Why Good Manufacturing Practices in Nutritional Supplements Matter

As a health-conscious consumer, you want to make sure that you are getting proper nutrition. If you’re like many people, this means that you’re likely to take some type of vitamin and mineral supplements from time to time. And you’ve probably also noticed that there is a wide variety of such nutritional supplements available. But have you ever wondered how you can be sure that the ones you buy really contain the things their labels say they contain? And have you ever wondered whether there’s really any real difference from one brand to the next when it comes to quality? If so, your questions get right to the heart of the matter—it takes the right ingredients and processes to produce nutritional supplements that are both safe and effective. In this article, we’ll provide you with a little information about Good Manufacturing Practices (GMP), and how you can use them to make wise purchasing decisions.

How are nutritional supplements regulated in the United States?

One of the things you should know about dietary and nutritional supplements is that, unlike drugs, the U.S. Food and Drug Administration (FDA) does not require research studies to prove that the supplements are safe before they are brought to market. If a vitamin, mineral, or nutritional supplement is found to be unsafe, or even dangerous, the FDA can take action only after it has hit the shelves of pharmacies and health food stores. Of course, by that time, there’s a very good chance that many people have already purchased and used it. The responsibility for making sure nutritional products are safe ultimately rests with the manufacturer of the supplements.

The same thing is true with regard to whether a given supplement is actually effective in supporting health, addressing a nutritional deficiency, or reducing the risk of developing a particular health problem. The manufacturers are not required to conduct or sponsor research studies to support their claims. You may also have noticed that this sort of language is included on the packaging of most nutritional supplements: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” These simple sentences are meant to inform consumers that the regulatory protections they have grown to expect when it comes to pharmaceutical products do not apply to nutritional products. The simple truth is that you can’t even be entirely certain that a bottle claiming on the label that it contains “mineral X” or “vitamin Y” actually contains it. It is simply not the FDA’s job to analyze the contents of dietary supplements.

So what are Good Manufacturing Practices?

In 2007, the FDA established a set of requirements and guidelines for dietary supplements, detailing how they should be manufactured, prepared, and stored to ensure quality. The Good Manufacturing Practices (GMP) guidelines seek to prevent manufacturers from including incorrect ingredients, to make sure they do include the ones they say are included, and to prevent possible contamination from bacteria, pesticides, and heavy metals. There are also guidelines about the packaging and labeling of products. These too are intended to ensure quality and prevent fraud.

Many manufacturers have voluntarily agreed to comply with the GMP guidelines, and a few of the most reputable companies actually follow the more stringent FDA GMP guidelines for drugs, which are even stricter. However, some manufacturers ignore the GMP guidelines and attempt to substitute their own quality assurances or seals of approval, using terms like “standardized”, “certified” or “verified” to describe their manufacturing processes. In many cases, these may be meaningless terms, depending on the standards or verification organization referred to (and whether or not there’s a meaningful testing and enforcement program involved).

Current Good Manufacturing Practices (cGMP) certification of a company’s manufacturing facilities is not free, and in fact it’s quite expensive to apply and qualify for this distinction. Thus if a company can prove that they are cGMP-compliant, it is usually a good indication that their products can be trusted. You can find listings of GMP-certified manufacturers at the Natural Products Association website (http://www.npainfo.org/), or in handouts provided by quality health food and supplement providers.

It’s important to understand that GMP certification by itself may not ensure that the vitamin or mineral supplement you take will provide the benefits you’ve seen or heard advertised. But it can help to make sure that you are getting what you pay for in the bottle, and that it’s been handled in a manner that attempts to ensure your safety.