Mickie Cathers
On March 6, 2023, FDA released its Dietary Supplement Ingredient Directory, a new way for consumers, manufacturers, and retailers to quickly locate information about products and ingredients marketed as dietary supplements.
This recently unveiled public directory replaces data and information previously scattered across different pages of the FDA website, collating the information in one spot. The supplement ingredient directory is presented in list form with links to FDA’s actions and communications for each ingredient on the list and an opportunity to download the data in Excel. You can type an ingredient into the search bar and find other known names for ingredients and related agency actions and statements.
For example, searching for “B12” brings up three product entries linked to a May 2001 agency statement on a settlement reached regarding health claims and bottle labeling. Typing “methylsynephrine,” a stimulant found in some weight-loss supplements, into the search box returns four alternate names (oxilofrine, p-hydroxyephedrine, para-hydroxyephedrine, and 4-hydroxyephedrine) and two agency actions/statements. The linked actions provide further details and a constituent update revealing that methylsynephrine does not meet the legal definition of a dietary ingredient. FDA considers any product declaring methylsynephrine as a dietary ingredient to be misbranded, and has issued warning letters to seven companies with product labels listing methylsynephrine.
What’s in a supplement?
Dietary supplements can contain two types of ingredients: dietary ingredients and other ingredients.
A dietary ingredient is a vitamin, mineral, herb or other botanical, amino acid, or “dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of any dietary ingredient from the preceding categories” as defined by the Federal Food, Drug, and Cosmetic Act.
“Other ingredients” in a dietary supplement are usually listed separately on the facts label and include binders, coloring agents, fillers, flavorings, preservatives, and sweeteners. FDA’s new ingredient directory covers dietary ingredients, but not other ingredients within a supplement such as cellulose gel or soybean oil.
FDA’s Dietary Supplements webpage provides information for consumers on dietary products and ingredients, including resources, links, and tips for consumers and industry, a way to report adverse events or other problems with dietary supplements, and guidance and background information for industry. Other popular topics include “What’s New in Dietary Supplements,” safety alerts, and recalls. FDA.gov provides a searchable directory of these, sorted by product type or terminated recall (where FDA has determined all reasonable efforts have been made to remove or correct a product per the recall strategy). They also offer the ability to subscribe to email updates for timely alerts.
While the new ingredient directory doesn’t represent a comprehensive list of dietary supplement ingredients and may not include all actions the agency may have taken, FDA will update the directory periodically to reflect new developments. FDA also encourages additional feedback and information regarding ingredients, which can be submitted to FDA’s Office of Dietary Supplement Programs at ODSP@fda.hhs.gov.
Regulating supplement and ingredients
FDA regulates both finished dietary supplement products and dietary ingredients under a different set of regulations than those covering conventional foods and drug products. Per the Dietary Supplement Health and Education Act (DSHEA) of 1994, FDA’s responsibility is to take action against adulterated or misbranded dietary supplements after, not before, they reach market shelves. DSHEA places responsibility for safety and labeling evaluation of products on manufacturers and distributors, not on FDA. It is the manufacturer that must ensure they meet all DSHEA and FDA regulations and requirements. ■