Supplement Regulation and Labeling: It’s complicated.

Dietary supplements are everywhere. Whether you’re in a store, online, or just chatting with a neighbor, you’re bound to get advice about which ones you should try. But information about how supplements are regulated, how to interpret their labels, or how they can significantly affect your health doesn’t get as much buzz. 

Learn the basics of supplements and how to decide if one is a good fit for you. 

What are dietary supplements?

Supplements are vitamins, minerals, herbals, and botanicals that can change the way your body functions. They were originally made to boost the levels of nutrients missing from our diet. Now, many people are taking supplements because they are marketed as “safe” or “natural.” However, it’s important to remember that they have risks similar to other types of meds, like interactions with food, meds, or health conditions and side effects.

There are different kinds of regulations. 

You may have heard that supplements are unregulated. That’s not entirely true, but they are regulated differently than other medications. Prescription drugs and over-the-counter medications sold in the United States are broadly regulated by the U.S. Food and Drug Administration (FDA). These products go through years of scientific review and approval to show that they’re safe and effective in treating certain symptoms or conditions.

Supplements, on the other hand, are only required to meet the FDA’s Good Manufacturing Practices (GMP). This only shows that a product is made, packaged, and stored properly. Manufacturers are required to ensure the product is safe and the labeling isn’t false or misleading. These products don’t require FDA review and approval before being sold. So actual practices can vary between manufacturers, and it can be difficult to be sure that all companies comply with the rules. 

Importantly, supplement manufacturers aren’t required to prove that ingredients are safe and effective in treating or preventing certain symptoms or conditions before hitting the shelves. This means a supplement could contain important ingredients that aren’t listed on the label or aren’t the right strength to help with the condition or issue.

If a product is found to be unsafe or against the law in some other way, the FDA can work with the company to make sure the product meets legal standards, ask the company to recall the product, or remove the product from the market.

The FDA has limited resources to analyze supplements. So, the agency focuses on public health emergencies and products that have caused injury or illness. 

Label certifications can help—sometimes. 

Take a close look at the product label. Some products may display various certification seals or logos. Independent companies may offer to “certify” supplement manufacturers or their products, but these aren’t connected to the FDA or any regulations. A GMP seal on a product package isn’t an official certification, only a marketing claim that the manufacturer follows the required manufacturing practices. 

However, there are some seals or logos—such as United States Pharmacopeia (USP), Underwriters Laboratories (UL), Banned Substances Control Group (BSCG), and National Sanitation Foundation (NSF) International—that indicate the product has gone through some additional safety testing. 

• USP and UL certifications mean the product was tested to make sure it contains the ingredients listed on the label. They also mean the product doesn’t contain harmful levels of contaminants and has been made by a company that has documented and consistent Good Manufacturing Practices.
• BSCG certification means the product has been tested for contaminants, verification of label claims, quality control, GMP compliance, and free of banned substances.
• NSF International certifies that the product contains what is listed on the label—and only those ingredients. NSF also assesses any risk for negative health or environmental effects in the products.

Take a closer look at the label.

A supplement company is responsible for proving the ingredients in its products are safe and the claims on the package are truthful and consistent with scientific evidence. But these claims aren’t reviewed by the FDA before the product is sold. Supplement makers aren’t legally allowed to claim that a product treats, diagnoses, prevents, or cures diseases. Don’t trust claims that a supplement works better than a prescription drug, is totally safe, or has no side effects. 

Look for the “Supplement Facts” panel. The FDA requires that it’s part of the label. It lists the contents, amount of active ingredients per serving, and other added ingredients—like fillers, binders, and flavorings. There will also be a serving size suggestion, but you and your doctor might decide a different amount is right for you.

The more you know, the better you feel (naturally).

The more you know about what you’re taking, the easier it is to make decisions and live your healthiest life. MOBE Pharmacists are supplement experts who can help you decide if a supplement is right for you.

References:

1. "Current Good Manufacturing Practice (CGMP) Regulations," U.S. Food & Drug Administration 12/29/2023. Accessed 8/09/2024. https://www.fda.gov/drugs/pharmaceutical-quality-resources/current-good-manufacturing-practice-cgmp-regulations
    
2. “Dietary Supplements” U.S. Food & Drug Administration. 2/21/2024. Accessed 08/09/2024. https://www.fda.gov/food/dietary-supplements#:~:text=FDA%20regulates%20both%20finished%20dietary,Act%20of%201994%20(DSHEA)%3A
    
3. “Supplement Your Knowledge” U.S. Food & Drug Administration. 5/22/2024. Accessed 08/09/2024. https://www.fda.gov/food/information-consumers-using-dietary-supplements/supplement-your-knowledge
    
4. “Questions and Answers on Dietary Supplements” U.S. Food & Drug Administration. 2/21/2024. Accessed 08/09/2024. https://www.fda.gov/food/information-consumers-using-dietary-supplements/questions-and-answers-dietary-supplements