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- What is a dietary supplement?
- Label approval may not be required to import or distribute a dietary supplement, but the FDA still keeps a close eye on them
- Other differences between Supplement Facts + Nutrition Facts (4)
- Why aren’t dietary supplements put through the same safety + effectiveness requirements that drugs + food products are?
- This means that the responsibility falls on the consumer to choose wisely
- What to look for in a dietary supplement
Most people are surprised to learn that dietary supplements aren’t put through the same safety and effectiveness requirements that drugs and food are. And while there are reasons why the Food and Drug Administration (FDA) regulates these products differently, it still means that the responsibility falls on the consumer to choose wisely—because yes, certain supplements can make illegal claims. Here’s what you need to know.
The types of products that fall under the FDA’s category of “dietary supplements” include vitamins, minerals, herbs, botanicals, amino acids, or concentrates/constituents/extracts—essentially anything that can be used to supplement one’s diet. (1) According to the Dietary Supplement Health and Education Act of 1994, the manufacturer of dietary supplements is responsible for ensuring that its product is safe prior to being marketed to consumers, but the FDA itself is not required to approve the product for safety or effectiveness. (2)
If, once a dietary supplement is marketed, the FDA deems that it is “unsafe,” it can take action to restrict the use of the product or remove it entirely from shelves. Also, the FDA mandates that manufacturers and distributors record, investigate, and share any reports they receive of serious adverse side effects. From there, the FDA evaluates the reports and, if necessary, takes action to protect the public from such products. (3)
- Serving information, calories, nutrients, + percent daily value (% DV)
These are required fields on a Nutrition Facts panel. (5)
- Reference Daily Intake (RDI) + Dietary Reference Values (DRV)
These two fields are required for dietary supplement ingredients but are not permitted in a nutrition facts panel for food.
- Ingredient source
While it’s permitted and often encouraged to list the source of a dietary ingredient in a supplement facts panel for full transparency, the same does not apply to dietary ingredients in a nutrition facts panel.
- Part of the plant from which an ingredient is derived
It’s required to include this information for dietary supplements, but it is not permitted on a nutrition facts label.
There are two main reasons for this:
- Unlike drugs, dietary supplements are unlikely to alter your biochemistry
“Many medications are foreign compounds and are known to target and alter a specific biochemical pathway either temporarily or sometimes permanently,” explains Alice Hirschel, PhD, Proper’s Head Formulation Scientist. “Dietary supplements are primarily sourced from foods, plants, and spices already in the food supply. Ingredients consumed in safe doses are meant to ‘supplement’ a healthy diet, and specific ingredients may even provide additional health benefits all without permanently altering the basic biochemistry of the body.”
- The potential side effects of supplements (compared to medications) are minimal
“As described above,” adds Hirschel, “the majority of dietary supplements are already a part of the food supply and when consumed in safe doses side effects are rare, especially compared to most medications. Dietary supplements may not support all health conditions, but they are a safe place to start when improving diet and lifestyle.”
Case in point: In a 2012 government study (6) of 127 supplements for immune support and weight loss, researchers reviewed the health claims to assess the extent to which they complied with FDA regulations. Results showed that 20% of the products made illegal claims and 7% lacked the required disclaimer, which raised “questions about the extent to which structure/function claims are truthful and not misleading.”
Wondering how to choose wisely? Here’s what to look for:
- Third-party tested for purity + verified free of heavy metals, microbes, + pesticides
- Contains botanical extracts standardized to guarantee consistent purity, potency, + efficacy
- Ingredients with human clinical studies proving safety + efficacy
- Free of artificial colors or binders
For CBD supplements, it’s also important to confirm whether the product is THC-free, especially if you have a drug test coming up. Hemp should be sourced from vertically-integrated suppliers for seed-to-shelf quality control and 100% traceability. Be sure to look for a Certificate of Analysis (COA) verifying the cannabinoid quantity and finally, consider the carrier oil used. Most CBD products use a lower-cost oil, whereas products like Proper solubilize their CBD in vegan omega-3 oil.
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