5 Things to Know about Dietary Supplement Regulations
By RDBA Executive Director Annette Maggi, MS, RDN, LD, FAND
With heightened interest in immune health and all the testing options now available to understand vitamin blood levels or the microbiome, supplements are more and more a part of retail dietitians’ engagement with shoppers. Here are five things you need to know about the regulation of dietary supplements.
#1 Dietary Supplement Definition
Technically, dietary supplements include vitamins, minerals, botanicals, sports nutrition supplements, weight management products and specialty supplements. Through the Dietary Supplement Health and Education Act of 1994 (DSHEA), Congress expanded the meaning of the term "dietary supplements" beyond essential nutrients to include substances like as ginseng, garlic, fish oils, psyllium, and enzymes.
#2 FDA Does Not Test Supplements
Under DSHEA, there are two types of supplement ingredients – those that are grandfathered, meaning they were used prior to 1994 and are deemed safe for continued consumer use, and new dietary ingredients. When introducing a new dietary ingredient, a manufacturer must submit documentation to FDA at least 75 days before the ingredient will appear in the marketplace showing the ingredient’s safety. FDA reviews this information but does not approve it for safety or efficacy; if the agency has concerns, they can request more information or deny the product moving forward. FDA has turned down about half of the new dietary supplement requests since 1994.
#3 Labeling of Supplements
Supplements must carry a nutrition label, which differs from the Nutrition Facts included on foods in format but lists the absolute amount of a nutrient as well as the percent Daily Value. The ingredient declaration must list the form of the various nutrients; herbal and botanical ingredients must state the part of the plant from which the ingredient is derived.
#4 Supplement Claims Similar to Food
Claims used on food, such as nutrient content and health claims, can also be made on supplements. Additionally, they may use structure-function claims, which relate a nutrient or ingredient to a structure of function in the human body. The manufacturer bears the responsibility of documenting substantiation that these statements are truthful and not misleading. When these statements are made, the label must include the language "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease."
#5: Supplement Enforcement Issues
Where supplement manufacturers tend to get into trouble is when they suggest a product or ingredient can diagnose, prevent, mitigate, treat, or cure a specific disease. These statements suggest the supplement is actually a drug, which requires an entirely different and more rigorous set of approvals. This issue is a common reason FDA will issue warning letters to companies. To review warning letters issues, click here.
While in the U.S. dietary supplements are regulated as a category of foods, in Canada, what Health Canada calls “Natural Health Products” (NHPs) are treated as non-prescription drugs. This article provides an overview of how U.S. and Canada supplement regulations differ.