Dietary supplements comprise minerals, vitamins, botanicals, herbs, amino acids, enzymes, and other dietary ingredients. Supplements are taken into the body in various forms: capsules, liquid, pills or tablets.
The National Institutes of Health (NIH) estimate that more than half of Americans take one or more dietary supplements on a daily or occasional basis. The reasons why people supplement their diets with such products include compensation for diet (nutrition), alleviating a medical condition, increasing energy levels, stabilizing mood, preventing ailments, and aiding sleep.
Compensation for nutritional lapses in diet is the most commonly cited reason for taking dietary supplements.
Carol Haggans, a registered dietitian and consultant to the NIH says: “It’s possible to get all the nutrients you need by eating a variety of healthy foods, so you don’t have to take one. But supplements can be useful for filling gaps in your diet.”
As many American diets do not include the necessary amounts of essential vitamins and nutrients, supplement use has become widespread.
Regulation of Supplements
The FDA regulates dietary supplements and dietary ingredients. As supplements are not classified as a “drug”, the products are regulated under a separate set of guidelines. Under current law, supplements are regulated similarly to food.
The Dietary Supplement Health and Education Act of 1994 (DSHEA) is considered the guiding legislation in the regulation of dietary supplements. Under the law, manufacturers and distributors of dietary supplements are “prohibited from marketing products that are adulterated or misbranded” and “are responsible for evaluating the safety and labeling of their products before marketing.” Companies that fail to comply with FDA or DSHEA regulations are subject to corrective action from the FDA.
Federal law also requires dietary supplements to be labeled accordingly. For example, labels must contain the term “dietary supplement” or include a term that depicts the product’s dietary ingredients (e.g. “herbal supplement” “calcium supplement.”)
According to the FDA, the agency’s regulatory responsibilities begin after products enter the market. FDA action against any real and potential health risks of supplements is possible at this juncture, as is action against supplements that have been adulterated or misbranded.
FDA jurisdiction does not include any processes that occur prior to a supplement product entering the market, a concern for those who propose stricter regulations in the production and inspection of dietary supplements.
Among the FDA’s responsibilities is certain safety monitoring actions. Companies privy to information regarding serious adverse events relating to the use of a supplement are required to report such events to the FDA. On occasion, the FDA conducts product label reviews and analysis of product information, including “package inserts, accompanying literature, and Internet promotion.”
Outside of a narrow regulatory framework that guides how supplements are marketed and labeled, few restrictions exist. For example, federal laws do not require supplement manufacturers to demonstrate that their products are safe in accordance with FDA standards, as prescription drug manufacturers are.
Various organizations, including the American Cancer Society, have pointed to the proliferation of supplements that include tainted ingredients as a potential reason to draft and enforce additional oversight and approval standards for supplements.
Additionally, current laws do not require supplement manufacturers to prove that claims made on their products are truthful. In early 2015, the Attorney General of the State of New York sent letters of reprimand to retailers who sold products that were shown to be misleading in their health benefit claims.
Particular attention is being paid to manufacturers of herbal supplements as a result of supplements that included ingredients – including prescription drugs – that were not listed on the product’s label. In one study, researchers analyzed 44 one-ingredient herbal supplements sold in the U.S. and Canada. Only 48 percent of the tested supplements contained the ingredients listed on the product’s label. More than half of the products contained ingredients that were classified as substitutions or fillers.
Some supplements that were labeled as “enhancers” or “muscle builders” were found to contain traces of substances similar to those found in Viagra and Cialis. Other “prostate health” supplements contained traces of terazosin, a prescription-only drug used to treat enlarged prostate. In another investigation, certain “weight loss” supplements included the drug sibutramine, which was banned for sale in the U.S. because of serious side effects, including stroke and heart attack.
Instances such as these have buttressed the arguments of influential people and organizations who insist that stricter regulations in the production and approval of dietary supplements are necessary. Such proposals face an uphill battle, as other FDA food safety efforts have taken precedence. Currently, the FDA is in the midst of fully implementing the statutes included in the Food Safety and Modernization Act.
It is feasible to consider the FDA taking future action, however. The creation of a branch of the FDA focusing specifically on the supplement industry may be an indication that stricter regulation of the industry is to come.