The FDA requires that dietary supplement manufacturers list certain details about their products on product labels. The general information required on the package includes the name of the product; the word “supplement” or a statement that the product is a supplement; the quantity of the package contents; the name and location of the manufacturer, packer, or distributor; and directions for using the product.

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In addition to the general information, a supplement must also have what is called a Supplement Facts Panel. This panel must include information on serving size and amount of product per serving size (by weight), the percent of Daily Value (%DV) that a particular ingredient or nutrient provides per serving (if this is known), and a list of the product’s dietary ingredients (INFOGRAPHIC 12.4). If a dietary ingredient is a botanical, the panel must list the scientific name of the plant or the common name that has been standardized in the reference book Herbs of Commerce (2000 edition). The panel must also include name of the plant part that has been used. If the dietary ingredient is a proprietary blend, meaning a blend that is exclusive to the manufacturer, the Supplement Facts Panel must list the total weight of the blend and its components in descending order of predominance by weight.

Question 12.3

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Supplements must also include another ingredients panel. This lists all nondietary components found in the product such as fillers; water; artificial colors; sweeteners; flavors; and processing aids, such as binders, gelatin, and stabilizers. These ingredients are listed by common name or proprietary blend in descending order of predominance by weight. The ingredients listed in this panel may include the sources of the dietary ingredients if they are not identified in the Supplement Facts Panel—for instance, a label might list rose hips as the source of vitamin C.

Finally, supplement labels may also contain cautionary statements about potential side effects, but if a supplement does not have a cautionary statement, it does not mean that the product is completely safe. Unlike conventional drugs, supplement manufacturers do not have to list known adverse effects on their labels.

Supplement labels can also include health claims that describe a relationship between a dietary supplement ingredient and a reduced risk of a disease or condition. The FDA must pre-approve these claims based on Significant Scientific Agreement (SSA) about the publicly available scientific evidence. A supplement containing calcium and vitamin D can legally claim that it reduces the risk of osteoporosis, for instance, and a folic acid supplement can say that it may prevent fetal neural tube defects. (INFOGRAPHIC 12.5) The FDA also allows the use of qualified health claims for conventional foods and dietary supplements when the evidence linking a food, food component, or supplement to a reduced risk of a disease is emerging but not well enough established to meet the SSA standard for a true health claim. For example, the number of studies demonstrating a beneficial effect may be limited, or the results of studies may be inconsistent. Qualifying language is included to indicate that the evidence supporting the relationship is limited—for instance, you might read on a label that “supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease.” But even qualified claims have to be approved by the FDA based on the quality and strength of the scientific evidence.

Question 12.4

Supplement manufacturers can’t make claims that their product treats, prevents, or cures disease unless it has been approved for a health claim or qualified health claim. However, companies can make a structure/function claim on the label about how that product could affect the body’s structure or function. (INFOGRAPHIC 12.6) “Calcium builds strong bones” is an example of a structure-related claim, whereas “fiber maintains bowel regularity” or “antioxidants maintain cell integrity” are function-related claims. Alternatively, these claims may state that consuming a nutrient or dietary ingredient may improve general well-being or describe a benefit related to a nutrient deficiency disease. Labels containing these claims must state in a disclaimer that the FDA has not evaluated the claim, and that the product is not intended to diagnose, treat, cure, or prevent any disease. Still, “more times than not, the label is going to be misleading, and the claims are going to be overly positive,” Cohen says.

Question 12.5

How do we know if supplements on the market are pure and of high quality? The FDA does not monitor supplements for quality assurance, potency, purity, or efficacy—there are far too many supplements for the agency to handle—but the FDA does track reports of illness, injury, or reactions that might occur in consumers after taking supplements. Supplement manufacturers are now required to report serious harmful effects to the FDA, too. Supplements may be labeled as “pure,” “natural,” or “quality-assured,” but, because the FDA does not regulate these terms, these claims may not be true. Supplements that claim to be “all natural,” for instance, are not always better or safer than refined or synthetic substances, because natural and synthetic forms generally have the same chemical structure and do not differ in terms of how they are absorbed or used by the body. They may, however, differ in price—the “natural” forms are often costlier.

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Consumers do have some ways of gauging supplement quality, though. Independent labs test supplements that manufacturers voluntarily submit; some labs also do product reviews. Organizations such as United States Pharmacopeial Convention (USP)—a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements distributed and consumed worldwide—provide seals of quality that companies can display on their products. Another independent lab that provides quality labels is NSF International (NSF).