561.404.4350 info@sriplaw.com

FDA_GRAS-150x150This article in Natural Products Insider contains an excellent discussion of FDA regulations regarding food additives that are Generally Recognized As Safe or GRAS. As the article notes, with the passage of DSHEA in 1994, dietary ingredients used in nutritional supplements no longer had to qualify as GRAS, but instead were regulated under a different regulatory scheme that I have described briefly in the Research Guide appended to this blog. Despite this, GRAS continues to be misunderstood, so this article is a welcome addition to the conversation.

Appended at the end of the article is a short piece entitled “Classification of Ingredients for Use in Dietary Supplements” by Anthony L. Young of Kleinfeld, Kaplan & Becker, respected food and drug attorneys in D.C. It is a thorough discussion in its own right. Unfortunately, NPI relegated the article to a footnote. 🙁


Joel B. Rothman represents clients in intellectual property infringement litigation involving patents, trademarks, copyrights, trade secrets, defamation, trade libel, unfair competition, unfair and deceptive trade practices, and commercial matters. Joel’s litigation practice also includes significant focus on electronic discovery issues such as e-discovery management and motion practice relating to e-discovery.