Good Manufacturing Practices (GMP). This ensures dietary supplement manufacturers meet strict guidelines for potency, cleanliness, and product stability. There are even industry-related agencies, such as the NNFA, that help co-regulate these governmental policies.

The FDA even holds the power to seize any dietary supplement if they have evidence to support that it poses a "significant or unreasonable risk of illness or injury" (defined by Section 402(f) of DSHEA). That is currently the pending case with ephedra (although some states, such as California, New York, and others, have already banned its sale before such action was taken by the FDA.)

The biggest difference, the way I see it, between a drug and a dietary supplement is that a drug company must first prove its drug to be reasonably safe (we'll raise questions about what is meant by "reasonably safe" later on) and relatively effective at producing a desired effect and passed by the FDA—but, only after certain federal requirements of animal and human clinical testing have been met. Some, or I should say most, supplement companies, unfortunately, do not use clinical evidence to support either safety or efficacy, before marketing and selling their products.

However, the good news is, there are a handful of supplement companies that do perform clinical research on their products before the products are in the hands of the public. (Most companies don't conduct studies on their supplements simply because, when faced with a $75,000 clinical research bill, they run away and "borrow" others' research and use that money for marketing instead). It's shameful, I know. But that's the cold, hard truth. That's why I always, always, always suggest you do business only with a reputable, first-rate company that can provide you (or show you) a copy of their human clinical study (that's either been published in a peer-reviewed journal or presented at a noted scientific conference). Please remember this the next time you make your supplement purchase!

Now, that doesn't mean the product will work. As with everything, including drugs, some things work better, or not at all, for some individuals. Nevertheless, you'll be purchasing something that has clinical evidence to support that it is safe and could be effective (at least if that's what the study showed).

#3 Drugs Have Their Flaws (As Do Supplements)

Since first allowed on our televisions in 1997, drug company advertisements are nearly impossible to avoid: sunny, happy scenes that promote some medicine as the "cure," followed by the rapid, "small print," monotone warnings of serious side effects. Newsweek reported that last year alone, drug companies spent over $14-billion on advertising and promotions, which included paying over 35,000 pharmaceutical sales representatives' lofty commissions and giving away lavish vacations and hefty incentives to doctors who prescribe their drugs to patients.

While the supplement industry has had its fair share of adverse event reports to the FDA (side effects ranging from headaches to nausea to more severe cases), what is concerning is that so many of us believe that because drugs are heavily regulated by the FDA, they are completely safe and void of any side effects.

That's simply not true.

According to ABC World News Tonight (April 3, 2000), an estimated 1.5 million Americans were admitted to hospitals after suffering adverse effects from prescription medications. And, in a recent study in the Journal of the American Medical Association, it was reported that each year, over 100,000 deaths are a result of reactions to prescription and over-the-counter drugs (from everyday items like aspirin).

More recently (probably as a result of new drugs entering the market), the FDA has charged several leading drug companies with a variety of violations regarding deceptive advertising, including minimizing or omitting the drug's risks, exaggerating the effectiveness of the drug, making false claims, and promoting unapproved uses for drugs... to name only a few allegations. The bottom line here is, advertised drugs are not necessary safe or effective. Drug advertisements should be looked at with the same discretion as supplement advertisements, and you should make yourself fully aware of the side effects that may accompany their use.

#4 Are Supplements the Solution?

Now, the supplement industry is not perfect, and it has its flaws too, but to say that drugs are safe and effective and supplements are not is simply not true.

While the supplement industry still has a long way to go, it offers many people the opportunity to enhance their own lives, performance, or physiques in a cost-effective, noninvasive, self-governing manner. In my opinion, supplements are ultimately a part of the solution to help get and keep Americans healthy, fit, and achieving great things in life! So, the question remains: are drugs superior to supplements, or are supplements superior to drugs? I believe this is a question best left to you. But let me be crystal clear about one last thing... supplements are not drugs, and drugs are not supplements—there's a clear, legally defined difference.

Until next time, keep your head up and your heart in the game.

Respectfully yours,

Stephen Adele
Editor-in-Chief
Real SOLUTIONS

P.S. I'd be very interested to know what you think about supplements and their safety, as well as whether or not you think they (supplements) should be more heavily regulated or if this "heated" debate has simply been blown out of proportion. Other than that, as always, I'd just love to hear from you. You can reach me at editors@RealSOLUTIONSmag.com. :-)

Fill out the no-obligation form below to TAKE your free issue of the printed version of Real SOLUTIONS Magazine now! Still not sure? Click here to listen to a special audio welcome from our editor, Stephen Adele.

Try a RISK-FREE Issue Today!
Plus, receive 3 FREE gifts with your paid subscription