FDA publishes guidance to clearly define parameters for classifying liquid dietary supplements from beverages. Guidance is designed to assist industry with dietary supplement compliance and conventional food compliance.
In January 2014, the FDA published two guidance documents entitled “Distinguishing Liquid Dietary Supplements from Beverages” and “Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements” to help dietary supplement and beverage manufacturers determine whether a liquid food product is properly classified as a dietary supplement or conventional food. Correct product classification will aid the industry with dietary supplement compliance.
The guidance document entitled “Distinguishing Liquid Dietary Supplements from Beverages” describes the various factors that must be taken into consideration to properly characterize liquid products that are dietary supplements from those liquid products that are considered beverages (which are classified under conventional foods). Such factors include:
The guidance document entitled “Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements” has been issued as a reminder to industry of the requirements in the Federal Food, Drug, and Cosmetic Act that apply to substances that are added to both conventional foods, such as beverages, and to dietary supplements. Clarity is provided regarding the regulatory status of an ingredient that is classified as a dietary ingredient, non-dietary ingredient, or conventional food.
In both guidance documents the FDA reminds industry that adding a dietary ingredient to a liquid does not necessarily make it a dietary supplement nor does presenting a dietary supplement as a conventional food in terms of packaging and claims make it a conventional food. Also when adding non-dietary ingredients to a dietary supplement or conventional foods, manufacturers should ensure that the ingredient meets the regulatory status for GRAS or approved food additive use.
It is important to note that liquid beverages or dietary supplements must be evaluated as a whole in terms of composition, public perceptions, and applicable regulatory status of ingredients to ensure dietary supplement compliance. Mislabelling a conventional food as a dietary supplement or vice-versa due to incorrect classification will still be considered an adulterated misbranded product subject to a FDA warning letter.
Although the FDA outlines very clearly their current thinking on classification of a liquid beverage and liquid dietary supplement in the guidance documents, the guidance documents are not legally enforceable other than specific regulations that are cited in the guidance documents. This means it is still up to the manufacturer/distributor of their product is correctly classified and in compliance with the appropriate regulations.
Dicentra offers can assist you with both dietary supplement compliance by conducting product classification, formulation reviews, and label reviews including nutrition facts and supplement facts creation. We specialize in the areas of natural health products, dietary supplements, foods, cosmetics and OTCs. We can be reached at 1-866-647-3279 or firstname.lastname@example.org