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FDA’s GRAS Review Process for Foods May Be Tested by Litigious Public Interest Group

By Bruce Silverglade and Mark L. Itzkoff

As reported in Politico this week, there has been a shake-up of sorts within the public interest advocacy community regarding the tactics used to pressure the Food and Drug Administration (FDA) into changing the way food ingredients deemed to be Generally Recognized as Safe (GRAS) are regulated or reviewed by FDA.  This development may have major implications for food companies who conduct self-determinations on the GRAS status of new ingredients and for companies who submit formal GRAS notifications to the agency.

For the last several years, policy controversies surrounding the FDA’s GRAS process have been a focus of the Pew Charitable Trusts which assigned two researchers to draft reports critical of the current process.  An essential pillar of the current law has been that a food company can self-affirm a substance as GRAS.  FDA approval or even notification is not needed.   Pew’s most recent report, published in the Journal of the American Medical Association,  found “ubiquitous” conflicts of interest in such GRAS determinations.  Pew researchers reviewed 451 GRAS notifications that companies voluntarily submitted to FDA between 1997 and 2012, and found that nearly two-thirds of those safety assessments were made by an expert panel selected by the manufacturer or a consulting firm.  About a fifth of those assessments were made by an employee of an additive manufacturer, according to Pew.

As we noted in an earlier post on this blog, the most recent Pew report suffers from major infirmities.  The authors of the Pew report do not take into account the fact that the safety evaluation in a GRAS determination must be based on peer-reviewed data that has been published in scientific journals.  In the blog post, we noted that before an article is published it is reviewed by independent experts in the same field.  When an article reports on scientific studies, such as toxicology studies, the experts review the study methodology, test data, and validity of any conclusions reached in the article.  Thus, contrary to Pew, the data used to support a GRAS determination is subject to independent review before it is even considered by the expert panel.

Nonetheless, the Pew researchers have now sought a new base to advocate for policy changes to the GRAS process.  The researchers left Pew and moved to the more aggressive Natural Resources Defense Council (NRDC).  This tussle within the public interest community may be of more than just passing interest.  Pew is known for its cooperative consensus building approach to working with the food industry and regulatory agencies.  NRDC doesn’t play that game.  Instead, it is known for using tactics ranging from bringing Hollywood celebrities to Washington, D.C. to lobby on Capitol Hill to running an aggressive public interest litigation project.  NRDC’s director of health programs, Linda Greer, Ph.D. an environmental scientist, says NRDC will focus on “whatever works” to strengthen food additive oversight.  This could include a mix of litigation and lobbying Congress.

NRDC’s litigation program is well known among the Bar; the group has brought dozens of precedent setting cases in the environmental protection area.  One case recently forced FDA action on the use of antibiotics in animal feed.  Dr. Greer, however, ought to re-familiarize herself with one of NRDC’s most famous Supreme Court cases, Chevron U.S.A. v. Natural Resources Defense Council.  That case set the Supreme Court’s legal test for determining whether to grant deference to a government agency’s interpretation of its own operating statute. Chevron is the Supreme Court’s clearest articulation of the legal principle “administrative deference,” i.e., the doctrine that requires courts reviewing an agency’s regulatory policies to defer to the agency’s own interpretations of it’s statutory authority even in situations where the intent of Congress is ambiguous, 104 S. Ct. 2781.

The GRAS Exemption is set forth in Section 201(s) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 USC §321(s).  It was included in the statutory definition of “food additive” that was enacted in the 1958 Food Additives Amendment to FFDCA.  At that time, Congress recognized that some food ingredients would not require FDA pre-market clearance because their safety had been established by either previous use in food or information readily available to scientists.  See FDA, Substances Generally Recognized as Safe, 62 Fed. Reg. 18938, 939 (April 17, 1997).  NRDC may choose to argue in federal court that FDA has misinterpreted the portion of FDCA that establishes the GRAS exemption, or they may challenge individual GRAS determinations on an ingredient by ingredient basis.  However, given the Supreme Court’s decision in Chevron, the group might be advised to focus on bringing celebrities to Capitol Hill and hoping for the best.

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