As those in the probiotic supplement industry know, business is booming. Likewise, dietary supplements in general have grown from 4,000 products just 25 years ago to about 80,000 today. These sheer numbers in addition to uncovered shenanigans—ginkgo-free gingko supplements in one example—has led the United States Food and Drug Administration (FDA) to announce strengthened regulation. […]
FDA
FDA Extends Comment Period for NDIs
The Food and Drug Administration (FDA) is extending the comment period for the revised draft guidance for industry entitled “Dietary Supplements: New Dietary Ingredient Notifications and Related Issues,” that appeared in the Federal Register of August 12, 2016. They are taking this action in response to requests to extend the comment period to allow interested […]
Regulation of Probiotics in the USA: Dietary Supplements
Regulation of Probiotics in the USA Part 2: Dietary Supplements The United States Food and Drug Administration’s (FDA) regulation of products containing probiotics is complex and largely depends on the claims that are made for the product. For example, they can be regulated as foods, dietary supplements, cosmetics, or drugs/biologics (a class of drugs which […]
Regulation of Probiotics in the USA: Food
Regulation of Probiotics in the USA Part 1: Food The United States Food and Drug Administration’s (FDA) regulation of products containing probiotics is complex and largely depends on the claims that are made for the product. For example, they can be regulated as foods, dietary supplements, cosmetics, or drugs/biologics. In this first of a four […]