What You Need to Know about Dietary Supplement Health Claims
In 2023, the US dietary supplement market was sized at $68.2 billion, and many of those dietary supplements are sold online via e-commerce marketplaces. While the market continues to grow — the number of consumers shopping online is steadily rising year over year. Read further to better understand what is a permissible and non-permissible health claim for a dietary supplement. Then contact us for a quick strategy session.
What Are the Laws Surrounding Dietary Supplement Health Claims?
In 1990, The Federal Food, Drug, and Cosmetic Act (FDCA) was amended by The Nutrition Labeling and Education Act (NLEA). The NLEA authorized the Food and Drug Administration (FDA) to “issue regulations authorizing health claims (i.e., labeling claims that characterize the relationship of a substance to a disease or health-related condition)” for conventional foods.
In 1994, The Dietary Supplement Health and Education Act (DSHEA) amended the FDCA again to put regulatory requirements in place for the health claims dietary supplements can make.
The act included procedures for:
- Structure/function claims
- Claims of general well-being
- And claims related to nutrient deficiency
Now, the FDA is seeking to modernize DSHEA again. According to the Summary of FY 2024 Legislative Proposals the FDA proposes the act should “(1) require all dietary supplements to be listed with FDA, with information to include product label and other basic information; and (2) clarify FDA’s authorities over products marketed as dietary supplements. These amendments would help FDA to know when new products are introduced and quickly identify dangerous or illegal products on the market to take appropriate action to protect consumers when necessary.”
How Does the FDCA Define Health Claims?
FDA regulations currently define a health claim as, “any claim made on the label or in labeling of a food, including a dietary supplement, that expressly or by implication … characterizes the relationship of any substance to a disease or health-related condition.”
DSHEA defines each dietary supplement health claim as follows.
Structure/function claims “may describe the role of a nutrient or dietary ingredient intended to affect the normal structure or function of the human body, for example, ‘calcium builds strong bones.’”
General well-being claims “describe general well-being from consumption of a nutrient or dietary ingredient.”
Nutrient deficiency disease “claims describe a benefit related to a nutrient deficiency disease (like vitamin C and scurvy), but such claims are allowed only if they also say how widespread such a disease is in the United States.”
Supplement Sellers Cannot Make These Disease or Structure/Function Claims
A supplement cannot be marketed with express or implied claims to cure, mitigate, prevent, or treat a disease. Additionally, they cannot be marketed with claims that suggest the supplement affects the structure or function of the body without adequate substantiation. Products making these claims are regulated as drugs under the FDCA.
Disease claims refer to statements that describe a supplement as having an effect on a specific disease or class of diseases. They can also include statements that mention identifiable characteristic signs or symptoms of a disease, leading to the inference that the product treats or prevents the disease. Additionally, claims that assert a supplement can be a substitute for a therapy for a disease or can augment a therapy or drug intended to diagnose, mitigate, treat, cure, or prevent a disease are also considered disease claims.
Examples of Disease Claims:
- "Treats all forms of cancer"
- "Miraculously kills cancer cells"
- "Shrinks malignant tumors"
- "More effective than chemotherapy"
- "Selectively kills cancer cells"
- "Treats varicose veins"
Structure/function claims describe the intended role of a nutrient or dietary ingredient in affecting the structure or function of the body in humans. These claims characterize the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function. Structure/function claims are permissible as long as they are adequately substantiated.
Examples of Structure/Function Claims:
- "Burns and blocks fat"
- "Reduces hair loss"
- "Breast enlargement supplement"
It is crucial for supplement sellers to avoid making explicit or implied disease or unsubstantiated structure/function claims in their supplement advertising, as it can lead to heightened regulatory scrutiny or enforcement.
LegitScript Marketplace Monitoring Helps Marketplaces Avoid FDA Warning Letters
Are you an e-commerce marketplace who’s received a warning letter from the FDA for selling dietary supplements that made non-permissible health claims? Marketplace Monitoring helps you reduce the risk of problematic listings by monitoring your marketplace using the largest database of high-risk and problematic products on the commercial internet. Confidently grow your business into new product categories and jurisdictions while eliminating false positives with LegitScript Marketplace Monitoring.
Contact us for a quick strategy session.