Supplement regulation and labeling: It’s complicated.

While many vitamins, minerals, and herbal products have documented benefits, not all supplements are proven to be safe or effective, or created equal. Before taking any supplements, it’s important to know the facts—learning more about regulation and labeling can help.

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). In addition to having regulated manufacturing standards, these products go through a scientific review and approval process, often taking many years, to demonstrate that they are 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) which demonstrate 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 do not require review and approval before being sold on the market; therefore, actual practices can vary between manufacturers, and it can be difficult to ensure that all companies comply with the rules upfront.

Importantly, supplement manufacturers are not required to prove that ingredients are safe and effective in treating or preventing particular symptoms or conditions before hitting the shelves. This means a supplement could contain important ingredients that are not listed on the label or are not the correct strength necessary to help with a specific condition or issue.

Label certifications can help—sometimes.

Take a close look at the product label. Some products may display various seals or logos claiming a type of certification. Independent companies may offer to “certify” supplement manufacturers or their products, but these are not connected to the FDA or any regulations. A GMP seal on a product package is not 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) and National Sanitation Foundation (NSF) International—that indicate the product has gone through some additional safety testing.

• USP certification means the product was tested for the ingredients listed on the label and it contains what is listed on the label, does not contain harmful levels of contaminants, and has been produced by a company that has documented, consistent Good Manufacturing Practices.
• 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 claims.

While a supplement company is responsible for proving that the ingredients in its products are safe, and that the claims it makes on the package are truthful and consistent with scientific evidence, these claims are not reviewed by the FDA before the product is sold. Supplement makers are not legally allowed to claim that a product treats, diagnoses, prevents, or cures diseases. If it seems too good to be true, it probably is.

In addition to paying special attention to the claims, look for the “Supplement Facts” panel, which the FDA requires as part of the label. It lists the contents, amount of active ingredients per serving, and other added ingredients—such as 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 based on your needs.

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

The more educated you are about what you are taking, the better you can make decisions that let you live your healthiest life. While supplements and herbal products may come from nature, natural doesn’t always mean harmless.

A licensed MOBE Pharmacist can help you minimize risks and make the most of your medications—including prescriptions, over-the-counter medications, herbals, and supplements. Get started today.

References:

1. Ranjani Starr, “Too Little, Too Late: Ineffective Regulation of Dietary Supplements,” American Journal of Public Health 105, no. 106 (March 2015): 478-485, https://www.ncbi.nlm.nih.gov/p....

2. Marcel O. Bonn-Miller et al., “Labeling Accuracy of Cannabidiol Extracts Sold Online,” Journal of the American Medical Association 318, no. 17 (November 2017): 1708-1709, https://www.ncbi.nlm.nih.gov/p....