One way herbs enter into consumers’ lives is as dietary supplements. A common misconception for consumers is that dietary supplements are regulated the same way as over-the-counter (OTC) drugs. In fact, they are not although it’s easy to come to that conclusion. They are packaged in similar ways, they come in similar forms (pills, liquids, etc.), they’re usually sold in the same stores often one aisle away from each other, and their labels even look similar. But, from a regulation stand point, they’re not.
What Are Dietary Supplements?
Let’s start by understanding how dietary supplements are defined. Below is the definition according to the FDA website. What is the FDA? The FDA (U.S. Food and Drug Administration) is a governmental agency that oversees the regulation of dietary supplements and OTC drugs in addition to many, many other things.
A dietary supplement is:
… a product taken by mouth that contains a “dietary ingredient” intended to supplement the diet. The “dietary ingredients” in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Dietary supplements can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders.
Here’s a quick comparison of supplements and OTC drugs.
|Product||Over-the-counter drug||Dietary supplement|
|FDA definition||A drug that is safe and effective for use by the general public without a doctor’s prescription.||A product taken by mouth that contains a “dietary ingredient” intended to supplement the diet.|
One is considered by the FDA to be a drug and one is basically considered a special kind of food to supplement the diet. This difference means that they are regulated differently.
(Note: From this point forward in this article, I’m going to be referring to herbal supplements specifically rather than dietary supplements in general since this blog is about herbs. The regulation information, however, applies to all dietary supplements.)
Regulation Differences Between OTC Drugs and Herbal Supplements
OTC drugs must be evaluated and approved by the FDA to be safe and effective before they can be sold on the market. Dietary supplements do not.* There are, however, regulations for supplement production including ingredient and product testing, current good manufacturing practices, quality control measures, labeling, etc., that the manufacturers of the herbal supplements are supposed to follow. The manufacturers don’t need FDA approval before putting their products on the market and they don’t need to prove to the FDA that the products are safe and effective before selling them. Keep in mind – these supplements are not, in a regulation-sense, seen as drugs but as a special kind of food.
This is where there can be confusion because many people use herbal supplements to help them deal with health issues. We also have many ways in our culture where we make that “herbs are medicine” connection, such as:
- a history of herbal/folk medicine in this country
- health care professionals that include herbs in treatment
- prescription drugs that are made, at least in part, from herbs (e.g. morphine, medical marijuana)
Getting back to the regulation piece, the FDA can, and does, conduct inspections of herbal supplement manufacturers to see if they are following regulations. The FDA can also step in after a supplement product has reached the market if a problem arises (as they do with other food products). The FDA must be the one to prove a product is unsafe before being able to take action and restrict its use or sale. They can hold companies accountable through warnings, product seizures and criminal enforcement. In addition, the Federal Trade Commission (FTC) regulates claims in advertising (print, broadcast and online) for supplements and often works together with the FDA on this. State Attorneys General also have some regulatory power (e.g., pulling products from store shelves) within their states.
Unfortunately, because of the way the regulations are structured for herbal supplements, it makes it easy for unscrupulous manufacturers to get ineffective and/or adulterated supplements onto the market and into unsuspecting consumers’ hands. While requiring herbal supplements to be regulated as OTC drugs seems like a solution, it isn’t that simple. For example, if I want to make cookies, would I have to buy cinnamon in capsules at the drugstore?
Ultimately, the point is that, as consumers, we need to be aware of the current regulations, and we have to have our “good consumer” wits about us when stepping into the herbal supplement marketplace.
So What’s A Consumer to Do?
Consumers should understand how supplements are regulated and how that differs from OTC drugs. Once you understand the difference, you may ask yourself, “How do I find a good herbal supplement manufacturer?” A place to start is to take the time to check out who the manufacturers are. There are ones out there that follow the FDA regulations and create good products. You can also check with your health care professional. And keep in mind the basic consumer tip that stands the test of time for anything – if it sounds too good to be true, it probably is. Many news reports on supplements that have harmed people have been for products for weight loss, sexual enhancement, and athletic performance.
Links to Learn More
FDA website – Q&A on Dietary Supplements
FDA website (This statement is about 10 years old and is a lot of text, but it has a lot of good information) – The Regulation of Dietary Supplements: A Review of Consumer Safeguards
FDA website – Tips for Dietary Supplement Users
*(One exception to this is if the supplement contains a new dietary ingredient. A new dietary ingredient is defined as one that was not sold in the U.S. in a dietary supplement before October 15, 1994. If it fits this definition, the ingredient would need to be reviewed for safety by the FDA prior to marketing.)
Next article – How to Really Read A Herbal Supplement Label