Text of S. 510: FDA Food Safety Modernization Act Read The Bill: S. 510 - GovTrack.us SEC. 113. NEW DIETARY INGREDIENTS. (a) In General- Section 413 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350b) is amended-- (1) by redesignating subsection (c) as subsection (d); and (2) by inserting after subsection (b) the following: ‘(c) Notification- ‘(1) IN GENERAL- If the Secretary determines that the information in a new dietary ingredient notification submitted under this section for an article purported to be a new dietary ingredient is inadequate to establish that a dietary supplement containing such article will reasonably be expected to be safe because the article may be, or may contain, an anabolic steroid or an analogue of an anabolic steroid, the Secretary shall notify the Drug Enforcement Administration of such determination. Such notification by the Secretary shall include, at a minimum, the name of the dietary supplement or article, the name of the person or persons who marketed the product or made the submission of information regarding the article to the Secretary under this section, and any contact information for such person or persons that the Secretary has. ‘(2) DEFINITIONS- For purposes of this subsection-- ‘(A) the term ‘anabolic steroid’ has the meaning given such term in section 102(41) of the Controlled Substances Act; and ‘(B) the term ‘analogue of an anabolic steroid’ means a substance whose chemical structure is substantially similar to the chemical structure of an anabolic steroid.’. (b) Guidance- Not later than 180 days after the date of enactment of this Act, the Secretary shall publish guidance that clarifies when a dietary supplement ingredient is a new dietary ingredient, when the manufacturer or distributor of a dietary ingredient or dietary supplement should provide the Secretary with information as described in section 413(a)(2) of the Federal Food, Drug, and Cosmetic Act, the evidence needed to document the safety of new dietary ingredients, and appropriate methods for establishing the identify of a new dietary ingredient.