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?
While adding supplements to your routine still requires some research on your part (and an open discussion with your trusted health care provider), you can rest assured that supplements from reputable brands are safe for the general public. Multivitamins, like all dietary supplements, are regulated by the U.S. Food & Drug Administration (FDA) and other entities too (FTC, NAD, state-specific laws, etc.), but we'll hone in on the FDA today.
What are dietary supplements?
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.
In addition to capsules, gelcaps, and tablets, you'll also find dietary supplements in the form of powders, liquids, gummies, and more.
How does the FDA regulate multivitamins?
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.
More similar to the "conventional food" category or umbrella of the FDA's regulations, but different from the "drug" category, dietary supplements are able to enter the market without preapproval from the FDA. However, a landmark regulation almost 30 years ago laid down loads of supplement-specific rules, so they can stay in their own unique lane (unique from food).
The Dietary Supplement Health and Education Act (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:
What the FDA does regulate:
- Each dietary supplement must be labeled with the term "dietary supplement" or a term that substitutes a description of the product's dietary ingredients—such as "vitamin C supplement" or "herbal supplement."
- Dietary supplement companies must relay any product-related serious adverse events reported by consumers or health care professionals to the FDA.
- Dietary supplements cannot be marketed as a treatment or cure for diseases, nor can they claim to alleviate symptoms of a specific disease.
- Dietary supplements must follow an extensive set of granular rules for labeling products, from the front of the bottle (jar, bag, etc.), to the Supplement Facts panel info and order, serving size info, nutritional information, Daily Value calculations, instructions for use, certain warnings, manufacturing info, contact info, and much more.
- Each and every type of claim that dietary supplements are allowed to make, from nutritive (nutrient content claims like "rich" or "excellent" source, "high-potency," and more) to non-nutritive claims, for example claims related to the structure and function of the body.
- The inclusion of required FDA disclaimer language for each and every structure-function claim made on supplement products and their advertising materials.
- Claims substantiation criteria (i.e., are the claims able to be substantiated and not untruthful or misleading?) and reporting, for example, structure-function claims for each product are required to be reported to the FDA within 30 days of the product launching.
- The enforcement of allergen laws (e.g., FALCPA), such that any of the eight major food allergens are required to be called out on the dietary supplement label after the Supplement Facts panel.
- An extensive set of current good manufacturing practices (cGMPs), laws related to the safety, manufacturing, and quality testing requirements for dietary supplements, from their raw materials to the final product (e.g., the multivitamin capsule). This includes periodic in-person audits.
- The FDA regularly issues warning letters and other enforcement of penalties (e.g., fines, removal of product from the market, legal consequences, etc.) for bad characters in the industry with unsafe or irresponsible practices or claims.
What the FDA does not regulate:
- Dietary supplements do not need to be proved safe via clinical trials (like drugs do) according to the FDA before they are marketed.
- Claims about dietary supplements or specific dietary ingredients do not need to be proved to be accurate, truthful, or substantiated by the FDA before appearing on the product's label.
- Dietary supplement brands do not need the FDA's approval before producing or selling their product.
As mentioned before, dietary supplement advertising—including radio and television ads, online product pages, and any media content supporting sales of a dietary supplement—must adhere to the FDA laws as an extension of the product itself, plus regulation of the Federal Trade Commission (FTC).
Limitations to FDA 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 Nutrition (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 about 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 claim 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."
With enough clinical evidence, the FDA allows products containing specific dietary ingredients to make substantiated health claims beyond the confines of DSHEA. But even then, the exact wording on labels and in marketing materials is strictly defined and regulated (for brands staying in the "FDA lanes"). Beware of irresponsible claims on dietary supplements. They are a red flag for the supplement brand's quality and trustworthiness overall.
The bottom line.
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.
Morgan Chamberlain is a supplement editor at mindbodygreen. She graduated from Syracuse University with a Bachelor of Science degree in magazine journalism and a minor in nutrition. Chamberlain believes in taking small steps to improve your well-being—whether that means eating more plant-based foods, checking in with a therapist weekly, or spending quality time with your closest friends. When she isn’t typing away furiously at her keyboard, you can find her cooking in the kitchen, hanging outside, or doing a vinyasa flow.