Federal regulation of dietary supplements The FDA is the federal agency that oversees both supplements and drugs, but the FDA regulations for dietary supplements are different from those for prescription or over-the-counter drugs. Drugs must be approved by the FDA before they can be sold or marketed. The marketing, manufacturing, labeling, and advertising of dietary supplements are covered by regulations imposed by the FDA and the Federal Trade Commission. Four out of 5 American adults say they have used dietary supplements, including vitamins, minerals, herbs and amino acids.
The Food and Drug Administration regulates these products under the Dietary Supplement Health and Education Act of 1994, but the agency cannot effectively or efficiently protect public health due to significant gaps in this outdated law. Two key issues that need to be addressed are the FDA's inability to know what supplements are on the market and its inability to demand the recall of supplemental products containing pharmacological ingredients. Part of the challenge is that the FDA relies heavily on post-market approaches (once the product is available to the public), such as Internet searches for claims of illegal marketing, inspections of manufacturing facilities, and reports from consumers or companies to identify products that may be causing harm. However, these tools provide a limited view of the up to 80,000 products on the supplement market.
This lack of basic market knowledge makes the United States an outlier among higher-income countries; regulatory agencies in Canada, Australia, China, and Europe all have some kind of registration requirement or central list for dietary supplements. While regulations and product definitions differ from jurisdiction to jurisdiction, these regulatory agencies require manufacturers to provide, at a minimum, basic information about their products before placing them on the market. A mandatory requirement in the product list is a low-cost, low-burden solution that would ensure that the FDA has the information it needs to provide adequate oversight of the supplement market. The vast majority of American adults (95%) support this requirement, and the agency has requested this authority in multiple budget requests.
While the FDA can order the recall of dietary supplements, this authority does not extend to drugs, which must be voluntarily recalled by the manufacturer. In cases where a supplement is contaminated with a pharmacological ingredient, a loophole makes the agency's recall authority unclear. These limitations raise serious questions about whether the FDA can take effective action when problems arise with supplements, especially if a company voluntarily refuses to recall its products from the market. Taken together, the list of products and a clear authority to recall them would greatly improve FDA oversight of supplements by providing the agency with critical information about products on the market and ensuring that it can act quickly when it becomes aware of a product that poses a risk to public health.
The FDA must have the authority to know what supplement products are on the market. Don't miss our most recent data, findings, and survey results at The Rundown Founded in 1948, The Pew Charitable Trusts uses data to make a difference. Pew addresses the challenges of a changing world by illuminating problems, creating common ground, and promoting ambitious projects that lead to tangible progress. Don't miss our latest data, findings and survey results on The Rundown.
In 1994, Congress passed the Dietary Supplement Health and Education Act (DSHEA), an important piece of legislation that provided a regulatory framework to ensure the safety of dietary supplements. Understanding the regulations that apply to a dietary supplement can be complex, especially considering that each state and ingredient will be subject to different rules and laws. Food and Drug Administration (FDA) authority to establish regulations regarding the manufacture of dietary supplements, regulate health claims and labeling. The FDA regulates dietary supplements according to a set of rules different from those that regulate conventional foods and pharmaceutical products.
Board membership includes the expectation of complying with certain state and federal regulations governing the manufacturing, quality control, marketing, and safety of dietary supplements. The NSF is the only independent third-party testing organization that offers real dietary supplement testing. Amended over the years, the FD&CA is the general regulation for foods and their subset, dietary supplements, which are specifically regulated under the DSHEA amendments to the FD&CA. It regulates both dietary ingredients and finished dietary supplement products and does so under a set of regulations different from those governing conventional products consumed such as foods and medicines.
For the budding dietary supplement company or entrepreneur, any time is a good time to sit down and take a closer look at the major federal and local agencies, regulations, and trade associations that oversee the supplement industry. The government agency not only sets rules and regulations, but also provides consumer education and updates to the general public. Project Non-GMO is not a government agency, but a non-profit organization that assumes the mission of building and protecting a supply of non-GMO food by educating consumers and conducting outreach programs. While not binding, these regulations cover current good manufacturing practices for dietary supplements (DS cGMP), which are subject to regulations, procedures, personnel, production and process control, product returns and complaints, labeling guidelines, and other detailed and general provisions.
The United States Department of Agriculture (USDA) provides general information and resources on dietary supplements and offers organic certification and accreditation of organic products by allowing private, foreign, or state organizations to certify processing facilities or farms. .
