1. Food Advisory Committee Meeting Risk assessments and susceptible life stages and populations December 16, 2014 Rachel Osterman Associate Chief Counsel, FDA Office of Chief Counsel

2.  Presentation: ◦ addresses food, dietary supplement, and cosmetic safety provisions that may be relevant to risk assessments ◦ does not address all circumstances under which foods, dietary supplements, and cosmetics may be adulterated

3.  Federal Food, Drug, and Cosmetic Act (FD&C Act) Provisions ◦ Section 402(a)(1) – food is adulterated  "if it bears or contains any poisonous or deleterious substance which may render it injurious to health;  but in case the substance is not an added substance such food shall not be considered adulterated under this clause if the quantity of such substance in such food does not ordinarily render it injurious to health" ◦ Two standards – one for "added," one for "non-added”

4.  Added -- May Render Injurious ◦ “Reasonable possibility of injury to consumer.” United States v. Anderson Seafoods, Inc., 622 F.2d 157 (5 th Cir. 1980) ◦ Encompasses protection of the health of vulnerable subpopulations

5.  FDA may set binding levels through notice-and- comment rulemaking.  FDA may issue non-binding guidance – so- called "action levels.”  FDA may take enforcement action against specific products that are adulterated within the meaning of section 402(a)(1).

6. Definition of “food additive.” Includes “any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food;” includes food contact substances;  Excludes substances that are “generally recognized by experts as safe” under their intended conditions of use (i.e., “GRAS” substances), pesticides, color additives and dietary supplement ingredients. [Section 201(s) of the FD&C Act] Premarket approval. Food additives are unsafe until determined by FDA by regulation to be safe for intended uses. Petition process for approval regulation. [Section 409 of the FD&C Act] Food contact substances. Food additives that also meet the definition of food contact substances may use a notification process instead of a petition process. Use of substance is lawful unless FDA objects within 120 days. [Section 409 of the FD&C Act]

7.  General Safety Standard: reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use [21 C.F.R. § 170.3(i)].  FDA must consider among other factors -probable consumption of the additive and of any substance formed in or on food because of the use of the additive -cumulative effect in the diet of man or animals, taking into account any chemically or pharmacologically related substance or substances in such diet -safety factors generally recognized by experts as appropriate for use of animal data [Section 409(c)(5) of the FD&C Act]

8.  No food additive shall be deemed safe if it is found to induce cancer when ingested by man or animals,  or if it is found, after tests which are appropriate for the evaluation of the safety of food additives, to induce cancer in man or animal [Section 409(c) of the FD&C Act]

9.  Definition: “a material which... when added or applied to a food, drug, or cosmetic, or to the human body or any part thereof, is capable... of imparting color...” [Section 201(t) of the FD&C Act]  No GRAS exception  General safety standard: convincing evidence that establishes with reasonable certainty that no harm will result from the intended use [21 CFR 70.3(i)]  Delaney Clause: similar to food additives; in addition, color additives not intended for ingestion are unsafe if, after appropriate tests, or after other relevant exposure of man or animal to such additive, it is found to induce cancer in man or animals [Section 721(b)(5)(B) of the FD&C Act]

10.  A dietary supplement is adulterated: ◦ if it presents a "significant or unreasonable risk of illness or injury" under the conditions of use recommended or suggested in the labeling, or if no conditions of use are suggested in the labeling, under ordinary conditions of use. [Section 402(f)(1)(A)] ◦ if it contains a new dietary ingredient for which there is inadequate information to provide reasonable assurance that the ingredient does not present a significant or unreasonable risk of illness or injury. [Section 402(f)(1)(B) of the FD&C Act.] ◦ if the Secretary of HHS declares that it poses an “imminent hazard” to public health or safety. [Section 402 (f)(1)(C) of the FD&C Act] ◦ if it contains a poisonous or deleterious substance that may render it injurious to health under conditions of use recommended or suggested in the labeling. [Section 402(f)(1)(D)]

11.  A cosmetic is adulterated if it bears or contains any poisonous or deleterious substances which may render it injurious to users under the conditions of use prescribed in the labeling thereof, or, under such conditions of use as are customary or usual (section 601(a) of the FD&C Act) * Coal-tar hair dye exemption