The FDA and Dietary Supplements: How Supplements Are Regulated

The FDA and Dietary Supplements: How Supplements Are Regulated

The Supplement Industry

Looking at some of the media coverage, you may think the dietary supplement industry is like the Wild West. No regulation. No standards . . . And consequently no safety.

This couldn’t be further from the truth.

  • Dietary supplements are regulated by the U.S. Food and Drug Administration (FDA), which is given authority to regulate the industry through the Dietary Supplement Health & Education Act (DSHEA). DSHEA is a federal statute passed in 1994 that defines what dietary supplements are, and includes guidelines on how they should be sold and regulated. The FDA regulates dietary supplement marketing, ingredient safety and manufacturing. Learn more about DSHEA.
  • The industry itself has established several third party organizations that independently monitor and verify product quality. Many of these programs exceed FDA standards for dietary supplements.
  • NOW® has participated in these programs from the start and adheres to standards that, in many cases, go well beyond what’s required. You can find out more about our exceptional track record by clicking here.

Certainly, dietary supplements are not required by law to go through the same kind of testing as pharmaceutical products. This is because the pharmaceutical chemicals developed in laboratories have never before been introduced to the human body.

In contrast, dietary supplements are categorized with food. This is because they are made with natural ingredients that have a long history of human use.

That being said, we still need regulations to make sure dietary supplements are safe and effective. Here’s how current regulations work to protect you and ensure quality.

How The FDA Regulates Dietary Supplements

The U.S. Food and Drug Administration (FDA) regulates dietary supplements in several ways:

  1. The FDA monitors the marketing claims made by dietary supplement companies. They make sure dietary supplement companies do not claim their products prevent, reduce the symptoms of, or cure diseases.
  2. The FDA reviews and approves the introduction of new ingredients to the market by affirming generally recognized as safe (GRAS) status, or as new dietary ingredients (NDI).
  3. If evidence indicates an ingredient is harmful, the FDA establishes supplement label warning requirements and – if necessary – mandates removal of an ingredient from the marketplace.
  4. The FDA inspects manufacturing facilities to make sure they follow Good Manufacturing Practices (GMPs).
  5. The FDA’s GMPs cover everything from raw material verification to finished product testing and accurate labeling.

When it comes to ensuring safety, effectiveness and quality, GMPs are perhaps one of the most critical areas of regulation.

How The FDA’s Good Manufacturing Practices Help Regulate Quality and Safety

The FDA has established different sets of GMPs for pharmaceutical products, medical devices, and foods. However, it took over a decade after legislation mandated it for the FDA to establish GMPs for dietary supplements.

It’s important to understand, while the FDA expects manufacturers of dietary supplements to comply with GMPs, the FDA does not certify companies to be in compliance. Instead, when the FDA inspects a manufacturing facility, it will issue “observations,” identifying deficiencies. The manufacturer then needs to correct these deficiencies.

Since FDA CGMPs were fully implemented for dietary supplements in 2009, NOW has been an industry leader in compliance.

  • NOW has been inspected twice by the FDA since 2009. Inspection violations have been few and minor.
  • In 2012 we received some recommendations for improvement, which we’ve since implemented. But we did not receive any observations of serious violations.
  • Our last FDA CGMP compliance inspection was in May 2015. NOW is currently fully GMP compliant.

In addition to the FDA’s CGMP federal compliance program, dietary supplement manufacturers can attain GMP manufacturing certification from a few non-governmental, third party organizations. NOW participates in several of these programs and has been audited by multiple third-party auditors.