Understanding the GRAS Process Martin J. Hahn Hogan Lovells US LLP Date: July 16, 2013 Food and Agriculture Group

2 Overview The evolution of the statutory and regulatory framework for food ingredient authorizations What enforcement tools are available to FDA? It’s 2013, why are we having this discussion 55 years after Congress passed the food additive amendments?

3 How Did We Get Here? The Federal Food, Drug, and Cosmetic Act of 1938 and its multiple amendments have provided FDA with the necessary tools to ensure the safety of the food supply Prior to 1958, the law placed the burden of proof on FDA in demonstrating a food or food ingredient was “unsafe” The 1958 Food Additive Amendments changed the burden of proof and required the industry to demonstrate safety for food additives

4 Food Additive Amendments The Food Additive Amendments of 1958 amended the FFDCA and required FDA approval of food additives –Defined food additives broadly as including any substance that directly or indirectly becomes a component of food –Required premarket approval and regulations for food additives –Exempted Generally Recognized as Safe (GRAS) ingredients from the food additive definition GRAS on basis of scientific procedures GRAS on basis of common use in foods prior to 1958 Food additives only can be marketed when FDA issues a food additive regulation GRAS ingredients lawfully may be marketed without any FDA review or premarket authorization

The Food Additive—GRAS Distinction Provides Needed Flexibility The food additive definition is so broad that it encompasses essentially every component added to food, including staples such as flour, vegetable oils, fruits, vegetables, spices, salt, pepper, vinegar, baking powder, baking soda, yeasts, and many other ingredients commonly found in pantries Should FDA review and authorize each of those ingredients? The “GRAS exemption” provided needed balance and flexibility 5

Robust Safety Standard for Food Additives Legislative History –“The concept of safety used in this legislation involves the question of whether a substance is hazardous to the health of man or animal. Safety requires proof of a reasonable certainty that no harm will result from the proposed use of an additive.” –“It does not—and cannot— require proof beyond any possible doubt that no harm will result under any conceivable circumstance.” H.R. Report No. 2284, 85 th Congress

7 Reasonable Certainty of No Harm Regulatory definition of “safe” or “safety” “there is a reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use. It is impossible in the present state of scientific knowledge to establish with complete certainty the absolute harmlessness of the use of any substance. Safety may be determined by scientific procedures or by general recognition of safety.” 21 CFR 170.3(i)

Publication: Creates and Added Burden for GRAS Ingredients Same safety standard applies to food additives and GRAS ingredients on the basis of scientific procedures (21 CFR (b)) The primary studies for GRAS ingredients, however, must be published In the absence of publication, the FDA position is clear: the ingredient cannot be GRAS 8

To File or Not to File? FDA review of GRAS Ingredients –Prior to 1997, companies could submit a petition seeking a regulation affirming the GRAS status (took 2-25 years) –In 1997, FDA replaced the GRAS affirmation program with a notification –While FDA never finalized the regulation, it has been accepting GRAS notification Self-GRAS –As a matter of law, a GRAS ingredient does not require FDA review –Companies routinely will review data and market products on basis of self- affirmation of GRAS status –No requirement to have any particular written documentation in files 9

Self-GRAS Self-GRAS provides needed flexibility Self-GRAS places the burden on the company to make certain sufficient data are available If FDA disagrees and concludes the ingredient is an unapproved food additive, every food made with that “unapproved food additive” is adulterated 10

Enforcement Powers FDA has the tools to monitor and confirm compliance Ingredient statements disclose presence of food ingredients As part of factory inspections, FDA can see list of food ingredients entering the facility 11

Enforcement Powers FDA has numerous tools to effectuate change –Press Conferences –Press Releases –Letters to Industry –483 Inspectional Observations –Warning Letters –Untitled Letters –FDA Consumer Magazine –Website FDA had a concern with the increasing number of conventional foods containing botanical ingredients with limited history of use in food, in January 2001, FDA sent a “Letter to Manufacturers” 12

The System is “Dynamic” The system is sufficiently flexible to accommodate changes in science If new credible studies question safety, GRAS or food additive status would be jeopardized As new science evolves regarding potential contaminants, specifications can, and are, modified (e.g., heavy metals) 13

Today’s System: Safety-based Has a robust “reasonable certainty of no harm” safety standard (except for dietary ingredients in dietary supplements) Can and does reflect the most current (credible) science Resource respectful Transparency in agency decisions in notifications and regulations 14

Why the New Focus on GRAS “Navigating the U.S. Food Additive Regulatory Program” (October 2011) –“Manufacturers and food trade associations made the remaining decisions [34%] without FDA review by concluding that the substances are generally recognized as safe” 15

Caffeine????? Proliferation of caffeine in food products January 2013: FDA begins “talking” to companies marketing caffeine in energy drinks, drink enhancers, gum, and other products 16

New Realities GRAS system is under attack Statutory changes likely would be needed to change the system While the politics in Washington are very challenging, it is difficult to predict if an issue will gain momentum Industry is exploring several options for further increasing transparency 17

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