How to Evaluate the Quality of a Dietary Supplement

So, you've found a Dietary Supplement that exactly fits your special need. The information on the supplier's website appears to be consistent with everything that you've read and heard, and now you're ready to buy.

But there are questions on your mind. "What is the quality of this product that I'm buying?" you ask. "Can I really trust this supplier?"

With the globalization of the Dietary Supplement market, these are valid questions. When you look at the retailer's website, or even the label on the bottle, you can't tell anything about the product. You can't tell who actually made it. You can't tell where it was made. And you can't tell whether the product is a quality product, or not.

What's a consumer to do? I can give you a few answers, but you don’t have an easy task ahead of you. Here's why.

First you need to understand the structure of the Dietary Supplement industry. Hold on because this is a little complicated.

There are many levels in the Dietary Supplement supply chain. Some of the companies may function in more than one level in the supply chain but most don't. They only do one part of the process. For instance, the company that you buy your Dietary Supplement from will usually be only a distributor. Here is a list of those levels:

  • Dietary Ingredient Manufacturers. These are the companies that manufacture the individual ingredients that you see listed on the labels of ribbon blenderthe Dietary Supplements that you buy. Some examples would be St. John's Wort, Echanacea, or Glucosamine. These products are sourced from all over the globe.
  • Dietary Supplement Manufacturers. These companies mix Dietary Ingredients together.
  • Tabletters and encapsulators. These companies convert the mixed Dietary Supplement into tablets or capsules.
  • Packagers. These companies package the tablets, capsules, powders, or liquid Dietary Supplements and apply labels.
  • Distributors. These are the companies that actually market the finished Dietary Supplement to consumers.

Herein lies your first big problem. The companies that perform these functions are not visible to you. The retailer that you buy your Dietary Supplement from may perform one or more of these functions. However, the chances are that your retailer does not do all of it. In fact there's a good chance that your retailer is only a distributor and contracts out ALL of the manufacturing operations.

Any Dietary Supplement that is offered for sale in the United States must comply with regulations of the US Food and Drug Administration (FDA). The Dietary Supplements that we buy are the safest in the world.

The FDA has enacted new regulations to improve the quality of Dietary Supplement manufacturing and FDA inspects all of the levels in the supply chain. However, those new regulations have only recently gone into effect and FDA has not inspected all the suppliers under the new regulations.

FDA does not give companies a certification, nor do they approve them after they have been inspected. So there is no stamp of approval from FDA that you could find on your retailer's website or in their literature that would define them as "FDA approved".  As a matter of fact, any health claim that a DS manufacturer makes must be accompanied by a disclaimer: 

"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.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."

On the other hand, if FDA inspects a facility and finds problems, it can issue a Warning Letter. The Warning Letter will be published on FDA's website, www.fda.gov. The link is visible on the bottom of the FDA home page, fda.gov. If you want to investigate a company, go to the Warning Letter page and search for the company.

Unfortunately the retailer is unlikely to be the manufacturer of the dietary supplement. But if you find that your supplier has a recent Warning Letter, find someone else to buy your dietary supplements from.

There are non-governmental organizations that inspect and certify Dietary Supplement manufacturers. These organizations will then allow the Dietary Supplement manufacturer to display their certificate or logo. The certificate will usually say something like "GMP Certified". GMP stands for Good Manufacturing Practices. These organizations inspect Dietary Supplement manufacturers to make sure that they follow Good Manufacturing Practices and to ensure that the manufacturer has GMP training in place for all of their employees.

The bottom line is that if you want an extra measure of safety when you look for a Dietary Supplement supplier, look for a GMP certification logo on the website or on the label of the product you buy. But don't stop there. Go to the website of the certifying organization and check to make sure that the Dietary Supplement supplier is listed as a certified company.

Educate yourself further by going to Questions and Answers on Dietary Supplements.

About the author:

Norm Howe is a Senior Partner at Validation & Compliance Institute, consultants for the food, pharmaceutical, and medical device industries. He got his BS at UC, Berkeley, and a PhD in chemistry at UCLA. He is an adjunct professor of Regulatory Science at the University of Michigan, Ann Arbor, and has held many management positions in FDA regulated industries. http://www.vcillc.com