Daily Rules, Proposed Rules, and Notices of the Federal Government
FDA is announcing the availability of a draft guidance entitled “Guidance for Industry: Factors that Distinguish Liquid Dietary Supplements from Beverages, Considerations Regarding Novel Ingredients, and Labeling for Beverages and Other Conventional Foods.” The draft guidance is intended to assist dietary supplement and beverage manufacturers and distributors in reaching a determination as to whether a liquid product may be labeled and marketed as a dietary supplement. The draft guidance describes factors that manufacturers and distributors can use to identify liquid products that are excluded from being dietary supplements because they are represented as conventional foods. Further, the draft guidance reminds manufacturers and distributors of beverages and other conventional foods, particularly those that contain novel ingredients, about the requirements of the act regarding ingredients and labeling.
FDA is issuing this draft guidance as Level 1 guidance consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the agency's current thinking on the topics discussed. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternate approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.
Interested persons may submit to the Division of Dockets Management (see
Persons with access to the Internet may obtain the draft guidance at