Third Eye

When I first became interested in complementary and alternative medicine, the general belief was the Food and Drug Administration did not care much about supplements. It’s true that the government does little to regulate the use of dietary supplements. The reason for this is dietary supplements are classified as foods, not drugs.

I learned very little about supplements in my college classes when I studied nutrition a few decades ago, and I suppose there was a good reason for that. It was not until 1994 that Congress decided on a definition of dietary supplement with a law known as the Dietary Supplement Health and Education Act (DSHEA).

Dietary supplements are products that contain ingredients such as vitamins, minerals, herbs, botanicals, and amino acids. They may also contain enzymes, organ tissue, glandulars, and metabolites. They come in tablets, softgels, liquids, and powders. You probably used one or more at some point.

Not Drugs or Foods

It’s important to note that DSHEA puts dietary supplements in a special category. They are not considered drugs, but they are not conventional foods either. They do fall under the umbrella of foods, but they must be specifically labeled as dietary supplements.

What’s new?

DSHEA also distinguishes between a “dietary ingredient” and a “new dietary ingredient.” This is important because the only time a manufacturer needs to inform the FDA about a new product is when the product contains a “new” dietary ingredient, that is, any ingredient that was not already being sold as a dietary supplement before October 15, 1994.

In other words, a company that makes vitamin C tablets does not need to get approval from the FDA before it makes this product. Since there’s no definitive list of “old” dietary supplements, it’s up to the manufacturer to determine whether an ingredient is new. (To use an extreme example, if you decided to market shredded paper as a dietary supplement, you’d have to clear it with the FDA first.)

Does the FDA regulate dietary supplements?

As long as there are no “new dietary ingredients” in a supplement, manufacturers do not need approval from the FDA to make and sell a product. However, firms do have to register with the FDA before they can legally manufacture and market dietary supplements.

For the most part, it’s up to the company that makes a supplement to do the necessary research to ensure that a product is safe and effective. Equally important is the responsibility of individual consumers to be aware of the ingredients in the products they are using and to learn as much as possible about the safety and efficacy of these ingredients.

Good practices

In 2007, the FDA published guidelines for companies to use when creating dietary supplements. According to the FDA website, “These regulations focus on practices that ensure the identity, purity, quality, strength and composition of dietary supplements.”

So if you want to know how reliable and safe a product is, find out if the company follows Current Good Manufacturing Practices (sometimes abbreviated CGMP or GMP) as dictated by the FDA.

How must supplements be labeled?

The FDA requires the following information to appear on all dietary supplement labels:

• the name of the supplement, which must include a statement that it is a supplement
• the name and address of the manufacturer, packer or  distributor
• the net contents of the product
• a “Supplement Facts” nutrition label that lists all ingredients in the product

All ingredients in the product must be listed either on the “Supplement Facts” panel or below the panel under the heading “other ingredients.”

Who ensures the safety of dietary supplements?

US law states that manufacturers are responsible for determining the safety of their products. Since supplement companies do not need approval from the FDA to sell most products, it’s up to you to decide whether or not you trust a particular brand and product. (Before you decide whether or not this is a good thing, consider that the FDA does approve prescription drugs, and some would say it’s not a stretch to say the drugs it approves are not always safe.)

So the bottom line is it’s up to you to find out what you’re taking, whether it’s safe, and whether it’s effective for the reason that you’re taking it. You should also be aware that while the FDA does not approve supplements, it can ban the sale of supplements shown to be unsafe.

Supplement manufacturers are required to submit reports of adverse side effects to the FDA, but it’s much more likely that health care providers and you, the consumer, will be the ones responsible for alerting the government when there is a problem with a product. You can do this by filing a report with FDA yourself.

How to choose supplements

Before you get the idea that I’m discouraging the use of supplements or that I think the FDA always has everyone’s interests in mind, let me say neither of these is necessarily the case.

I do think many supplements have tremendous value. And there are many more that are useless and a waste of money. Hopefully, there are not too many that are downright dangerous.

Supplements which have been on the market for a long time are probably safe (though this doesn’t mean they’re effective). Newer supplements may not have been around long enough to determine whether or not they’re safe. However, even if you’re buying something as common as calcium, it’s still a good idea to do some research and choose wisely. The FDA does have some commonsense tips on this:

• Consider your overall diet before deciding that you need a supplement.
• Talk to your doctor and get his or her input on the need, safety and efficacy of a supplement you want to use.
• Find out if the supplement you are considering has any interactions with any prescription or over-the-counter medications you are taking.
• Carefully evaluate the source of information you find on the web or in other places, and look for actual research studies that support any claim that a supplement manufacturer makes.
• Think twice before accepting a claim that sounds too good to be true.
• Don’t assume that “natural” necessarily means “safe.”
• Contact the manufacturer for more information about a product if you have any remaining doubts about using it.

It’s up to you

When it comes to dietary supplements and your health, it’s up to you to decide what’s good for you and what’s not. That can mean finding someone you trust who has done the necessary research for you or taking the time to do it yourself. In most cases, it will probably mean a combination of both.