The Food and Drug Administration (FDA) regulates a variety of product categories from infant and toddler foods to snacks to vegetables and meats. One category that falls within the food regulations umbrella is dietary supplements. Dietary supplements are defined to have an intention to add or supplement the diet and are different from conventional foods [1]. Common supplements are vitamins, minerals, botanicals/herbs, botanical compounds, amino acids, and live microbials [1].
Dietary supplements are not regulated as drugs, even though many of them can have strong biological effects which can have an impact on a medical condition or a conflict with a medication [2]. This is why there are a variety of regulations that govern the labeling claims of dietary supplements. There are five main types of claims; (1) FDA Modernization Act of 1997 (FDMA) Health and Nutrient Content Claims, (2) Health Claims That Meet Significant Scientific Agreement (SSA), (3) Qualified Health Claims, (4) Nutrient Content Claims, (5) and Structure / Function Claims for Dietary Supplements and Conventional Foods [3].
FDMA claims are based on an authoritative statement from scientific and governmental entities (National Academy of Science, bodies of the U.S. Government, etc.). These claims can be utilized after 120 days of submitting a health claim notification to the FDA. Authorized health claims are supported with scientific evidence and reviewed by the FDA. There must be significant scientific agreement (SSA) among experts for the FDA to allow the claim onto a dietary supplement. Qualified health claims are supported by scientific evidence but do not hold up to the SSA standard. The FDA does not approve these types of claims and will issue an enforcement discretion for use of the claim in letter form to the manufacturer. FDA permits the usage of claims that characterize the level of nutrients in food and supplements if they have been authorized by the FDA. Structure / Function claims must be submitted to the FDA no later than 30 days after marketing the product. This type of claim is most common in dietary supplements as it requires the labeler to have a disclaimer that the FDA has not evaluated their claims. Many of these claims are very general as they aim to describe the role of a nutrient or ingredient intended to affect the human body’s’ normal structure or function.
Understanding the regulatory pathways of the FDA can be quite difficult, especially for dietary supplements. If you want to market a dietary supplement or food product that is FDA compliant, the team of experts at EMMA International can help! Contact us today at info@emmainternational.com or by calling 248-987-4497.
Resources:
[1] FDA. (2022, June 02). FDA 101: Dietary Supplements. U.S. Food and Drug Administration. https://www.fda.gov/consumers/consumer-updates/fda-101-dietary-supplements
[2] FDA. (2021, December 21). Dietary Supplements. U.S. Food and Drug Administration. https://www.fda.gov/consumers/consumer-updates/dietary-supplements#:~:text=Dietary%20supplements%20are%20regulated%20by,medical%20condition%20you%20may%20have.
[3] FDA. (2022, March 07). Label Claims for Conventional Foods and Dietary Supplements. U.S. Food and Drug Administration. https://www.fda.gov/food/food-labeling-nutrition/label-claims-conventional-foods-and-dietary-supplements
