Multivitamin Regulations: Ingredients, Labeling, Marketing & More

It's tough enough to do your research on single-ingredient supplements; how can you tell if a multivitamin with 10, 20, 30-plus ingredients is 100% safe and effective to take?

A dietary supplement is defined as a product taken by mouth that contains a "dietary ingredient" (or multiple dietary ingredients in the case of a multivitamin)—which includes vitamins, minerals, amino acids, herbs, and botanicals. Dietary supplements are not designed to treat or prevent disease but rather supplement an individual's nutrition and/or lifestyle. 

Just because supplements aren't prescribed in the same clinical manner or regulated in the same way as pharmaceutical drugs doesn't mean they can't provide value.

In the same way that foods, functional or otherwise, can deliver nutrition and bioactives (think phytonutrients) to nourish and elevate our health, so can dietary supplements (often, in a more targeted and reliable manner). Healthful food and supplements are synergistic.

The Dietary Supplement Health and Education Act2 (DSHEA) was passed in 1994 by the FDA and regulates the dietary supplement market in many specific ways. First of all, because dietary supplements are not clinical drugs, companies cannot claim (or imply) that their products can cure or treat any medical diseases. 

Furthermore, the FDA is responsible for safety monitoring, enforcing a host of detailed manufacturing requirements, issuing scathing FDA warning letters (or worse) for companies not following the rules, and much more within the dietary supplement industry.

There are many laws and regulations dictating what can and cannot be said on supplement product labels and related advertising online (product page, social, etc.). To give just one example: There are certain nutrient content claims that require specific criteria to legally use—e.g., multivitamins cannot claim they are "high potency" unless two-thirds of their ingredients present 100% or more of the required daily intake (RDI). Other terms—such as "complete," "comprehensive," "doctor-formulated," and "pharmacist recommended"—do not (yet) have distinct laws of appropriate use. (Although per the FTC, claims cannot be misleading or untruthful ever.)

While the dietary ingredients must have proof of safety before inclusion in the product, regulation of the finished product supplement begins when it enters the marketplace. The FDA can (and will) take action against a product if it presents a serious risk of illness or injury or is misbranded to the public. 

Here are some things that the FDA can (and cannot) enforce when it comes to dietary supplement regulation:

While the FDA certainly regulates the dietary supplement market and provides detailed guidelines for manufacturers to produce safe products, there are checks and balances that prevent the FDA from overstepping their bounds.

Organizations such as the Council for Responsible Nutrition4 (CRN) call on the FDA to modernize dietary supplement regulations when the science and market command necessary shifts. At times, the FDA is navigating uncharted territory—such as determining regulations to guide the safe use of hemp-derived CBD in the dietary supplement market (an issue CRN has been quite vocal about5 over the past few years). 

Other times, a product that has been on the market for years is later established as a valuable supplement to individuals with certain health needs, such as marine omega-3s EPA and DHA. In these cases, the FDA reviews extensive amounts of published clinical science and substantiation for claims that certain dietary ingredients have clinical evidence to help with specific health conditions.

For example, in 2019 the FDA announced a new qualified health claim6 that EPA and DHA combined may reduce blood pressure and reduce the risk of hypertension, a risk factor for CHD (coronary heart disease) when the product meets certain criteria (i.e, provides at least 800 mg of EPA and DHA per serving and includes the claim in its entirety as it related to the brand's specific product). Products with these omega-3 dietary ingredients can make this specific claim about blood pressure, hypertension, and CHD—as long as they include the exact language approved by the FDA. 

For mindbodygreen, since we meet the FDA criteria for this special claim, we're happy to share that language as it relates to our high-potency omega-3 product: "Consuming EPA and DHA combined may reduce blood pressure and reduce the risk of hypertension, a risk factor for CHD (coronary heart disease). However, FDA has concluded that the evidence is inconsistent and inconclusive. One serving of omega-3 potency+ provides 1.5 grams of EPA and DHA."

Multivitamins are, indeed, regulated. Anyone who says otherwise hasn't spent much time reading the regulations or speaking with experts in the industry. As a consumer, it's important to cover your bases: do research on the ingredients and dosages of the product before you purchase, research the integrity and quality of the company that the product comes from, and talk to your health care provider to make sure your dietary supplement doesn’t have any interactions with your current medications.