Who Regulates the Supplement Industry?

The media—and even some medical journals—perpetuate the myth that the dietary supplement industry is unregulated. This is remarkably untrue. In fact, the dietary supplement industry is highly regulated by both the Food and Drug Administration (FDA) and Federal Trade Commission (FTC).

Just as in all industries, there are “renegade” companies that do not follow the rules and create a bad name for the companies that work diligently to meet the regulatory requirements. The most troubling aspect of these renegade companies operating within the dietary supplement industry is that they put unsafe products on the market until they are caught.

Over the past five (or so) years, the FDA has raised the bar on enforcement. All dietary supplement manufacturers are inspected, and, if they do not meet the current good manufacturing practices (cGMPs), they receive warnings and potentially can be shut down. Depending on the infraction, the company’s officers may even go to jail. Many individuals who work for ethical companies feel strongly that the FDA should be quicker to eliminate any company that sells products with ingredients tainted by pharmaceuticals or are otherwise unsafe.

The FDA enforces a vast quantity of regulations for the dietary supplement industry, and it is the company’s responsibility to understand and comply with these regulations. While there can be some disagreement in regards to how to comply—such as with product claims—there is a certain bar that no respectable company should go beneath. This is particularly important in regard to complying with manufacturing cGMPs.

When manufacturing cGMPs are followed, there is a high likelihood of a consistent, safe, and effective product. If a company is not performing appropriate testing, purchasing quality ingredients, or following sanitary procedures in its facility, the product is not something anyone would want to purchase—even if the product is significantly cheaper than others on the market. When the FDA inspects a dietary supplement company, it goes through the facility and the standard operating procedures (SOPs) with a fine-tooth comb. The inspectors request to review any adverse event reports received by the company over the last six years, they review product labels, and they may even take and test product. These inspections sometimes take weeks.

The FTC plays a role in regulating the dietary supplement industry, as well. The FTC gives great deference to the FDA in regard to compliance with laws and regulations. And the FTC will back up the FDA, when necessary, to level a one-two punch to the noncompliant company.

The FTC’s main focus is to review advertising claims. These claims include direct claims, such as, “Our product will take away your arthritis,” to indirect or implied claims, such as, “Our product takes it away,” in conjunction with an image that suggests excessive joint pain.

There is another entity that helps regulate the supplement industry—and that is the supplement industry!

From the FDA’s perspective, it would view both of these as disease claims, and therefore, the claims would be viewed as noncompliant and require enforcement action. From the FTC perspective, it would consider if the claim is true or not true and/or misleading. Do the ingredients take away arthritis? Is there proof of this in the form of clinical trials? Will someone avoid medical treatment because he or she is using this product? The FTC will take action when it believes the public is at risk because of the claim. Enforcement by the FTC is much more dangerous for a company because it usually involves legal action, fines, and jail time.

There is another entity that helps regulate the supplement industry—and that is the supplement industry! Several organizations are made up of ethical companies that desire to be in compliance with the regulations but also desire fair treatment from the regulating agencies. These organizations want to get rid of the renegade companies and build trust within the marketplace.

One way they are doing this is by providing financial support to the National Advertising Division (NAD) of the Better Business Bureau by the Council of Responsible Nutrition (CRN). The NAD has dedicated an attorney to a special program to monitor the truth and accuracy of advertising by dietary supplement companies. Any company or person can bring questionable claims to the NAD for review. If the NAD finds that the claims are not supportable, it will contact the company making the claims and ask for substantiation.

Once this is reviewed, the NAD will provide a decision to the company. If the organization finds the claims are unsupportable, it will ask the company to change the claims within a designated timeframe. If the company does not do this or does not respond to the original request, the NAD will turn the case over to the FTC, which will make it a high priority for action.

If you want to purchase high-quality dietary supplements, search for companies with a solid reputation, as well as membership in industry organizations, including United Natural Products Alliance (UNPA) and American Herbal Products Association (AHPA).

If you see claims or advertisements for dietary supplements that include disease claims or claims that are too good to be true—there’s a good chance that company is not complying with the regulations, which may signal it is also not complying on the manufacturing end.

Dietary supplements can provide invaluable health support that can be life-changing for many people. Be thankful for the regulations, as they help keep quality products on the market and available for you.

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About Lisbeth Benoit

Lisbeth Benoit is a Certified Nutrition Specialist with a Master’s Degree in food science and nutrition. She has 28 years of experience working in the dietary supplement industry as an international trainer, writer, and most recently as a regulatory affairs project manager for Metagenics. Lisbeth has broad expertise in medical foods, supplements, foods, and nutrition. Currently, Lisbeth works as a consultant for dietary supplement companies.

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